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| ID | Type | Description | Link |
|---|---|---|---|
| 2023.13402.PEX | Other Grant/Funding Number | Fundação para a Ciência e Tecnologia (FCT) |
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| Name | Class |
|---|---|
| Unidade Local de Saúde de Coimbra, EPE | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-ACT | Experimental | 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) |
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| Sham-VR | Sham Comparator | 8 2D non-immersive distracting video animations delivered through a VR headset |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR-ACT | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | - The Numeric Rating Scale (NRS) | From enrollment to the end of treatment at 8 weeks |
| Pain Impact | - Pain Disability Index (PDI) | From enrollment to the end of treatment at 8 weeks |
| Mental Health | Mental Health: - Depression Anxiety and Stress Scale (DASS-21) | 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) | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mindful Awareness | Mindful Awareness: - Mindful Attention Awareness Scale (MAAS) | From enrollment to the end of treatment at 8 weeks |
| Emotional Regulation | Emotional Regulation: - Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sérgio A Carvalho, PhD | Contact | +351 239 851 450 | sergiocarvalho@fpce.uc.pt |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sham-VR | Behavioral | 8 2D non-immersive distracting video-animations delivered through a VR headset. |
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| From enrollment to the end of treatment at 8 weeks |
| Psychological Flexibility | Psychological Flexibility: - Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT) | From enrollment to the end of treatment at 8 weeks |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |