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.

backgroundIndividuals that identify as transgender or gender diverse (TGD) are more likely to experience chronic pain that impacts quality of life. Chronic pain is a known risk factor for suboptimal post-surgical pain control and outcomes (Rosenberger and Pogatzki-Zahn, BJA Educ 22:190-196, 2022) and there is limited data for TGD individuals with a history of chronic pain seeking gender-affirming surgery. Empowered Relief is an empirically validated, two-hour group session targeting discouraging thoughts and emotions related to pain. This may improve surgical outcomes and reduce TGD individuals' experience of pain-related distress pre- and post-surgery.

methodsThis is a single-blinded randomized controlled trial to evaluate the efficacy and feasibility of Empowered Relief in pain management prior to gender-affirming surgery at a single academic health center in the United States. Seventy-eight pre-surgical adult patients will be recruited based on their baseline chronic pain, experience with behavioral health interventions for pain, and surgical plans. Study participants will be randomized (1:1) into an intervention and control group. Feasibility will be assessed through responses to self-report measures completed before the intervention and 1-day, 2-weeks, 2-months, and 6-months after the intervention. DISCUSSION: Our protocol describes the design and implementation of a randomized controlled trial studying the role of Empowered Relief for TGD patients with baseline chronic pain who are preparing for gender-affirming surgery. Challenges in protocol design and implementation include recruiting a patient cohort that experiences systemic oppression within and outside of the healthcare system, limiting selection bias, and optimizing study adherence. This research aims to provide valuable information regarding the role of Empowered Relief as an intervention for TGD surgical patients.

trial registrationThe trial was prospectively registered at clinicaltrials.gov (NCT06443164) on 05/15/2024. The study was approved by the Oregon Health and Science University Institutional Review Board (STUDY IRB #00026520) and performed in accordance with ethical standards as defined by the 1964 Declaration of Helsinki and subsequent amendments. Informed consent will be obtained from all participants. Any amendments to the protocol will be approved by the OHSU IRB before implementation in the study.