The Effect of Reiki Therapy on Colic Symptoms and Crying Duration in Infants With Infantile Colic, and on Maternal Fatigue and Quality of Life: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Infantile Colic Symptom Score
研究概览
简要总结
This double-blind, randomized controlled experimental study aims to determine the effect of Reiki therapy administered to infants with infantile colic (aged 3 weeks to 6 months) on infants' colic symptoms and crying duration, as well as on mothers' fatigue levels and quality of life.
The study population consists of infants aged 3 weeks to 6 months who are diagnosed with infantile colic and present to pediatric health and disease outpatient clinics between July 2025 and July 2026. A total of 44 infants meeting the inclusion criteria will be randomly assigned to either the Reiki group (n = 22) or the control group (n = 22).
Data will be collected using the Mother and Infant Descriptive Information Form, the Infantile Colic Scale, the Crying Duration Recording Form, the Visual Analogue Scale for Fatigue (for mothers), and the World Health Organization Quality of Life Scale (WHOQOL) (for mothers).
Reiki therapy will be administered to the intervention group twice on alternate days for 20-30 minutes per session. The control group will not receive any intervention.
详细描述
The study population consisted of infants aged 3 weeks to 6 months who were diagnosed with infantile colic and met the inclusion criteria, presenting to pediatric health and disease outpatient clinics.
This study was designed as a double-blind, randomized controlled experimental study with a pretest-posttest design to determine the effect of Reiki therapy administered to infants with infantile colic on infants' colic symptoms and crying duration, as well as on mothers' fatigue levels and quality of life.
To ensure homogeneous distribution of the groups, randomization was performed using a computer-based program (http://www.randomization.com
, balanced permutation method). Infants who met the inclusion criteria and whose families agreed to participate were randomly assigned to either the experimental (Reiki) group or the control group according to the randomization list.
The control variables of the study were the infants' demographic characteristics, while the dependent variables were colic pain, crying duration, maternal fatigue level, and maternal quality of life scores.
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
- Single (Participant)
盲法说明
The research consists of 2 groups. These groups are Reiki group, control group.
入排标准
- 年龄范围
- 3 Weeks 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged between 3 weeks and 6 months.
- •Diagnosed with infantile colic by a physician during the study period.
- •Birth weight between 2500 and 4000 grams.
- •No presence of any chronic disease in the infant.
- •Family voluntarily agrees to participate in the study.
- •Mother has no visual or hearing impairments.
- •Mother is open to communication and cooperation.
- •Mother is able to read and understand Turkish.
- •Neither the mother nor the infant has received any form of energy therapy (e.g., yoga, Reiki, massage, meditation, or healing touch) within the last five months.
排除标准
- •Infants with any acute or chronic illness.
- •Infants with congenital anomalies.
- •Mothers with diagnosed psychological or mental health disorders.
- •Infants diagnosed with lactose intolerance by a physician.
- •Infants who have previously been diagnosed with infantile colic and are continuing medical treatment for this condition.
研究组 & 干预措施
Control Group
Infants in the control group will receive only routine pediatric care and will not receive any Reiki therapy or additional intervention.
Reiki Group
Infants in the Reiki group will receive Reiki therapy twice on alternate days, with each session lasting 20-30 minutes, administered by a certified Reiki practitioner following a standardized protocol.
干预措施: Reiki (Other)
结局指标
主要结局
Change in Infantile Colic Symptom Score
时间窗: At baseline and 7th day
Measured using the Infantile Colic Scale completed by the mother.
Crying Duration of Infants with Infantile Colic
时间窗: Recorded by the mother over a 7-day period (24 hours per day).
The mother records the start and end time of each crying episode over a 24-hour period for seven consecutive days to determine the total daily crying duration.
Change in Maternal Fatigue Level
时间窗: At baseline and 7th day
Maternal fatigue is assessed using the Visual Analogue Scale for Fatigue (VAS-F), completed by both the mother and an independent nurse. Measurements are taken to evaluate changes in maternal fatigue level.
Change in Maternal Quality of Life
时间窗: At baseline and 7th day
Maternal quality of life is assessed using the World Health Organization Quality of Life Assessment (WHOQOL), completed by both the mother and an independent nurse. Measurements are taken to evaluate changes in maternal quality of life
Change in Infantile Colic Symptom Score
时间窗: At baseline and 7th day
Measured using the Infantile Colic Scale completed by the mother.
Crying Duration of Infants with Infantile Colic
时间窗: Recorded by the mother over a 7-day period (24 hours per day).
The mother records the start and end time of each crying episode over a 24-hour period for seven consecutive days to determine the total daily crying duration.
Change in Maternal Fatigue Level
时间窗: At baseline and 7th day
Maternal fatigue is assessed using the Visual Analogue Scale for Fatigue (VAS-F), completed by both the mother and an independent nurse. Measurements are taken to evaluate changes in maternal fatigue level.
Change in Maternal Quality of Life
时间窗: At baseline and 7th day
Maternal quality of life is assessed using the World Health Organization Quality of Life Assessment (WHOQOL), completed by both the mother and an independent nurse. Measurements are taken to evaluate changes in maternal quality of life
次要结局
未报告次要终点
研究者
Duygu Demir
PhD, RN
University of Yalova