CompletedNot Applicable

Enriched Environments in Endometriosis

Puerto Rico56 participantsStarted 2019-09-13

Plain-language 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.

Who can participate

Age range18 Years – 49 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Pain Perception

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

Quality of Life (QoL)

Timeframe: 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)

Trial details

NCT IDNCT04179149

SponsorPonce Medical School Foundation, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-30

Results submitted2023-08-23

View on ClinicalTrials.gov More Endometriosis-related Pain trials