Enriched Environments in Endometriosis

Sponsor
Ponce Medical School Foundation, Inc.
Study ID
NCT04179149
Status
Completed

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Sep 13, 2019
Status verified
May 2025
Primary completion
Jun 30, 2022
Completion
Jul 31, 2022

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Environmental enrichment
    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.
  • No Intervention: Controls
    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.

Primary Outcome Measure

Pain Perception [ Time Frame: at baseline, at end of the intervention and 3 months after the end of intervention ]

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