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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 8
- 主要终点
- Participants´ System Usability and VR Headset Comfort as assessed by the SUS for participants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The statisticians and researchers involved in data analysis will be masked to the identity of participants, using a random code for each participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: VR-Enhanced Psychoeducational Program for Chronic Pain (Behavioral)
结局指标
主要结局
Participants´ System Usability and VR Headset Comfort as assessed by the SUS for participants
时间窗: Immediately after the last intervention session (within 30 minutes of completing the 8th session)
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.
Professionals System Usability as measured by the SUS for Professionals
时间窗: Immediately after the last intervention session (within 30 minutes of completing the 8th session)
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.
Participant Satisfaction with the VR-enhanced Psychoeducational Program as measured by the Participants Satisfaction Questionnaire
时间窗: Immediately after the last intervention session (within 30 minutes of completing the 8th session)
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.
次要结局
- 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))
- 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))
- Central Sensitization as measured by the CSI(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))
- 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)
研究者
Jose Ferrer Costa
Clinical Researcher at the Innovation and Projects department
Badalona Serveis Assistencials