VR-Enhanced Psychoeducation for Chronic Pain: A Primary Care Pilot Study
NCT ID: NCT06361706
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-12-04
2026-03-31
Brief Summary
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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.
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Detailed Description
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Study Design Overview:
The study is structured as a prospective, non-randomized pilot intervention spanning September 2023 to December 2025 across select Primary Care Centers within Badalona Serveis Assistencials. Targeting adults with chronic pain, the intervention seeks to determine the feasibility, usability, and preliminary efficacy of incorporating VR into pain management protocols.
Recruitment and Selection Process Initial Information: The Primary Care Team is informed about the study and introduces it to potential participants that they identifiy in their daily clinical work, who are then scheduled for an evaluation through the centers electronic system.
Selection Procedure: Interested candidates are contacted via phone for further selection through a face-to-face recruitment visit, assessing eligibility by the Inclusion and Exclusion Criteria and collecting informed consent along with baseline data.
Data Collection and Analysis Specifics:
Data will be meticulously collected on paper before being digitized for analysis, ensuring a robust process for capturing and analyzing participant responses, feedback, and outcomes. This process underscores the study's commitment to methodological rigor and data integrity.
Ethical Considerations: Detailed information on informed consent, data management, privacy, and confidentiality will be addressed in the ethical considerations section.
Innovative Intervention Approach:
Participants are introduced to VR as a tool for understanding and managing their condition, with sessions designed to align VR experiences with educational content. The program includes 8 weekly sessions, each lasting 90 minutes, with VR experiences embedded into the curriculum to reinforce learning objectives and engage participants in their care process actively.
Technological and Methodological Framework:
The intervention leverages Oculus Quest 2 headsets, chosen for their standalone capability and immersive quality. Custom content developed using Unity software focuses on mindfulness, pain education, and self-management techniques, ensuring that VR sessions are directly relevant to participants' learning and therapeutic goals.
Overview of Sessions The intervention framework consists of 8 weekly, 90-minute sessions conducted in session rooms within healthcare centers. Each session incorporates a dedicated 15-20 minute segment for VR experiences designed to complement the session\'s theme and objectives.
Recruitment Visit A 30-minute recruitment visit initiates the study process, involving eligibility assessment through anamnesis, detailing the study\'s scope, and gathering informed consent from participants.
Session Breakdown
1. Introduction to VR Begins with an overview presented by healthcare professionals, followed by an introduction to VR technology, including a practical demonstration to acquaint patients with VR, capped with a 15-minute mindfulness technique using VR.
2. Pain Neurophysiology and Self-management Techniques Focuses on explaining the neurophysiology of pain and introducing pain self-management techniques, including habit changes. Features an educational video to deepen the acquired knowledge.
3. Psychological Aspects of Pain Concentrates on the psychological dimensions of pain, including the gate control theory. Utilizes 360-degree VR videos, controlled by a psychologist with a tablet, explaining techniques for pain awareness and acceptance.
4 \& 6: Reeducation of the Central Nervous System (CNS) Through Physical Activity Engages patients in CNS reeducation activities using interactive VR games designed to encourage physical activity in a fun and engaging manner, overseen by a physiotherapist.
5: Psychological Aspects of Pain - Emotions and Thoughts Addresses emotions and thoughts associated with chronic pain through an educational VR session on emotional management techniques.
7: Emotions and Self-esteem Focuses on acceptance, self-esteem, and emotion management, incorporating a VR educational session on compassionate acceptance techniques.
8: Farewell A closing session that reviews covered content and concludes with a final VR session on attentive breathing techniques for relaxation and skill consolidation.
Expected Outcomes and Contributions:
Through a detailed exploration of VR's role in psychoeducation for chronic pain, the REDOCVR study aims to provide valuable insights into how digital health innovations can enhance traditional therapeutic modalities. The findings are anticipated to inform future interventions, guide clinical practice, and contribute to the broader dialogue on integrating technology into patient care.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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VR-Enhanced Chronic Pain Management Program
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.
VR-Enhanced Psychoeducational Program for Chronic Pain
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.
Interventions
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VR-Enhanced Psychoeducational Program for Chronic Pain
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Department of Health, Generalitat de Catalunya
OTHER_GOV
Badalona Serveis Assistencials
OTHER
Responsible Party
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Jose Ferrer Costa
Clinical Researcher at the Innovation and Projects department
Principal Investigators
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Jose Ferrer Costa, MD
Role: PRINCIPAL_INVESTIGATOR
Badalona Serveis Assistencials
Locations
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Primary Care Progrès-Raval
Badalona, Barcelona, Spain
Primary Care Center Apenins-Montigalà
Badalona, Barcelona, Spain
Primary Care Center Morera-Pomar
Badalona, Barcelona, Spain
CAP Montgat- Dr Jardi
Montgat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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24/047-P
Identifier Type: -
Identifier Source: org_study_id
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