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Functional ConstipationNCT06290830

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

A study testing Abdominal massage group, Kegel Exercises group and Both abdominal massage and kegel exercises to gether in people with Functional Constipation and Constipation, run by Ondokuz Mayıs University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
What is being tested?
Abdominal massage group, Kegel Exercises group and Both abdominal massage and kegel exercises to gether
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
15 Mar 2024to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • Less than 3 defecations per week
  • Loose stools are rarely present without the use of laxatives
  • Insufficient criteria for irritable bowel syndrome

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet.

Şükran Başgöl contact

+903623121919

sukran.basgol@omu.edu.tr

About this study

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

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.

Read the detailed 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.

Being tested
Abdominal massage group, Kegel Exercises group, Both abdominal massage and kegel exercises to gether
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abdominal massage groupBehavioural

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

  • Kegel Exercises groupBehavioural

    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 getherBehavioural

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

Study groups in NCT06290830
Study groupRoleWhat they receive
Abdominal massage groupExperimentalAbdominal 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.
Receives: Behavioral: Abdominal massage group
Kegel Exercises groupExperimentalIn 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.
Receives: Behavioral: Kegel Exercises group
Both abdominal massage and kegel exercises to getherExperimentalstudents will perform both abdominal massage and kegel exercises to gether for a total of 12 weeks
Receives: Behavioral: Both abdominal massage and kegel exercises to gether
Control groupNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline and at the end of the day (12 weeks later) of study, constipation severity will assessed.

  2. 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

    Measured: At baseline and at the end of the day (12 weeks later) of study, Quality of Life will assessed.

  3. 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)".

    Measured: At baseline and at the end of the day (12 weeks later) of study, constipation severity will assessed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start15 Mar 2024 (estimated)
  3. Primary completion31 May 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06290830
Sponsor's protocol ID
OMUŞükranBaşgöl01
Status last verified
Mar 2024
First submitted
26 Feb 2024
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Abdominal massage group, Kegel Exercises group and Both abdominal massage and kegel exercises to gether in people with Functional Constipation and Constipation, run by Ondokuz Mayıs University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Şükran Başgöl (+903623121919, sukran.basgol@omu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Constipation severity change (time frame: At baseline and at the end of the day (12 weeks later) of study, constipation severity will assessed.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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