The Effect of Abdominal Massage and Kegel Exercises on Constipation and Quality of Life in Female Students With Functional Constipation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 主要终点
- Quality of Life change
研究概览
简要总结
In this prospective, randomized controlled study, n=140 female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study. Between 15.03.2024 and 31.05.2024, n=140 (35=control group, 35=kegel exercise group, 35=abdominal exercise group, 35=abdominal and kegel exercise group) volunteered to participate in the study. Female students with functional constipation will be randomly divided into four groups as intervention and control groups. Personal Information Form", "Bristol Stool Scale", "Constipation Severity Scale", and "Patient Assessment of Constipation Quality of Life Questionnaire" will be used in this study. The scales will be used in the research two times: pre and post-test (scales were reassessed at the end of the study after the exercise intervention). Descriptive statistics, Pearson, and Spearman's correlation analyses will be used in the analysis of research data.
详细描述
This study aimed to investigate the effect of abdominal massage and kegel exercises on constipation and quality of life in female students with functional constipation.
Type of Research: This study was conducted in a prospective, four-arm, and randomized controlled manner.
Female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study.
The power analysis of this study was performed with G*POWER 3.1.9.7 (Power analysis statistical software). The sample size of the study was based on the average score of the Patient Assessment of Constipation Quality of Life Questionnaire (Patient Assessment of Constipation Quality of Life Questionnaire). It was determined that 31 individuals from each group would be sufficient to participate in the study with an effect size of 0.64, α = 0.05 margin of error, and minimum power = 80% (β = 0.2). Considering the possible missing data, it was calculated that each group should consist of 35 female students with functional constipation with a 10% increase.
Data Collection Tools-Validity and Reliability Information In the study, the "Personal Information Form", "Bristol Stool Scale", "Constipation Severity Scale", and "Patient Assessment of Constipation Quality of Life Questionnaire" will be used. The scales will be used in the research two times: pre and post-test (scales were reassessed at the end of the study after the exercise intervention).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must include two or more of the following:
- •Straining during more than ¼ (25%) of defecations
- •Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
- •Sensation of incomplete evacuation of more than ¼ (25%) of defecations
- •Sensation of anorectal obstruction/blockage of more than ¼ (25%) of defecations
- •Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor)
- •Less than 3 defecations per week
- •Loose stools are rarely present without the use of laxatives
- •Insufficient criteria for irritable bowel syndrome
排除标准
- •the study included patients with intra-abdominal infection
- •advanced heart disease
- •previous bowel surgery
- •cancer diagnosis
- •irritable bowel syndrome
- •any intestinal problem, metabolic, endocrine, and neurological constipation, current or past smoker
- •congenital megacolon, pseudo-obstruction, and anorectal disorder
- •any mental, psychological, and physical disorder any medication,
- •fecal and urinary incontinence,
- •do not volunteer to participate in the research will not be included.
研究组 & 干预措施
Abdominal massage group
Abdominal massage is demonstrated by the researchers to a female student with functional constipation. The student will apply exfoliation (superficial and deep), petrissage, and vibration massage movements for about 15 minutes twice a day in the morning and evening hours and at least 30 minutes after the nutritional meal, 5 days a week, for a total of 12 weeks.
干预措施: Abdominal massage group (Behavioral)
Control group
No intervention
Kegel Exercises group
In this group students will perform Kegel exercises; 2 times a day in the morning and evening hours, 5 days a week, for a total of 12 weeks.
干预措施: Kegel Exercises group (Behavioral)
Both abdominal massage and kegel exercises to gether
students will perform both abdominal massage and kegel exercises to gether for a total of 12 weeks
干预措施: Both abdominal massage and kegel exercises to gether (Behavioral)
结局指标
主要结局
Quality of Life change
时间窗: At baseline and at the end of the day (12 weeks later) of study, Quality of Life will assessed.
As assessed by Patient Assessment of Constipation Quality of Life Questionnaire, for measuring quality of life in constipation. This is a 28-item self-assessment scale consisting of "Worry/Anxiety" (11 items), "Physical Discomfort" (4 items), "Psychosocial Discomfort" (8 items), and "Satisfaction" (5 items) subscales. The highest score that can be obtained from the scale is 140 and the lowest score is 28. It is thought that quality of life is negatively affected as the scores obtained from the scale increase
Constipation severity change
时间窗: At baseline and at the end of the day (12 weeks later) of study, constipation severity will assessed.
As assessed by Constipation Severity Scale, for determining the frequency, intensity, and difficulty/difficulty during defecation. In addition, it was aimed to measure the constipation symptoms of the participants through this scale. There are 16 questions on the scale. The scale has three sub-dimensions: fecal obstruction, large bowel laziness, and pain. The lowest total score that can be obtained from this scale is 0 and the highest score is 73. A high score on the scale indicates that the symptoms are serious.
Bristol stool form score change
时间窗: At baseline and at the end of the day (12 weeks later) of study, constipation severity will assessed.
As assessed by Bristol stool form scale is a graded visual scale of stool density from type 1 (hard to pass) to type 7 (the fluid kind). it shows the participant's stool shapes together with precise descriptions regarding form and consistency, and using easily recognizable examples (for example, in type 1, by an illustration of faces as separate balls, a description: "separate hard lumps, like nuts"). In the Bristol Stool Scale, the transit time of the stool through the intestine is evaluated over seven different stool types. According to Bristol Stool Scale, 1-2 points are shown as "hard stool", 3-4-5 points as "normal stool" and 6-7 points as "soft-watery stool (diarrhea)".
次要结局
未报告次要终点
研究者
Sukran Basgol
Assistant Professor
Ondokuz Mayıs University