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Crochet Octopus in Reducing Procedural Pain During Heel Lance in Preterm Neonates (RCT)

2026年9月15日 更新者:Sara Mustafa Hamza Taha、Mansoura University

Effect of a Crochet Octopus in Reducing Procedural Pain and Improving Physiological and Behavioral Responses During Heel Lance in Preterm Neonates: A Randomized Controlled Trial

Neonates, particularly those hospitalized in neonatal intensive care units (NICUs), are subjected to numerous painful procedures essential for their diagnosis and monitoring. Heel lance, performed for routine blood sampling, stands as one of the most frequently encountered painful experiences for these vulnerable infants, as robust neurobiological evidence confirms that even preterm infants possess the anatomical and functional capacity to perceive pain, manifesting measurable physiological, hormonal, and behavioral responses. The daily average of acute painful events can reach up to 10-15 procedures in the NICU, and repeated exposure to inadequately managed procedural pain has been associated with immediate physiological instability as well as longer-term alterations in stress regulation, somatosensory processing, and neurodevelopmental outcomes. These vulnerabilities are further compounded in preterm and low birth weight infants who require prolonged hospitalization and specialized care.

研究概览

地位

尚未招聘

详细说明

While pharmacological analgesia is available, its use in neonates is often limited by concerns regarding dosing complexity, potential adverse effects, and safety in this vulnerable population. Consequently, non-pharmacological strategies have become central to neonatal pain management. Interventions such as kangaroo care (skin-to-skin contact), facilitated tucking, breastfeeding, sweet solutions, non-nutritive sucking, and various forms of auditory and tactile stimulation have consistently demonstrated effectiveness in reducing both behavioral and physiological indicators of pain. Breastfeeding has also been identified as the most effective method to reduce pain during heel lance in term newborns. Moreover, auditory interventions such as white noise and mother-sung lullabies have been shown to significantly reduce neonatal pain scores. These findings underscore the growing evidence base supporting non-pharmacological approaches.

garnered attention as a simple, low-cost, and potentially effective tool for neonatal pain management. The crochet octopus is a soft, handmade toy with long, curled tendrils that neonates can grasp, providing tactile stimulation theorized to operate via the gate control theory of pain, whereby non-painful tactile input can close the "gates" to painful signals in the spinal cord. A seminal randomized controlled study by Çövener Özçelik et al. (2023), conducted with 100 term neonates, demonstrated that infants who touched a crochet octopus during heel lance had significantly higher oxygen saturation levels, shorter crying durations, and lower pain scores compared to the control group. More recently, Reddy et al. (2025) confirmed these findings in a randomized controlled trial involving 100 neonates, showing that octopus therapy significantly reduced pain scores, stabilized physiological parameters, and decreased crying duration during minor procedures. The intervention, where the octopus is provided 10 minutes before the procedure, has been shown to affect physiological measurements positively and reduce procedural pain.

研究类型

介入性

注册 (估计的)

98

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria

  • Preterm neonates: Gestational age 32-37 weeks
  • Age: 2-30 days postnatal
  • Clinically stable
  • Requiring heel lance for routine blood sampling Exclusion Criteria
  • Major congenital anomalies
  • Neurological disorders
  • Received pharmacological analgesia within 24 hours prior to the procedure
  • Receiving mechanical ventilation or continuous positive airway pressure (CPAP)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention Group (Crochet Octopus)
  1. A standard crochet octopus will be placed with the neonate 10 minutes before the heel lance procedure.
  2. The octopus will be positioned so that the neonate can touch its tendrils.
  3. The octopus will remain with the neonate during the heel lance procedure.
  4. The octopus will remain with the neonate for 10 minutes after the procedure completion.
  5. Standard nursing care will be provided as per unit protocol.

Crochet Octopus Specifications:

  • Handmade using 100% cotton yarn
  • Soft, with 8 curled tendrils approximately 15-20 cm in length
  • Hypoallergenic materials
  • Washable and sterilizable
  • Standard design consistent with published protocols
无干预:Control Group (Standard Care)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Neonatal Pain
大体时间:through study completion, an average of 3 months
The Premature Infant Pain Profile (PIPP) will be used to assess pain in preterm neonates (gestational age 32-36 weeks).
through study completion, an average of 3 months
Behavioral State
大体时间:through study completion, an average of 3 months
The Brazelton Neonatal Behavioral Assessment Scale (NBAS) state categories will be used to classify the neonate's behavioral state
through study completion, an average of 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年9月11日

首先提交符合 QC 标准的

2026年9月15日

首次发布 (实际的)

2026年9月18日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data (IPD) will not be shared publicly because the dataset contains potentially identifiable participant information. Sharing the raw data could compromise participants' privacy and confidentiality. Therefore, IPD will not be made publicly available. However, anonymized or aggregated data may be considered for sharing upon reasonable request, subject to ethical approval, institutional policies, and applicable data-protection regulations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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