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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
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    April 9, 2022
    Last Updated
    April 9, 2022
    Sponsor
    Ankara Yildirim Beyazıt University
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    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

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