Exploring bowel habits, development and evaluation of implementation of an educational resource for constipation (BowelEvaC) among adult rural women of Udupi taluk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- The interventional study (Phase III) will assess the feasibility metrics using qualitative interview and quantitative metrics (modified IMPACT SF to assess bowel function)
Study Overview
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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 59.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The interventional study (Phase III) will assess the feasibility metrics using qualitative interview and quantitative metrics (modified IMPACT SF to assess bowel function)
Time Frame: Two point- After one week (qualitative feedback) and four weeks of intervention(IMPACT SF and feasibility metrics
Secondary Outcomes
- Phase IB(To assess bowel habits and associated factors such as demographic variables, physical activity, diet, sleep and self perceived stress)
- Phase II:(To explore the beliefs and knowledge associated with bowel habits)
Investigators
Neha Shetty
Manipal College of Health Professions