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临床试验/NCT07828795
NCT07828795尚未招募不适用

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

Mansoura University0 个研究点目标入组 98 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
98
主要终点
Neonatal Pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

  • Research assistants performing pain score assessments will be blinded to group allocation (video assessments will be conducted by assessors unaware of group assignment).
  • Parents cannot be blinded due to the nature of the intervention.
  • Nurses performing the heel lance cannot be blinded due to the visibility of the intervention.
  • Data analysts will be blinded to group allocation

入排标准

年龄范围
2 Days 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm neonates: Gestational age 32-37 weeks
  • Age: 2-30 days postnatal
  • Clinically stable
  • Requiring heel lance for routine blood sampling

排除标准

  • Major congenital anomalies
  • Neurological disorders
  • Received pharmacological analgesia within 24 hours prior to the procedure
  • Receiving mechanical ventilation or continuous positive airway pressure (CPAP)

研究组 & 干预措施

Intervention Group (Crochet Octopus)

Experimental

Intervention Group (Crochet Octopus)

干预措施: Crochet Octopus (Device)

Control Group (Standard Care)

No Intervention

Control Group (Standard Care)

结局指标

主要结局

Neonatal Pain

时间窗: 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).

Behavioral State

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Mustafa Hamza Taha

Lecture of Pediatric Nursing, Faculty of Nursing, Mansoura Yniversity

Mansoura University

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