NCT05330728

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

April 9, 2022

Last Update Submit

April 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Life quality

    change from baseline at 4 weeks

  • Bowel habits

    change from baseline at 4 weeks

  • Stool consistency

    change from baseline at 4 weeks

  • Perception of recovery

    change from baseline at 4 weeks

Study Arms (3)

Massage group

EXPERIMENTAL

Suggestions for lifestyle changes + abdominal massage will be performed.

Other: Suggestions for lifestyle changes+ Abdominal massage

Taping group

ACTIVE COMPARATOR

Suggestions for Lifestyle Changes + Kinesio taping will be performed.

Other: Suggestions for lifestyle changes+ Kinesio taping

Control group

OTHER

Suggestions for lifestyle changes will be performed.

Other: Suggestions for lifestyle changes

Interventions

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.

Massage group

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.

Taping group

Suggestions including regular and balanced diet, fluid consumption, regular walking and abdominal exercises and correct toilet habits will be given once.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years of age
  • Having been diagnosed with chronic constipation according to the Rome 4 diagnostic criteria by a gastroenterologist
  • Being volunteer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constipation

Interventions

Suggestion

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 9, 2022

First Posted

April 15, 2022

Study Start

June 15, 2022

Primary Completion

August 15, 2022

Study Completion

June 15, 2023

Last Updated

April 15, 2022

Record last verified: 2022-04