N/A
N=56
Enriched Environments in Endometriosis
Endometriosis-related Pain · Endometriosis · Pelvic Pain · Quality of Life · Inflammation Pelvic
Bottom Line
View on ClinicalTrials.gov: NCT04179149 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Pain Perception — 7.0; 6.2; 7.2; 5.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Environmental enrichment (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ponce Medical School Foundation, Inc.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Perception |
7.0; 6.2; 7.2; 5.1; 6.3; 6.6 | — |
| PRIMARY Quality of Life (QoL) |
61.0; 60.1; 56.6; 56.2; 50.9 | — |
| SECONDARY Perceived Stress Levels 14 |
30.0; 28.8; 28.2; 27.5; 25.7 | — |
| SECONDARY Depressive Symptomatology |
10.8; 11.3; 9.0; 8.9; 6.9 | — |
| SECONDARY Anxiety Symptomatology |
11.7; 10.9; 8.9; 10.1; 6.9 | — |
Summary
The investigators propose to conduct a randomized behavioral trial that will produce a clinically useful multi-level integrative medicine model to be used in stress- and inflammation-related disorders that can easily be implemented with current pharmacological interventions to alleviate pain and improve QoL.
Eligibility Criteria
Inclusion Criteria
- premenopausal adult women
- adults 18 and 49 y/o
- diagnosed with endometriosis by surgery
- symptomatic
- refractory to hormonal treatment
- able to provide written informed consent
Exclusion Criteria
- Pregnant women (or who become pregnant during the study period)
- Asymptomatic
- Documented visual, cognitive or physical impairment that would interfere with participation or consent.
- Currently under mental health pharmacological treatment
- Currently using steroid medications.
- Diagnosis of pain syndromes (e.g., fibromyalgia, chronic fatigue syndrome).
Data sourced from ClinicalTrials.gov (NCT04179149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.