Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443164
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-05
First Post:
2024-03-29
Brief Title:
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Efficacy of a Single-session Treatment for Reducing Chronic Pain Prior to Gender-affirming Surgery
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None