By InvitationNot Applicable

Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery

United States78 participantsStarted 2024-05-15

Plain-language summary

The primary objective of this study is to examine a single-session, 2-hour group intervention provided to a population of transgender or gender-diverse patients with chronic pain prior to gender-affirming surgery, to determine if participants who receive the intervention have less pain-related distress compared to participants randomly assigned to the control group.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. affiliated with the OHSU Transgender Health Program and have completed their initial consultation for gender-affirming surgery,
✓. who have chronic pain (defined as \> 3 months of pain),
✓. who rate their average level of pain intensity as at least a 4 or higher (on 0-10 pain scale)
✓. who have fluency in English. Empowered Relief may only be delivered by a certified instructor, and for this research study the instructor is only able to offer the curriculum in English.

Exclusion criteria

✕. have had a pain-focused behavioral therapy in the past year, or
✕. have severe depression and/or moderate or higher risk of suicidality based on the person's score on the PHQ-9 greater than 20.

What they're measuring

Pain Catastrophizing

Timeframe: Participants will be assessed as part of a cohort for up to 7 months. There will be a total of three cohorts.

Trial details

NCT IDNCT06443164

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Pain Catastrophizing trials