The influence of skin-to-skin contact on Cortical Activity during Painful procedures in preterm infants in the neonatal intensive care unit (iCAP mini): study protocol for a randomized control trial.

BACKGROUND: Strong evidence suggests that maternal-infant skin-to-skin contact (SSC) is effective in reducing behavioural responses to pain. Given the multi-sensory benefits of SSC, it is highly likely that SSC provided during pain in early life may reduce pain-induced brain activity. The aim of this study is to examine the effect of SSC compared to 24% sucrose on pain-induced activity in the preterm infant brain during a medically required heel lance. Secondary objectives include determining (a) differences between behavioural pain response and noxious-related brain activity during heel lance and (b) rate of adverse events across groups. METHODS: We will randomly assign 126 babies (32 to 36 completed weeks gestational age) admitted to the neonatal intensive care unit, and their mothers within the first seven days of age to receive (i) SSC plus sterile water and (ii) 24% oral sucrose. Each baby will receive a medically indicated heel lance, following a no treatment baseline period. The primary outcome is noxious-related brain activity measured using an electroencephalogram (EEG) pain-specific event-related potential. Secondary outcomes include pain intensity measured using a bio-behavioural infant pain assessment tool (Premature Infant Pain Profile-Revised) and rate of adverse events. DISCUSSION: This will be the first clinical trial to compare the effect of SSC and 24% sucrose on pain-induced brain activity in the preterm infant brain during a clinical noxious stimulus, measured using EEG. Given the negative neurodevelopmental outcomes associated with unmanaged pain, it is imperative that preterm babies receive the most effective pain-reducing treatments to improve their health outcomes. Our findings will have important implications in informing optimal pain assessment and management in preterm infants. TRIAL REGISTRATION: ClinicalTrials.gov NCT03745963 . Registered on November 19, 2018.

What is the definition of acute episodic and chronic pain in critically ill neonates and infants? A global, four-stage consensus and validation study.

OBJECTIVES: To define and validate types of pain in critically ill neonates and infants by researchers and clinicians working in the neonatal intensive care unit (NICU) and high dependency unit (HDU). DESIGN: A qualitative descriptive mixed-methods design. PROCEDURE/S: Each stage of the study was built on and confirmed the previous stages. Stage 1 was an expert panel to develop definitions; stage 2 was a different expert panel made up of neonatal clinicians to propose clinical characteristics associated with the definitions from stage 1; stage 3 was a focus group of neonatal clinicians to provide clinical case scenarios associated with each definition and clinical characteristics; and stage 4 was a survey administered to neonatal clinicians internationally to test the validity of the definitions using the clinical case scenarios. RESULTS: In stage 1, the panel (n=10) developed consensus definitions for acute episodic pain and chronic pain in neonates and infants. In stage 2, a panel (n=8) established clinical characteristics that may be associated with each definition. In stage 3, a focus group (n=11) created clinical case scenarios of neonates and infants with acute episodic pain, chronic pain and no pain using the definitions and clinical characteristics. In stage 4, the survey (n=182) revealed that the definitions allowed an excellent level of discrimination between case scenarios that described neonates and infants with acute episodic pain and chronic pain (area under the receiver operating characteristic=0.87 and 0.89, respectively). CONCLUSIONS: This four-stage study enabled the development of consensus-based and clinically valid definitions of acute episodic pain and chronic pain. There is a need to define and validate other pain types to inform a taxonomy of pain experienced by neonates and infants in the NICU and HDU.

Neonatal pain: A journey spanning three decades.

From 1980 into present day, 2020, the evolution of neonatal pain research is told as a journey by one researcher, Celeste Johnston. At the beginning of her work, there was essentially no interest or work in the area. She was fortunate to be led into the area by a clinical problem: how to determine the amount of pain babies in the NICU were experiencing. That question resulted in over three decades of work with neonates. Measuring pain was the first challenge and is one that remains a focus of current research. Initially, the only choices for treating pain in neonates were either opioids or anesthetics, each with problems. Research on sweet taste and more recently on skin-to-skin contact has offered effective and safe options for procedural pain. Although progress has been made in the incidence of pain management in infants, it still is far less than it could be. Steps along the way of measurement, treatment, and knowledge utilization are chronicled by this researcher.

Nonpharmacologic Management of Pain During Common Needle Puncture Procedures in Infants: Current Research Evidence and Practical Considerations: An Update.

Infants undergo painful procedures involving skin puncture as part of routine medical care. Pain from needle puncture procedures is suboptimally managed. Numerous nonpharmacologic interventions are available that may be used for these painful procedures, including swaddling/containment, pacifier/non-nutritive sucking, rocking/holding, breastfeeding and breastmilk, skin-to-skin care, sweet tasting solutions, music therapy, sensorial saturation, and parental presence. Adoption these interventions into routine clinical practice is feasible and should be a standard of care in quality health care for infants. This review summarizes the epidemiology of pain from common needle puncture procedures in infants, the effectiveness of nonpharmacologic interventions, implementation considerations, and unanswered questions.

Skin-to-skin care for procedural pain in neonates.

BACKGROUND: Skin-to-skin care (SSC), often referred to as 'kangaroo care' (KC) due to its similarity with marsupial behaviour of ventral maternal-infant contact, is one non-pharmacological intervention for pain control in infants. OBJECTIVES: The primary objectives were to determine the effect of SSC alone on pain from medical or nursing procedures in neonates compared to no intervention, sucrose or other analgesics, or additions to simple SSC such as rocking; and to determine the effects of the amount of SSC (duration in minutes), method of administration (e.g. who provided the SSC) of SSC in reducing pain from medical or nursing procedures in neonatesThe secondary objectives were to determine the safety of SSC care for relieving procedural pain in infants; and to compare the SSC effect in different postmenstrual age subgroups of infants. SEARCH METHODS: For this update, we used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1); MEDLINE via PubMed (1966 to 25 February 2016); Embase (1980 to 25 February 2016); and CINAHL (1982 to 25 February 2016). We also searched clinical trials' databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials. SELECTION CRITERIA: Studies with randomisation or quasi-randomisation, double- or single-blinded, involving term infants (≥ 37 completed weeks' postmenstrual age (PMA) to a maximum of 44 weeks' PMA and preterm infants (< 37 completed weeks PMA) receiving SSC for painful procedures conducted by healthcare professionals. DATA COLLECTION AND ANALYSIS: The main outcome measures were physiological or behavioural pain indicators and composite pain scores. A mean difference (MD) with 95% confidence interval (CI) using a fixed-effect model was reported for continuous outcome measures. We included variations on type of tissue-damaging procedure, provider of care, and duration of SSC. MAIN RESULTS: Twenty-five studies (n = 2001 infants) were included. Nineteen studies (n = 1065) used heel lance as the painful procedure, one study combined venepuncture and heel stick (n = 50), three used intramuscular injection (n = 776), one used 'vaccination' (n = 60), and one used tape removal (n = 50). The studies were generally strong and had low or uncertain risk of bias. Blinding of the intervention was not possible, making them subject to high risk, depending on the method of scoring outcomes.Seventeen studies (n = 810) compared SSC to a no-treatment control. Although 15 studies measured heart rate during painful procedures, data from only five studies (n = 161) could be combined for a mean difference (MD) of -10.78 beats per minute (95% CI -13.63 to -7.93) favouring SSC. Meta-analysis of four studies (n = 120) showed no difference in heart rate following the painful procedure (MD 0.08, 95% CI -4.39 to 4.55). Two studies (n = 38) reported heart rate variability with no significant differences. Two studies (n = 101) in a meta-analysis on oxygen saturation at 30 and 60 seconds following the painful procedure did not show a difference. Duration of crying meta-analysis was performed on four studies (n = 133): two (n = 33) investigated response to heel lance (MD = -34.16, 95% CI -42.86 to -25.45), and two (n = 100) following IM injection (MD = -8.83, 95% CI -14.63 to -3.02), favouring SSC. Five studies, one consisting of two substudies (n = 267), used the Premature Infant Pain Profile (PIPP) as a primary outcome, which favoured SCC at 30 seconds (MD -3.21, 95% CI -3.94 to -2.47), at 60 seconds (3 studies; n = 156) (MD -1.64, 95% CI -2.86 to -0.43), and at 90 seconds (n = 156) (MD -1.28, 95% CI -2.53 to -0.04); but at 120 seconds there was no difference (n = 156) (MD 0.07, 95% CI -1.11 to 1.25). No studies on return of heart rate to baseline level, cortisol levels, and facial actions could be combined for meta-analysis findings.Eight studies compared SSC to another intervention with or without a no-treatment control. Two cross-over studies (n = 80) compared mother versus other provider (father, another female) on PIPP scores at 30, 60, 90, and 120 seconds with no significant difference. When SSC was compared to other interventions, there were not enough similar studies to pool results in an analysis. One study compared SSC (n = 640) with and without dextrose and found that the combination was most effective and that SSC alone was more effective than dextrose alone. Similarly, in another study SSC was more effective than oral glucose for heart rate (n = 95). SSC either in combination with breastfeeding or alone was favoured over a no-treatment control, but not different to breastfeeding. One study compared SSC alone and in combination with both sucrose and breastfeeding on heart rate (HR), NIPS scores, and crying time (n = 127). The combinations were more effective than SSC alone for NIPS and crying. Expressed breast milk was compared to SSC in one study (n = 50) and found both equally effective on PIPP scores. There were not enough participants with similar outcomes and painful procedures to compare age groups or duration of SSC. No adverse events were reported in any of the studies. AUTHORS' CONCLUSIONS: SSC appears to be effective as measured by composite pain indicators with both physiological and behavioural indicators and, independently, using heart rate and crying time; and safe for a single painful procedure. Purely behavioural indicators tended to favour SSC but with facial actions there is greater possibility of observers not being blinded. Physiological indicators were mixed although the common measure of heart rate favoured SSC. Two studies compared mother-providers to others, with non-significant results. There was more heterogeneity in the studies with behavioural or composite outcomes. There is a need for replication studies that use similar, clearly defined outcomes. Studies examining optimal duration of SSC, gestational age groups, repeated use, and long-term effects of SSC are needed. Of interest would be to study synergistic effects of SSC with other interventions.

Effects of Cycled Lighting Versus Continuous Near Darkness on Physiological Stability and Motor Activity Level in Preterm Infants.

BACKGROUND: Preterm infants generally spend weeks in the neonatal intensive care unit where light intensity can fluctuate as well as be high, leading to physiological instability and increased motor activity in these infants. To date, 2 lighting control methods have been studied: cycled lighting and continuous near darkness. The most appropriate method of lighting is still unknown due to ambivalent results from the studies that have assessed these 2 interventions. OBJECTIVE: To compare the effects of cycled lighting versus continuous near darkness on physiological stability and motor activity level in preterm infants born between 28 and 32 weeks of gestation. METHODS: A randomized clinical trial was conducted to compare physiological stability and motor activity level in preterm infants assigned to cycled lighting or continuous near darkness. Thirty-eight participants were recruited and randomly assigned to one of the lighting conditions for 24 hours. Physiological stability was measured using the Stability of the Cardiorespiratory System in Premature Infants (SCRIP) score, the means, and the coefficient of variation of each physiological parameter measured. The level of motor activity was measured with an accelerometer. RESULTS: There were no significant differences between the 2 groups with regard to physiological stability measured by the SCRIP score, means, and coefficient of variation as well as motor activity level. Participants in both groups were physiologically stable and their motor activity level was comparable. IMPLICATIONS FOR PRACTICE AND RESEARCH: Neither cycled lighting nor continuous near darkness negatively impacted infant's physiologic stability and motor activity level. Further research is required to identify the most appropriate lighting control method for preterm infants born between 28 and 32 weeks of gestation.

Skin-to-skin contact for procedural pain in neonates: acceptability of novel systematic review synthesis methods and GRADEing of the evidence.

AIMS: The aim of this study was to assess the acceptability of methods that increase trial inclusion in meta-analyses, and the level of evidence for skin-to-skin contact for procedural pain in infants. BACKGROUND: The current Cochrane review of skin-to-skin contact for pain in newborns found it to be an effective intervention, but identified several methodological limitations. DESIGN: Meta-re-analysis METHODS: Trial designs included randomized trials reporting a validated pain assessment tool as a primary outcome including term and pre-term infants undergoing a tissue-breaking painful procedure. The search in the original review was conducted to January 2013. Scores of validated tools were scaled to the premature infant pain profile in a fixed-effect meta-re-analysis. The GRADE was used to assess quality of meta-analysed evidence. RESULTS: New analysis vs. original found a mean difference: -3·11 in favour of skin-to-skin contact vs. -3·21 at 30 seconds; and -2·71 vs. -1·85 at 60 seconds for heel lance. Based on cut-off scores for the Neonatal Infant Pain Scale, infants receiving skin-to-skin contact during IM injection were more likely to display low pain after injection; and during recovery. CONCLUSION: Scaling scores to a single outcome can provide additional information in meta-analyses, simplifies interpretability of pooled scores, and can improve GRADE outcomes. Sensitivity analyses of scaled scores improve confidence in their validity. Risk of bias subgroups simplified the GRADE process, and confidence intervals for heterogeneity statistics assisted in interpretation of sensitivity analyses.

Staff Nurse Utilization of Kangaroo Care as an Intervention for Procedural Pain in Preterm Infants.

BACKGROUND: Skin-to-skin contact between mother and infant, commonly referred to as Kangaroo Care (KC), has demonstrated efficacy as a pain-relieving strategy for infants, yet, it remains underutilized in clinical practice. PURPOSE: To evaluate changes in neonatal intensive care unit staff nurse beliefs, utilization, and challenges related to practice change in implementing KC as an intervention for management of procedural pain in preterm infants between 2 time points. METHODS: Nurses who participated in a larger clinical trial examining the sustained efficacy of KC were asked to complete a questionnaire at 2 time points: 1- and 6 month(s) following study initiation. Identified benefits, expectations, frequency of use, and challenges related to practice change uptake were described using frequencies and percentages. Data from the 2 different time points were compared using χ analysis. RESULTS: Of the 40 nurses approached, all completed the questionnaire (19 at the 1-month and 21 at the 6-month time point). Of the sample (n = 40), 97% of participants indicated that they expected KC to provide good pain relief or better. Staff nurses reported significantly improved preconceived ideas (χ = 22.68, P < .01) and significantly fewer concerns (χ = 22.10, P = .01) related to using KC as a pain-relieving intervention between the 2 time points. No significant differences were seen in the frequency of using KC as an intervention between time points. IMPLICATIONS FOR RESEARCH AND PRACTICE: Despite increasingly positive preconceived ideas and reduced concerns, the frequency of using KC for procedural pain relief remained unchanged. Further research addressing ways to overcome barriers to utilizing KC as an intervention for procedural pain is warranted.

Perceptions of health professionals on pain in extremely low gestational age infants.

Extremely low gestational age infants (<28 weeks at birth) experience significant pain from repeated therapeutic procedures while hospitalized in the neonatal intensive care unit. As part of a program of research examining pain in preterm infants, we conducted a qualitatively driven mixed-methods design, supplemented with a qualitative and quantitative component, to understand how health care professionals (HCPs) assess and manage procedural pain for tiny and underdeveloped preterm infants. Fifty-nine HCPs from different disciplines across four tertiary-level neonatal units in Canada participated in individual or focus group interviews and completed a brief questionnaire. Four themes from the content analysis were (a) subtlety and unpredictability of pain indicators, (b) infant and caregiver attributes and contextual factors that influence pain response and practices, (c) the complex nature of pain assessment, and (d) uncertainty in the management of pain. The information gleaned from this study can assist in identifying gaps in knowledge and informing unit-based and organizational knowledge translation strategies for this vulnerable population.

Relationship Between Empathy and Well-Being Among Emergency Nurses.

INTRODUCTION: A large number of patients who are in pain upon arriving at the emergency department are still in pain when they are discharged. It is suggested that nurses' personal traits and their level of empathy can explain in part this issue in pain management. The purpose of this study was to better understand the shortfalls in pain management provided by emergency nurses by considering nurses' characteristics. METHODS: A cross-sectional descriptive correlational design was used for this pilot study. French validated self-administrated questionnaires (sociodemographic characteristics, empathy, psychological distress, and well-being) were presented to 40 emergency nurses. Thirty emergency nurses completed all questionnaires during work hours. Descriptive statistics, group comparisons, and correlation analyses were used for the data analysis. RESULTS: Emergency nurses appear to have low levels of empathy. High levels of psychological distress and low levels of well-being were also observed in our sample. Among these variables, only empathy and well-being appear to be related, because we found higher empathy scores in nurses with higher well-being. DISCUSSION: The poor mental health we found among emergency nurses is alarming. A clear need exists for supportive interventions for nurses. Finally, well-being was the only variable related to empathy. To our knowledge, this is the first study to report this relationship in nurses.

The premature infant pain profile-revised (PIPP-R): initial validation and feasibility.

OBJECTIVES: To describe revisions to the Premature Infant Pain Profile (PIPP) and initial construct validation and feasibility of the Premature Infant Pain Profile-Revised (PIPP-R). METHODS: The PIPP was revised to enhance validity and feasibility. To validate the PIPP-R, data from 2 randomized cross-over studies were utilized to: (1) calculate and compare PIPP and PIPP-R scores in extremely low gestational age infants undergoing a painful and nonpainful event (N=52; dataset #1) and (2) calculate and compare PIPP and PIPP-R scores in assessing the effectiveness of (a) sucrose, (b) non-nutritive sucking (NNS)+sucrose, and (c) facilitated tucking+NNS+sucrose during heel lance (N = 85; dataset #2). Pearson correlations between PIPP and PIPP-R scores were calculated, and Student t tests and 1-way analysis of variance were used to determine construct validity during painful and nonpainful events. To establish feasibility, a survey of 31 Neonatal Intensive Care Unit nurses was conducted. RESULTS: PIPP-R scores were significantly lower during nonpainful (mean, 8.3; SD = 2.9) compared with painful (mean, 9.9; SD=3.1; t95 = 4.51, P = 0.036) events in extremely low gestational age infants in dataset #1. In dataset #2, PIPP-R scores were significantly lower in infants 25 to 41 weeks gestation in the group receiving NNS+sucrose compared with the other 2 groups (F2,79 = 2.9, P<0.05). Overall, nurses rated the PIPP-R as feasible. DISCUSSION: Initial construct validation and feasibility of the PIPP-R was demonstrated. Further testing with infants of varying gestational ages, diagnoses, and pain conditions is required; as is exploration of PIPP-R in relation to other types of physiological and cognitive responses.

Validation of the Premature Infant Pain Profile-Revised (PIPP-R).

OBJECTIVES: To examine the construct validity, inter-rater reliability, and feasibility of the Premature Infant Pain Profile-Revised in infants of varying gestational ages, diagnoses, and procedures. METHODS: A prospective cross-over study with infants in three gestational age groups (26-31, 32-36, and ≥37 weeks) at three university-affiliated Neonatal Intensive Care Units in Canada. One hundred and ninety five bedside nurses and expert raters rated 202 hospitalized infants' pain during scheduled procedures using the measure. An expert rater and a nurse independently assessed infants' pain scores, using the Premature Infant Pain Profile-Revised, during 246 scheduled pairs of painful and non-painful procedures in the 202 infants. Nurses also completed a feasibility survey on using the measure in a clinical setting. To establish construct validity, pain scores were computed during painful and non-painful procedures. Inter-rater reliability between pain experts and nurses was calculated. A 5-point Likert scale was used to measure feasibility in terms of clarity, ease of use, and time to complete. RESULTS: Irrespective of gestational age, Premature Infant Pain Profile-Revised scores were significantly higher during painful procedures (mean 6.7 [SD 3.0]) compared to non-painful procedures (mean 4.8 [SD 2.9]). There was a high degree of correlation between nurses' and experts' ratings for painful (all R(2)=0.92, p<0.001) and non-painful (all R(2)=0.87, p<0.001) procedures. Mean scores on all feasibility indicators were equal to or higher than 3.8. DISCUSSION: The Premature Infant Pain Profile Revised has beginning construct validation, inter-rater reliability, and is considered feasible by clinicians. Concurrent validation studies should be considered.

Skin-to-skin care for procedural pain in neonates.

BACKGROUND: Skin-to-skin care (SSC), otherwise known as Kangaroo Care (KC) due to its similarity with marsupial behaviour of ventral maternal-infant contact, is one non-pharmacological intervention for pain control in infants. OBJECTIVES: The primary objectives were to determine the effect of SSC alone on pain from medical or nursing procedures in neonates undergoing painful procedures compared to no intervention, sucrose or other analgesics, or additions to simple SSC such as rocking; and the effects of the amount of SSC (duration in minutes) and the method of administration (who provided the SSC, positioning of caregiver and neonate pair).The secondary objectives were to determine the incidence of untoward effects of SSC and to compare the SSC effect in different postmenstrual age subgroups of infants. SEARCH METHODS: The standard methods of the Cochrane Neonatal Collaborative Review Group were used. Databases searched in August 2011: Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library); Evidence-Based Medicine Reviews; MEDLINE (1950 onwards); PubMed (1975 onwards); EMBASE (1974 onwards); CINAHL (1982 onwards); Web of Science (1980 onwards); LILACS database (1982 onwards); SCIELO database (1982 onwards); PsycInfo (1980 onwards); AMED (1985 onwards); Dissertation-Abstracts International (1980 onwards). Searches were conducted throughout September 2012. SELECTION CRITERIA: Studies with randomisation or quasi-randomisation, double or single-blinded, involving term infants (> 37 completed weeks postmenstrual age (PMA)) to a maximum of 44 weeks PMA and preterm infants (< 37 completed weeks PMA) receiving SSC for painful procedures conducted by doctors, nurses, or other healthcare professionals. DATA COLLECTION AND ANALYSIS: The main outcome measures were physiological or behavioural pain indicators and composite pain scores. A weighted mean difference (WMD) with 95% confidence interval (CI) using a fixed-effect model was reported for continuous outcome measures. We included variations on type of tissue-damaging procedure, provider of care, and duration of SSC. MAIN RESULTS: Nineteen studies (n = 1594 infants) were included. Fifteen studies (n = 744) used heel lance as the painful procedure, one study combined venepuncture and heel stick (n = 50), two used intramuscular injection, and one used 'vaccination' (n = 80). The studies that were included were generally strong and free from bias.Eleven studies (n = 1363) compared SSC alone to a no-treatment control. Although 11 studies measured heart rate during painful procedures, data from only four studies (n = 121) could be combined to give a mean difference (MD) of 0.35 beats per minute (95% CI -6.01 to 6.71). Three other studies that were not included in meta-analyses also reported no difference in heart rate after the painful procedure. Two studies reported heart rate variability outcomes and found no significant differences. Five studies used the Premature Infant Pain Profile (PIPP) as a primary outcome, which favoured SCC at 30 seconds (n = 268) (MD -3.21, 95% CI -3.94 to -2.48), 60 seconds (n = 164) (MD -1.85, 95% CI -3.03 to -0.68), and 90 seconds (n = 163) (MD -1.34, 95% CI -2.56 to -0.13), but at 120 seconds (n = 157) there was no difference. No studies provided findings on return of heart rate to baseline level, oxygen saturation, cortisol levels, duration of crying, and facial actions that could be combined for analysis.Eight studies compared SSC to another intervention with or without a no-treatment control. Two cross-over studies (n = 80) compared mother versus other provider on PIPP scores at 30, 60, 90, and 120 seconds with no significant difference. When SSC was compared to other interventions, there were not enough similar studies to pool results in an analysis. One study compared SSC with and without dextrose and found that the combination was most effective and that SSC alone was more effective than dextrose alone. Similarly, in another study SSC was more effective than oral glucose for heart rate but not oxygen saturation. SSC either in combination with breastfeeding or alone was favoured over a no-treatment control, but was not different to breastfeeding. There were not enough participants with similar outcomes and painful procedures to compare age groups or duration of SSC. No adverse events were reported in any of the studies. AUTHORS' CONCLUSIONS: SSC appears to be effective, as measured by composite pain indicators and including both physiological and behavioural indicators, and safe for a single painful procedure such as a heel lance. Purely behavioural indicators tended to favour SSC but there remains questionable bias regarding behavioural indicators. Physiological indicators were typically not different between conditions. Only two studies compared mother providers to others, with non-significant results. There was more heterogeneity in the studies with behavioural or composite outcomes. There is a need for replication studies that use similar, clearly defined outcomes. New studies examining optimal duration of SSC, gestational age groups, repeated use, and long-term effects of SSC are needed.

Trial of repeated analgesia with Kangaroo Mother Care (TRAKC Trial).

BACKGROUND: Skin-to-skin contact (SSC) between mother and infant, commonly referred to as Kangaroo Mother Care (KMC), is recommended as an intervention for procedural pain. Evidence demonstrates its consistent efficacy in reducing pain for a single painful procedure. The purpose of this study is to examine the sustained efficacy of KMC, provided during all routine painful procedures for the duration of Neonatal Intensive Care Unit (NICU) hospitalization, in diminishing behavioral pain response in preterm neonates. The efficacy of KMC alone will be compared to standard care of 24% oral sucrose, as well as the combination of KMC and 24% oral sucrose. METHODS/DESIGN: Infants admitted to the NICU who are less than 36 6/7 weeks gestational age (according to early ultrasound), that are stable enough to be held in KMC, will be considered eligible (N = 258). Using a single-blinded randomized parallel group design, participants will be assigned to one of three possible interventions: 1) KMC, 2) combined KMC and sucrose, and 3) sucrose alone, when they undergo any routine painful procedure (heel lance, venipuncture, intravenous, oro/nasogastric insertion). The primary outcome is infant's pain intensity, which will be assessed using the Premature Infant Pain Profile (PIPP). The secondary outcome will be maturity of neurobehavioral functioning, as measured by the Neurobehavioral Assessment of the Preterm Infant (NAPI). Gestational age, cumulative exposure to KMC provided during non-pain contexts, and maternal cortisol levels will be considered in the analysis. Clinical feasibility will be accounted for from nurse and maternal questionnaires. DISCUSSION: This will be the first study to examine the repeated use of KMC for managing procedural pain in preterm neonates. It is also the first to compare KMC to sucrose, or the interventions in combination, across time. Based on the theoretical framework of the brain opioid theory of attachment, it is expected that KMC will be a preferred standard of care. However, current pain management guidelines are based on minimal data on repeated use of either intervention. Therefore, regardless of the outcomes of this study, results will have important implications for guidelines and practices related to management of procedural pain in preterm infants. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01561547.

Nonpharmacological management of pain during common needle puncture procedures in infants: current research evidence and practical considerations.

All infants undergo painful procedures involving skin puncture as part of routine medical care. Pain from needle puncture procedures is suboptimally managed. Numerous nonpharmacologic interventions are available for these painful procedures, including swaddling, holding, skin-to-skin care, pacifier, sweet-tasting solutions, and breast-feeding. Adoption of nonpharmacologic pain-relieving interventions into routine clinical practice is feasible and should be a standard of care in the delivery of quality health care for infants. This review summarizes current knowledge about the epidemiology of pain from common needle puncture procedures in infants, the effectiveness of nonpharmacologic interventions, implementation considerations, and unanswered questions for future research.

Therapeutic touch is not therapeutic for procedural pain in very preterm neonates: a randomized trial.

BACKGROUND: Preterm neonates below 30 weeks' gestational age undergo numerous painful procedures. Many management approaches are not appropriate for this population. Therapeutic Touch, an alternative approach based on the theory of energy medicine, has been shown to promote physiological stability in preterm neonates and reduce pain in some adult studies. The objective was to determine whether Therapeutic Touch is efficacious in decreasing pain in preterm neonates. METHODS: Infants < 30 weeks' gestational age participated in a randomized control trial in 2 level III neonatal intensive care units. All evaluations, analyses, and heel lance procedure were conducted with only the therapist knowing the group assignment. Immediately before and after the heel lance procedure, the therapist performed nontactile Therapeutic Touch (n = 27) with infant behind curtains, leaving the curtained area for the heel lance, performed by another. In the sham condition (n = 28), the therapist stood by the incubator with hands by her side. The Premature Infant Pain Profile was used for pain response and time for heart rate to return to baseline for recovery. Heart rate variability and stress response were secondary outcomes. RESULTS: There were no group differences in any of the outcomes. Mean Premature Infant Pain Profile scores across 2 minutes of heel lance procedure in 30-second blocks ranged from 7.92 to 8.98 in the Therapeutic Touch group and 7.64 to 8.46 in the sham group. INTERPRETATION: Therapeutic Touch given immediately before and after heel lance has no comforting effect in preterm neonates. Other effective strategies involving actual touch should be considered.

The characteristics and severity of psychological distress after abortion among university students.

Controversy over abortion inhibits recognition and treatment for women who experience psychological distress after abortion (PAD). This study identified the characteristics, severity, and treatment preferences of university students who experienced PAD. Of 151 females, 89 experienced an abortion. Psychological outcomes were compared among those who preferred or did not prefer psychological services after abortion to those who were never pregnant. All who had abortions reported symptoms of post-traumatic stress disorder (PTSD) and grief lasting on average 3 years. Yet, those who preferred services experienced heightened psychological trauma indicative of partial or full PTSD (Impact of Event Scale, M = 26.86 versus 16.84, p < .05), perinatal grief (Perinatal Grief Scale, M 62.54 versus 50.89, p < 0.05), dysthymia (BDI M = 11.01 versus 9.28, p < 0.05), (M = 41.86 versus 39.36, p < 0.05), and co-existing mental health problems. PAD appeared multi-factorial, associated with the abortion and overall emotional health. Thus, psychological interventions for PAD need to be developed as a public health priority.

Intervention minimizing preterm infants' exposure to NICU light and noise.

Neonatal intensive care unit (NICU) light and noise may be stressful to preterm infants. This research evaluated the physiological stability of 54 infants born at 28- to 32-weeks' gestational age while wearing eye goggles and earmuffs for a 4-hour period in the NICU. Infants were recruited from four NICUs of university-affiliated hospitals and randomized to the intervention-control or control-intervention sequences. Heart rate (HR), heart rate variability (HRV), and oxygen saturation (O2 sat) were collected using the SomtéTM device. Confounding variables such as position and handling were assessed by videotaping infants during the study periods. Results indicated that infants had more stress responses while wearing eye goggles and earmuffs since maximum HR was found to be significantly higher and high-frequency power of HRV significantly lower during the intervention as compared with the control period. Therefore, this intervention is not recommended for the clinical practice.

Alternative female kangaroo care for procedural pain in preterm neonates: a pilot study.

AIM: To determine the feasibility and effect size of kangaroo care (KC) for pain from heel lance in preterm neonates provided by either the infant's mother (MKC) or an unrelated alternate female (AFKC). METHODS: Using a randomized crossover design, preterm neonates (n = 18) between 28 and 37 weeks gestational age within 10 days of life from two university-affiliated level III NICU's undergoing routine heel lance were assigned to receive KC 30 min before and during the procedure from either their mother (MKC) or an unrelated woman. In the second heel lance procedure at least 24 h later but within 10 days, the infants were crossed over to the other condition. RESULTS: There was a 48% participation rate, with only 40 of 82 eligible cases having maternal consent. The main reason for refusal was discomfort with another woman providing kangaroo care. The effect sizes on the pain scores (PIPP) were small, ranging from .23 to .43 across the first 2 min of procedure. CONCLUSION: The difference between nonrelated females and the mother in decreasing pain response is small, although not negligible. Given the high refusal rate, nonrelated females are a less desirable alternative to mothers than fathers.