Clinical trial NCT06361706: VR-Enhanced Psychoeducation for Chronic Pain: A Primary Care Pilot Study
Official title: Desenvolupament i Avaluació de l'Experiència en Realitat Virtual en la Prova Pilot Per a Pacients Amb Dolor Crònic i Sensibilització Central Als Centres d'Atenció Primària de Badalona Serveis Assistencials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Badalona Serveis Assistencials
Sponsor class: OTHER
Collaborators: name: Department of Health, Generalitat de Catalunya
First posted: 2024-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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\&#39; 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\&#39; 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\&#39;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.

Detailed description: The REDOCVR study is an innovative initiative to evaluate the adjunctive use of Virtual Reality (VR) within a psychoeducational framework for managing chronic pain and central sensitization. This initiative aims to harness the immersive potential of VR to enhance traditional psychoeducational strategies, thereby providing a more engaging and impactful patient experience.

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\&#39;s theme and objectives.

Recruitment Visit A 30-minute recruitment visit initiates the study process, involving eligibility assessment through anamnesis, detailing the study\&#39;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 \&amp; 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Participant Satisfaction with the VR-enhanced Psychoeducational Program as measured by the Participants Satisfaction Questionnaire
timeFrame: Immediately after the last intervention session (within 30 minutes of completing the 8th session)
measure: Participants´ System Usability and VR Headset Comfort as assessed by the SUS for participants
timeFrame: Immediately after the last intervention session (within 30 minutes of completing the 8th session)
measure: Professionals System Usability as measured by the SUS for Professionals
timeFrame: Immediately after the last intervention session (within 30 minutes of completing the 8th session)
Secondary outcomes:
measure: Mental Well-being as assessed by the WEMWBS-7
timeFrame: Baseline and immediately after the last intervention session (within 30 minutes of completing the 8th session)
measure: Anxiety and Depression Severity as measured by the HADS
timeFrame: Baseline and immediately after the last intervention session (within 30 minutes of completing the 8th session)
measure: Central Sensitization as measured by the CSI
timeFrame: Baseline and immediately after the last intervention session (within 30 minutes of completing the 8th session)
measure: Changes in Functionality and Mobility as assessed by the EuroQol-5D-5L Scale
timeFrame: Baseline and immediately after the last intervention session (within 30 minutes of completing the 8th session)
measure: Adherence to the VR-enhanced Psychoeducational Program as indicated by session attendance and program completion rates
timeFrame: After the last intervention session, up to 16 weeks
Other outcomes:
measure: Participant Feedback as recorded on the Participant Comment Sheet
timeFrame: Immediately at the end of each session
Locations:
city: Badalona
country: Spain
facility: Primary Care Progrès-Raval
state: Barcelona
city: Badalona
country: Spain
facility: Primary Care Center Apenins-Montigalà
state: Barcelona
city: Badalona
country: Spain
facility: Primary Care Center Morera-Pomar
state: Barcelona
city: Montgat
country: Spain
facility: CAP Montgat- Dr Jardi
state: Barcelona
Study officials:
affiliation: Badalona Serveis Assistencials
name: Jose Ferrer Costa, MD
role: PRINCIPAL_INVESTIGATOR
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