This Study Complies with the Requirements of the Final Rule (42 CFR Part 11) for Clinical Trials with a Start Date of January 18, 2017, or Later, Including the Registration and Reporting of Results As Per the Applicable Regulations.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Newborn comfort (measured with the KONFOR Neo scale)
研究概览
简要总结
This study will be conducted as a randomized controlled trial to examine the effects of different bathing methods on neonatal comfort. The study will take place in the Neonatal Intensive Care Unit (NICU) of İzmir Tepecik Training and Research Hospital, with a total sample size of 64 neonates who meet the inclusion criteria.
Neonates born at 37 weeks or later, with stable physiological parameters, and receiving their first bath will be included. Those diagnosed with sepsis, on mechanical ventilation, or with impaired skin integrity will be excluded.
The swaddled bath will be applied to the intervention group, while the wipe bath will be applied to the control group. Neonatal comfort levels will be assessed by a second nurse at 10 and 60 minutes after bathing. Data collection will utilize the COMFORT Neo scale, and statistical analyses will be performed using IBM SPSS. T-tests, ANOVA, and correlation tests will be used to compare the effects of bathing methods on neonatal comfort.
详细描述
This study is designed as a randomized controlled trial to compare the effects of swaddled bathing and wipe bathing on neonatal comfort in Neonatal Intensive Care Units (NICUs). The study will be conducted in the NICU of İzmir Tepecik Training and Research Hospital, and after obtaining ethical approval, 64 neonates meeting the inclusion criteria will be enrolled.
As part of the study, the swaddled bath will be applied to the intervention group, while the wipe bath will be applied to the control group. The bathing procedures will be carried out by the researcher according to standard protocols. Neonatal comfort levels will be assessed by a second nurse working in the NICU at 10 and 60 minutes after bathing, using the COMFORT Neo scale.
Data Analysis:
Collected data will be analyzed using IBM SPSS Statistical Package Program. Descriptive statistics (mean, percentage, standard deviation) will be calculated, and t-tests, ANOVA, and correlation analysis will be conducted to evaluate differences between the groups.
Ethical Considerations:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born at 37 weeks of gestation or later
- •Aged between 2 and 7 days
- •Born after 24 hours
- •Stable physiological parameters
- •Spontaneous respiration
- •Birth weight ≥ 2000 grams
- •No skin problems that would prevent the administration of swaddle or wipe bath
- •Both vaginal and cesarean deliveries are accepted
排除标准
- •Using sedative or muscle relaxant medications
- •Previously exposed to any bath method
- •On mechanical ventilation
- •Diagnosed with sepsis
- •Within the first 78 hours post-operatively
- •Having a central catheter
- •Having disrupted skin integrity
- •Having cranial hemorrhage
- •Major congenital, chromosomal, or neurological anomalies
结局指标
主要结局
Newborn comfort (measured with the KONFOR Neo scale)
时间窗: Data collection will include comfort assessments at the 10th and 60th minutes after the bath.
次要结局
未报告次要终点
研究者
Gamze Gocmen
ebe
Ege University