protocolSection identificationModule nctId: NCT06361706, orgStudyIdInfo id: 24/047-P, briefTitle: VR-Enhanced Psychoeducation for Chronic Pain: A Primary Care Pilot Study, acronym: REDOCVR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Badalona Serveis Assistencials, class: OTHER, collaborators name: Department of Health, Generalitat de Catalunya, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Pain, conditions: Central Sensitization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 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., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: The statisticians and researchers involved in data analysis will be masked to the identity of participants, using a random code for each participant., enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: VR-Enhanced Psychoeducational Program for Chronic Pain, outcomesModule primaryOutcomes measure: Participant Satisfaction with the VR-enhanced Psychoeducational Program as measured by the Participants Satisfaction Questionnaire, primaryOutcomes measure: Participants´ System Usability and VR Headset Comfort as assessed by the SUS for participants, primaryOutcomes measure: Professionals System Usability as measured by the SUS for Professionals, secondaryOutcomes measure: Mental Well-being as assessed by the WEMWBS-7, secondaryOutcomes measure: Anxiety and Depression Severity as measured by the HADS, secondaryOutcomes measure: Central Sensitization as measured by the CSI, secondaryOutcomes measure: Changes in Functionality and Mobility as assessed by the EuroQol-5D-5L Scale, secondaryOutcomes measure: Adherence to the VR-enhanced Psychoeducational Program as indicated by session attendance and program completion rates, otherOutcomes measure: Participant Feedback as recorded on the Participant Comment Sheet, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Primary Care Progrès-Raval, status: RECRUITING, city: Badalona, state: Barcelona, zip: 08912, country: Spain, contacts name: Jose Ferrer Costa, MD, role: CONTACT, phone: 0034933951779, email: jfcosta@bsa.cat, contacts name: Elena Villabona López, MSc, role: CONTACT, phone: 0034933890695, email: evlopez@bsa.cat, contacts name: Elena Villabona Lopez, MSc, role: SUB_INVESTIGATOR, contacts name: Jose Ferrer Costa, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Melanie Rodriguez Belloso, BSc, role: SUB_INVESTIGATOR, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Primary Care Center Apenins-Montigalà, status: RECRUITING, city: Badalona, state: Barcelona, zip: 08917, country: Spain, contacts name: José Ferrer Costa, MD, role: CONTACT, phone: 0034933951779, email: jfcosta@bsa.cat, contacts name: Christian Torrecillas Camacho, BSc, role: CONTACT, phone: 0034933951779, email: ctcamacho@bsa.cat, contacts name: José Ferrer Costa, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Christian Torrecillas Camacho, BSc, role: SUB_INVESTIGATOR, contacts name: Alexandra Fernandez Brusco, BSc, role: SUB_INVESTIGATOR, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Primary Care Center Morera-Pomar, status: RECRUITING, city: Badalona, state: Barcelona, country: Spain, contacts name: Nuria Moran Blanco, MD, role: CONTACT, phone: 0034934655200, email: nmoran15@bsa.cat, contacts name: Laura Villares Urgell, MSc, role: CONTACT, phone: 0034934655200, email: lvurgell@bsa.cat, contacts name: Jose Ferrer Costa, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Nuria Moran Blanco, MD, role: SUB_INVESTIGATOR, contacts name: Laura Villare Urgel, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 41.45004, lon: 2.24741, hasResults: False