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临床试验/NCT06171997
NCT06171997已完成不适用

The Effect of Safe Swaddling After Bathing on Stress and Comfort in Newborns

Funda Kardas Ozdemir1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
change in comfort

研究概览

简要总结

The research will be conducted experimentally in the form of randomized controlled studies to determine the effect of safe swaddling of newborns after bathing on stress and comfort. The population of the research consists of newborns receiving treatment and care in the Neonatal Intensive Care Unit of a State Hospital located in the north of Turkey, and the sample consists of 72 babies who meet the sample selection criteria. Descriptive Characteristics Form, Newborn Stress Scale and Newborn Comfort Behavior Scale were used to collect data. Babies will be bathed in the bathtub and then swaddled. The baby will be placed in the incubator and kept for 15 minutes. After 15 minutes, the swaddle will be opened quietly and slowly, without disturbing the body posture. Stress and comfort scores will be given by two observers by video recording the babies before bathing, before swaddling and after swaddling.

详细描述

Baby bathing is a nursing intervention with individual benefits. Today, there are ongoing discussions about when the infant bath, which is an important part of skin care, should be done first. However, the World Health Organization recommends not bathing newborns for the first 24 hours and waiting until vital signs stabilized. Postponing the bathing of newborns to 48 hours after birth is both effective in maintaining the baby's body temperature and improves skin integrity. Since the thermoregulation abilities of newborns are very limited, it is necessary to maintain body temperature, provide appropriate environmental conditions and warming after bathing.

Although the bathing process, which is an important part of hospital care, protects the health of the newborn, it is also a stressful action for babies and stress symptoms are observed in these babies after bathing. Swaddling the baby in stressful situations such as bathing contributes to the baby's self-calming. The swaddling technique mimics the uterus for newborns and is a technique that ensures the continuation of the intrauterine environment.

Neonatal nursing has come to the forefront in recent years with the development of strategies that increase comfort and has become a frequently used concept in neonatal intensive care units.Among the interventions frequently applied by pediatric nurses to increase comfort are practices such as relaxing positioning, massage, bathing, and wrapping.The practices of nurses to increase the comfort level of the baby and reduce stress with practices with increased level of evidence are very important in terms of nursing care and physical and neuromotor development of the bab.In the light of all this information, this study was planned to investigate the effect of safe swaddling after bathing on stress and comfort in newborns.

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, Investigator, Outcomes Assessor)

盲法说明

Triple

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • The week of gestation is between 37 and 41 weeks,
  • Birth weight being 2500 g and above,
  • Having spontaneous breathing,
  • Its physiological parameters are stable,
  • Having completed the first 24 hours of life,
  • No invasive interventions should be made before the bathing process.

排除标准

  • Preterms with a gestational age of 22-37 weeks,
  • Connected to mechanical ventilator,
  • Those who have been wiped or bathed in the last 12 hours,
  • Within the first 78 hours of the post-operative period,
  • With central catheter,
  • Diagnosed with sepsis,
  • Those who use sedative and/or muscle relaxants,
  • Those with congenital, chromosomal anomalies,

研究组 & 干预措施

Swaddling after bath group

Experimental

Newborns in this group will be swaddled safely after bath.

干预措施: Swaddling after bath group (Other)

No swaddling after bath group

No Intervention

No action will be taken after bath.

结局指标

主要结局

change in comfort

时间窗: 15th minute after the procedure

Newborn Comfort Behavior Scale (COMFORTneo) will be used to evaluate comfort in babies. It has been stated that the lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6 and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort. A change in comfort is expected after bathing compared to before bathing through safe swaddling.

change in stress

时间窗: 15th minute after the procedure

The Newborn Stress scale will be used to evaluate stress in babies. The scale consists of 8 subgroups including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities and posture, and a total of 24 items in a 3-point Likert type. In scoring, each subgroup is evaluated between 0-2 points. The minimum score obtained from the scale is 0 points and the maximum is 16 points. An increase in the score indicates that the baby's stress level has increased. A change in stress is expected through safe swaddling after bathing compared to before bathing.

次要结局

未报告次要终点

研究者

发起方
Funda Kardas Ozdemir
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Funda Kardas Ozdemir

Associate Professor

Kafkas University

研究点 (1)

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