Effect of Crochet Octopus on stress in Preterm Newborns A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Growing preterm infants experience stress during routine NICU care. Soft comfort objects such as crochet octopus toys are increasingly used in neonatal units, but scientific evidence regarding their effect on stress in preterm infants is limited. This randomized controlled trial will evaluate whether the use of a sterile handmade crochet octopus toy placed near the infant reduces physiological stress measured by serum cortisol levels. The study will also assess the effect of the toy on pain response using the Premature Infant Pain Profile Revised score. Sixty stable preterm infants will be randomly assigned to either the intervention group receiving the crochet octopus toy or the control group receiving routine NICU care. Stress and pain outcomes will be measured on Day zero and Day seven. The findings of this study may help in understanding whether a simple low cost comfort intervention can support better physiological stability in preterm infants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Year(s) 至 0.23 Year(s)（—）
- 性别
- All
入选标准
- •Growing Preterm infants less than 34 weeks of gestational age.
- •Hemodynamically stable.
- •Not on any respiratory support.
- •Free from any comorbidities.
- •Expected to stay for more than 7 days.
排除标准
- •Major congenital anomalies.
- •Parental refusal .
- •Suspected or confirmed cortisol deficiency.
研究者
Dr Shivangi Kachhwaha
Sri Aurobindo Medical College and PG Institute Indore