Johnston Celeste, Campbell-Yeo Marsha, Disher Timothy, Benoit Britney, Fernandes Ananda, Streiner David, Inglis Darlene, Zee Rebekah
Ingram School of Nursing, McGill University, Quebec, QC, Canada, H3A 2T5.
Neonatal Intensive Care Unit, IWK Health Centre, 5850/5980 University Avenue, PO Box 9700, Halifax, NS, Canada, B3K 6R8.
Cochrane Database Syst Rev. 2017 Feb 16;2(2):CD008435. doi: 10.1002/14651858.CD008435.pub3.
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.
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.
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.
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.
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.
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.
皮肤接触护理(SSC),因其与有袋动物母婴腹部接触行为相似,常被称为“袋鼠式护理”(KC),是一种用于控制婴儿疼痛的非药物干预措施。
主要目的是确定与无干预、蔗糖或其他镇痛药,或在简单的皮肤接触护理基础上增加如摇晃等方式相比,单纯皮肤接触护理对新生儿医疗或护理操作所致疼痛的影响;并确定皮肤接触护理的时长(以分钟为单位)、实施方式(如由谁提供皮肤接触护理)对减轻新生儿医疗或护理操作所致疼痛的效果。次要目的是确定皮肤接触护理缓解婴儿操作疼痛的安全性;并比较皮肤接触护理在不同月经龄亚组婴儿中的效果。
本次更新中,我们采用Cochrane新生儿综述小组的标准检索策略,检索Cochrane对照试验中心注册库(CENTRAL;2016年第1期);通过PubMed检索MEDLINE(1966年至2016年2月25日);Embase(1980年至2016年2月25日);以及CINAHL(1982年至2016年2月25日)。我们还检索了临床试验数据库、会议论文集以及检索到的随机对照试验和半随机试验文章的参考文献列表。
采用随机或半随机、双盲或单盲的研究,纳入足月儿(月经龄≥37足周至最大44周)和早产儿(月经龄<37足周),由医护人员对其进行疼痛操作时给予皮肤接触护理。
主要结局指标为生理或行为疼痛指标及综合疼痛评分。对于连续性结局指标,报告采用固定效应模型计算的平均差(MD)及95%置信区间(CI)。我们纳入了组织损伤操作类型、护理提供者以及皮肤接触护理时长等方面的差异。
纳入25项研究(共2001名婴儿)。19项研究(共1065名婴儿)采用足跟采血作为疼痛操作,1项研究将静脉穿刺和足跟采血相结合(共50名婴儿),3项研究采用肌肉注射(共776名婴儿),1项研究采用“疫苗接种”(共60名婴儿),1项研究采用去除胶布(共50名婴儿)。这些研究总体质量较高,偏倚风险较低或不确定。由于无法对干预措施进行盲法处理,根据结局评分方法,这些研究存在较高偏倚风险。17项研究(共810名婴儿)将皮肤接触护理与无治疗对照进行比较。尽管15项研究在疼痛操作期间测量了心率,但仅有5项研究(共161名婴儿)的数据可合并计算平均差,结果显示支持皮肤接触护理,平均差为每分钟-10.78次心跳(95%CI -13.63至-7.93)。对4项研究(共120名婴儿)进行的荟萃分析显示,疼痛操作后心率无差异(MD 0.08,95%CI -4.39至4.55)。2项研究(共38名婴儿)报告心率变异性无显著差异。对疼痛操作后30秒和60秒时氧饱和度进行的荟萃分析中,2项研究(共101名婴儿)未显示差异。对4项研究(共133名婴儿)进行了哭声持续时间的荟萃分析:2项研究(共33名婴儿)研究了对足跟采血的反应(MD = -34.16,95%CI -42.86至-25.45),2项研究(共100名婴儿)研究了肌肉注射后的反应(MD = -8.83,95%CI -14.63至-3.02),均支持皮肤接触护理。5项研究,其中1项包括2个亚研究(共267名婴儿),将早产儿疼痛量表(PIPP)作为主要结局指标,结果显示在30秒时支持皮肤接触护理(MD -3.21,95%CI -3.9至-2.47),60秒时(共3项研究;共156名婴儿)(MD -1.64,95%CI -2.86至-0.43),90秒时(共156名婴儿)(MD -1.2至-2.53至-0.04);但在120秒时无差异(共156名婴儿)(MD 0.07,95%CI -1.11至1.25)。关于心率恢复到基线水平、皮质醇水平和面部动作的研究,无法合并进行荟萃分析。8项研究将皮肤接触护理与另一种干预措施进行比较,有或无无治疗对照。2项交叉研究(共80名婴儿)比较了母亲与其他提供者(父亲、另一名女性)在30秒、60秒、90秒和120秒时的PIPP评分,无显著差异。当将皮肤接触护理与其他干预措施进行比较时,没有足够的相似研究来汇总结果进行分析。1项研究比较了有和没有葡萄糖情况下的皮肤接触护理(共640名婴儿),发现两者结合最有效,且单纯皮肤接触护理比单纯葡萄糖更有效。同样,在另一项研究中,皮肤接触护理在心率方面比口服葡萄糖更有效(共95名婴儿)。皮肤接触护理与母乳喂养联合或单独使用均优于无治疗对照,但与母乳喂养无差异。1项研究比较了单纯皮肤接触护理以及与蔗糖和母乳喂养联合使用对心率(HR)、NIPS评分和哭声时间的影响(共127名婴儿)。联合使用比单纯皮肤接触护理在NIPS评分和哭声方面更有效。1项研究(共50名婴儿)比较了挤出的母乳与皮肤接触护理,发现两者在PIPP评分上同样有效。没有足够多具有相似结局和疼痛操作的参与者来比较年龄组或皮肤接触护理的时长。所有研究均未报告不良事件。
从综合疼痛指标(包括生理和行为指标)以及独立使用心率和哭声时间来衡量,皮肤接触护理似乎是有效的;并且对于单次疼痛操作是安全的。单纯行为指标倾向于支持皮肤接触护理,但对于面部动作,观察者不设盲的可能性更大。生理指标结果不一,尽管常用的心率指标支持皮肤接触护理。2项研究比较了母亲提供者与其他提供者,结果无显著差异。行为或综合结局的研究中存在更多异质性。需要进行重复研究,采用相似、明确界定的结局指标。需要开展研究以考察皮肤接触护理的最佳时长、胎龄组、重复使用情况以及长期效果。研究皮肤接触护理与其他干预措施的协同效应将很有意义。