| CTRI Number |
CTRI/2025/10/096193 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Behavioural Program to Reduce Pain, Anxiety, and Improve Productivity and Quality of Life in Women Living with Endometriosis |
|
Scientific Title of Study
|
Effectiveness of a Multifaceted Behavioural Economics-Based Intervention for Reducing Pain and Anxiety, Improving Productivity and Quality of Life among Women with Endometriosis: A Randomized Controlled Trial in a Tertiary Health Care Setting |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Sharma |
| Designation |
Ph.D. Scholar |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER) |
| Address |
Department of Community Medicine and School of Public Health, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876710228 |
| Fax |
|
| Email |
divya2809.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Tanvi Kiran |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER) |
| Address |
Room no. 128, Department of Community Medicine and School of Public Health, PGIMER, Sector 12, Chandigarh-160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876867850 |
| Fax |
|
| Email |
tanvikiran3@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Sharma |
| Designation |
Ph.D. Scholar |
| Affiliation |
Post Graduate Institute of Medical Education and Research (PGIMER) |
| Address |
Department of Community Medicine and School of Public Health, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876710228 |
| Fax |
|
| Email |
divya2809.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research (PGIMER), Sector-12, Chandigarh-160012, India |
|
|
Primary Sponsor
|
| Name |
Divya Sharma |
| Address |
Room no. 007, Department of Community Medicine and School of Public Health, PGIMER, Sector 12, Chandigarh-160012, India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Divya Sharma |
Post Graduate Institute of Medical Education and Research (PGIMER) |
Department of Community Medicine and School of Public Health, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9876710228
divya2809.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of PGIMER |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multifaceted behavioural economics-based intervention |
The behavioural economics–based intervention for women with endometriosis will be implemented over a total period of three months. Participants will attend one session per month, each lasting approximately 60 to 90 minutes. Sessions will be conducted primarily face-to-face in a designated setting, with select components offered online. The program integrates behavioural economics principles such as anchoring, positive framing, nudging, temporal discounting, and social incentives, supported by the health belief, transtheoretical, and socio-ecological models.
In Month 1, participants will receive structured IEC materials, couple counselling focused on emotional and dietary guidance, physical activity, and pelvic exercise training (e.g., Kegel and stretching routines), and mindful meditation sessions for pain and anxiety management.
In Month 2, these activities will be reinforced with new IEC materials, continued couple counselling, participant-led physical activity sessions, and online guided meditation. A new component, gratitude journaling (with at least three entries per week), will be introduced to promote a positive mindset and overall well-being.
In Month 3, the intervention will expand to include women’s support group sessions moderated by a multidisciplinary team (gynaecologists, physiotherapists, and mental health experts) to foster peer support and sustain behaviour change. All sessions will be coordinated and facilitated by the Ph.D. scholar, with relevant professionals co-delivering or moderating specific components.
The total duration of the intervention is 3 months, and outcomes will be assessed at the following time points
A) Immediately after the intervention (within 24-48 hours after the delivery of the last session of the intervention)
B) Outcomes will also be assessed after 3 months post-intervention. |
| Comparator Agent |
Routine-based gynaecological consultations and counselling
|
The control group shall be given basic counselling and awareness sessions to manage endometriosis. The frequency of the basic counselling and awareness sessions shall be once per month for a period of 3 months. The duration of the session will be 10-15 minutes for each participant. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
i. Women aged 18 to 40 years with endometriosis.
ii. Confirmed diagnosis- Women aged 18 to 40 years diagnosed by a physician with mild to severe endometriosis with endometrioma less than 6 cm, confirmed through laparoscopy, imaging such as ultrasound, MRI, or symptom history with pain for a minimum of 6 months, will be included in the study.
iii. Symptoms of endometriosis- Women aged 18 to 40 years with a confirmed diagnosis of endometriosis, experiencing symptoms such as pelvic pain, dysmenorrhea, dyspareunia, dysuria, and bladder or bowel dysfunction that negatively impact productivity and quality of life, will be included in the study.
iv. Women undergoing Hormonal Replacement Therapy (HRT) or recommended gynecological treatment for endometriosis will be included in the study.
v. Literacy and ability to self-report symptoms/outcomes- Women who can read and write with comprehension in Hindi, English, or Punjabi and can effectively communicate their symptoms and the impact of interventions through questionnaires and other assessment tools will be included.
vi. Women who have access to a smartphone, desktop, laptop, or tablet with access to the internet.
vii. Willingness to participate in the intervention and provide written consent- Women who are willing to participate and provide written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
i. Women with severe psychological conditions (e.g., active psychosis, depression) will be excluded.
ii. Women with severe endometriosis requiring immediate surgical intervention will be excluded from the study.
iii. Women with endometriosis who refuse to take the recommended gynaecological treatment (hormonal replacement therapy) and behavioural intervention.
iv. Women with Polycystic Ovarian Disease or Syndrome (PCOD)/(PCOS) will be excluded from the study.
v. Women who are recommended or undergoing Assisted Reproductive Technology (ART).
vi. Women having any other severe medical condition (such as carcinoma, etc.) or those who have undergone surgical intervention for endometriosis or any other illness within the past year will be excluded.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
i.Pain scores and categorization of women into mild, moderate, and severe pain levels.
ii.Anxiety scores and categorization of women into minimal, mild, moderate, and severe anxiety levels.
iii.Percent work time lost (absenteeism), Percent productivity impairment while working (presenteeism), and Total activity impairment.
iv.Utility scores (EQ-5D-5L) and EQ-VAS score for self-reported health status.
v.Endometriosis Health Profile score
|
The study outcomes will be assessed at the following time points
A) Baseline (before starting the intervention)
B) At 12 weeks, i.e., immediately after the intervention (within 24-48 hours after the delivery of the last session of the 3-month intervention)
C) At 24 weeks, i.e., outcomes will also be assessed after 3 months post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anthropometric measurements- will be collected to assess the physical characteristics of participants, including:
1. height
2. weight
3. body mass index (BMI)
4. waist-to-hip ratio (WHR)
|
The secondary outcomes will be assessed at the following time points
A) Baseline (before starting the intervention)
B) At 12 weeks, i.e., immediately after the intervention (within 24-48 hours after the delivery of the last session of the 3-month intervention)
C) At 24 weeks, i.e., outcomes will also be assessed after 3 months post-intervention. |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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)
|
02/01/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [divya2809.sharma@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Endometriosis
is a chronic and often underdiagnosed condition that affects many women of
reproductive age, leading to severe pain, anxiety, reduced productivity, and
poor quality of life. Its complex symptoms and psychological burden call for
more comprehensive and tailored management approaches. This study aims to
develop and evaluate a multifaceted behavioural economics-based intervention
that combines mindfulness-based stress reduction, physical activity, peer
support, couple counselling, and gratitude journaling to address the physical,
emotional, and social challenges faced by women with endometriosis. A
systematic review of existing literature on behavioural economics interventions
in healthcare, focusing on endometriosis management, will be conducted. Key
components and strategies will be identified and evaluated based on their
effectiveness, feasibility, and impact on patient outcomes. Data will be
synthesized from randomized controlled trials, observational studies, and
expert opinions published in peer-reviewed and indexed journals to inform the
final intervention framework. A
cross-sectional survey will be conducted for the second objective to collect
data on pain, anxiety, productivity, quality of life, and the health profile of
women with endometriosis. Standardized questionnaires and validated scales
(e.g., Numeric Pain scale, GAD 7, EQ 5D-5L) will be used to gather
self-reported data. Descriptive and inferential statistics will be applied to
analyze the factors contributing to health outcomes. For the third objective, a multifaceted behavioural economics-based intervention
will be developed, integrating techniques such as nudging, anchoring, and
motivation. The intervention will be pilot-tested with a small group of women
with endometriosis to assess feasibility, acceptability, and preliminary
effects on pain, anxiety, productivity, and quality of life. A
randomized controlled trial (RCT) will then be conducted with two groups: an
intervention group receiving the standard care plus the behavioural
economics-based intervention, and a control group receiving only the standard
care. The trial will assess the impact of the intervention on pain, anxiety,
productivity, quality of life, and the endometriosis health profile. Pre and
post-intervention data will be collected and analyzed using the Generalized
Estimating Equations (GEE) to determine effectiveness. An
economic evaluation will be conducted alongside a one-year RCT evaluating the
multifaceted behavioural intervention for the last objective. A
cost-effectiveness analysis (CEA) will be performed from a limited societal and
healthcare perspective. Costs associated with the intervention (e.g.,
development, implementation) and outcomes (e.g., reduction in pain and anxiety
scores) will be measured.
|