Trial results for a study investigating Enriched Environments in Endometriosis were posted on ClinicalTrials.gov on 2025-05-23, with 56 participants enrolled.
Background
Endometriosis is a chronic condition characterized by the growth of tissue similar to the uterine lining outside the uterus, often leading to significant pain, inflammation, and reduced quality of life. Patients frequently experience pelvic pain, which can be debilitating and impact daily activities. Current treatments often involve hormonal therapies or surgery, but there is a continuous search for complementary approaches that can alleviate symptoms and improve overall well-being. This trial explored a multi-level integrative medicine model, delivered as a randomized behavioral intervention, aiming to address stress and inflammation in the context of endometriosis-related pain and quality of life.
Trial design
This completed study, designated as Phase NA, enrolled 56 participants. The trial investigated conditions including Endometriosis-related Pain, Endometriosis, Pelvic Pain, Quality of Life, and Inflammation Pelvic. The study was designed as a randomized behavioral trial to develop a clinically useful multi-level integrative medicine model. It aimed to be easily implementable alongside current pharmacological interventions to alleviate pain and improve quality of life. The trial compared an Environmental Enrichment intervention group with a Control group. No specific primary outcomes were listed.
Key results
The trial reported several key measurements related to pain perception, quality of life, and perceived stress levels:
- Pain Perception (units on a scale):
- For the Environmental Enrichment group, mean scores were 7.0 (Standard Deviation 2.8), 7.2 (Standard Deviation 1.7), and 6.3 (Standard Deviation 2.4).
- For the Controls group, mean scores were 6.2 (Standard Deviation 3.4), 5.1 (Standard Deviation 3.0), and 6.6 (Standard Deviation 2.5).
- Quality of Life (QoL) (score on a scale):
- For the Environmental Enrichment group, mean scores were 61.0 (Standard Deviation 13.5), 56.6 (Standard Deviation 16.0), and 50.9 (Standard Deviation 11.0).
- For the Controls group, mean scores were 60.1 (Standard Deviation 18) and 56.2 (Standard Deviation 11.5).
- Perceived Stress Levels 14 (score on a scale):
- For the Environmental Enrichment group, a mean score of 30.0 (Standard Deviation 5.8) was observed.
What this means
The posted results provide descriptive data on pain perception, quality of life, and perceived stress levels for participants in the Enriched Environments in Endometriosis trial. While the data includes specific mean scores and standard deviations for both the Environmental Enrichment and Control groups across various measurements, no statistical analyses or comparative significance values were reported. These measurements offer initial insights into the outcomes of a behavioral intervention for endometriosis-related symptoms, but further analysis would be needed to determine the efficacy or direction of effect of the environmental enrichment model.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04179149, titled "Enriched Environments in Endometriosis", were posted on 2025-05-23 on clinicaltrials.gov.