The Effect of Maternal Scent and Knitted Octopus Application on Pain in Infants Diagnosed With Neonatal Asphyxia and Receiving Therapeutic Hypothermia Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- N-PASS Pain Score
研究概览
简要总结
This study was designed to determine the effects of maternal scent and knitted octopus application on pain in infants born with asphyxia beyond 36 weeks' gestation and receiving Therapeutic Hypothermia (TH) treatment in the Neonatal Intensive Care Unit (NICU) of Gaziantep Private Anka Hospital. The study is a randomized controlled experimental study. Block randomization will be used as the randomization method.
详细描述
Detailed Description
The neonatal period is characterized by increased sensitivity to environmental stimuli, including olfactory inputs. Early exposure to maternal odors may support physiological stability and behavioral regulation in newborns. In neonatal intensive care settings, maternal scent is commonly introduced using odor-bearing materials placed near the infant. In addition, supportive positioning tools such as soft objects may provide comfort and reduce stress-related responses.
This randomized controlled trial is designed to evaluate the effects of maternal scent exposure and the use of a knitted octopus on pain response in newborns undergoing therapeutic hypothermia for perinatal asphyxia. Participants will be randomly assigned to receive either maternal scent exposure, a knitted octopus intervention, or standard care.
Maternal scent exposure will be provided using maternal clothing and odor-absorbing materials placed near the infant to allow continuous exposure throughout the treatment period. The knitted octopus intervention involves placing a soft, hypoallergenic object in contact with the infant to provide tactile comfort.
Pain assessments will be performed at predefined intervals during the therapeutic hypothermia period using a validated neonatal pain scale. Data will be collected prospectively and analyzed to compare pain responses between groups.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Babies with a gestational age of ≥36 and a postpartum age of ≤6 hours.
- •Babies diagnosed with asphyxia and receiving TH treatment in the NICU.
- •Babies not receiving respiratory support.
- •Newborns with family consent.
排除标准
- •Babies with congenital disorders,
- •Babies with syndromes/chromosomal disorders,
- •Babies who experience seizures while being warmed,
- •Babies whose parents wish to withdraw from the study during the study period,
- •Babies receiving analgesics
研究组 & 干预措施
Plasebo
No intervention will be made to this branch
intervention arm
This arm will be applied with mother scent and knitted octopus.
干预措施: scent (Other)
结局指标
主要结局
N-PASS Pain Score
时间窗: From 6 hours after initiation of therapeutic hypothermia up to 72 hours (assessed every 3 hours)
The Neonatal Pain, Agitation, and Sedation Scale (N-PASS) will be used to assess pain levels in newborns undergoing therapeutic hypothermia. The scale evaluates behavioral and physiological parameters, with higher scores indicating increased pain.
次要结局
未报告次要终点
研究者
Alev Sivasli
assistant professor, head of child nursing department
Istanbul Nisantasi University