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.

An estimated 40% to 65% of stroke survivors develop chronic poststroke pain (CPSP), which severely affects quality of life and mental health.

• The prevalence range of 40% to 65% is cited from existing studies in the literature.
• CPSP is described as severely affecting both quality of life and mental health.
• Existing treatments are characterized as 'often fall short,' underscoring the need for innovative interventions.

The VR-ACT study is a pilot randomized controlled trial with a total sample size of 30 participants comparing a VR-based ACT intervention with a sham VR control.

• The trial is described as a feasibility randomized controlled trial (N=30).
• The intervention arm receives VR-based ACT; the control arm receives sham VR.
• The study follows a mixed methods approach combining quantitative and qualitative data collection.
• The intervention duration is 8 weeks.

Quantitative outcomes include pain intensity, psychological symptoms, quality of life via self-report measures, and brain network connectivity of the Triple Network via functional magnetic resonance imaging (fMRI).

• Pain intensity, psychological symptoms, and quality of life are assessed via self-report measures.
• Brain network connectivity is assessed using functional magnetic resonance imaging (fMRI) targeting the Triple Network.
• Feasibility outcomes include adherence, engagement, and acceptability.
• Qualitative feedback will be collected post-intervention.

The combined application of virtual reality and acceptance and commitment therapy (ACT) in chronic poststroke pain remains unexplored at the time of this protocol.

• Virtual reality is described as providing 'valuable tools in stroke rehabilitation.'
• ACT is described as offering 'promising pain management and mental health resources' that 'seem to be feasible in VR formats.'
• Despite individual evidence for VR and ACT separately, 'their combined application in CPSP remains unexplored.'

The study was funded by the Portuguese Foundation for Science and Technology in February 2025, with data collection expected from December 2025 to June 2026 and results anticipated in fall/winter 2026/2027.

• Funding was granted 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 fall/winter 2026/2027.

The trial is expected to support the hypothesis that a VR-delivered ACT program is feasible, acceptable, and potentially effective for pain self-management and mental health in CPSP patients, with the goal of laying groundwork for larger multicenter trials.

• The trial is explicitly described as a feasibility study intended to precede larger multicenter trials.
• Primary hypotheses include feasibility, acceptability, and potential effectiveness of VR-ACT for CPSP.
• The outcomes are framed as supporting 'pain self-management and mental health' in the CPSP population.