Maternal Heartbeat Sounds and Therapeutic Touch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- comfort
研究概览
简要总结
This randomized controlled study aims to evaluate the effects of maternal heartbeat sounds and gentle human touch (GHT), a form of therapeutic touch, on heart rate, comfort, and behavioral scores in neonates born between 32 and 40 weeks and admitted to the neonatal intensive care unit (NICU).
详细描述
This parallel, randomized controlled trial will be conducted in the Neonatal Intensive Care Unit of a regional hospital. The sample will consist of 120 neonates with gestational ages of 32 to ≤40 weeks and randomly assigned to four groups (maternal heart sound, therapeutic touch, maternal heart sound + therapeutic touch, and control group). The data of the study are the Newborn Information Form, the Anderson Behavioral Status Scoring System, and Newborn Comfort Behavior Scale. Demographic data will be compared between groups (maternal heartbeat sound group (Group 1), light human touch group (Group 2), combined maternal heartbeat sound and light human touch group (Group 3), and control group (Group 4)). Video recordings will be used to compare heart rate, behavioral status, and comfort scale scores obtained before, during, and after the interventions. The time it takes to fall asleep will also be evaluated. A t-test will be applied to evaluate the score differences 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
- None
入排标准
- 年龄范围
- 32 Weeks 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Newborns between >32 and ≤40 weeks gestational age.
- •Admission to neonatal intensive care unit (NICU) after birth.
- •Parental consent form obtained.
排除标准
- •• Absence of neurological and cardiac problems.
- •No use of corticosteroids.
- •No use of muscle relaxants.
- •Not past the postnatal 10th day.
- •Not receiving non-invasive or invasive respiratory support.
研究组 & 干预措施
Control Group
In this group, preterm infants will be recorded with a camera for 20 minutes between 13:00-13:20, 19:00-19:20, and 01:00-01:20, after their routine care and feeding have been completed, with no interventions applied to the baby.
Maternal Heartbeat
Researchers will schedule a time with the mother within 48 hours after the baby's birth to record the heartbeat. The recording of the mother's heartbeat will be done when the mother's mood is stable and the environment is quiet. A Doppler fetal heart monitor will be used to detect the mother's heartbeat. After ensuring a regular and stable heart rate, the mother's heartbeat will be recorded for 15 minutes using a recording device.
干预措施: Maternal Heartbeat (Behavioral)
Gentle Human Touch
GHT will be applied to the babies at the designated times.
干预措施: Gentle Human Touch (Behavioral)
Maternal Heartbeat and Gentle Human Touch
For this group, maternal heartbeat will be played and GHT steps will be applied simultaneously at the designated times. Camera recording will start 2 minutes before the intervention and continue for an additional 2 minutes after the intervention.
干预措施: Maternal Heartbeat and Gentle Human Touch (Behavioral)
结局指标
主要结局
comfort
时间窗: 0 minutes (pre-intervention), 5 minutes, 15 minutes, and 20 minutes (post-intervention)
It is a Likert-type scale consisting of seven parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tonus. As well as determining comfort, the COMFORTneo scale is a tool that includes numeric rating scales, which allow nurses to assess the pain and distress of the infant. The lowest score on the scale is 6, and the highest is 30. If the total score on the scale is between 14 and 30, the infant has pain or distress, is uncomfortable, and needs intervention to provide comfort. In addition, 4-6 points indicate moderate pain and distress, and 7-10 points indicate severe pain and distress
次要结局
- behavior(0 minutes (pre-intervention), 5 minutes, 15 minutes, and 20 minutes (post-intervention))
研究者
Gülçin Özalp Gerçeker
Proffesor, Pediatric Nursing Department
Dokuz Eylul University