Abdominal Massage and Kegel Exercises on Constipation and Quality of Life in Female Students

Quality of Life Clinical Trial

Official title:

The Effect of Abdominal Massage and Kegel Exercises on Constipation and Quality of Life in Female Students With Functional Constipation: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290830
• Other study ID #: OMUSükranBasgöl01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Ondokuz Mayis University
• Contact: Sükran Basgöl
• Phone: +903623121919
• Email: sukran.basgol[@]omu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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). Personal Information Form: The information form developed by the researchers by analyzing the literature consisted of 10 questions about sociodemographic characteristics, health status, and variables affecting constipation. Bristol Stool Scale: The type of stool is classified into 7 different groups. 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)". Constipation Severity Scale: It is a 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 score that can be obtained from the Faecal Obstruction sub-dimension is 0-28, the score that can be obtained from the Large Bowel sub-dimension is 0-29, and the score that can be obtained from the Pain sub-dimension is 0-16. 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. Internal consistency (α = 0.88-0.91) and test-retest reliability (intraclass correlation coefficients = 0.84-0.91) were reported to be high for all subscales. Patient Assessment of Constipation Quality of Life Questionnaire: This scale measures the 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 item scores of the five-point Likert-type scale vary between 1-5. The highest score 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. The Cronbach alpha reliability coefficient of the scale is 0.91. The Cronbach alpha reliability coefficient of the "Physical Discomfort" subscale is 0.88, the total item correlation coefficient is 0.91, the Cronbach alpha reliability coefficient of the "Psychosocial Discomfort" subscale is 0.87, the total item correlation coefficient is 0. 82, Cronbach alpha reliability coefficient of "Worry and Anxiety" subscale was 0.85, the total item correlation coefficient was 0.84 and Cronbach alpha reliability coefficient of "Satisfaction" subscale was 0.76, total item correlation coefficient was 0.80. The female students included in the study will be taught abdominal massage and kegel exercises by the researcher in an appropriate environment according to the interventional group determined as a result of the randomization assignment. The intervention and control groups will be initially trained on nutrition in constipation. Abdominal massage group (35 students): 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. Kegel exercise group (35 students): 2 times a day in the morning and evening hours, 5 days a week, for a total of 12 weeks. Abdominal massage and kegel exercise group (35 students): students will do both abdominal and kegel exercises for 12 weeks Control group (35 students): No intervention will be made to the control group. Ethical Aspects of the Research For the ethical suitability of the research, The University Rectorate Ethical approval was obtained at the meeting of the Social and Human Sciences Ethics Committee dated 30.01.2024 and numbered "2023-0844" and written permission was obtained from two universities for data collection. Written informed consent is also obtained from the participating students. The research was conducted following the rules of the Declaration of Helsinki.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: June 1, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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,
• pregnant
• do not volunteer to participate in the research will not be included.

Related Conditions & MeSH terms

• Constipation
• Functional Constipation
• Quality of Life

Intervention

Behavioral:
• Abdominal massage group
abdominal massage creates reflex and mechanical movement of the intestines by applying pressure to the rectum and changing intra-abdominal pressure.
• Kegel Exercises group
Kegel exercises (also called pelvic floor exercises) have a functional connection with other core muscles and contribute to the synergistic effect of the abdominal and pelvic floor muscles
• Both abdominal massage and kegel exercises to gether
with both exercises are performed to accelerate the peristalsis movement by mechanical movements

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constipation severity change	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.	At baseline and at the end of the day (12 weeks later) of study, constipation severity will assessed.
Primary	Quality of Life change	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	At baseline and at the end of the day (12 weeks later) of study, Quality of Life will assessed.
Primary	Bristol stool form score change	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)".	At baseline and at the end of the day (12 weeks later) of study, constipation severity will assessed.