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

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · May 29, 2024

Keywords

ClinConnect Summary

This study is testing whether a single 2-hour group session called Empowered Relief, given before gender-affirming surgery, can reduce pain-related distress for transgender or gender-diverse adults who have chronic pain. Participants will be randomly assigned to either receive the class plus usual care or to receive usual care alone. The main goal is to see if the class lowers “pain catastrophizing” (negative thoughts about pain) over up to 7 months. Researchers will also look at whether overall pain levels decline and will hold a follow-up focus group to learn more about participants’ experiences. No results are available yet.

Who can join: adults 18 to 100 who identify as transgender or gender-diverse and are planning gender-affirming surgery, have chronic pain for more than 3 months, and report an average pain level of at least 4 out of 10, and who are fluent in English. They must be connected with the OHSU Transgender Health Program. Exclusions include having had a pain-focused behavioral therapy in the past year or having severe depression or high suicide risk. The trial takes place at the OHSU Comprehensive Pain Center in Portland, Oregon, is currently enrolling by invitation, and plans to enroll about 78 people. Participants will be asked to consent, can withdraw at any time, and data will be kept confidential. Results are not yet known, and the study aims to finish primary data collection by the end of 2025.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. affiliated with the OHSU Transgender Health Program and have completed their initial consultation for gender-affirming surgery,
• • 2. who have chronic pain (defined as \> 3 months of pain),
• • 3. who rate their average level of pain intensity as at least a 4 or higher (on 0-10 pain scale)
• • 4. 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:
• • 1. have had a pain-focused behavioral therapy in the past year, or
• • 2. have severe depression and/or moderate or higher risk of suicidality based on the person's score on the PHQ-9 greater than 20.