Single-Session "Empowered Relief" Class for Marfan Syndrome and Related Conditions

NCT05980104 | Completed

• 1 other identifier: 68906
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Empowered Relief (ER) is a 1-session pain relief skills intervention that is delivered in-person or online by certified clinicians to groups of patients with acute or chronic pain. Prior work in has shown ER efficacy for reducing chronic pain, pain-related distress, and other symptoms 6 months post-treatment. The purpose of this study is to conduct the first feasibility and early efficacy test of online ER (two hours total treatment time) delivered to individuals with Marfan syndrome, Vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, and related conditions. Participants will be followed for 3 months via 5 follow-up surveys.

Conditions

Chronic Pain; Marfan Syndrome; Vascular Ehlers-Danlos Syndrome; Loeys-Dietz Syndrome

Outcome Measures

Primary Outcomes (3)

• Number of participants registered for class

  Full registration for the online session (N=100)

  baseline

• Class Attendance

  At least 70% attendance for the registered Empowered Relief online class

  at treatment

• Treatment appraisal

  7 items assess treatment appraisal/satisfaction using 7-point scales (0-6) where higher ratings represent greater appraisal/satisfaction with the treatment. The investigators hypothesize \>=80% ratings for treatment appraisal/satisfaction rated immediately post-treatment.

  immediately post-treatment

Secondary Outcomes (2)

• Pain Intensity

  post-treatment month 3

• Pain Catastrophizing

  post-treatment month 3

Other Outcomes (20)

• Pain Intensity

  post-treatment month 1

• Pain Catastrophizing

  post-treatment month 1

• Pain Interference

  post-treatment month 3

Study Arms (1)

1-Session pain relief skills class (online Empowered Relief)

EXPERIMENTAL

Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to a group of patients by a certified instructor using a standardized treatment manual and electronic slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use.

Behavioral: Empowered Relief

Interventions

Empowered Relief BEHAVIORAL

The participants will attend an online pain relief skills intervention (Empowered Relief). The two-hour group session is delivered by a certified instructor and includes pain neuroscience education, 3 core pain management skills, experiential exercises, completion of a personalized plan for empowered relief. Participants download a binaural relaxation audio file for daily use.

Also known as: 1-Session Pain Relief Skills Intervention

1-Session pain relief skills class (online Empowered Relief)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females 18 years of age or older
• Marfan Syndrome, Vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome or related connective tissue disease and chronic pain
• English fluency
• Ability to adhere to and complete study protocols

You may not qualify if:

• Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.

Sponsors & Collaborators

• Stanford University: lead
• The Marfan Foundation: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Chronic Pain; Marfan Syndrome; Ehlers-Danlos Syndrome, Type IV; Loeys-Dietz Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Ehlers-Danlos Syndrome; Hemostatic Disorders; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Skin Diseases, Genetic; Collagen Diseases; Skin Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Aortic Aneurysm; Aortic Diseases

Study Officials

• Beth Darnall, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Stanford Pain Relief Innovations Lab

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 7, 2023
• Study Start: March 21, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)