NCT06443164

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

Efficacy of a Single-session Treatment for Reducing Chronic Pain Prior to Gender-affirming Surgery

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective of this study is to examine a single-session, 2-hour group intervention provided to a population of transgender and 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. This study will help extend the research literature on chronic pain experienced by transgender patients, and specifically will examine if a brief, group intervention is effective for reducing pain catastrophizing and pain distress prior to surgery. Safety and effectiveness of the Empowered Relief intervention used in this study has been demonstrated in multiple clinical trials, but has not been studied yet with this particular population. The Empowered relief intervention was created by Beth Darnall © Stanford University. The hypothesis of this research study is that transgender patients with chronic pain who receive the group intervention, prior to having a gender-affirming surgery, will have lower scores on the pain catastrophizing scale after completing the intervention compared to participants in the control group: Hypothesis: µ1 \<(\<=) µ2. The primary endpoint of this study is to test if the mean change in the score on the Pain Catastrophizing Scale is different between the treatment and the control group. The secondary endpoint, is to examine if pain severity scores decreased. An exploratory endpoint, after data collection and analysis is complete, is to run a focus group with participants who received the intervention to learn more about their experience to inform future treatment and research. Safety endpoints are that participants will receive informed consent, which will include learning they may discontinue participation in the study at any time, as well as procedures for maintaining confidentiality of identifying information. Each person screened will already be referred to the Transgender Health Program by a primary care provider and/or mental health provider. If screening indicates that a person has severe depression or regular thoughts involving suicidal content, then that person will not be included in the study but instead will be offered resources and highly recommended to contact their referring provider for additional support.

Conditions

• Pain Catastrophizing
• Pain, Chronic
• Gender Identity

Interventions

Type	Name	Description
BEHAVIORAL	Empowered Relief	Pain Management Course that has been used to treat pain in patients with different pain conditions.
OTHER	Standard of Care	Gender Affirming surgery without any attention to pain conditions prior to surgery.

Timeline

• Start date: 2024-05-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-06-05
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States