Health Condition 1: N809- Endometriosis, unspecified
Conditions
Interventions
Intervention1: Multifaceted behavioural economics-based intervention: The behavioural economics–based intervention for women with endometriosis will be implemented over a total period of three months.
Sponsors
Divya Sharma
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 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
| Measure | Time frame |
|---|---|
| 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) Timepoint: 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. | — |
Countries
India
Contacts
Public ContactDivya Sharma
Post Graduate Institute of Medical Education and Research (PGIMER)
Outcome results
None listed