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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Comprehensive Pain Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pain Management Class
Pain Management Class Prior to Gender Affirming Surgery
|
Pain Management Course that has been used to treat pain in patients with different pain conditions.
|
|
Active Comparator: SOC - No Class
SOC for Gender Affirming Surgery
|
Gender Affirming surgery without any attention to pain conditions prior to surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Catastrophizing
Time Frame: Participants will be assessed as part of a cohort for up to 7 months. There will be a total of three cohorts.
|
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.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00026520
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.