JMIR research protocols · 2026
Virtual Reality to Improve Pain Management and Mental Health in Stroke Survivors With Chronic Pain: Study Protocol for a Feasibility Randomized Controlled Trial on Virtual Reality-Acceptance and Commitment Therapy.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Carvalho Sérgio A, Menezes Paulo, Duarte Catarina, Skvarc David, Sousa E Silva Ana Rita, Valentim Ana, Emanuel Diogo João, Sargento-Freitas João, Trindade Inês A, Castilho Paula, Lapa Teresa, Andersson Gerhard, Castelo-Branco Miguel
Аннотация
BACKGROUND: Studies suggest that 40% to 65% of stroke survivors develop chronic poststroke pain (CPSP), which severely affects their quality of life and mental health. Empirical evidence suggests that existing treatments often fall short, underscoring the need for innovative, integrative interventions. Virtual reality (VR) seems to provide valuable tools in stroke rehabilitation. Also, contextual-behavioral psychological approaches, such as acceptance and commitment therapy (ACT), offer promising pain management and mental health resources, which seem to be feasible in VR formats. However, their combined application in CPSP remains unexplored.
OBJECTIVE: This study protocol describes the VR-ACT study, which will test the feasibility and preliminary efficacy of an 8-week VR-ACT program for CPSP.
METHODS: This pilot randomized controlled trial (N=30) will compare a VR-based ACT intervention with a sham VR control. The study will follow a mixed methods approach. Quantitative outcomes include pain intensity, psychological symptoms, and quality of life (via self-report measures), and brain network connectivity of the Triple Network (via functional magnetic resonance imaging). Feasibility will be evaluated through adherence, engagement, and acceptability. Qualitative feedback will be collected postintervention.
RESULTS: This study was funded by the Portuguese Foundation for Science and Technology in February 2025. Data collection is expected to start in December 2025 and end in June 2026. Results are expected to be published in the fall/winter of 2026/2027.
CONCLUSIONS: This trial is expected to support the hypothesis that a VR-delivered ACT program is a feasible, acceptable, and potentially effective tool to support pain self-management and mental health in patients with CPSP, thereby laying the groundwork for larger multicenter trials.
OBJECTIVE: This study protocol describes the VR-ACT study, which will test the feasibility and preliminary efficacy of an 8-week VR-ACT program for CPSP.
METHODS: This pilot randomized controlled trial (N=30) will compare a VR-based ACT intervention with a sham VR control. The study will follow a mixed methods approach. Quantitative outcomes include pain intensity, psychological symptoms, and quality of life (via self-report measures), and brain network connectivity of the Triple Network (via functional magnetic resonance imaging). Feasibility will be evaluated through adherence, engagement, and acceptability. Qualitative feedback will be collected postintervention.
RESULTS: This study was funded by the Portuguese Foundation for Science and Technology in February 2025. Data collection is expected to start in December 2025 and end in June 2026. Results are expected to be published in the fall/winter of 2026/2027.
CONCLUSIONS: This trial is expected to support the hypothesis that a VR-delivered ACT program is a feasible, acceptable, and potentially effective tool to support pain self-management and mental health in patients with CPSP, thereby laying the groundwork for larger multicenter trials.