Xu Lingxue, Xiang Lali, Pan Lihui, Xue Peipei, Li Juan, He Yurong, Liu Hongyan, Hu Yuwei, Zheng Bo
NICU, Yuhuan People's Hospital, Taizhou, China.
Global Visiting Scholar Program, UNC of Greensboro, Greensboro, NC, United States.
Front Pediatr. 2025 May 22;13:1547308. doi: 10.3389/fped.2025.1547308. eCollection 2025.
Newborns are particularly vulnerable to pain, and non-pharmacological methods are frequently employed for pain management due to their lack of side effects. However, there is a lack of comprehensive comparison and ranking of the effectiveness of various non-pharmacological interventions.
To evaluate the effectiveness of non-pharmacological interventions and to determine whether differences exist in the efficacy of various interventions.
Systematic review and network meta-analysis.
RCTs studies in MEDLINE, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials from inception to November 1, 2024.
Up to November 1, 2024, we conducted a comprehensive search across four databases to identify studies meeting our inclusion criteria. A Bayesian model was employed for the analysis, and heterogeneity was quantified using random-effects standard deviation (RESD), ², and I² statistics. The certainty of the synthesized evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. This study protocol has been registered with PROSPERO.
Initially, we identified 20 citations and included 59 trials involving 2,028 participants for network meta-analysis. Due to many interventions being supported by only one or two original studies, we excluded interventions with fewer than three studies. Ultimately, we identified 13 citations, including 31 trials with a total of 1,141 participants. Regarding efficacy, several interventions were found to be effective. Breast milk (BM), sweet taste (ST), Yakson touch (YT), swaddling, and heel warming (HW) demonstrated significant effectiveness, with mean differences (MDs) in NIPS scores as follows: BM vs. control, -1.71 [95% credible interval (CrI): -2.29, -1.17]; ST vs. control, -1.35 (CrI: -2.13, -0.52); YT vs. control, -1.41 (CrI: -2.09, -0.74); swaddling vs. control, -0.65 (CrI: -1.23, -0.13); and HW vs. control, -0.53 (CrI: -0.89, -0.01). In pairwise comparisons between interventions, significant efficacy differences were observed: BM vs. HW, -1.89 (CrI: -2.70, -1.05); BM vs. non-nutritive sucking (NNS), -1.89 (CrI: -2.70, -1.05); BM vs. ST, -0.88 (CrI: -1.61, -0.11); BM vs. YT, -0.82 (CrI: -1.56, -0.03); BM vs. swaddling, -1.59 (CrI: -2.20, -0.78); NNS vs. ST, 0.98 (CrI: 0.11, 1.89); NNS vs. YT, 1.06 (CrI: 0.12, 2.03); and HW vs. YT, 0.89 (CrI: 0.23, 1.69). Notably, NNS was not found to be effective. The Surface Under the Cumulative Ranking Curve (SUCRA) analysis suggested that BM may be the most effective non-pharmacological intervention for neonatal pain management. SUCRA rankings for the interventions were as follows: BM > ST > YT > swaddling > HW > NNS > control. However, the certainty of the evidence ranged from moderate to very low. Heterogeneity assessments indicated a random-effects standard deviation (RESD) of 0.28 (CrI: 0.04, 0.73) in the consistent model and 0.36 (CrI: 0.01, 1.36) in the inconsistent model, with ² = 100% and ² = 2.22.
Given the limitation of high heterogeneity, this study should be regarded as a clinical effectiveness comparison. Among the included interventions, breast milk (BM), sweet taste (ST), Yakson touch (YT), heel warming (HW), and swaddling were found to be efficacious, while non-nutritive sucking (NNS) was not effective. The top three interventions, based on ranking, were BM, YT, and ST. However, some effects should be interpreted with caution, as they are derived from small sample sizes. Future research should focus on identifying factors associated with individual responses through large, multicenter studies.
Findings will inform nurse managers of an ideal environment for the non-pharmacological pain management for newborn.
https://www.crd.york.ac.uk/PROSPERO/view/CRD42023399924, PROSPERO CRD42024567338.
新生儿尤其容易受到疼痛影响，由于非药物方法没有副作用，因此经常用于疼痛管理。然而，各种非药物干预措施的有效性缺乏全面比较和排名。
评估非药物干预措施的有效性，并确定各种干预措施的疗效是否存在差异。
系统评价和网状Meta分析。
检索MEDLINE、EMBASE、科学网、Cochrane对照试验中心注册库中从建库至2024年11月1日的随机对照试验研究。
截至2024年11月1日，我们在四个数据库中进行了全面检索，以识别符合纳入标准的研究。采用贝叶斯模型进行分析，并使用随机效应标准差（RESD）、²和I²统计量对异质性进行量化。使用推荐分级、评估、制定与评价（GRADE）方法评估综合证据的确定性。本研究方案已在国际前瞻性注册系统（PROSPERO）注册。
最初，我们识别出20条引文，并纳入59项试验，涉及2028名参与者进行网状Meta分析。由于许多干预措施仅得到一两项原始研究的支持，我们排除了研究少于三项的干预措施。最终，我们识别出13条引文，包括31项试验，共1141名参与者。在疗效方面，发现几种干预措施有效。母乳（BM）、甜味（ST）、亚克森抚触（YT）、襁褓包裹和足跟保暖（HW）显示出显著疗效，新生儿婴儿疼痛评分量表（NIPS）得分的平均差（MDs）如下：BM与对照组相比，-1.71[95%可信区间（CrI）：-2.29，-1.17]；ST与对照组相比，-1.35（CrI：-2.13，-0.52）；YT与对照组相比，-1.41（CrI：-2.09，-0.74）；襁褓包裹与对照组相比，-0.65（CrI：-1.23，-0.13）；HW与对照组相比，-0.53（CrI：-0.89，-0.01）。在干预措施的两两比较中，观察到显著的疗效差异：BM与HW相比，-1.89（CrI：-2.70，-1.05）；BM与非营养性吸吮（NNS）相比，-1.89（CrI：-2.70，-1.05）；BM与ST相比，-0.88（CrI：-1.61，-0.11）；BM与YT相比，-0.82（CrI：-1.56，-0.03）；BM与襁褓包裹相比，-1.59（CrI：-2.20，-0.78）；NNS与ST相比，0.98（CrI：0.11，1.89）；NNS与YT相比，1.06（CrI：0.12，2.03）；HW与YT相比，0.89（CrI：0.23，1.69）。值得注意的是，未发现NNS有效。累积排序曲线下面积（SUCRA）分析表明，BM可能是新生儿疼痛管理最有效的非药物干预措施。干预措施的SUCRA排名如下：BM＞ST＞YT＞襁褓包裹＞HW＞NNS＞对照组。然而，证据的确定性从中度到非常低不等。异质性评估表明，一致性模型中的随机效应标准差（RESD）为0.28（CrI：0.04，0.73），不一致模型中的RESD为0.36（CrI：0.01，1.36），²=100%，²=2.22。
鉴于高异质性的局限性，本研究应被视为临床有效性比较。在所纳入的干预措施中，发现母乳（BM）、甜味（ST）、亚克森抚触（YT）、足跟保暖（HW）和襁褓包裹有效，而非营养性吸吮（NNS）无效。根据排名，前三项干预措施是BM、YT和ST。然而，由于样本量小，一些结果应谨慎解释。未来的研究应通过大型多中心研究，专注于识别与个体反应相关的因素。
研究结果将为新生儿非药物疼痛管理的理想环境告知护理管理者。
https://www.crd.york.ac.uk/PROSPERO/view/CRD42023399924，PROSPERO CRD42024567338。
