ConstipationNCT05330728
Comparison of the Effects of Abdominal Massage and Kinesio Taping in Women With Chronic Constipation
A study testing Suggestions for lifestyle changes+ Abdominal massage, Suggestions for lifestyle changes+ Kinesio taping and Suggestions for lifestyle changes in people with Constipation, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of this study is to compare the effects of abdominal massage and kinesio taping on constipation severity, quality of life, bowel habits and perception of recovery in women with chronic constipation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- Suggestions for lifestyle changes+ Abdominal massage, Suggestions for lifestyle changes+ Kinesio taping and Suggestions for lifestyle changes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2022to 15 Jun 2023
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age
- Having been diagnosed with chronic constipation according to the Rome 4 diagnostic criteria by a gastroenterologist
- Being volunteer
Who cannot join
- Concomitant colon or gastrointestinal problems
- Body mass index >35 kg/m2
- Those who have difficulty defecating, those with anorectal dyssynergia
- Being pregnant
- Having neurological, metabolic and/or malignant disease
- Having an open wound, mass, infection and/or hernia in the area to be massaged
Show all 10Show fewer
- Having abdominal surgery or abdominal radiotherapy in the last 1 year
- Having a mental problem that prevents cooperation
- Taking laxative therapy at least 4 weeks before participating in the study
- To have received physiotherapy and rehabilitation applications related to constipation in the last 1 year
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to compare the effects of abdominal massage and kinesio taping on constipation severity, quality of life, bowel habits and perception of recovery in women with chronic constipation.
Read the detailed description
Constipation is not a disease but a subjective symptom characterized by inadequate defecation, the definition of which varies from person to person. It is known that abdominal massage, which is one of the physiotherapy approaches, reduces the severity of gastrointestinal symptoms and increases bowel movements. Kinesio taping applied for constipation can also increase bowel movement, increase the frequency of defecation and decrease the duration of defecation. However, there is a need for studies comparing the effects of these two different applications.
- Conditions
- Constipation
- Being tested
- Suggestions for lifestyle changes+ Abdominal massage, Suggestions for lifestyle changes+ Kinesio taping, Suggestions for lifestyle changes
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suggestions for lifestyle changes+ Abdominal massageOther
Suggestions for lifestyle changes+ abdominal massage will be applied. Suggestions including regular and balanced diet, fluid consumption, regular walking and abdominal exercises and correct toilet habits will be given once. Abdominal massage will be applied 3 times a week for 4 weeks.
Suggestions for lifestyle changes+ Kinesio tapingOther
Suggestions including regular and balanced diet, fluid consumption, regular walking and abdominal exercises and correct toilet habits will be given once. Kinesio taping will be applied 3 times a week for 4 weeks.
Suggestions for lifestyle changesOther
Suggestions including regular and balanced diet, fluid consumption, regular walking and abdominal exercises and correct toilet habits will be given once.
| Study group | Role | What they receive |
|---|---|---|
| Massage group | Experimental | Suggestions for lifestyle changes + abdominal massage will be performed. Receives: Other: Suggestions for lifestyle changes+ Abdominal massage |
| Taping group | Active comparator | Suggestions for Lifestyle Changes + Kinesio taping will be performed. Receives: Other: Suggestions for lifestyle changes+ Kinesio taping |
| Control group | Other | Suggestions for lifestyle changes will be performed. Receives: Other: Suggestions for lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation severity
Constipation severity will be evaluated with Constipation Severity Scale. According to constipation severity scale, women's defecation frequency, intensity and difficulty/difficulty during defecation will be determined. The scale, which includes sixteen questions, consists of 3 sub-groups: obstructive defecation, colonic inertia and pain. The score that can be obtained from the obstructive defecation subgroup is 0-28, the score that can be obtained from the colonic inertia subgroup is 0-29, and the score that can be obtained from the pain subgroup is between 0-16. The lowest total score that can be obtained from the constipation severity scale is 0, and the highest is 73. As the score obtained from the scale increases, the severity of the symptoms increases.
Measured: change from baseline at 4 weeks
Secondary outcomes (4)
Life quality
Life quality will be evaluated with Constipation Quality of Life Scale. It includes a total of 28 items in 4 subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Item scores of the five-point Likert-type scale range from 1 to 5. The highest score that can be obtained from the scale is 140, and the lowest score is 28. It is stated that as the scores obtained from the scale increase, the quality of life may also be negatively affected.
Measured: change from baseline at 4 weeks
Bowel habits
Bowel habits will be evaluated with 7-day bowel diary. This diary included items related to frequency of bowel movement, defecation time, feeling of incomplete evacuation, medication use, and changes in food and liquid consumption.
Measured: change from baseline at 4 weeks
Stool consistency
Stool consistency will be assessed using Bristol Stool Scale on a 7-point scale (from 1 to 7) which is a quick and useful indicator of colonic transit time: type 1 = separate hard lumps, like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage or snake, but with cracks on its surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges; 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = water, no solid pieces.
Measured: change from baseline at 4 weeks
Perception of recovery
Perception of recovery will be evaluated using a 4-point Likert-type scale. Accordingly, women will be asked to choose one of the statements as "worse, same, better or better" regarding the decrease in the severity of constipation when compared before and after treatment
Measured: change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start15 Jun 2022 (estimated)
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330728
- Sponsor's protocol ID
- 2022/04/10
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Abdominal Massage and Kinesio Taping in Women With Chronic Constipation
- ClinicalTrials.gov ID
- NCT05330728
- Acronym / sponsor ID
- 2022/04/10
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 15 Apr 2022 (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.
The aim of this study is to compare the effects of abdominal massage and kinesio taping on constipation severity, quality of life, bowel habits and perception of recovery in women with chronic constipation.
Detailed description
Constipation is not a disease but a subjective symptom characterized by inadequate defecation, the definition of which varies from person to person. It is known that abdominal massage, which is one of the physiotherapy approaches, reduces the severity of gastrointestinal symptoms and increases bowel movements. Kinesio taping applied for constipation can also increase bowel movement, increase the frequency of defecation and decrease the duration of defecation. However, there is a need for studies comparing the effects of these two different applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage group | Experimental | Other: Suggestions for lifestyle changes+ Abdominal massageSuggestions for lifestyle changes + abdominal massage will be performed. |
| Taping group | Active comparator | Other: Suggestions for lifestyle changes+ Kinesio tapingSuggestions for Lifestyle Changes + Kinesio taping will be performed. |
| Control group | Other | Other: Suggestions for lifestyle changesSuggestions for lifestyle changes will be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years of age
- Having been diagnosed with chronic constipation according to the Rome 4 diagnostic criteria by a gastroenterologist
- Being volunteer
Key exclusion criteria (10 listed)
- Concomitant colon or gastrointestinal problems
- Body mass index >35 kg/m2
- Those who have difficulty defecating, those with anorectal dyssynergia
- Being pregnant
- Having neurological, metabolic and/or malignant disease
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 |
|---|---|---|
| Suggestions for lifestyle changes+ Abdominal massageSuggestions for lifestyle changes+ abdominal massage will be applied. Suggestions including regular and balanced diet, fluid consumption, regular walking and abdominal exercises and correct toilet habits will be given once. Abdominal massage will be applied 3 times a week for 4 weeks. | Other | Massage group |
| Suggestions for lifestyle changes+ Kinesio tapingSuggestions including regular and balanced diet, fluid consumption, regular walking and abdominal exercises and correct toilet habits will be given once. Kinesio taping will be applied 3 times a week for 4 weeks. | Other | Taping group |
| Suggestions for lifestyle changesSuggestions including regular and balanced diet, fluid consumption, regular walking and abdominal exercises and correct toilet habits will be given once. | Other | Control group |
Primary outcome
Constipation severity
Time frame: change from baseline at 4 weeks
Constipation severity will be evaluated with Constipation Severity Scale. According to constipation severity scale, women's defecation frequency, intensity and difficulty/difficulty during defecation will be determined. The scale, which includes sixteen questions, consists of 3 sub-groups: obstructive defecation, colonic inertia and pain. The score that can be obtained from the obstructive defecation subgroup is 0-28, the score that can be obtained from the colonic inertia subgroup is 0-29, and the score that can be obtained from the pain subgroup is between 0-16. The lowest total score that can be obtained from the constipation severity scale is 0, and the highest is 73. As the score obtained from the scale increases, the severity of the symptoms increases.
4 secondary outcomes
Life quality
Time frame: change from baseline at 4 weeks
Bowel habits
Time frame: change from baseline at 4 weeks
Stool consistency
Time frame: change from baseline at 4 weeks
Perception of recovery
Time frame: change from baseline at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Suggestions for lifestyle changes+ Abdominal massage, Suggestions for lifestyle changes+ Kinesio taping and Suggestions for lifestyle changes in people with Constipation, run by Ankara Yildirim Beyazıt 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 3 inclusion and 10 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 15 Apr 2022. 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 Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation severity (time frame: change from baseline at 4 weeks). 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 15 Apr 2022.