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.
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
- Conditions the study is for
- Functional Constipation, Constipation, Quality of Life
- What is being tested?
- Abdominal massage group, Kegel Exercises group and Both abdominal massage and kegel exercises to gether
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Functional Constipation, Constipation, Quality of Life
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Behavioral: Both abdominal massage and kegel exercises to gether |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
- First posted4 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukran Basgol, Ondokuz Mayıs University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06290830
- Acronym / sponsor ID
- OMUŞükranBaşgöl01
- Conditions
- Functional Constipation, Constipation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Abdominal massage group | Experimental | Behavioral: Abdominal massage groupAbdominal 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 Exercises group | Experimental | Behavioral: Kegel Exercises groupIn 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. |
| Both abdominal massage and kegel exercises to gether | Experimental | Behavioral: Both abdominal massage and kegel exercises to getherstudents will perform both abdominal massage and kegel exercises to gether for a total of 12 weeks |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (11 listed)
- the study included patients with intra-abdominal infection
- advanced heart disease
- previous bowel surgery
- cancer diagnosis
- irritable bowel syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal massage groupabdominal massage creates reflex and mechanical movement of the intestines by applying pressure to the rectum and changing intra-abdominal pressure. | Behavioural | Abdominal massage group |
| Kegel Exercises groupKegel 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 | Behavioural | Kegel Exercises group |
| Both abdominal massage and kegel exercises to getherwith both exercises are performed to accelerate the peristalsis movement by mechanical movements | Behavioural | Both abdominal massage and kegel exercises to gether |
Primary outcome
Constipation severity change
Time frame: 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.
Quality of Life change
Time frame: 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
Bristol stool form score change
Time frame: 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)".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.