The Effect of Therapeutic Touch at Different Times on Colic Symptoms in Infants With Infantile Colic According to Watson's Theory of Human Care: 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
- 96
- 试验地点
- 1
- 主要终点
- Crying Time
研究概览
简要总结
Aim: The purpose of the study is to determine the effect of therapeutic touch applied to infants with infantile colic at different times on infant colic scale score, crying and sleep duration, according to Watson's theory of human care. Thus, it is aimed to contribute to the development of an effective care approach in eliminating or reducing the symptoms in infants with infantile colic.
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 three groups as intervention (The first group; the group in which therapeutic touch was applied for one week and the second group; the group in which the therapeutic touch was applied for two weeks) 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 three groups as intervention (The first group; the group in which therapeutic touch was applied for one week and the second group; the group in which the therapeutic touch was applied for two weeks) 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 32 for each group and 96 in total. 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 three groups according to block randomization in the computer environment. The randomization, therapeutic touch will be applied to the intervention group (The first group; the group in which therapeutic touch was applied for one week and the second group; the group in which the therapeutic touch was applied for two weeks). 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 8 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 8 weeks
- •The birth weight is between 2500-4500 g
- •The infant has been diagnosed with infantile colic by a physician
- •Mothers' ability to read, write and speak Turkish
- •New diagnosis of infantile colic
排除标准
- •The baby has any chronic disease
- •The baby has a congenital anomaly
- •The mother has a diagnosed mental and mental problem
- •Mother's smoking
- •The diagnosis of infants with lactose intolerance by the physician
结局指标
主要结局
Crying Time
时间窗: In eight weeks.
Infants' weekly crying times will be recorded (Every day of the week). Weekly crying time will be taken.
Sleeping Time
时间窗: In eight weeks.
Infants' weekly sleeping times will be recorded (Every day of the week). Weekly sleeping time will be taken.
次要结局
- Infantile Colic Scale(In eight weeks.)
研究者
Selda Ateş Beşirik
Karamanoğlu Mehmetbey University, Faculty of Health Science, Pediatric Nursing Department
Karamanoğlu Mehmetbey University