"Hurts less, lasts longer"; a qualitative study on experiences of young people receiving high-dose subcutaneous injections of benzathine penicillin G to prevent rheumatic heart disease in New Zealand.

BACKGROUND: Four-weekly intramuscular (IM) benzathine penicillin G (BPG) injections to prevent acute rheumatic fever (ARF) progression have remained unchanged since 1955. A Phase-I trial in healthy volunteers demonstrated the safety and tolerability of high-dose subcutaneous infusions of BPG which resulted in a much longer effective penicillin exposure, and fewer injections. Here we describe the experiences of young people living with ARF participating in a Phase-II trial of SubCutaneous Injections of BPG (SCIP). METHODOLOGY: Participants (n = 20) attended a clinic in Wellington, New Zealand (NZ). After a physical examination, participants received 2% lignocaine followed by 13.8mL to 20.7mL of BPG (Bicillin-LA®; determined by weight), into the abdominal subcutaneous tissue. A Kaupapa Maori consistent methodology was used to explore experiences of SCIP, through semi-structured interviews and observations taken during/after the injection, and on days 28 and 70. All interviews were recorded, transcribed verbatim, and thematically analysed. PRINCIPAL FINDINGS: Low levels of pain were reported on needle insertion, during and following the injection. Some participants experienced discomfort and bruising on days one and two post dose; however, the pain was reported to be less severe than their usual IM BPG. Participants were 'relieved' to only need injections quarterly and the majority (95%) reported a preference for SCIP over IM BPG. CONCLUSIONS: Participants preferred SCIP over their usual regimen, reporting less pain and a preference for the longer time gap between treatments. Recommending SCIP as standard of care for most patients needing long-term prophylaxis has the potential to transform secondary prophylaxis of ARF/RHD in NZ and globally.

Ultrasound-Guided Peripheral Venipuncture Decreases the Procedure's Pain and Positively Impacts Patient's Experience: The PRECISE Randomized Clinical Trial.

This study aimed to compare patients' experience of pain during ultrasound (US)-guided peripheral venipuncture versus conventional peripheral venipuncture. This randomized clinical trial was conducted at a public university hospital in 2021. Adult patients with indication for intravenous therapy compatible with peripheral intravenous catheters (PIVCs) were included: intervention group (IG), US peripheral venipuncture executed by specialist nurses; control group (CG), conventional peripheral venipuncture executed by clinical practice nurses. The primary outcome was patient experience of pain during the procedure and patient experience related to the PIVC placement method. Sixty-four patients were included, 32 for each group. The pain experienced was none-to-mild in the IG for 25 patients (78.1%) and moderate-to-severe in the CG for 21 patients (65.7%; P < .001). The overall pain rating was 2 (1-3) in the IG and 4 (3-6) in the CG (P < .001). The recommendation of the procedure in IG (net promoter score [NPS] + 90.6%) versus CG (NPS + 18.8%) was considered excellent and good, respectively (P < .001). Patients had less pain and significantly recommended the US-guided procedure. Patient experience with US-guided PIVC, performed by a specialist nurse, was superior to that of conventional peripheral venipuncture.

Effectiveness and safety of Buzzy device in needle-related procedures for children under twelve years of age: A systematic review and meta-analysis.

BACKGROUND: Pain transcends simple physiology, encompassing biological, emotional, psychological, and social facets. Children show pronounced immediate and enduring responses to pain-related procedures. The aim of this meta-analysis is to investigate the efficacy and safety of the Buzzy device for needle-related procedures in children aged twelve years or younger. METHODS: PubMed, Web of Science, and Embase were searched from inception to July 2023. Only randomized controlled trials utilizing the Buzzy device for needle-related procedures in children under twelve years old were included. Two reviewers independently conducted study selection, data extraction, and risk of bias assessment. Random-effects models were utilized, and analyses were performed using mean differences or standardized mean differences as well as risk ratios. RESULTS: A total of 19 studies were included, involving 2846 participants (Buzzy = 1095, Control = 1751). Compared to no intervention, the Buzzy device significantly reduced pain response [self-report SMD = -1.90 (-2.45, -1.36), parental SMD = -3.04 (-4.09, -1.99), observer SMD = -2.88 (-3.75, -2.02)] and anxiety scores [self-report SMD = -1.97 (-3.05, -0.88), parental SMD = -2.01 (-2.93, -1.08), observer SMD = -1.92 (-2.64, -1.19)]. Compared to virtual reality (VR), the Buzzy device reduced self-reported anxiety levels SMD = -0.47 (-0.77, -0.17), and compared to distraction cards, the Buzzy device reduced parental and observer-reported pain [parental SMD = -0.85 (-1.22, -0.48), observer SMD = -0.70 (-1.00, -0.40)] and anxiety [parental SMD = -0.96 (-1.46, -0.47), observer SMD = -0.91 (-1.40, -0.42)]. Subgroup analysis results showed that procedure type, patient age, measurement scales used, and distance of operation were not the reason of heterogeneity. The summarized first puncture attempt success rate did not differ from other interventions. There were no significant adverse events in the included studies. CONCLUSION: The Buzzy device reduces pain and anxiety in children during needle procedures, ensuring success and safety. Additionally, the effectiveness of the Buzzy device in reducing pain during venipuncture is superior when compared to its effectiveness during intramuscular injections.

Reducing Pain and Anxiety in the Blood Collection Unit: The Impact of the Child-Friendly Design.

Purpose: The study aimed to examine the effect of a child-friendly design on the pain and anxiety levels during blood draw in children aged 1-3 years and the satisfaction levels of their parents toward the environment in which they receive health care services. Methods: The nonrandomized study was conducted with 158 children aged 1-3 years and their parents. Data were obtained with the "Personal Information Form," "Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale," "Visual Analog Scale (VAS) Anxiety Scale," and "Parental Satisfaction Scale-VAS." Data were collected from the control group before the design and from the intervention group after the design. Results: During the blood draw, the VAS Anxiety score of the children in the intervention group was 3.17 ± 1.44 and that of the control group was 7.00 ± 2.51 (t = 246.500, p < .001). The FLACC score was 3.94 ± 1.65 in the intervention group and 7.32 ± 2.51 in the control group (t = 915.000, p < .001). The mean satisfaction scores of the parents in the intervention group for the environment where they received health care were 10.00 ± 0.00, and those of the parents in the control group were 4.85 ± 1.68 (test = -11.561, p < .001). Conclusion: The child-friendly design effectively reduced children's pain and anxiety levels during blood draws and increased parents' satisfaction with the environment in which health care was received. Practical Implications: Implementing a child-friendly design in blood collection units is recommended to alleviate the pain and anxiety associated with children's blood draws, thereby enhancing parental satisfaction with the care provided.

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.

Efficacy of Lidocaine Spray for Pain Reduction during Colposcopy-Directed Cervical Biopsies: A Randomized Controlled Trial.

Objectives: The objective of this study was to evaluate the efficacy of lidocaine spray in reducing the pain during colposcopy-directed cervical biopsy (CDB). Methods: From December 2017 to February 2019, 312 women undergoing CDBs were enrolled. The participants were randomized to three groups: group 1 (lidocaine spray), in which lidocaine spray was applied thoroughly to the cervix; group 2 (placebo), in which normal saline was applied thoroughly to the cervix; and group 3 (control), in which no anesthetic agent was applied to the cervix. Each woman completed a 10 cm visual analog scale to classify the subjective pain experience at three time points: baseline, immediately after biopsy, and 10 min after the procedure. The primary outcome of this study was the biopsy pain score. Results: The 312 enrolled women were randomly assigned to the three groups, amounting to 104 women per group. The clinical and pathological characteristics of the participants in all groups were comparable. The baseline, the biopsy, and the post-procedure pain scores were comparable among the three groups. There was a significant increase in the pain score from baseline to biopsy and from baseline to post-procedure in each group. The pain-score changes from baseline to biopsy in the lidocaine spray group significantly decreased when compared with the normal saline group (<0.001), and tended to decrease, though not significantly (p = 0.06), when compared with the control group. No complication with the intervention was observed. Conclusions: The application of lidocaine spray to the cervix has the benefit of reducing the pain associated with CDBs by a small amount. However, the intervention is safe and may be considered in nulliparous and/or overly anxious women undergoing the procedure.

The Effect of Preprocedural Low-Dose Ketamine for Pain and Anxiety in Patients during Thoracic Epidural Catheterization.

Background and Objectives: Thoracic epidural catheterization (TEC) can be both uncomfortable and fearful for patients when performed awake with the thought that the procedure may be painful. The aim of this study was to assess the effect of low-dose intravenous ketamine administration on pain and anxiety during the TEC procedure. Materials and Methods: Sixty patients were randomly divided into two groups to receive intravenous (IV) placebo (Group P) and IV low-dose (0.15 mg/kg) ketamine (LDK) (Group K) 3 min before the procedure in a double-blind manner. A visual analog scale (VAS) was used to measure anxiety (VAS-A) and pain (VAS-P) scores. Vital parameters were monitored before premedication (T1), 20 min after premedication (T2), during skin anesthesia (T3), during TEC (T4), and 5 min after TEC (T5). VAS-A values were recorded at T1, T3, T4, and T5 periods, and VAS-P levels were noted at T3, T4, and T5 periods. Results: During TEC (T4), both VAS-P and VAS-A were significantly lower in Group K (p < 0.001). The mean VAS-A value was 10.6 mm lower, and the mean VAS-P value was 9 mm lower in Group K than in Group P at the T4 time point. Additionally, the mean VAS-P value was 7.7 mm lower in Group K compared to Group P at the T3 time point (p < 0.001). Both groups showed a statistically significant difference in VAS-A measurements when compared at their respective time points (p < 0.001). However, only Group P demonstrated a statistically significant difference in VAS-P measurements (p < 0.001). VAS-P values remained stable in Group K. The number of patients who did not recall the procedure was significantly higher in Group K (p < 0.001). Furthermore, the number of patients who would consent to the same procedure in the future was significantly higher in Group K (p = 0.007). Conclusions: A preprocedural LDK (0.15 mg/kg) can effectively prevent anxiety and pain experienced by patients during the TEC procedure. Administration of LDK may provide a more comfortable procedure process without causing ketamine-induced side effects (hemodynamic, respiratory, and psychological).

The effect of virtual reality glasses applied during intrauterine device insertion on pain, anxiety and satisfaction: Randomized controlled study.

BACKGROUND AND AIM: This study was carried out to determine the effect of the use of "virtual reality glasses," on anxiety, pain, and satisfaction level in order to reduce anxiety and pain during intrauterine device (IUD) insertion, which is a painful and stressful procedure for women and to divert attention to increase satisfaction. METHODS: This randomized controlled study in the gynecology clinic of a state hospital with 80 women who were accepted to participate in the study. Data were collected using structured patient information form, numerical pain rating scale, state-trait anxiety inventory, patient satisfaction evaluation form, and virtual reality glasses. RESULTS: Post-procedural pain scores in the control group after IUD application were higher than post-procedural pain in the virtual reality group. Measurements of post-procedure anxiety in the control group were higher than measurements of post-procedural in the virtual reality group. Satisfaction levels of women with virtual reality glasses during IUD insertion were also found to be high. CONCLUSIONS: It was determined that the use of virtual reality glasses, one of the methods of distraction during IUD insertion, was effective in reducing pain and anxiety and increasing patient satisfaction.

Effect of pacifier and pacifier with dextrose in reducing pain during orogastric tube insertion in newborns: a randomized controlled trial.

OBJECTIVE: This study aimed to assess the efficacy of pacifier use, with and without 25% dextrose, in reducing pain during orogastric tube insertion in newborns. STUDY DESIGN: In a randomized controlled trial involving 60 newborns at a public hospital from April to December 2019, participants were divided into three groups: pacifier (n = 20), pacifier with 25% dextrose (n = 20), and control (n = 20). A pacifier, with and without dextrose, was used for the experimental groups, while the control group performed a routine procedure. Neonatal infant pain scale, crying duration, heart rate (HR), and oxygen saturation (SpO2) were evaluated. RESULTS: Results indicated that the control group experienced significantly higher pain levels, elevated HRs, decreased SpO2, and prolonged crying. Conversely, the pacifier with 25% dextrose group showed a notable reduction in crying duration. CONCLUSION: A pacifier, with and without 25% dextrose, effectively reduces pain and improves physiological and behavioral parameters during orogastric tube insertion. CLINICAL TRIAL NUMBER: NCT05462964 CLINICAL TRIAL REGISTRATION: The protocol for this randomized controlled experimental trial is registered on ClinicalTrials.gov. The clinical trial registration number is https://clinicaltrials.gov ; NCT05462964.

SimSAARlabim study - The role magic tricks play in reducing pain and stress in children.

BACKGROUND: Vaccination is an essential preventative medical intervention, but needle fearandinjection painmay result in vaccination hesistancy. STUDY PURPOSE: To assess the role of magic tricks - no trick vs. one trick ("disappearing handkerchief trick") vs. three tricks ("disappearing handkerchief trick", "jumping rubber band trick", and "disappearing ring trick") - performed by a professional magician and pediatrician during routine vaccination in reducing discomfort/pain and the stress response (heart rate, visual analogue scale (VAS), and biomarkers (cortisol, Immunoglobulin A (IgA), α-amylase, and overall protein concentration in saliva before and after vaccination). PATIENTS AND METHODS: Randomized controlled trial (RCT) in healthy children aged 6-11 years undergoing routine vaccination in an outpatient setting. RESULTS: 50 children (26 female) were enrolled (no trick: n = 17, 1 trick: n = 16, 3 tricks: n = 17) with a median age of 6.9 years (range: 5.3-10.8 years). We detected no significant differences among the three groups in their stress reponse (heart rate before and after vaccination and cortisol, IgA, α-amylase, and overall protein concentrations in saliva before and after vaccination) or regarding pain assessment using the VAS. CONCLUSIONS: Although children undergoing routine outpatient vaccination appeared to enjoy a magician's presence, the concomitant performance of magic tricks revealed no significant effect on the stress response.

EFFECTIVENESS OF ICE APPLICATION AT SELECTED ACUPOINT (LI-4) PRIOR TO INTRAMUSCULAR INJECTION ON LEVEL OF PAIN AMONG CHILDREN IN A SELECTED HOSPITAL, CHENNAI, TAMIL NADU, INDIA.

Immunization is an effective and safest way to prevent vaccine-preventable diseases and thereby reduce morbidity and mortality in children. Injections given for immunization are the most usual ground in order to abstract agony or pain, which is the fifth vital sign leading to long-term physically and psychologically detrimental effects. A basic experimental (control group only for post-test) design using the technique of probability of simple random sampling in order to obtain sample size 105 was conducted in an Immunization Clinic at a selected PHC, Tamil Nadu, India. Ice cube was applied for about 30 seconds that is enfolded with gauze and then injected intramuscularly to administer the IM vaccine. In order to assess the pain level, an observation checklist based on Children's Hospital Eastern Ontario pain scale and Wong Baker's Faces pain scale was used. The study results manifest the higher statistical difference in the level of children's pain between the control groups and the experimental groups at a significance level of p<0.001. In order to reduce the pain level, the application of ice at LI-4 acupoint is effective. The children who are being vaccinated pass through stressful events through the application of an intramuscular injection. The findings revealed that ice application at LI-4 acupoint was very effective in pain reduction, which is a simple, safe, non-invasive, very efficient, easy-to-administer intervention and cost-effective without side effects than any other pharmacological pain intervention.

Recurrent infections drive persistent bladder dysfunction and pain via sensory nerve sprouting and mast cell activity.

Urinary tract infections (UTIs) account for almost 25% of infections in women. Many are recurrent (rUTI), with patients frequently experiencing chronic pelvic pain and urinary frequency despite clearance of bacteriuria after antibiotics. To elucidate the basis for these bacteria-independent bladder symptoms, we examined the bladders of patients with rUTI. We noticed a notable increase in neuropeptide content in the lamina propria and indications of enhanced nociceptive activity. In mice subjected to rUTI, we observed sensory nerve sprouting that was associated with nerve growth factor (NGF) produced by recruited monocytes and tissue-resident mast cells. Treatment of rUTI mice with an NGF-neutralizing antibody prevented sprouting and alleviated pelvic sensitivity, whereas instillation of native NGF into naïve mice bladders mimicked nerve sprouting and pain behavior. Nerve activation, pain, and urinary frequency were each linked to the presence of proximal mast cells, because mast cell deficiency or treatment with antagonists against receptors of several direct or indirect mast cell products was each effective therapeutically. Thus, our findings suggest that NGF-driven sensory sprouting in the bladder coupled with chronic mast cell activation represents an underlying mechanism driving bacteria-independent pain and voiding defects experienced by patients with rUTI.

Efficacy of ScopeGuide-Assisted Training in Enhancing Colonoscopy Competence and Reducing Patient Discomfort.

OBJECTIVE: In this study, we aimed to evaluate the efficacy of the Magnetic Scope Guide Assist (ScopeGuide) in enhancing the procedural competence of endoscopists and reducing patient discomfort during colonoscopy. METHODS: This was a retrospective study with 88 trainee participants. The study participants were trained on patients who underwent colonoscopy without anesthesia. Both ScopeGuide-assisted training and conventional training (without ScopeGuide) were utilized for colonoscopy instruction. The outcomes of training were compared, with a particular emphasis on the competency of looping resolution. RESULTS: ScopeGuide-assisted training was superior to conventional training in multiple aspects, including looping resolution ( Z =-3.681, P <0.001), pain scores ( Z =-4.211, P <0.001), time to reach the cecum ( Z =-4.06, P <0.001), willingness to undergo repeat colonoscopy ( Z =-4.748, P <0.001), competence of positional changes ( Z =-4.079, P <0.001), and the effectiveness of assisted compression ( Z =-3.001, P =0.003). Further stratified analysis revealed that the ScopeGuide-assisted training mode was more beneficial for junior endoscopists ( P <0.05 in all parameters) but not for intermediate endoscopists ( P >0.05) and partially beneficial for senior endoscopists ( P <0.05 for all parameters except looping resolution). CONCLUSION: ScopeGuide-assisted training can significantly facilitate endoscopists in resolving loops and reducing patient pain, thereby enhancing their colonoscopy abilities.

The effectiveness of customised 3D-printed insoles on perceived pain, comfort, and completion time among frequent Park Runners: Study protocol for a pragmatic randomised controlled trial (The ZOLES RCT).

BACKGROUND: Running, a popular recreational activity, often leads to the experience of pain and discomfort among participants impacting performance and participation longevity. The ZOLES trial evaluates customised 3D-printed insoles for reducing pain in frequent parkrunners aged 35 and over. An innovative process of foot-scanning and responses to questions relating to size, pain, discomfort, and previous medical conditions are combined leading to the production of personalised 3D-printed orthotics. METHODS: The ZOLES trial is a pragmatic, outcome assessor blinded, randomised, controlled, superiority trial involving 200 recreational runners, randomised to receive either customised 3D-printed insoles (ZOLES) or to a "do-as-usual" control group. The study follows a robust protocol, ensuring adherence to established guidelines for clinical trials, and is based at St Mary's University, Twickenham, London. The primary outcome is change in running-related pain over a 10-week period, assessed using an 11-point Numeric Rating Scale. Secondary outcomes include overall pain and discomfort, running-related comfort, 5k-completion time, time-loss due to injuries, running exposure, and adherence to the intervention. A balanced-block randomisation process is stratified by sex and parkrun location, and an intention-to-treat analyses will be employed on all outcomes in the primary trial report. The trial includes a 52-week post-market surveillance to assess long-term effects of the customised insoles. DISCUSSION: The ZOLES trial aims to provide insights into real-world applicability and effectiveness of customised 3D-printed insoles in reducing running-related pain and enhancing overall running experience. Despite the limitation of a subjective primary outcome measure without participant blinding, the methodological rigor, including external outcome assessment and data handling, we anticipate results that are academically credible and applicable in real-world settings The results of this trial may have important implications for runners, clinicians, and the sports footwear industry, as evidence for the use of individualised insoles to improve running experience and prevention of pain may become evident. TRIAL REGISTRATION: The trial was pre-registered at ClinicalTrials.gov with the trial identifier NCT06034210 on September 4, 2023, and publicly posted on September 13, 2023 (https://clinicaltrials.gov/study/NCT06034210). PROTOCOL VERSION: Version 1, September 27, 2023.

Randomized split-face study using a post-procedural biotech cellulose mask to improve patient comfort and downtime.

BACKGROUND: There are many post-procedural treatments touted to improve comfort and decrease downtime, but very few prospective randomized studies. AIMS: To analyze the safety and efficacy of a post-procedural biotech cellulose mask. PATIENTS/METHOD: Fifteen patients undergoing either a microneedling with radiofrequency (n = 5), non-ablative fractional (n = 5), or full erbium:YAG resurfacing (n = 5) treatment were randomized to receive a biotech cellulose mask on one side of the face for 30 min after the procedure and for 2 h a day until healed. Standardized photos and thermal images were taken 30 min after the procedure and daily until healed. The investigator and blind evaluators reviewed the photos, and subjects answered daily questionnaires. RESULTS: An analysis of the thermal images showed a significant reduction in facial temperature on the biotech cellulose mask side as compared to the control side in all groups with an average of 2.2 (range 0.2-6.5) degree Celsius reduction across all 15 subjects. All subjects reported less pain and heat immediately upon application of the mask. Thirty minutes after application, 13/15 continued to report less pain and heat, and 11/15 reported less erythema and swelling on the mask side while blind evaluators were able to choose which side had the mask 80% of the time. On average, subjects also reported significantly less swelling on Day 1 and Day 2. CONCLUSION: The biotech cellulose mask decreased patient's facial temperature, feelings of heat and pain, as well as downtime without any side effects for the subjects in this study undergoing a variety of treatments.

Comparative Efficacy of Breastfeeding or Feeding of Breast Milk on Blood Sampling Pain Relief in Full-Term Neonates: A Systematic Review and Meta-Analysis.

Objectives: To evaluate the efficacy of breastfeeding or feeding of breast milk in reducing blood sampling pain in full-term neonates by comparing with other intervention measures. Methods: Related literature was searched from PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials (Central). Only randomized controlled trials (RCTs), which reported the effect of breastfeeding or feeding of breast milk on blood sampling pain in full-term neonates, were eligible. The primary outcome was set as pain score on scales, and the secondary outcomes as physiological and behavioral indicators. The risk of bias in included studies was assessed by the Cochrane Collaboration's tool. Data analysis was performed using RevMan 5.4.1. Main Results: A total of 17 RCTs were included. Breastfeeding showed a stronger effectiveness in reducing blood sampling pain, compared with nonintervention, placebo, mother's holding, breast milk odor, mother's heartbeat, music therapy, skin-to-skin, and Eutectic Mixture of Local Anesthetics ointment. However, the efficacy of glucose or sucrose (12.5%-30% concentration) seems better than breastfeeding. When compared with other interventions, feeding of breast milk yielded different results. Its effect was only stronger than placebo (sterile water or distilled water), massage, or nonintervention. Conclusions: Breastfeeding might be effective for alleviating blood sampling pain in full-term neonates. Its effect is second only to that of glucose/sucrose. The efficacy of feeding of breast milk in reducing blood sampling pain in full-term neonates might not be guaranteed.

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.

If we know better, why don't we do better? A rapid quality improvement project to increase utilization of comfort measures to reduce pain and distress in children in a COVID-19 mass vaccination clinic.

INTRODUCTION: Many evidence-based tools exist to address pain and distress associated with injections; however, there remains a large gap between the knowledge of these tools and their utilization. Our hospital began a quality improvement (QI) project prior to COVID-19, with the goal of increasing the utilization of Comfort Promise measures during needle procedures. When COVID-19 vaccinations were approved, our mass vaccination clinics provided an opportunity to rapidly increase utilization across the institution. The primary aim was to increase the percentage of comfort measures (CM) offered with COVID-19 vaccinations. METHODS: Through this QI project, nurses and other professionals implemented CMs during COVID mass vaccination clinics. Clinics occurred in 3 age-based waves. Waves served as Plan-Do-Study-Act (PDSA) cycles. Families completed post-vaccination surveys to determine what CMs were offered and intention for future use with vaccinations. RESULTS: Uptake of CMs (PainEase, ShotBlockers, Comfort Positioning, Alternative Focus, Topical Lidocaine, and Breastfeeding/Sucrose) throughout the waves increased and generally remained stable. CMs also seemed to decrease pain/distress with vaccinations (70.5 to 88.7%), and children/caregivers intended to use some combination for future vaccinations (82.5 to 98.5%). CONCLUSIONS: Fast-paced mass vaccination clinics provided an ideal opportunity to significantly increase utilization of CMs. Across age groups CMs yielded high satisfaction and interest in future utilization. Clinic nurses returned to their own sub-specialties and became change agents. IMPLICATIONS: If all healthcare providers can work together to achieve consensus while incorporating comfort measures into daily practice, sustained change with incorporation of these evidence-based tools can be achieved. Future directions are discussed.