Pain Experience and Image Quality with Curved versus Standard Compression for Breast Cancer Screening Mammography: A Randomized Controlled Trial.

Background A curve-shaped compression paddle could reduce the pain experienced by some women at breast cancer screening. Purpose To compare curved and standard compression systems in terms of pain experience and image quality in mammography screening. Materials and Methods In this randomized controlled trial conducted between October 2021 and February 2022, participants screened at three screening sites in the Netherlands were randomized to either a curved-paddle or sham-paddle group. The sham paddle was a standard paddle that was presented as a new paddle. At a standard screening examination, one additional image was acquired with a curved or sham paddle. Pain was measured on a numerical rating scale (range, 0-10). Participants provided a pain score after compression with the standard and test paddles, resulting in two scores per participant. Differences in pain scores were compared between groups using analysis of covariance, adjusting for pain score after standard-paddle compression. Two radiographers and two radiologists performed unblinded paired comparisons of curved-paddle vs standard-paddle images, using standard image quality criteria (radiographers evaluated 1246 image pairs using 12 criteria; radiologists evaluated 320 image pairs using six criteria). The one-sample Wilcoxon signed-rank test was used to determine if there was a significant preference for either paddle. Results In total, 2499 female participants (mean age, 61.6 years ± 7.1 [SD]) were studied; 1250 in the curved-paddle group and 1249 in the sham-paddle group. The mean pain score decreased by an additional 0.19 points in the curved-paddle group compared with the sham-paddle group (95% CI: 0.09, 0.28; P < .001). In terms of image quality, the observers showed no preference or a preference for the standard paddle. Decreased image contrast (range Bonferroni-corrected P values: P < .001 to P > .99) and visibility of structures were the main concerns for curved-paddle images. Conclusion The use of the curved paddle resulted in a minimal pain reduction during mammography breast compression but image quality was reduced. © RSNA, 2024 Supplemental material is available for this article.

Probiotic and high-fat diet: effects on pain assessment, body composition, and cytokines in male and female adolescent and adult rats.

Obesity in adolescence is increasing in frequency and is associated with elevated proinflammatory cytokines and chronic pain in a sex-dependent manner. Dietary probiotics may mitigate these detrimental effects of obesity. Using a Long-Evans adolescent and adult rat model of overweight (high-fat diet (HFD) - 45% kcal from fat from weaning), we determined the effect of a single-strain dietary probiotic [Lactiplantibacillus plantarum 299v (Lp299v) from weaning] on the theoretically increased neuropathic injury-induced pain phenotype and inflammatory cytokines. We found that although HFD increased fat mass, it did not markedly affect pain phenotype, particularly in adolescence, but there were subtle differences in pain in adult male versus female rats. The combination of HFD and Lp299v augmented the increase in leptin in adolescent females. There were many noninteracting main effects of age, diet, and probiotic on an array of cytokines and adipokines with adults being higher than adolescents, HFD higher than the control diet, and a decrease with probiotic compared with placebo. Of particular interest were the probiotic-induced increases in IL12p70 in female adolescents on an HFD. We conclude that a more striking pain phenotype could require a higher and longer duration caloric diet or a different etiology of pain. A major strength of our study was that a single-strain probiotic had a wide range of inhibiting effects on most proinflammatory cytokines. The positive effect of the probiotic on leptin in female adolescent rats is intriguing and worthy of exploration.NEW & NOTEWORTHY A single-strain probiotic (Lp299v) had a wide range of inhibiting effects on most proinflammatory cytokines (especially IL12p70) measured in this high-fat diet rat model of mild obesity. The positive effect of probiotic on leptin in female adolescent rats is intriguing and worthy of exploration.

A Four-Arm Randomized Clinical Trial of Topical Pain Control for Sentinel Node Radiotracer Injections in Patients with Breast Cancer.

BACKGROUND: Radioactive tracer injections for breast cancer sentinel lymph node mapping can be painful. In this randomized trial, we compared four approaches to topical pain control for radiotracer injections. METHODS: Breast cancer patients were randomized (9 April 2021-8 May 2022) to receive the institutional standard of ice prior to injection (n = 44), or one of three treatments: ice plus a vibrating distraction device (Buzzy®; n = 39), 4% lidocaine patch (n = 44), or 4% lidocaine patch plus ice plus Buzzy® (n = 40). Patients completed the Wong-Baker FACES® pain score (primary outcome) and a satisfaction with pain control received scale (secondary). Nuclear medicine technologists (n = 8) rated perceived pain control and ease of administration for each patient. At study conclusion, technologists rank-ordered treatments. Data were analyzed as intention-to-treat. Wilcoxon rank-sum tests were used to compare pain scores of control versus pooled treatment arms (primary) and then control to each treatment arm individually (secondary). RESULTS: There were no differences in pain scores between the control and treatment groups, both pooled and individually. Eighty-five percent of patients were 'satisfied/very satisfied' with treatment received, with no differences between groups. No differences in providers' perceptions of pain were observed, although providers perceived treatments involving Buzzy© more difficult to administer (p < 0.001). Providers rated lidocaine patch as the easiest, with ice being second. CONCLUSION: In this randomized trial, no differences in patient-reported pain or satisfaction with treatment was observed between ice and other topical treatments. Providers found treatments using Buzzy® more difficult to administer. Given patient satisfaction and ease of administration, ice is a reasonable standard.

Comparison of trace image colors for kids-book with two active distractions in reducing pain and fear of children during the venipuncture procedure.

This study investigated the effectiveness of trace image and coloring for kids-book (TICK-B), cough trick, and balloon inflation techniques in reducing pain and fear in children during venipuncture. The current study is a prospective, controlled, and randomized trial (RCT). School-aged children who required venipuncture were involved in the study. Pediatric patients were randomly assigned to four groups: the TICK-B group, the cough trick group, the inflation of balloons, and the control groups. Before and after the procedure, the children and their parents were interviewed. Wong-Baker (FACES) Pain Rating Scale was applied to measure the severity of pain. Children's Fear Scale was applied to measure children's fear. This study involved the 160 children (mean age, 8.39-2.18 years). The severity of pain and fear levels among the children during and after the procedure were significantly different (p = 0.001). Pain and fear were significantly decreased in children in the intervention groups compared with those in the control group (p < 0.05). In the TICK-B group, participants reported significantly less pain and fear during the venipuncture procedure than in the cough trick, balloon inflation, and control groups (P = 0.001, p = 0.001, p = 0.001) and after the procedure (p = 0.001, p = 0.002, p = 0.002). There was a similar significance found in the level of fear during the procedure (p = 0.001, p = 0.002, p = 0.006), and after the procedure (p = 0.001, p = 0.008, p = 0.015).    Conclusion: TICK-B was the most effective method for decreasing the pain and fear of children associated with venipuncture procedures. Furthermore, the distraction technique of coughing and inflating balloons also proved efficacious in decreasing the pain and fear of children during venipuncture.    Trial registration: The study has been registered with ClinicalTrials.org under the number NCT04983303. It was retrospectively registered on July 26, 2021. What is Known: • Venipuncture, one of the most painful and uncomfortable procedures for children, caused great fear and discomfort during the procedure. What is New: • The TICK-B technique, music listening, and cartoon watching techniques are effective, simple, and safe ways to reduce children's fear and pain. These interventions provide a good way for children and their parents to collaborate during painful medical procedures. • No studies have compared the impact of TICK-B during venipuncture.

Non-pharmacological interventions for the prevention of pain during endotracheal suctioning in ventilated neonates.

BACKGROUND: Pain, when treated inadequately, puts preterm infants at a greater risk of developing clinical and behavioural sequelae because of their immature pain system. Preterm infants in need of intensive care are repeatedly and persistently exposed to noxious stimuli, and this happens during a critical window of their brain development with peak rates of brain growth, exuberant synaptogenesis and the developmental regulation of specific receptor populations. Nearly two-thirds of infants born at less than 29 weeks' gestation require mechanical ventilation for some duration during the newborn period. These neonates are endotracheally intubated and require repeated endotracheal suctioning. Endotracheal suctioning is identified as one of the most frequent and most painful procedures in premature infants, causing moderate to severe pain. Even with improved nursing performance and standard procedures based on neonatal needs, endotracheal suctioning remains associated with mild pain. OBJECTIVES: To evaluate the benefits and harms of non-pharmacological interventions for the prevention of pain during endotracheal suctioning in mechanically ventilated neonates. Non-pharmacological interventions were compared to no intervention, standard care or another non-pharmacological intervention. SEARCH METHODS: We conducted searches in June 2023 in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via PubMed, Embase, CINAHL and three trial registries. We searched the reference lists of related systematic reviews, and of studies selected for inclusion. SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs and cluster-RCTs that included term and preterm neonates who were mechanically ventilated via endotracheal tube or via tracheostomy tube and required endotracheal suctioning performed by doctors, nurses, physiotherapists or other healthcare professionals. DATA COLLECTION AND ANALYSIS: Our main outcome measures were validated composite pain scores (including a combination of behavioural, physiological and contextual indicators). Secondary outcomes included separate physiological and behavioural pain indicators. We used standard methodological procedures expected by Cochrane. For continuous outcome measures, we used a fixed-effect model and reported mean differences (MDs) with 95% confidence intervals (CIs). For categorical outcomes, we reported the typical risk ratio (RR) and risk difference (RD) and 95% CIs. We assessed risk of bias using the Cochrane RoB 1 tool, and assessed the certainty of the evidence using GRADE. MAIN RESULTS: We included eight RCTs (nine reports), which enroled 386 infants, in our review. Five of the eight studies were included in a meta-analysis. All studies enrolled preterm neonates. Facilitated tucking versus standard care (four studies) Facilitated tucking probably reduces Premature Infant Pain Profile (PIPP) score during endotracheal suctioning (MD -2.76, 95% CI 3.57 to 1.96; I² = 82%; 4 studies, 148 infants; moderate-certainty evidence). Facilitated tucking probably has little or no effect during endotracheal suctioning on: heart rate (MD -3.06 beats per minute (bpm), 95% CI -9.33 to 3.21; I² = 0%; 2 studies, 80 infants; low-certainty evidence); oxygen saturation (MD 0.87, 95% CI -1.33 to 3.08; I² = 0%; 2 studies, 80 infants; low-certainty evidence); or stress and defensive behaviours (SDB) (MD -1.20, 95% CI -3.47 to 1.07; 1 study, 20 infants; low-certainty evidence). Facilitated tucking may result in a slight increase in self-regulatory behaviours (SRB) during endotracheal suctioning (MD 0.90, 95% CI 0.20 to 1.60; 1 study, 20 infants; low-certainty evidence). No studies reported intraventricular haemorrhage (IVH). Familiar odour versus standard care (one study) Familiar odour during endotracheal suctioning probably has little or no effect on: PIPP score (MD -0.30, 95% CI -2.15 to 1.55; 1 study, 40 infants; low-certainty evidence); heart rate (MD -6.30 bpm, 95% CI -16.04 to 3.44; 1 study, 40 infants; low-certainty evidence); or oxygen saturation during endotracheal suctioning (MD -0.80, 95% CI -4.82 to 3.22; 1 study, 40 infants; low-certainty evidence). No studies reported SRB, SDB or IVH. White noise (one study) White noise during endotracheal suctioning probably has little or no effect on PIPP (MD -0.65, 95% CI -2.51 to 1.21; 1 study, 40 infants; low-certainty evidence); heart rate (MD -1.85 bpm, 95% CI -11.46 to 7.76; 1 study, 40 infants; low-certainty evidence); or oxygen saturation (MD 2.25, 95% CI -2.03 to 6.53; 1 study, 40 infants; low-certainty evidence). No studies reported SRB, SDB or IVH. AUTHORS' CONCLUSIONS: Facilitated tucking / four-handed care / gentle human touch probably reduces PIPP score. The evidence of a single study suggests that facilitated tucking / four-handed care / gentle human touch slightly increases self-regulatory and approach behaviours during endotracheal suctioning. Based on a single study, familiar odour and white noise have little or no effect on any of the outcomes compared to no intervention. The use of expressed breast milk or oral sucrose suggests that there is no discernible advantage of one method over the other for reducing pain during endotracheal suctioning. None of the studies reported on any of the prespecified secondary outcomes of adverse events.

Initial arch wires used in orthodontic treatment with fixed appliances.

BACKGROUND: Initial arch wires are the first arch wires inserted into fixed appliance at the beginning of orthodontic treatment. With a number of different types of orthodontic arch wires available for initial tooth alignment, it is important to understand which are most efficient and which cause the least amount of root resorption and pain during the initial aligning stage of treatment. This is the third update of a Cochrane review first published in 2010. OBJECTIVES: To assess the effects of initial arch wires for the alignment of teeth with fixed orthodontic braces, in terms of the rate of tooth alignment, amount of root resorption accompanying tooth movement, and intensity of pain experienced by patients during the initial alignment stage of treatment. SEARCH METHODS: We searched Cochrane Oral Health's Trials Register, CENTRAL, MEDLINE, Embase, and two ongoing trials registries on 4 July 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of different initial arch wires used to align teeth with fixed orthodontic braces. We included people with full-arch fixed orthodontic appliances on the upper arch, lower arch, or both arches. DATA COLLECTION AND ANALYSIS: Two independent review authors were responsible for study selection, data extraction, and assessment of risk of bias in included studies. We contacted corresponding authors of included studies to obtain missing information. We resolved disagreements by discussion between the review authors. Our main outcomes were alignment rate (movement of teeth in mm), root resorption, time to alignment, and intensity of pain measured on a 100-mm visual analogue scale (VAS). We pooled data from studies with similar interventions and outcomes using random-effects models. We reported mean differences (MDs) with 95% confidence intervals (CIs) for continuous data, risk ratios (RRs) with 95% CIs for dichotomous data, and alignment rate ratios with 95% CIs for time-to-event data. Two independent review authors assessed the certainty of evidence. We resolved disagreements by discussion between the review authors. MAIN RESULTS: We included 29 RCTs with 1915 participants (2581 arches) in this review. Studies were generally small (sample sizes ranged from 14 to 200 participants). Duration of follow-up varied between three days and six months. Eleven studies received funding, six received no funding, and 12 provided no information about funding sources. We judged eight studies at high risk of bias, nine at low risk, and 12 at unclear risk. We grouped the studies into six main comparisons. Multistrand stainless steel wires versus wires composed of other materials Six studies with 409 participants (545 arches) evaluated multistrand stainless steel (StSt) wires versus wires composed of other materials. We are very uncertain about the effect of multistrand StSt wires versus other wires on alignment rate (4 studies, 281 participants, 417 arches; very low-certainty evidence). There may be little to no difference between multistrand StSt wires and other wires in terms of intensity of pain (MD -2.68 mm, 95% CI -6.75 to 1.38; 2 studies, 127 participants, 127 arches; low-certainty evidence). Conventional nickel-titanium wires versus superelastic nickel-titanium wires Four studies with 266 participants (274 arches) evaluated conventional nickel-titanium (NiTi) wires versus superelastic NiTi wires. There may be little to no difference between the different wire types in terms of alignment rate (124 participants, 124 arches, 2 studies; low-certainty evidence) and intensity of pain (MD -0.29 mm, 95% CI -1.10 to 0.52; 2 studies, 142 participants, 150 arches; low-certainty evidence). Conventional nickel-titanium wires versus thermoelastic copper-nickel-titanium wires Three studies with 210 participants (210 arches) evaluated conventional Ni-Ti versus thermoelastic copper-nickel-titanium (CuNiTi) wires. We are very uncertain about the effects of the different arch wires on alignment rate (1 study, 66 participants, 66 arches; very low-certainty evidence). There may be little to no difference between conventional NiTi wires and thermoelastic CuNiTi wires in terms of time to alignment (alignment rate ratio 1.30, 95% CI 0.68 to 2.50; 1 study, 60 participants, 60 arches; low-certainty evidence). Superelastic nickel-titanium wires versus thermoelastic nickel-titanium wires Twelve studies with 703 participants (936 arches) evaluated superelastic NiTi versus thermoelastic NiTi wires. There may be little to no difference between superelastic NiTi wires and thermoelastic NiTi wires in alignment rate at four weeks (MD -0.28 mm, 95% CI 0.62 to 0.06; 5 studies, 183 participants, 183 arches; low-certainty evidence). We are very uncertain about the effects of the different wires on root resorption (2 studies, 52 participants, 312 teeth; very low-certainty evidence). Superelastic NiTi wires compared with thermoelastic NiTi wires may result in a slight increase in time to alignment (MD 0.5 months, 95% CI 0.21 to 0.79; 1 study, 32 participants, 32 arches; low-certainty evidence) but are probably associated with a slight increase in intensity of pain (MD 6.96 mm, 95% CI 1.82 to 12.10; 3 studies, 94 participants, 138 arches, moderate-certainty evidence). Single-strand superelastic nickel-titanium wires versus coaxial superelastic nickel-titanium wires Three studies with 104 participants (104 arches) evaluated single-strand superelastic NiTi versus coaxial superelastic NiTi wires. Use of single-strand superelastic NiTi wires compared with coaxial superelastic NiTi wires probably results in a slight reduction in alignment rate at four weeks (MD -2.64 mm, 95% CI -4.61 to -0.67; 2 studies, 64 participants, 64 arches, moderate-certainty evidence). Different sizes of nickel-titanium wires Two studies with 149 participants (232 arches) compared different types of NiTi wires. There may be little to no difference between different sizes of NiTi wires in terms of pain (low-certainty evidence). AUTHORS' CONCLUSIONS: Superelastic NiTi wires probably produce slightly more pain after one day than thermoelastic NiTi wires, and single-strand superelastic NiTi wires probably have a lower alignment rate over four weeks compared with coaxial superelastic NiTi wires. All other evidence on alignment rate, root resorption, time to alignment, and pain is of low or very low certainty in all comparisons. Therefore, there is insufficient evidence to determine whether any particular arch wire material or size is superior to any other. The findings of this review are imprecise and unreliable; well-designed larger studies are needed to give better estimates of the benefits and harms of different arch wires. Orthodontists should exercise caution when interpreting the findings of this review and be prepared to adapt their treatment plans based on individual patient needs.

Assessing the Acceptability and Effectiveness of a Novel Therapeutic Footwear in Reducing Foot Pain and Improving Function among Older Adults: A Crossover Randomized Controlled Trial.

INTRODUCTION: Nearly, a quarter of older adults suffer from frequent foot pain, impacting their quality of life. While proper footwear can alleviate this, design issues often hinder regular use. This study evaluated novel therapeutic footwear, designed for aesthetics and custom fit, to reduce foot pain. We hypothesized that older adults would experience less foot pain and favor the new footwear over their own. METHODS: This 12-week crossover randomized controlled trial evaluated the effectiveness of OrthoFeet therapeutic footwear on reducing foot pain in older adults (n = 50, age = 65 ± 5, 18% male) with moderate to severe pain. Participants were assigned to either the AB or BA sequence. In AB, they wore OrthoFeet shoes for 6 weeks and then their own shoes for another 6 weeks; BA followed the reverse order. Pain and function were measured using the Foot Function Index. Acceptability was assessed through a technology acceptance model (TAM) questionnaire. Data collected at baseline, six, and 12 weeks were analyzed using t tests, χ2 tests, and generalized linear model. RESULTS: Compared to participants' own shoes, OrthoFeet shoes significantly reduced foot pain and disability. Notable improvements were observed in "foot pain at its worst," "foot pain at the end of the day," "overall pain score," and "overall Foot Function Index score," all showing statistically significant reductions (p < 0.050). Participants reported high adherence to wearing the OrthoFeet shoes, averaging 8 h per day and 5.8 days per week. TAM scores favored OrthoFeet shoes over participants' own shoes in terms of ease of use, perceived benefit, and intention to recommend. Significant differences were noted in components representing perceived joint pain relief (p < 0.001, χ2 = 21.228) and the intention of use as determined by the likelihood of recommending the shoes to a friend with a similar condition (p < 0.001, χ2 = 29.465). Additionally, a majority of participants valued the appearance of the shoes, with 66% prioritizing shoe appearance and 96% finding the study shoes more stylish than their previous ones. CONCLUSION: This study underscores the significance of design and custom fit in promoting continuous wear for effective foot pain reduction in older adults. More research is needed on the intervention's long-term impacts.

Split-face study to evaluate efficacy of global cryomodulation for reduction of pain and inflammation after nonablative fractional resurfacing.

OBJECTIVES: Cryomodulation, or the delivery of controlled cooling to downregulate inflammatory processes in the skin, has been proposed to mitigate acute side effects following various dermatologic treatments. A new controlled cooling device has been developed to deliver cryomodulation for a range of different indications. In this clinical study, we evaluate the device for the reduction of pain, erythema, and edema following nonablative fractional resurfacing (NAFR). METHODS: A single-blind, prospective, randomized, split-face study was conducted to assess the efficacy of the controlled dermal cooling device for the reduction of pain, edema, and erythema following nonablative fractional resurfacing with the dual 1550 nm erbium-doped fiber and 1927 nm thulium fiber laser. Subjects were randomized to receive a 10-min controlled cooling treatment to either the left or right side of the face immediately following full face NAFR. Pain ratings were recorded immediately postlaser treatment and immediately postcryomodulation treatment. At follow-up, subjects were surveyed for reduction of side effects and treatment satisfaction. Blinded review of photographs by two physicians was conducted to assess efficacy. RESULTS: The average pain score for subjects immediately post-NAFR was 5.15. Following cryomodulation, the average pain score on the treatment side was reduced by 69%, to an average of 1.6. The untreated side of the face was reduced by 19%, to an average of 4.2. Overall, 90% of subjects endorsed reduced discomfort. At follow-up, 70% of subjects reported a noticeable improvement in edema and 50% reported a noticeable improvement in erythema between the treatment and control sides. The average subject satisfaction score for the cryomodulation treatment was 4.2. All subjects (100%) indicated that they would elect to undergo the cryomodulation treatment again. Both blinded physician reviewers were successful in identifying the cryomodulation-treated side of the face in 70% of subjects' posttreatment photographs. CONCLUSIONS: The results of this split-face study support the efficacy of a global cryomodulation device for the reduction of pain, edema, and erythema following NAFR treatment. Cryomodulation was delivered in a simple 10 min procedure and yielded high patient satisfaction.

The effect of maternal voice and non-nutritional sucking on repeated procedural pain of heel prick in neonates: a quasi-experimental study.

BACKGROUND: Neonates in the neonatal intensive care unit undergo frequent painful procedures. It is essential to reduce pain using safe and feasible methods. PURPOSE: To evaluate the effects of non-nutritional sucking, mother's voice, or non-nutritional sucking combined with mother's voice on repeated procedural pain in hospitalized neonates. METHODS: A quasi-experimental study was conducted in which 141 neonates were selected in a hospital in Changsha, China. Newborns were divided into four groups: non-nutritional sucking (NNS) (n = 35), maternal voice (MV) (n = 35), NNS + MV (n = 34), and control (n = 37) groups. The Preterm Infant Pain Profile-Revised Scale (PIPP-R) was used to assess pain. RESULTS: During the heel prick, the heart rate value and blood oxygen saturation were significantly different between the groups (P < 0.05). Both non-nutritional sucking and maternal voice significantly reduced PIPP-R pain scores of hospitalized newborns (P < 0.05). The pain-relief effect was more robust in the combined group than in other groups. CONCLUSIONS: This study showed that both non-nutritional sucking and the mother's voice alleviated repeated procedural pain in neonates. Therefore, these interventions can be used as alternatives to reduce repeated procedural pain.

The effect of the simulated intrauterine sound on behavioral and physiological indices of pain during capillary blood sampling for screening preterm infants: a randomized clinical trial study.

INTRODUCTION: Due to medical procedures, preterm infants are at high risk for side effects of pain. In this regard, heel lancing for capillary blood sampling is a common painful procedure. The present study was conducted to assess the effectiveness of a simulated intrauterine sound on behavioral and physiological indices of pain due to heel-prick blood sampling in preterm infants. METHODS: A double­blind randomized clinical trial (RCT) was conducted. The data were collected from September 23 to December 22, 2019. We measured the effect of a simulated intrauterine sound on changes in the behavioral and physiological parameters of pain (heart rate, SPO2) caused by heel lance that was measured 5 min before the intervention, during the sampling, and 5 min after the procedure. We measured behavioral pain by video recording the infants' faces and then the scoring neonatal infant pain scale (NIPS). Heart rate and SPO2 were measured using a pulse oximeter device. The data were analyzed using analysis of variance (ANOVA) and independent t­test in SPSS software version 20.0. RESULTS: Eighty infants were randomized (40 in each group). Mean scores NIPS during and after intervention were in the intervention group (3.55 ± 0.84, 95% CI: 3.30-3.80(, and (1.15 ± 0.84, 95%: 0.95-1.35) and in the control group (5.57 ± 0.95, 95% CI:5.30-5.85) and (3.00 ± 0.98) respectively. There were significant differences in scores of NIPS between the two study groups during (p < 0.001) and five min after heel lancing (p < 0.001). Mean scores of heart rate in the three phases of before, during, and five min after the intervention were respectively in the intervention group (127.57 ± 4.45, 95% CI:126.27-128.99), (131.07 ± 6.54, 95% CI:129.20-133.22), (128.45 ± 5.15, 95% CI:127.02-130.07) and in the control group (128.67 ± 4.57, 95% CI:127.32-130.07), (136.07 ± 7.24, 95% CI:133.90-138.37), and (132.42 ± 6.47, 95% CI:130.37-134.49). There were significant differences in heart rate between the intervention and the control group during (p = 0.002) and five min after the heel lance (p = 0.003). Mean scores of SPO2 in the three phases of baseline, during, and five min after the intervention were respectively in the intervention group (96.72 ± 0.93, 95% CI:96.42-97.00), (91.47 ± 1.46, 95% CI:91.05-91.92), (94.17 ± 1.03, 95% CI:93.22-94.00) and in the control group (96.6 ± 0.84, 95% CI:96.35-96.85), (91.5 ± 1.24, 95% CI:91.12-91.87), and (93.60 ± 1.27, 95% CI:93.85-94.50). CONCLUSION: This study showed that the simulated intrauterine sound reduces the behavioral pain and heart rate in the intervention group during and after heel lance. These results suggest using the method during the painful heel lancing to reduce pain parameters in preterm infants.

Maternal singing reduced pain indexes in 2-month-old infants and increased proximity during vaccinations.

AIM: Immunisation is a global health priority, but methods of non-pharmacological pain relief are not widely used in routine clinical practice. In this study, we set out to investigate the effects of maternal singing during the routine vaccination of infants. METHODS: We recruited 67 mother-infant pairs at Health Centres in the Aosta Region of Italy. Infants aged 2-4 months were randomly allocated to a singing intervention group or to a control group whose injections were administered following standard practice. Pre- and post-immunisation pain was blindly assessed using the Modified Behavioural Pain Scale, and mother-infant proximity indexes were assigned based on muted video-tracks. RESULTS: When assessed for pain, the infants in the maternal singing group were assigned significantly lower movement indexes (p = 0.032) and marginally significantly lower cry indexes (p = 0.076). A higher frequency of mother-to-infant gaze (p < 0.005) was observed in the singing group dyads. Finally, the intervention group mothers' self-perceived ease in singing was correlated with their previous singing experience and with lower anxiety following the vaccination procedure (p < 0.05). CONCLUSION: Maternal singing during immunisation procedures benefits both mothers and babies. The practice of singing is a biologically rooted and adaptive form of intuitive parental communication that should be encouraged, especially in at-risk populations.

Avoiding pain during propofol injection in pediatric anesthesia: Hypnoanalgesia of the hand versus intravenous lidocaine.

INTRODUCTION: Pain related to injection of propofol during induction of anesthesia decreases from 66.8% without prevention, to 22-31% of cases when lidocaine is associated. Hypnoanalgesia of the hand is currently used for painful procedures in children but has never been evaluated in this indication. The primary aim of this prospective randomized single-blind study was to evaluate the efficacy of hypnoanalgesia of the hand for the prevention of moderate to severe pain during intravenous injection of propofol alone in comparison to lidocaine admixture. The secondary aim was to compare the global satisfaction of children in both methods. PATIENTS AND METHODS: One hundred patients aged 7-14 years, ASA 1-2, admitted for scheduled surgery under general anesthesia were randomized into two groups. Group L received a mixture of 1% propofol (3 mg/kg) and 1% Lidocaine (0.3 mg/kg). Group H received 1% propofol (3 mg/kg) after hypnoanalgesia of the hand realized by a single experimented operator. A video was made in order to evaluate the pain related to propofol injection by a blinded observer using the 4-point score of Cameron (painful ≥ 2). The global satisfaction of children was evaluated in postanesthesia care unit and documented if visual analog score was <7/10. RESULTS: Ninety-six patients were analyzed. The rate of painful patients did not differ significantly between groups (8.5% in group H [n = 47] vs 6.1% in group L [n = 49], OR= 0.70; 95% CI [0.13-3.35], p = 0.65), nor did the rate of nonsatisfied patients (10.6 in group H vs. 12.2% in group L, OR = 0.85; 95% CI [0.19-3.65], p = 1). CONCLUSIONS: Our results suggest that hypnoanalgesia of the hand alone is effective to prevent the pain related to propofol injection in children. No significant difference was found in comparison with lidocaine admixture nor for pain or satisfaction.

Neural interfacing architecture enables enhanced motor control and residual limb functionality postamputation.

Despite advancements in prosthetic technologies, patients with amputation today suffer great diminution in mobility and quality of life. We have developed a modified below-knee amputation (BKA) procedure that incorporates agonist-antagonist myoneural interfaces (AMIs), which surgically preserve and couple agonist-antagonist muscle pairs for the subtalar and ankle joints. AMIs are designed to restore physiological neuromuscular dynamics, enable bidirectional neural signaling, and offer greater neuroprosthetic controllability compared to traditional amputation techniques. In this prospective, nonrandomized, unmasked study design, 15 subjects with AMI below-knee amputation (AB) were matched with 7 subjects who underwent a traditional below-knee amputation (TB). AB subjects demonstrated significantly greater control of their residual limb musculature, production of more differentiable efferent control signals, and greater precision of movement compared to TB subjects (P < 0.008). This may be due to the presence of greater proprioceptive inputs facilitated by the significantly higher fascicle strains resulting from coordinated muscle excursion in AB subjects (P < 0.05). AB subjects reported significantly greater phantom range of motion postamputation (AB: 12.47 ± 2.41, TB: 10.14 ± 1.45 degrees) when compared to TB subjects (P < 0.05). Furthermore, AB subjects also reported less pain (12.25 ± 5.37) than TB subjects (17.29 ± 10.22) and a significant reduction when compared to their preoperative baseline (P < 0.05). Compared with traditional amputation, the construction of AMIs during amputation confers the benefits of enhanced physiological neuromuscular dynamics, proprioception, and phantom limb perception. Subjects' activation of the AMIs produces more differentiable electromyography (EMG) for myoelectric prosthesis control and demonstrates more positive clinical outcomes.

The effects of warm perineal compress on perineal trauma and postpartum pain: a systematic review with meta-analysis and trial sequential analysis.

BACKGROUND: In order to reduce the complications of perineal damage and the pain caused by it for the mother, this study was conducted to determine the effect of warm perineal compress on perineal trauma (1st-, 2nd-, 3rd-, and 4th-degree perineal tears), postpartum pain, intact perineum (primary outcomes), episiotomy, length of the second stage, and APGAR score at 1 and 5 min after childbirth (secondary outcome). METHODS: PubMed, Scopus, Cochrane Central Register of Controlled Trials, Google Scholar, Web of Science, SID, Magiran, and ClinicalTrials.gov were searched to identify the relevant articles from inception to November 1, 2022, with language restriction (only English and Persian). A manual search was also performed. Risk of bias 2 (RoB2) and ROBIN-I were employed to evaluate the quality of the included papers. Meta-analysis was conducted using RevMan 5.3. Heterogeneity was assessed using I2. In cases with high heterogeneity, subgroup analysis was utilized based on the parity and ethnicity, and time of pain measurement after delivery also a random-effects model was used instead of a fixed-effects model. Trial sequential analysis (TSA) was performed for the primary outcomes. The certainty of evidence was assessed using the GRADE approach. RESULTS: A total number of 228 articles were found in databases. Of these articles, eighty-six were screened by title, 27 by abstract, and 21 by full text. Finally, 14 articles were included, of which ten were RCT and four were non-RCT. Meta-analysis results revealed that warm perineal compress significantly reduced perineal pain (RR 0.23, 95% CI 0.08-0.66; P = 0.0006), average pain (SMD - 0.73, 95% CI 1.23 to - 0.23; P = 0.004), second-degree perineal tear (RR 0.65, 95% CI 0.54-0.79; P˂0.00001), third-degree perineal tear (RR 0.32, 95% CI 0.15-0.67; P = 0.003), fourth-degree perineal tear (RR 0.11, 95% CI 0.01-0.87; P = 0.04), episiotomy (RR 0.63, 95% CI 0.46-0.86; P = 0.004), and intact perineum significantly increased (RR 3.06, 95% CI 1.79-5.22; P < 0.0001) compared to the control group. However, there was no statistically significant difference in terms of first-degree tear (RR 1.04, 95% CI 0.86-1.25; P = 0.72), length of the second stage of labor (MD - 0.60, 95% CI - 2.43 to 1.22; P = 0.52), the first minute (MD - 0.03, 95% CI - 0.07 to 0.02; P = 0.24) and the fifth minute Apgar score (MD - 0.02, 95% CI - 0.07 to 0.03; P = 0.46) between the two groups. CONCLUSION: Warm perineal compress administered during the second stage of labor reduce postpartum pain, second and third-degree perineal tears, and episiotomy rate while it increases the incidence of intact perineum compared to the control group.

The prophylactic effect of photobiomodulation therapy on pain perception due to infiltration injection: a randomized clinical trial.

OBJECTIVES: Fear of pain in dentistry especially the injection involved in most of the processes has always been an important issue preventing the patients from consulting a dentist at the right time. This study aims to evaluate the effect of photobiomodulation therapy on reduction of pain in infiltration injection. MATERIALS AND METHODS: This trial is a crossover study including 30 patients. The patients are divided into two groups (laser therapy in the first period and placebo effect in the next period or vice versa with split-mouth design) using the covariate adaptive randomization method. All the patients received bilateral maxillary canine anesthesia in two periods performed with an ICT injection device (amount of anesthesia solution loaded: 1.8 mL) at a speed of 1 mL/min and a temperature of the solution of 37 °C. In each period, patients received either a prophylactic dose of 940-nm laser (500 mW, 10 J/cm2) or its placebo effect before the injection. The degree of pain perception after each sort of treatment is evaluated by both SEM (Sound, Eye, Motor, and Pain) and VAS (Visual Analogue Scale) scales. RESULTS: According to analysis, all the patients scored a VAS scale under 3 in the period they received intervention. Also considering the SEM scale, most of the patients scored 0 in the intervention period. No adverse effect was reported during or after the process. CONCLUSIONS: The study showed a significant effect of photobiomodulation on reducing pain perception during infiltration injection. CLINICAL RELEVANCE: This method can be useful in order to lower the pain for the patients consulting a dentist and therefore facilitate consulting at early stages of the dental issues. TRIAL REGISTRATION: The registration number (date) of the clinical trial in a Primary Registry in the WHO Registry Network is IR.ARAKMU.REC.1398.248(13/03/2020). The related URL is https://en.irct.ir/trial/45362 .

Actions to Avoid in Pain Management and Sedoanalgesia Procedures in Pediatric Emergencies.

OBJECTIVES: The aim of this study was to show the process of elaboration and the results obtained of the list of "do not do" recommendations for pain management and sedoanalgesia procedures in pediatric patients within the Working Group on Analgesia and Sedation of the Spanish Society of Pediatric Emergencies (Grupo de Trabajo de Analgesia y Sedación de la Sociedad Española de Urgencias de Pediatría [GTAS-SEUP]). METHODS: The process of drawing up the list was carried out in 3 phases: (1) "brainstorming," open to all members of the GTAS-SEUP; (2) selection of recommendations, after a modified Delphi methodology; and (3) drafting and consensus of the final document. RESULTS: Initially, 57 proposed recommendations were obtained, which were reduced to 39 by unifying those that were similar. Of the 14 "do not do" in pain management, 6 were accepted: 3 in the first round and 3 in the second round. Of the 25 "do not do" recommendations for sedoanalgesia procedures, 6 were accepted: 4 in the first round and 2 in the second round. The final text consisted of 12 actions to avoid, 6 referring to pain management and 6 to sedoanalgesia procedures. CONCLUSIONS: The list of "do not do" recommendations for pain management and sedoanalgesia procedures in the pediatric patient is a consensual tool, within the GTAS-SEUP. These recommendations promote an improvement in the quality of care offered to these patients, based on avoiding unnecessary measures, which can sometimes be harmful.

Efficacy of Buzzy Device Versus EMLA Cream for Reducing Pain During Needle-Related Procedures in Children: A Randomized Controlled Trial.

OBJECTIVES: Several pain management tools exist but with limitations in their efficacy or applicability. The EMLA (eutectic mixture of local anesthetics) cream is currently used for pain relief for needle-related procedures; however, it needs a minimum of 30 to 45 minutes to be effective. The Buzzy is a device that generates vibrations with cold leading to quicker pain relief. Our aim was to evaluate the effect of the Buzzy device in pain and anxiety reduction compared with EMLA cream in children requiring intravenous cannulation or venepuncture. METHODS: This was a randomized clinical trial comparing pain and anxiety reduction by Buzzy device with the standard care (EMLA cream) in children aged 2 to 14 years who required blood extraction or intravenous cannulation based on their clinical needs. Eligible patients were randomized to either Buzzy device as the intervention or EMLA cream as the control. The outcome measures were the degree of pain scores and anxiety ratings at different stages of the needle-related procedures. RESULTS: A total of 300 patients with a mean age of 6.5 ± 3.1 years were enrolled. Baseline characteristics were similar between the Buzzy device and EMLA cream groups. The observed pain scores by research nurses and a parent were significantly lower in the EMLA group compared with the Buzzy device group; however, the pain scores by the self-assessment scale were not statistically significant with mean difference of -0.332, 95% confidence interval, -0.635 to -0.028 ( P = 0.062). The level of anxiety was significantly lower in EMLA compared with Buzzy device ( P = 0. 0.0001). Both staff and parents' satisfaction, success rate of cannulation, type of blood tests, and comment on the physician on the results were similar in both groups. CONCLUSIONS: Pain and anxiety relief using the Buzzy device is not as effective as EMLA cream in children requiring venepuncture. However, rapid onset of action of the Buzzy device is valuable in decreasing waiting time in a busy emergency department. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT05354739.

The effectiveness of non-pharmacological interventions on reducing pain in patients undergoing bone marrow aspiration and biopsy: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Patients often consider bone marrow aspiration and biopsy to be one of the most painful medical procedures. The effectiveness of non-pharmacological interventions to reduce pain during bone marrow aspiration and biopsy remains unclear. AIM: To synthesize existing evidence regarding the effectiveness of non-pharmacological interventions in mitigating procedural pain among patients undergoing bone marrow aspiration and biopsy. DESIGN: A systematic review and meta-analysis of randomized controlled trials. METHODS: Six electronic databases, including PubMed, EMBASE, CINAHL, PsycINFO, Cochrane Library and Web of Science were searched from inception to July 15, 2023. The risk of bias was assessed using the Cochrane Risk of Bias Tool Version 2.0. Meta-analysis was conducted using STATA 16. The certainty of the evidence was assessed by the GRADE approach. RESULTS: This meta-analysis included 18 studies derived from 17 articles involving a total of 1017 participants. The pooled results revealed statistically significant pain reduction effects using distraction (SMD: -.845, 95% CI: -1.344 to -.346, p < .001), powered bone marrow biopsy system (SMD: -.266, 95% CI: -.529 to -.003, p = .048), and acupoint stimulation (SMD: -1.016, 95% CI: -1.995 to -.037, p = .042) among patients undergoing bone marrow aspiration and biopsy. However, the pooled results on hypnosis (SMD: -1.228, 95% CI: -4.091 to 1.515, p = .368) showed no significant impact on pain reduction. Additionally, the pooled results for distraction did not demonstrate a significant effect on operative anxiety (MD: -2.942, 95% CI: -7.650 to 1.767, p = .221). CONCLUSIONS: Distraction, powered bone marrow biopsy system and acupoint stimulation are effective in reducing pain among patients undergoing bone marrow aspiration and biopsy. PATIENT OR PUBLIC CONTRIBUTION: Not applicable. RELEVANCE TO CLINICAL PRACTICE: This meta-analysis highlights the effectiveness of distraction, powered bone marrow biopsy system and acupoint stimulation for reducing pain in patients undergoing bone marrow biopsy. Healthcare professionals should consider integrating these interventions into pain management practices for these patients. REGISTRATION: (PROSPERO): CRD42023422854.

The effect of vibrating cold application and puppet use on pain and fear during phlebotomy in children: A randomized controlled study.

BACKGROUND: Non-pharmacological methods are often used as a creative strategy to reduce pain and fear in children during a painful procedure such as phlebotomy. OBJECTIVES: This study was conducted to evaluate the effects of Bee Buzzy and puppet use on pain and fear during phlebotomy in children. METHODS: This randomized controlled study was conducted in the pediatric phlebotomy unit of a university hospital. The CONSORT checklist was used in this study. The sample of 3-6 years children (n = 105) was divided into groups by block randomization. Children's pain and fear scores were evaluated with the Wong-Baker Faces Pain Rating Scale and Children's Fear Scale by the parents and the nurse who attempted phlebotomy during phlebotomy. RESULTS: A statistically significant difference was found between the Bee Buzzy and puppet and Bee Buzzy and control groups in pain scores (p < .05). Pain scores were lower in the Bee Buzzy group than in the puppet and control groups. A statistical difference was found between Bee Buzzy and the control group or puppet and control group according to all fear scores (p < .05). Fear scores were lower in the Bee Buzzy and puppet group (p < .05). CONCLUSIONS: The results show that the use of Bee Buzzy during phlebotomy has a pain-relieving effect, and the use of Bee Buzzy and puppet has an anti-fear effect in 3-6-year-old children. IMPLICATIONS FOR PRACTICES: The use of Bee-Buzzy and puppets is effective in reducing pain and fear in children as they increase effective communication and distract attention. CLINICAL TRIAL REGISTRATION: National Institutes of Health (NIH), ClinicalTrials.gov, NCT05827783.

Goldfish or aquatic turtle? Impact of two animal assisted interventions on children's pain, anxiety, and fear during IV catheterization: A randomized controlled trial.

PURPOSE: This study aimed to determine the effect of goldfish and aquatic turtle nursing interventions on children's pain, anxiety, and fear during IV catheter insertion. DESIGN AND METHODS: The randomized controlled trial included 98 children (control group = 32, goldfish group = 33, aquatic turtle group = 33) aged 5-6 years, attending outpatient clinic for blood sampling and catheterisation procedures. Pain was measured using the Wong Baker Facial Pain Scale, anxiety was measured using the Child Anxiety Scale-State, and child fear was measured using the Child Fear Scale, before, during, and after catheterization. RESULTS: When analyzing the pain, anxiety, and fear findings, no statistical difference was found between the scores of the mother, child, and researcher before the procedure. During the catheterization procedure, the pain, anxiety, and fear scores of the children in the fish and turtle groups increased statistically less than those in the control group. When analyzing the post-procedure findings, the pain, anxiety, and fear scores of the control group were similar to those before the procedure. In the fish and turtle groups, anxiety and fear scores were statistically the lowest (p < 0.05). CONCLUSION: It can be concluded that animal-assisted practices reduce anxiety and fear during and after the catheterization procedures while diverting attention from pain. PRACTICE IMPLICATIONS: Goldfish or aquatic turtle intervention improve children's attitudes toward pain, anxiety, and fear during IV catheter insertion. Pediatric nurses could consider incorporating, such as the animal assisted intervention, into their clinical practice to reduce the pain, anxiety, and fear experienced by children during medical/nursing procedures.