VR-Enhanced Psychoeducation for Chronic Pain: A Primary Care Pilot Study

NCT06361706 | Recruiting

• 1 other identifier: 24/047-P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

This pilot study aims to evaluate the integration of virtual reality (VR) with a psychoeducational program for individuals experiencing chronic pain and central sensitization. Chronic pain significantly hampers daily life, and the condition of central sensitization intensifies this challenge by making the pain more acute. Our research is grounded in the hypothesis that VR, when used to complement conventional psychoeducational methods, can enhance engagement and understanding of pain management strategies, thus potentially improving patient outcomes. Key objectives and related measured variables include: Usability and Feasibility: Evaluated through the System Usability Scale (SUS) responses from both participants and healthcare professionals, assessing the ease of use and integration of VR into the psychoeducational program. Participant Engagement and Program Adherence: Determined by participants\' satisfaction with the VR system, using Likert scale questionnaires, and tracked through session attendance and program completion rates. Impact on Chronic Pain Management and Emotional Well-being: Assessed through changes in the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), and the Hospital Anxiety and Depression Scale (HADS) collected at baseline, post-intervention, and 4-8 weeks follow-up Self-management of Chronic Pain: Monitored through the Central Sensitization Inventory (CSI) and changes in patient functionality and mobility using the EuroQol-5D-5L scale, measured at baseline, post-intervention, and 4-8 weeks follow-up. Healthcare Professionals\' Perceptions: Investigated using SUS scores and qualitative feedback on the applicability and benefits of VR in clinical practice for chronic pain management. Participants will complete eight 90-minute sessions, engaging with VR to supplement the program\'s content. This approach aims to provide immersive experiences that deepen the understanding and management of chronic pain. Participant feedback on the VR experience, alongside observed changes in pain management and overall well-being, will be critically examined. By targeting individuals suffering from chronic pain, this research aims to offer healthcare professionals an innovative tool for enhancing pain management strategies. Integrating VR into psychoeducational content, the study seeks to promote more engaging and effective learning experiences, potentially leading to improved outcomes in chronic pain management.

Conditions

Chronic Pain; Central Sensitization

Keywords

chronic pain; central sensitization; virtual reality; patient education as a topic; pain management; behavioral therapy; digital health; primary health care

Outcome Measures

Primary Outcomes (3)

• Participant Satisfaction with the VR-enhanced Psychoeducational Program as measured by the Participants Satisfaction Questionnaire

  The Participant Satisfaction Questionnaire assesses with 10 itens various aspects of the VR-enhanced psychoeducational program, including content relevance, VR experience, and perceived benefits in managing chronic pain. This questionnaire uses a Likert scale for responses, providing a quantitative measure of participant satisfaction. The questionnaire's design allows for a comprehensive evaluation of the program's impact on participants, with higher scores indicating greater satisfaction.

  Immediately after the last intervention session (within 30 minutes of completing the 8th session)

• Participants´ System Usability and VR Headset Comfort as assessed by the SUS for participants

  The SUS is a two-part Likert Scale with options ranging from "Strongly disagree" to "I quite agree," designed to evaluate both the system's usability and the comfort of the VR headset used. Participants will respond to 16 statements, with 8 focused on system usability and 8 on headset comfort. Statements are rated on a scale from 1 to 5. For usability, positive experiences are reflected by statements 1, 3, 4, 6, and 7, while for headset comfort, statements assess aspects like weight, ease of use, and physical discomfort. The overall SUS score is calculated to assess usability and comfort, with higher scores indicating better usability and comfort levels.

  Immediately after the last intervention session (within 30 minutes of completing the 8th session)

• Professionals System Usability as measured by the SUS for Professionals

  The SUS for Professionals is designed to evaluate healthcare professionals' perceptions of the VR system's usability within the clinical setting for this educational program. This assessment uses a Likert Scale from "Strongly disagree" to "I quite agree," focusing on ease of use, integration into practice, and the system's effectiveness in enhancing patient care. Higher scores on the SUS for Professionals indicate a positive assessment of the system's usability and potential impact on patient treatment.

  Immediately after the last intervention session (within 30 minutes of completing the 8th session)

Secondary Outcomes (5)

• Mental Well-being as assessed by the WEMWBS-7

  Baseline and immediately after the last intervention session (within 30 minutes of completing the 8th session)

• Anxiety and Depression Severity as measured by the HADS

  Baseline and immediately after the last intervention session (within 30 minutes of completing the 8th session)

• Central Sensitization as measured by the CSI

  Baseline and immediately after the last intervention session (within 30 minutes of completing the 8th session)

• Changes in Functionality and Mobility as assessed by the EuroQol-5D-5L Scale

  Baseline and immediately after the last intervention session (within 30 minutes of completing the 8th session)

• Adherence to the VR-enhanced Psychoeducational Program as indicated by session attendance and program completion rates

  After the last intervention session, up to 16 weeks

Other Outcomes (1)

• Participant Feedback as recorded on the Participant Comment Sheet

  Immediately at the end of each session

Study Arms (1)

VR-Enhanced Chronic Pain Management Program

EXPERIMENTAL

Participants in this arm will undergo a comprehensive psychoeducational program tailored for chronic pain and central sensitization management, significantly enhanced with Virtual Reality (VR) experiences.

Behavioral: VR-Enhanced Psychoeducational Program for Chronic Pain

Interventions

VR-Enhanced Psychoeducational Program for Chronic Pain BEHAVIORAL

Participants undergo eight weekly sessions that include VR to learn pain physiology, mindfulness, and self-management techniques. Each session is 90 minutes, with 15-20 minutes of VR activities designed to complement the educational content. Activities simulate pain management exercises and mindfulness meditation. The program, led by pain management and VR specialists, aims to improve pain management skills, emotional well-being, and quality of life.

VR-Enhanced Chronic Pain Management Program

Eligibility Criteria

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

You may qualify if:

• Patients experiencing chronic pain with elements of central sensitization, emotional discomfort related to pain, kinesiophobia, or inadequate response to prescribed treatments.
• Patients aged 18 years or older assigned to the assigned to Badalona Serveis Assistnecials´ Primary Care.
• Patients capable of providing consent to participate in the study, signing the informed consent form, and responding to the variable-related questions.

You may not qualify if:

• Patients with acute pain (less than 3 months)
• Diagnosis of systemic diseases or severe mental disorders, cognitive impairment, vertigo, epilepsy, or significant visual/auditory impairments that prevent the use of VR headsets.
• Withdrawal Criteria:
• \- Presence of VR-related side effects or patient's decision to withdraw.

Sponsors & Collaborators

• Badalona Serveis Assistencials: lead
• Department of Health, Generalitat de Catalunya: collaborator

Study Sites (4)

Primary Care Progrès-Raval

Badalona, Barcelona, 08912, Spain

RECRUITING

Primary Care Center Apenins-Montigalà

Badalona, Barcelona, 08917, Spain

RECRUITING

Primary Care Center Morera-Pomar

Badalona, Barcelona, Spain

RECRUITING

CAP Montgat- Dr Jardi

Montgat, Barcelona, Spain

RECRUITING

Related Publications (13)

• Brown CA, Jones AK. Psychobiological correlates of improved mental health in patients with musculoskeletal pain after a mindfulness-based pain management program. Clin J Pain. 2013 Mar;29(3):233-44. doi: 10.1097/AJP.0b013e31824c5d9f.

  PMID: 22874090 BACKGROUND

• Grossman P, Tiefenthaler-Gilmer U, Raysz A, Kesper U. Mindfulness training as an intervention for fibromyalgia: evidence of postintervention and 3-year follow-up benefits in well-being. Psychother Psychosom. 2007;76(4):226-33. doi: 10.1159/000101501.

  PMID: 17570961 BACKGROUND

• Ma J, Zhao D, Xu N, Yang J. The effectiveness of immersive virtual reality (VR) based mindfulness training on improvement mental-health in adults: A narrative systematic review. Explore (NY). 2023 May-Jun;19(3):310-318. doi: 10.1016/j.explore.2022.08.001. Epub 2022 Aug 5.

  PMID: 36002363 BACKGROUND

• Yang H, Cai M, Diao Y, Liu R, Liu L, Xiang Q. How does interactive virtual reality enhance learning outcomes via emotional experiences? A structural equation modeling approach. Front Psychol. 2023 Jan 6;13:1081372. doi: 10.3389/fpsyg.2022.1081372. eCollection 2022.

  PMID: 36687987 BACKGROUND

• Moro C, Stromberga Z, Raikos A, Stirling A. The effectiveness of virtual and augmented reality in health sciences and medical anatomy. Anat Sci Educ. 2017 Nov;10(6):549-559. doi: 10.1002/ase.1696. Epub 2017 Apr 17.

  PMID: 28419750 BACKGROUND

• Barteit S, Lanfermann L, Barnighausen T, Neuhann F, Beiersmann C. Augmented, Mixed, and Virtual Reality-Based Head-Mounted Devices for Medical Education: Systematic Review. JMIR Serious Games. 2021 Jul 8;9(3):e29080. doi: 10.2196/29080.

  PMID: 34255668 BACKGROUND

• Pascual K, Fredman A, Naum A, Patil C, Sikka N. Should Mindfulness for Health Care Workers Go Virtual? A Mindfulness-Based Intervention Using Virtual Reality and Heart Rate Variability in the Emergency Department. Workplace Health Saf. 2023 Apr;71(4):188-194. doi: 10.1177/21650799221123258. Epub 2022 Nov 14.

  PMID: 36377263 BACKGROUND

• Meese MM, O'Hagan EC, Chang TP. Healthcare Provider Stress and Virtual Reality Simulation: A Scoping Review. Simul Healthc. 2021 Aug 1;16(4):268-274. doi: 10.1097/SIH.0000000000000484.

  PMID: 32890319 BACKGROUND

• Tack C. Virtual reality and chronic low back pain. Disabil Rehabil Assist Technol. 2021 Aug;16(6):637-645. doi: 10.1080/17483107.2019.1688399. Epub 2019 Nov 20.

  PMID: 31746250 BACKGROUND

• Goudman L, Jansen J, Billot M, Vets N, De Smedt A, Roulaud M, Rigoard P, Moens M. Virtual Reality Applications in Chronic Pain Management: Systematic Review and Meta-analysis. JMIR Serious Games. 2022 May 10;10(2):e34402. doi: 10.2196/34402.

  PMID: 35536641 BACKGROUND

• Ummels D, Cnockaert E, Timmers I, den Hollander M, Smeets R. Use of Virtual Reality in Interdisciplinary Multimodal Pain Treatment With Insights From Health Care Professionals and Patients: Action Research Study. JMIR Rehabil Assist Technol. 2023 Nov 10;10:e47541. doi: 10.2196/47541.

  PMID: 37948109 BACKGROUND

• de Vries FS, van Dongen RTM, Bertens D. Pain education and pain management skills in virtual reality in the treatment of chronic low back pain: A multiple baseline single-case experimental design. Behav Res Ther. 2023 Mar;162:104257. doi: 10.1016/j.brat.2023.104257. Epub 2023 Jan 18.

  PMID: 36731183 BACKGROUND

• Brown L, DiCenso-Fleming T, Ensign T, Boyd AJ, Monaghan G, Binder DS. Chronic pain education delivered with a virtual reality headset in outpatient physical therapy clinics: a multi-site exploratory trial. Am J Transl Res. 2023 May 15;15(5):3500-3510. eCollection 2023.

  PMID: 37303618 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Jose Ferrer Costa, MD

  Badalona Serveis Assistencials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Ferrer Costa, MD

CONTACT

0034933951779; jfcosta@bsa.cat

Nuria Moran Blanco, MD

CONTACT

0034934655200; nmoran15@bsa.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The statisticians and researchers involved in data analysis will be masked to the identity of participants, using a random code for each participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher at the Innovation and Projects department

Model Details: The REDOCVR study utilizes a Single-Group Interventional Model, where all participants receive the same VR-enhanced psychoeducational intervention for chronic pain management. This model facilitates a focused evaluation of VR's effectiveness and usability within a structured psychoeducational framework, allowing for direct assessment of participant experiences and outcomes.

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 12, 2024
• Study Start: December 4, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The digitized IPD will be made available to approved researchers starting 12 months after the publication of the main study results. This window allows sufficient time for the meticulous preparation of the data for external use. The data will be accessible for a period of up to 3 years, during which requests for access can be submitted and reviewed.
• Access Criteria: Access to IPD will be granted to researchers submitting scientifically valid proposals that align with ethical guidelines. A review committee will evaluate proposals based on their objectives, methodology, and compliance with data protection standards. Successful applicants will sign a data use agreement detailing secure data handling and confidentiality requirements. Instructions for secure data access, including anonymization protocols and secure transfer methods, will be provided to approved researchers. Data will be accessible via a secure platform within the BSA intranet, ensuring data integrity and participant privacy are maintained.

Locations

ES (4)