The Effect of Four Different Methods Used During Body Weight Measurement in Newborns on Comfort and Physiological Variables
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- COMFORTneo scores during the procedure
研究概览
简要总结
The study, planned to be conducted in a single-center, parallel-armed, randomized experimental design, aims to determine the effect of four different methods (Routine Care, Holding, Swaddling, Swaddling + Holding) on comfort scores as the primary outcome and on heart rate (HR) and peripheral capillary oxygenation (SaPO2) as secondary outcomes.
Research hypotheses
Primary Hypothesis:
H1/1: There is a difference between the mean comfort scores of the groups.
Secondary Hypothesis:
H1/2: There is a difference between the mean HR values of the groups. H1/3: There is a difference between the mean SaPO2 values of the groups.
详细描述
Aim: The study, planned to be conducted in a single-center, parallel-armed, randomized experimental design, aims to determine the effect of four different methods (Routine Care, Holding, Swaddling, Swaddling + Holding) on comfort scores as the primary outcome and on heart rate (HR) and peripheral capillary oxygenation (SaPO2) as secondary outcomes.
Research hypotheses
Primary Hypothesis:
H1/1: There is a difference between the mean comfort scores of the groups.
Secondary Hypothesis:
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight measurement is planned as part of follow-up at the Mersin University Hospital Newborn Follow-up Clinic,
- •The parent gives consent for the baby and themselves to participate in the study,
- •The parent's body weight is less than 100 kg,
- •The newborn's birth weight is 2500 g or more,
- •The newborn's gestational age at birth is less than 37 weeks,
- •The newborn's postnatal age is 28 days or less,
- •The newborn is physiologically stable
排除标准
- •The newborn has undergone surgery,
- •The newborn has a genetic, metabolic, or congenital disorder,
- •The newborn has a neuroendocrine disorder,
- •The newborn's gestational age at birth is greater than 37 weeks,
- •The newborn's postnatal age is greater than 28 days.
研究组 & 干预措施
Routine Care
Routine Care
干预措施: Routine Care (Other)
Holding
Holding
干预措施: Holding (Other)
Swaddling
Swaddling
干预措施: Swaddling (Behavioral)
Swaddling + Holding
Swaddling + Holding
干预措施: Swaddling + Holding (Behavioral)
结局指标
主要结局
COMFORTneo scores during the procedure
时间窗: during the body weight measurement procedure
Turkis version of COMFORTneo consists of six behavioral items (alertness, calmness/agitation, respiratory response, crying, body movement, facial tension, and muscle tone), of which six items should be scored (respiratory response or crying depends on the presence of invasive ventilation). Each item has a score range of 1 to 5 and the total score ranges from 6 to 30. Higher values represent lower comfort.
COMFORTneo scores after the procedure
时间窗: 2 minutes after the body weight measurement procedure
Turkis version of COMFORTneo consists of six behavioral items (alertness, calmness/agitation, respiratory response, crying, body movement, facial tension, and muscle tone), of which six items should be scored (respiratory response or crying depends on the presence of invasive ventilation). Each item has a score range of 1 to 5 and the total score ranges from 6 to 30. Higher values represent lower comfort.
次要结局
- Heart rate during the procedure(during the body weight measurement)
- Heart rate after the procedure(2 minutes after the body weight measurement)
- Oxygen saturation during the procedure(during the body weight measurement)
- Oxygen saturation after the procedure(2 minutes after the body weight measurement)
研究者
Guzide UGUCU
Res. Assist., RN, MScN, PhD
Mersin University