The Comparison of the Effects of a Single-Session Physiotherapy Intervention and Massage in Premature Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Neonatal Infant Stress Scale (NISS)
研究概览
简要总结
This study investigates the effects of a single-session physiotherapy intervention compared to massage in premature infants hospitalized in the neonatal intensive care unit. Premature babies are vulnerable to stress, pain, and sleep disturbances due to medical procedures and the intensive care environment. The study aims to evaluate whether physiotherapy or massage can reduce stress and pain, improve sleep, bilirubin levels, and cerebral oxygenation. Infants will be randomly assigned to three groups: control (routine care), massage, and physiotherapy (Moyer-Mileur protocol). The results will contribute to developing evidence-based interventions to support the health and development of premature infants
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
盲法说明
This is an open-label study. Neither participants, care providers, investigators, nor outcome assessors are blinded to group allocation.
入排标准
- 年龄范围
- 0 Days 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born between 20 and 37 gestational weeks
- •Apgar score ≥ 4 at the 5th minute after birth
- •Parental consent obtained for participation
- •Infants able to receive oxygen via CPAP (Continuous Positive Airway Pressure) or nasal prongs during the intervention if necessary
排除标准
- •Congenital anomalies or chromosomal abnormalities
- •Chronic medical conditions such as bronchopulmonary dysplasia
- •Intraventricular hemorrhage grade III or IV (IVH)
- •Necrotizing enterocolitis (NEC)
- •Asphyxia or seizures
研究组 & 干预措施
Control Group
Infants in this group will receive routine neonatal intensive care without any additional physiotherapy or massage intervention. This arm serves as the standard care control group.
Massage Group
Infants in this group will receive infant massage as an intervention. Massage will be performed by a trained physiotherapist following a standardized protocol. The purpose is to evaluate the effects of massage on physiological stability, weight gain, and overall development in premature infants.
干预措施: Infant Massage (Behavioral)
Physiotherapy Group
Infants in this group will receive a single-session physiotherapy intervention based on the Moyer-Mileur protocol. The intervention includes gentle range of motion and flexion-extension exercises designed to stimulate neuromuscular development in premature infants. The effects will be compared with those of massage and routine neonatal care.
干预措施: Physiotherapy (Moyer-Mileur Protocol) (Behavioral)
结局指标
主要结局
Change in Neonatal Infant Stress Scale (NISS)
时间窗: Pre-intervention to 30 minutes post-intervention
Change in Neonatal Infant Stress Scale (NISS, range 0-2; higher scores indicate greater stress) before and after the intervention.
Change in Neonatal Infant Pain Scale(NIPS)
时间窗: Pre-intervention to 30 minutes post-intervention
Change in Neonatal Infant Pain Scale (NIPS, range 0-7; higher scores indicate more pain) before and after the intervention.
Change in Total Sleep Duration (Brief Infant Sleep Questionnaire)
时间窗: Baseline (pre-intervention) and within 24 hours after the intervention
Total sleep duration will be assessed using the Brief Infant Sleep Questionnaire (BISQ). Parents will be asked to report the infant's sleep pattern, and the total amount of time (in minutes) the infant sleeps during a 24-hour period will be recorded. The comparison will be made between pre-intervention and post-intervention data to evaluate whether the intervention has an effect on the infant's overall sleep time. A longer total sleep duration will be interpreted as an improvement in sleep quality.
Change in Number of Night Awakenings (Brief Infant Sleep Questionnaire)
时间窗: Baseline (pre-intervention) and within 24 hours after the intervention
Night awakenings will be assessed using the Brief Infant Sleep Questionnaire (BISQ). Parents will record the number of times the infant wakes up during the night within a typical 24-hour period. The data will be collected before and after the intervention to determine whether the procedure reduces the frequency of nighttime awakenings. A decrease in the number of awakenings will be considered as an indicator of improved sleep continuity and quality.
Change in Sleep Onset Latency (Brief Infant Sleep Questionnaire)
时间窗: Baseline (pre-intervention) and within 24 hours after the intervention
Sleep onset latency (the time it takes for the infant to fall asleep) will be measured using the Brief Infant Sleep Questionnaire (BISQ). Parents will report the average duration (in minutes) from when the infant is put to bed until the infant falls asleep. Comparisons will be made between pre-intervention and post-intervention values. A shorter sleep onset latency will be interpreted as a positive outcome, suggesting that the intervention may help infants fall asleep more quickly.
次要结局
- Change in Oxygen Saturation (SpO₂-peripheral oxygen saturation)(15 minutes before intervention, 5 minutes during intervention, and 15 minutes after intervention)
- Change in Heart Rate(15 minutes before intervention, 5 minutes during intervention, and 15 minutes after intervention)
研究者
Seyma Atalar
Principal Investigator
Necmettin Erbakan University