Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361706
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-07
Brief Title:
VR-Enhanced Psychoeducation for Chronic Pain A Primary Care Pilot Study
Sponsor:
Badalona Serveis Assistencials
Organization:
Badalona Serveis Assistencials
Study Overview
Official Title:
Desenvolupament i Avaluació de lExperiència en Realitat Virtual en la Prova Pilot Per a Pacients Amb Dolor Crònic i Sensibilització Central Als Centres dAtenció Primària de Badalona Serveis Assistencials
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDOCVR
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 participants39 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 Professionals39 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 program39s 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
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 participants39 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 Professionals39 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 program39s 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 studys 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 session39s theme and objectives
Recruitment Visit A 30-minute recruitment visit initiates the study process involving eligibility assessment through anamnesis detailing the study39s 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 VRs 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
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 studys 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 session39s theme and objectives
Recruitment Visit A 30-minute recruitment visit initiates the study process involving eligibility assessment through anamnesis detailing the study39s 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 VRs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None