| CTRI Number |
CTRI/2025/02/080258 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find factors affecting bowel habits to develop an educational resource for treatment of constipation among women of Udupi Taluk |
|
Scientific Title of Study
|
Exploring bowel habits, development and evaluation of implementation of an educational resource for constipation (BowelEvaC) among adult rural women of Udupi taluk |
| Trial Acronym |
BowelEvaC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Shetty |
| Designation |
Ph.D. scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9322729670 |
| Fax |
|
| Email |
neha8.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bhamini Krishna Rao |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8660644145 |
| Fax |
|
| Email |
bhamini.kr@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Neha Shetty |
| Designation |
Ph.D. scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9322729670 |
| Fax |
|
| Email |
neha8.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104 |
|
|
Primary Sponsor
|
| Name |
Neha Shetty |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Neha Shetty |
Rural Maternity and Child Welfare Centres and surrounding homes and camps in Udupi Taluk |
Department of Community Medicine and Department of Physiotherapy, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9322729670
neha8.mchpmpl2023@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Constipation |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
BowelEvaC |
A handout will be designed based on the final range of topics ascertained by the personal interview and qualitative interviews. The anticipated topics are education about good bowel physiology, straining maneuvers, pelvic floor exercises, physical activity promotion strategies and toileting behaviors, good sleep patterns, stress management and dietary modification. We shall also incorporate cultural aspects and motivational strategies for maximum uptake of information in the handout and audiovisual clip. An audiovisual clip will be prepared which provides a concise version of the handout. The validation of the handout and audiovisual aid will be conducted by 6 experts using Patient Education Materials Assessment Tool (PEMAT -Printable and AV). The experts will be requested to critically review the domains and content in the items for refinement.
A feasibility study will be conducted where education and coaching will be key components using handout and audiovisual aid.The objectives of the feasibility study are to evaluate: (a) participant eligibility criteria, (b) acceptability by the participants, (c) suitability of the intervention, (d) usage of resources and (e) data collection procedures. A concise list of focused questions is to address each objective will be provided to guide the feasibility phase of the intervention research process. The 12 participants will be selected based on the fulfilment of each criterion in Rome IV for constipation. The sample characteristics of the participants will be reported by administering the demographic questionnaire and the modified IMPACT SF questionnaire before the first face-to-face session with the physiotherapist The field notes regarding difficulty in administering and filling will be taken by the physiotherapist while the participants fill the outcome measure. During the first session, the physiotherapist will have one on one session in person with the patient. He/ She will educate the patient by identifying the urge to defecate; understand how their bowel functions and apply techniques for coordinated abdominal and pelvic floor muscle contraction for evacuation of bowels. The in-person session will be audio-recorded for intervention fidelity assessment. The physiotherapist will provide the handout at the end of session. The patient will be followed up with a telephonic conversation during first week of four week intervention. Intervention fidelity will be evaluated using a structured fidelity checklist administered by a blind assessor based on the audio recordings. The checklist will enlist adherence of the components of the educational resource and quality of intervention delivery. A qualitative interview will be undertaken to report feedback from the participants at the end of intervention. Examination of both quantitative and qualitative outcome measures will suggest whether the intervention approach has a promise of being successful with women having constipation.
|
| Comparator Agent |
Not applicable |
Not applicable
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Female |
| Details |
Phase IA
10 female respondents who complain and do not of constipation
Phase IB
Women of age 18-59 years of age who can understand, read or write Kannada or English
Phase II:
Women of age 18-59 years who have normal and abnormal bowel habits
Phase III:
Women of age 18-59 years who suffer from constipation
|
|
| ExclusionCriteria |
| Details |
Phase IB
Pregnant and postpartum women (less than 8 weeks post delivery)
Organic gastrointestinal disease
Irritable bowel syndrome (IBS)
Major colorectal and gall bladder removal surgery
Previous pelvic floor surgery
Hypothyroidism
Significant neurological disease deemed to be causative of constipation
Significant connective tissue disease
Major active psychiatric diagnosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The interventional study (Phase III) will assess the feasibility metrics using qualitative interview and quantitative metrics (modified IMPACT SF to assess bowel function) |
Two point- After one week (qualitative feedback) and four weeks of intervention(IMPACT SF and feasibility metrics |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Phase IB
To assess bowel habits and associated factors such as demographic variables, physical activity, diet, sleep and self perceived stress
|
Cross sectional study |
Phase II:
To explore the beliefs and knowledge associated with bowel habits
|
Qualitative interview |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study
To explore the bowel habits and associated factors among rural adult women and develop and evaluate the implementation of educational resources to aid health care providers to effectively improve the health knowledge and toileting behaviors of women who suffer from constipation.1. To determine bowel habits and associated lifestyle factors among rural women with and without self-perceived constipation that fits the Rome IV criteria as determined by a clinical history(Phase IB)2. To explore the knowledge, beliefs and attitudes associated with bowel habits among rural women with and without self-perceived constipation that fits the Rome IV criteria( Phase II) 3. To evaluate (a)participant characteristics and recruitment capability (b) data collection procedures (c) acceptability and suitability (d) participant responses (e) resources for management of chronic constipation with educational resources (Phase III)Summary: Phase IB : cross sectional study where personal interviews of 366 participants will be included by screening in Rural Maternity and Child Welfare (RMCW) centers situated at 5 – 25 kms from Manipal under the direct administration of Department of Community Medicine. The bowel habits, sociodemographic variables, physical activity, diet, self-perceived stress and sleep will be assessed using validated outcome measures. Participants will be stratified into various groups of constipation and who do not have constipation. Phase II is a qualitative study which explores beliefs and knowledge associated with bowel habits among 25-30 women who have constipation versus who are not. An educational resource (BowelEvaC) based on the information gathered from phase IB and II will be created for Phase III. Phase III is a feasibility interventional study for 12 women complaining of constipation where in first in -person session will be with a physiotherapist who shall explain about the topics included in BowelEvaC. The intervention will be for four weeks. A follow-up will be conducted in the first week of the intervention where the participant will be asked for feedback. At the end of the intervention, all the feasibility metrics and modified IMPACT SF will be assessed.
|