The Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children: 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
- 60
- 试验地点
- 2
- 主要终点
- Primary Results Follow-up Form
研究概览
简要总结
The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children.
详细描述
Functional constipation (FK) is a common functional gastrointestinal disorder that affects children's quality of life. The reported prevalence of functional constipation in infants and young children varies according to diagnostic criteria between studies. Laxatives and probiotics are commonly used to treat functional constipation. Therefore, treating constipation is very costly and there is not enough reliable data on this subject. When the literature is examined, the use of non-pharmacological methods to reduce, prevent and eliminate constipation has been increasing recently. When the studies were examined, studies using different methods were found. The main methods used in the care of children with constipation are; massage, aromatherapy, probiotics, laxatives, reflexology and acupuncture. The effect of therapeutic touch is thought to have positive results, especially in newborns, infants and children.Based on the studies conducted in line with the literature, this research has a randomized controlled experimental design to determine the effect of therapeutic touch applied to infants and children diagnosed with functional constipation according to Rome IV criteria on constipation.
This study is a prospective, randomized and controlled trial. The study population consisted of infants and children aged 6 to 24 months. Sample of the study consisted of a total of 60 children who met the sample selection criteria and were selected via randomization method. Children were randomized into two groups: intervention gorup (n=30) and control group (n=30). Data were collected using the Interview and Observation Form, Primary Results Follow-up Form, and Bristol stool form scale.
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 (Outcomes Assessor)
盲法说明
The data analyst will be blinded to the procedure and results of randomization, group allocation, and intervention.
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The infant is between 6-24 months,
- •The infant was born at term,
- •Birth weight between 2500-4500 g,
- •Must have been diagnosed with functional constipation by the physician according to ROMA IV criteria,
- •Mothers' ability to read, write and speak Turkish,
- •Parent's willingness to participate in the research.
排除标准
- •The infant has a congenital anomaly,
- •The infant has any chronic disease,
- •Having a secondary disease that causes constipation such as cow's milk allergy, celiac disease, hypercalcemia and hypothyroidism, neurological diseases,Children with any organic or metabolic diseases
- •The parent has a verbal and written communication barrier.
结局指标
主要结局
Primary Results Follow-up Form
时间窗: In four weeks
Weekly Bowel sounds (movements) (min)
次要结局
- Bristol Stool Scale(In four weeks)
- Constipation discomfort(In four weeks)
研究者
Selda Ateş Beşirik
Principal Investigator
Burdur Mehmet Akif Ersoy University