Pain CatastrophizingNCT06443164
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
A study testing Empowered Relief in people with Pain Catastrophizing and Pain, Chronic, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Catastrophizing, Pain, Chronic, Gender Identity
- What is being tested?
- Empowered Relief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OHSU Comprehensive Pain Center
Portland, Oregon, 97239
About this study
Official title: Efficacy of a Single-session Treatment for Reducing Chronic Pain Prior to Gender-affirming Surgery
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.
Read the 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
- Being tested
- Empowered Relief, Standard of Care
- Keywords
- Chronic Pain, Gender Diversity, Gender Affirming Surgery
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
Pain Management Course that has been used to treat pain in patients with different pain conditions.
Standard of CareOther
Gender Affirming surgery without any attention to pain conditions prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pain Management Class | Experimental | Pain Management Class Prior to Gender Affirming Surgery Receives: Behavioral: Empowered Relief |
| SOC - No Class | Active comparator | SOC for Gender Affirming Surgery Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be assessed as part of a cohort for up to 7 months. There will be a total of three cohorts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start15 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain CatastrophizingStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional Group Control Group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Stapleton, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443164
- Sponsor's protocol ID
- STUDY00026520
- Status last verified
- Oct 2026
- First submitted
- 29 Mar 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If information is shared in the future outside OHSU it will be deidentified and shared as a data set.
Publications
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;26(1):60. doi: 10.1186/s12893-025-03423-5.
PubMed 41402818
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Single-session Treatment for Reducing Chronic Pain Prior to Gender-affirming Surgery
- ClinicalTrials.gov ID
- NCT06443164
- Acronym / sponsor ID
- STUDY00026520
- Conditions
- Pain Catastrophizing, Pain, Chronic, Gender Identity
- Keywords
- Chronic Pain, Gender Diversity, Gender Affirming Surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional Group Control Group
| Arm | Type | Receives |
|---|---|---|
| Pain Management Class | Experimental | Behavioral: Empowered ReliefPain Management Class Prior to Gender Affirming Surgery |
| SOC - No Class | Active comparator | Other: Standard of CareSOC for Gender Affirming Surgery |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered ReliefPain Management Course that has been used to treat pain in patients with different pain conditions. | Behavioural | Pain Management Class |
| Standard of CareGender Affirming surgery without any attention to pain conditions prior to surgery. | Other | SOC - No Class |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 41402818Stapleton 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;26(1):60. doi: 10.1186/s12893-025-03423-5.
- Individual participant dataSharing planned: Undecided. If information is shared in the future outside OHSU it will be deidentified and shared as a data set.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief in people with Pain Catastrophizing and Pain, Chronic, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06443164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.