Comparison of the Effects of Abdominal Massage and Kinesio Taping in Women With Chronic Constipation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation
• Intervention / Treatment: Other: Suggestions for lifestyle changes+ Abdominal massage; Other: Suggestions for lifestyle changes+ Kinesio taping; Other: Suggestions for lifestyle changes

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Massage group; Suggestions for lifestyle changes + abdominal massage will be performed.	Other: Suggestions for lifestyle changes+ Abdominal massage; 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.
ACTIVE_COMPARATOR: Taping group; Suggestions for Lifestyle Changes + Kinesio taping will be performed.	Other: Suggestions for lifestyle changes+ Kinesio taping; 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.
OTHER: Control group; Suggestions for lifestyle changes will be performed.	Other: Suggestions for lifestyle changes; Suggestions including regular and balanced diet, fluid consumption, regular walking and abdominal exercises and correct toilet habits will be given once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	change from baseline at 4 weeks

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 15, 2022
• Primary Completion (ANTICIPATED): August 15, 2022
• Study Completion (ANTICIPATED): June 15, 2023

Study Registration Dates

• First Submitted: April 9, 2022
• First Submitted That Met QC Criteria: April 9, 2022
• First Posted (ACTUAL): April 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 2022/04/10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No