The Effect of Pelvic Floor Muscle Exercises on Bowel Evacuation Problems and Quality of Life in Individuals With Closed Stoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bowel Evacuation Habits
研究概览
简要总结
This study was conducted to evaluate the effect of pelvic floor muscle exercises on bowel evacuation problems and quality of life in individuals after stoma closure.
详细描述
Sample of study was calculated as 32 using G*Power Software (ver. 3.1.9.2) for 80% power and medium effect size (f=0.25) at 95% confidence level in line with the data of Lin et al. Participants were assigned to the experimental and control groups by the stratified block randomization method. The locks were assigned to layers using Microsoft Excel.
The individuals in the experimental group received pelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training. The patients received a PFME training booklet prepared by the researcher. Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery. Data was collected a day before discharge, first, second, third, and sixth months after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 18 and 75,
- •Being literate,
- •Having a stoma due to colorectal cancer,
- •Having no previous anal trauma,
- •Having no anal surgery other than colorectal cancer surgery,
- •Having no congenital anorectal anomaly,
- •Having no neurological problem,
- •Having no physical disability,
- •Having no previous experience of PFMEs before the surgery,
- •Being cognitively able to answer questions
排除标准
- •Wanting to leave the study,
- •Having had previous biofeedback and electrical stimulation therapy applications,
- •Having another stoma,
- •Not being reachable by phone.
研究组 & 干预措施
Experimental
pelvic floor exercise
干预措施: pelvic floor muscle exercise (Other)
control group
no intervention
结局指标
主要结局
Bowel Evacuation Habits
时间窗: 6 month
evaluated with "Assessment Form for Bowel Evacuation Habits and Psychosocial Problems". This form was developed by the researcher. Patients answer the question yes or no
Wexner Scale Score
时间窗: 6 month
Wexner Scale used to evaluate fecal incontinence. Minimum point is "0" an maximum point is "20". A score of 1 or above indicates a fecal incontinence problem
Psychosocial Problems
时间窗: 6 month
evaluated with "Assessment Form for Bowel Evacuation Habits and Psychosocial Problems". This form was developed by the researcher. The form include questions about psychosocial problems related bowel evacuation problems Patient answer the questions yes or no
Health-related Quality of Life
时间窗: 6 month
evaluated with Short Form 36 (SF-36) Health-related Quality of Life Scale. This scale include 8 subdimensions. scale does not have a single total score: the score for each dimension is calculated separately. For each subdimension minimum point is 0 and maximum point is 100. Higher score indicate best quality of life
次要结局
未报告次要终点
研究者
Dilek Aktaş
Research Assistant Doctor
Ankara Yildirim Beyazıt University