The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Infantile Colic Scale
研究概览
简要总结
Aim: The purpose of this study is to determine the effect of therapeutic touch applied to infants with infantile colic on infant colic scale score, crying and sleep time.
Method: The study will be conducted as a single-blind, randomized controlled trial. The population of the study will be infants who come to the Pediatrics Outpatient Clinic and are diagnosed as infantile colic according to the evaluation of the pediatrician and have no other health problems. The infants will be divided into two groups as intervention and control groups according to stratified block randomization in the computer environment. After the randomization, therapeutic touch will be applied to the intervention group. No method will be applied to the control group.
详细描述
The research will be carried out with two groups as intervention and control groups. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 27 for each group and 54 in total. Considering the possible case losses, 20% of the sample was increased. The sample consisted of 64 babies, 32 intervention and 32 control. Mothers of the infants meeting the study inclusion criteria will be informed both in written and verbally. Written consent will be obtained. The infants will be divided into two groups according to stratified block randomization in the computer environment. The infants will be stratified by gender and age. After the randomization, therapeutic touch will be applied to the intervention group. No method will be applied to the control group by the researcher. In obtaining research data, 4 tools will be used: "Mother-infant Information Form", "Infantile Colic Scale", Crying Time Registration Form and Sleep Time Registration Form.
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
Single blind will be done in the study. Only parents will be blinded. Two weeks follow up will be done in both groups. Since the researcher should implement the intervention, evaluate and manage the process, it will not be blinded.
入排标准
- 年龄范围
- 4 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family volunteering to participate in the research
- •The infant was born at term
- •The infant is between 4 weeks and 12 weeks
- •The birth weight is between 2500-4500 g
- •The infant has been diagnosed with infantile colic according to Wessel criteria
- •Mothers' ability to read, write and speak Turkish
- •New diagnosis of infantile colic
排除标准
- •The infant has any chronic illness and congenital anomaly
- •Mothers have diagnosed mental and mental problems
- •Mother smoking
- •The diagnosis of lactose intolerance to infants by the physician
结局指标
主要结局
Infantile Colic Scale
时间窗: In two weeks
Ellet et al. (2002) developed a Likert-type scale to determine the factors causing colic and to diagnose colic. Cetinkaya and Başbakkal (2007) tested the validity and reliability of the scale for the Turkish population. The scale consists of 5 sub-dimensions and 19 items.The low total score average from the scale indicates that the colic decreases, and the high average score indicates that the colic increases.
次要结局
- Crying Time(In two weeks)
- Sleeping Time(In two weeks)
研究者
Selda Ateş Beşirik
Karamanoğlu Mehmetbey University, Faculty of Health Science, Pediatric Nursing Department
Karamanoğlu Mehmetbey University