An interventional study of VR-ACT and Sham-VR in Chronic Pain and Stroke, sponsored by University of Coimbra. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by University of Coimbra · Not applicable, Interventional, and Supportive care
This exploratory project aims to develop and pilot test, in a parallel group randomized controlled trial (RCT) design, the feasibility, acceptability, and preliminary efficacy of a self-management virtual reality (VR) 8-week program for pain management and mental health in patients with chronic post-stroke pain (CPSP), in two assessment moments (pre- to post-intervention).
This project has three objectives: O1) to develop and test the feasibility and acceptability of a 8-week VR ACT program (VR-ACT) in a sample of CPSP patients; O2) to pilot test the efficacy of VR-ACT in improving pain, mental health, and adaptive psychological processes and skills, and in reducing the functional connectivity of the Triple Network (DMN, SN, and FPN); O3) To examine the cost-effectiveness of the VR-ACT. The current project will conduct a parallel group design Randomized Controlled Trial (RCT) and will follow a multi-method approach (qualitative and quantitative assessment).
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →University of Coimbra is the lead sponsor of 84 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8 modules of 3D immersive skills training (2 targeting awareness regulation skills; 3 promoting acceptance; 3 focused on behavioral change and commitment to valued action)
Behavioral: VR-ACT
8 2D non-immersive distracting video animations delivered through a VR headset
Behavioral: Sham-VR
8 MODULES OF 3D VIRTUAL REALITY Modules 1 \& 2: Awareness Regulation Skills Modules 3, 4 \& 5: Acceptance of Pain and Internal Experiences Modules 6, 7 \& 8: Behavior Change and Valued Action
8 2D non-immersive distracting video-animations delivered through a VR headset.
Pain intensity
- The Numeric Rating Scale (NRS)
Time frame: From enrollment to the end of treatment at 8 weeks
Pain Impact
- Pain Disability Index (PDI)
Time frame: From enrollment to the end of treatment at 8 weeks
Mental Health
Mental Health: - Depression Anxiety and Stress Scale (DASS-21)
Time frame: From enrollment to the end of treatment at 8 weeks
Psychological and Physical Quality of Life
- World Health Organization Quality of Life - Bref (WHOQOL- Bref)
Time frame: From enrollment to the end of treatment at 8 weeks
Mindful Awareness
Mindful Awareness: - Mindful Attention Awareness Scale (MAAS)
Time frame: From enrollment to the end of treatment at 8 weeks
Emotional Regulation
Emotional Regulation: - Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
Time frame: From enrollment to the end of treatment at 8 weeks
Psychological Flexibility
Psychological Flexibility: - Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)
Time frame: From enrollment to the end of treatment at 8 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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University of Coimbra