Comparison of the Effects of Abdominal Massage and Kinesio Taping in Women With Chronic Constipation
Primary Purpose
Constipation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Suggestions for lifestyle changes+ Abdominal massage
Suggestions for lifestyle changes+ Kinesio taping
Suggestions for lifestyle changes
Sponsored by
About this trial
This is an interventional treatment trial for Constipation
Eligibility Criteria
Inclusion Criteria:
- 18 to 65 years of age
- Having been diagnosed with chronic constipation according to the Rome 4 diagnostic criteria by a gastroenterologist
- Being volunteer
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Massage group
Taping group
Control group
Arm Description
Suggestions for lifestyle changes + abdominal massage will be performed.
Suggestions for Lifestyle Changes + Kinesio taping will be performed.
Suggestions for lifestyle changes will be performed.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
Full Information
NCT ID
NCT05330728
First Posted
April 9, 2022
Last Updated
April 9, 2022
Sponsor
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT05330728
Brief Title
Comparison of the Effects of Abdominal Massage and Kinesio Taping in Women With Chronic Constipation
Official Title
Comparison of the Effects of Abdominal Massage and Kinesio Taping in Women With Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2022 (Anticipated)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Massage group
Arm Type
Experimental
Arm Description
Suggestions for lifestyle changes + abdominal massage will be performed.
Arm Title
Taping group
Arm Type
Active Comparator
Arm Description
Suggestions for Lifestyle Changes + Kinesio taping will be performed.
Arm Title
Control group
Arm Type
Other
Arm Description
Suggestions for lifestyle changes will be performed.
Intervention Type
Other
Intervention Name(s)
Suggestions for lifestyle changes+ Abdominal massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Suggestions for lifestyle changes+ Kinesio taping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Suggestions for lifestyle changes
Intervention Description
Suggestions including regular and balanced diet, fluid consumption, regular walking and abdominal exercises and correct toilet habits will be given once.
Primary Outcome Measure Information:
Title
Constipation severity
Description
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.
Time Frame
change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Life quality
Description
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.
Time Frame
change from baseline at 4 weeks
Title
Bowel habits
Description
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.
Time Frame
change from baseline at 4 weeks
Title
Stool consistency
Description
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.
Time Frame
change from baseline at 4 weeks
Title
Perception of recovery
Description
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
Time Frame
change from baseline at 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 65 years of age
Having been diagnosed with chronic constipation according to the Rome 4 diagnostic criteria by a gastroenterologist
Being volunteer
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda Toprak Celenay
Phone
+90312 906 1000
Email
sydtoprak@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda Toprak Celenay
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effects of Abdominal Massage and Kinesio Taping in Women With Chronic Constipation
We'll reach out to this number within 24 hrs