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

NCT06290830 | Not Yet Recruiting

• 1 other identifier: OMUŞükranBaşgöl01
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Functional Constipation; Constipation; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (4)

Abdominal massage group

EXPERIMENTAL

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.

Behavioral: Abdominal massage group

Kegel Exercises group

EXPERIMENTAL

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.

Behavioral: Kegel Exercises group

Both abdominal massage and kegel exercises to gether

EXPERIMENTAL

students will perform both abdominal massage and kegel exercises to gether for a total of 12 weeks

Behavioral: Both abdominal massage and kegel exercises to gether

Control group

NO INTERVENTION

No intervention

Interventions

Abdominal massage group BEHAVIORAL

abdominal massage creates reflex and mechanical movement of the intestines by applying pressure to the rectum and changing intra-abdominal pressure.

Abdominal massage group

Kegel Exercises group BEHAVIORAL

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

Kegel Exercises group

Both abdominal massage and kegel exercises to gether BEHAVIORAL

with both exercises are performed to accelerate the peristalsis movement by mechanical movements

Both abdominal massage and kegel exercises to gether

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Şükran Başgöl

CONTACT

+903623121919; sukran.basgol@omu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: March 15, 2024
• Primary Completion: May 31, 2024
• Study Completion: June 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share