Enriched Environments in Endometriosis

NCT04179149 | Completed Results

• 1 other identifier: 1R21HD098481-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis-related Pain; Endometriosis; Pelvic Pain; Quality of Life; Inflammation Pelvic

Keywords

endometriosis; chronic pelvic pain; quality of life; inflammation; stress

Outcome Measures

Primary Outcomes (2)

• Pain Perception

  Mean level of maximum pain using the Visual Analog Scale (VAS), in which 1 is no pain and 10 is the worst pain imaginable. Categories: 1-4 low pain; 5-7 moderate pain; 8-10 severe pain. Therefore, the higher the score in the VAS the higher the pain level.

  at baseline, at end of the intervention and 3 months after the end of intervention

• Quality of Life (QoL)

  QoL global impact scores measured using the Endometriosis Health Profile 30 (EHP-30), a disease-specific questionnaire to measure health related quality of life. The EHP-30 was developed by Jones et al., in 2001. Part 1 The first part contains 30 questions relevant to all women with endometriosis covering five areas: pain, emotional well-being, control and powerlessness, social support and self imaging scales. Each domain score is calculated by dividing the total scores of each item in the domain by the maximum possible score of all items in the domain multiplied by 100. Our outcome of interest is the global impact score, calculated as the mean of all completed subscale scores, with a range of 0 to 100. The global impact score ranges from 0 (indicating the best health status) to 100 (indicating the worst health status). No subscales are reported.

  at baseline, at end of the intervention and 3 months after the end of intervention (for intervention); at baseline and end of intervention (for controls)

Secondary Outcomes (3)

• Perceived Stress Levels 14

  at baseline, at end of the intervention and 3 months after the end of intervention (for the intervention); at baseline and end of the intervention (for controls)

• Depressive Symptomatology

  at baseline, at end of the intervention and 3 months after the end of intervention; and at baseline and post-intervention for the control group.

• Anxiety Symptomatology

  at baseline, at end of the intervention and 3 months after the end of intervention (for the intervention group) and at baseline and end of the intervention (for the control group)

Study Arms (2)

Environmental enrichment

EXPERIMENTAL

Subjects randomized to the intervention condition will receive the environmental enrichment intervention (social support, open spaces, novel stress relief activities) as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period.

Behavioral: Environmental enrichment

Controls

NO INTERVENTION

Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period plus an online patient training module.

Interventions

Environmental enrichment BEHAVIORAL

The experimental group will participate in six modules that mimic and integrate the three hallmarks of environmental enrichment: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention

Environmental enrichment

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ponce Medical School Foundation, Inc.: lead
• University of Oxford: collaborator
• DHR Health Institute for Research and Development: collaborator

Study Sites (1)

Ponce Medical School Foundation

Ponce, PR, 00732, Puerto Rico

Location

Related Publications (2)

• Nieves-Vazquez CI, Detres-Marquez AC, Torres-Reveron A, Appleyard CB, Llorens-De Jesus AP, Resto IN, Lopez-Rodriguez V, Ramos-Echevarria PM, Castro EM, Flores I. Feasibility and acceptability of an adapted environmental enrichment intervention for endometriosis: A pilot study. Front Glob Womens Health. 2023 Jan 4;3:1058559. doi: 10.3389/fgwh.2022.1058559. eCollection 2022.

  PMID: 36683601 RESULT

• De Hoyos G, Ramos-Sostre D, Torres-Reveron A, Barros-Cartagena B, Lopez-Rodriguez V, Nieves-Vazquez C, Santiago-Saavedra F, Appleyard CB, Castro EM, Flores I. Efficacy of an environmental enrichment intervention for endometriosis: a pilot study. Front Psychol. 2023 Oct 10;14:1225790. doi: 10.3389/fpsyg.2023.1225790. eCollection 2023.

  PMID: 37885745 RESULT

MeSH Terms

Conditions

Endometriosis; Pelvic Pain; Pelvic Inflammatory Disease; Inflammation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Infection; Infections; Adnexal Diseases; Pathologic Processes

Results Point of Contact

• Title: Dr. Idhaliz Flores
• Organization: Ponce Research Institute, Ponce Health Sciences University

iflores@psm.edu

787-840-2575

Study Officials

• Idhaliz Flores, PhD

  Ponce Medical School Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators will not be blinded because the two arms are receiving different interventions. However, data will be coded such that data entry and initial analysis can be done in a blinded fashion as to intervention group until ad hoc analysis are conducted.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this RCT study, subjects randomized to the intervention condition will receive the Environmental Enrichment (EE) intervention as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period. Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period in addition to an online patient training online seminar.

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: November 27, 2019
• Study Start: September 13, 2019
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)