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

NCT06443164 | Enrolling By Invitation

• 1 other identifier: STUDY00026520
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Catastrophizing; Pain, Chronic; Gender Identity

Keywords

Chronic Pain; Gender Diversity; Gender Affirming Surgery

Outcome Measures

Primary Outcomes (1)

• Pain Catastrophizing

  This measure is a 13-item self-assessment instrument of pain-related negative thoughts, and measures constructs of rumination, magnification and helplessness. It is the primary outcome measure of this research study. Each item is measured on a 5-point Likert scale, with endpoints 0 (not at all) to 4 (all the time) and possible scores ranging from 0-52. In a clinical setting, such as a pain clinic providing treatments for chronic pain, a score on this measure of "10" or higher indicates a person could benefit from treatment; however, the published cut-off scores are higher and as follows: a Total Score of 20 is considered in the average range (50th percentile), and a Total Score of \>= 30 is above average (75th percentile). This measure is shown to have excellent internal consistency (coefficient alphas: total PCS = .87, rumination = .87, magnification = .66, and helplessness = .78.

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

Study Arms (2)

Pain Management Class

EXPERIMENTAL

Pain Management Class Prior to Gender Affirming Surgery

Behavioral: Empowered Relief

SOC - No Class

ACTIVE COMPARATOR

SOC for Gender Affirming Surgery

Other: Standard of Care

Interventions

Empowered Relief BEHAVIORAL

Pain Management Course that has been used to treat pain in patients with different pain conditions.

Pain Management Class

Standard of Care OTHER

Gender Affirming surgery without any attention to pain conditions prior to surgery.

SOC - No Class

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Anyone who identifies as gender diverse or transgender and seeking gender affirming surgical care.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU Comprehensive Pain Center

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Stapleton JW, Bohacek SH, Marsiglio M, Kachmarik JE, Carson JW. Efficacy and feasibility of a telehealth intervention (Empowered Relief) for reducing pain-related discouraging thoughts and emotions for gender-diverse adults prior to surgery: protocol for a randomized controlled trial. BMC Surg. 2025 Dec 17. doi: 10.1186/s12893-025-03423-5. Online ahead of print.

  PMID: 41402818 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Interventional Group Control Group

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: June 5, 2024
• Study Start: May 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)