Chronic PainVR-ACTNCT06990646
VR-ACT After Stroke: a Feasibility Study
A study testing VR-ACT in people with Chronic Pain and Stroke, run by University of Coimbra.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain, Stroke
- What is being tested?
- VR-ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical diagnosis of CPSP;
- age between 18 and 80;
- implicit de facto internet and computer literacy;
- willingness to comply with the study procedures.
Who cannot join
- currently with active malignancy; -
- severe cognitive impairment;
- currently undergoing any psychological intervention or VR-delivered pain management program;
- current severe psychiatric symptoms (i.e., psychosis; severe depression; non-suicidal self-injury; suicide attempt in the last month);
- language impairment with severe comprehension deficit;
- history of photosensitive epilepsy or previous experience of severe simulator sickness;
- other neurological conditions (e.g., dementia; Parkinson´s).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: VR-ACT After Stroke: a Feasibility RCT of a Virtual Reality Delivery of ACT for Pain Management and Mental Health in Patients With Chronic Post-Stroke Pain
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).
Read the detailed description
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).
- Conditions
- Chronic Pain, Stroke
- Being tested
- VR-ACT, Sham-VR
- Keywords
- chronic post-stroke pain, contextual-behavioral approaches, virtual reality, acceptance and commitment therapy
- Medical subject headings
- Chronic Pain, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-ACTBehavioural
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
Sham-VRBehavioural
8 2D non-immersive distracting video-animations delivered through a VR headset.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: VR-ACT |
| Sham-VR | Sham comparator | 8 2D non-immersive distracting video animations delivered through a VR headset Receives: Behavioral: Sham-VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
- The Numeric Rating Scale (NRS)
Measured: From enrollment to the end of treatment at 8 weeks
Pain Impact
- Pain Disability Index (PDI)
Measured: From enrollment to the end of treatment at 8 weeks
Mental Health
Mental Health:
- Depression Anxiety and Stress Scale (DASS-21)
Measured: 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)
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (3)
Mindful Awareness
Mindful Awareness:
- Mindful Attention Awareness Scale (MAAS)
Measured: From enrollment to the end of treatment at 8 weeks
Emotional Regulation
Emotional Regulation:
- Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
Measured: From enrollment to the end of treatment at 8 weeks
Psychological Flexibility
Psychological Flexibility:
- Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study startNov 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde de Coimbra, EPE
- Responsible party
- Principal investigator, Sérgio Andrade Carvalho, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990646
- Sponsor's protocol ID
- 2023.13402.PEX
- Other IDs
- 2023.13402.PEX, 2023
- Acronym
- VR-ACT
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carvalho SA, Menezes P, Duarte C, Skvarc D, Sousa E Silva AR, Valentim A, Emanuel Diogo J, Sargento-Freitas J, Trindade IA, Castilho P, Lapa T, Andersson G, Castelo-Branco M. 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. JMIR Res Protoc. 2026 Feb 6;15:e80611. doi: 10.2196/80611.
PubMed 41650200
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-ACT After Stroke: a Feasibility RCT of a Virtual Reality Delivery of ACT for Pain Management and Mental Health in Patients With Chronic Post-Stroke Pain
- ClinicalTrials.gov ID
- NCT06990646
- Acronym / sponsor ID
- VR-ACT / 2023.13402.PEX
- Conditions
- Chronic Pain, Stroke
- Keywords
- chronic post-stroke pain, contextual-behavioral approaches, virtual reality, acceptance and commitment therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde de Coimbra, EPE
- Study start
- Nov 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-ACT | Experimental | Behavioral: VR-ACT8 modules of 3D immersive skills training (2 targeting awareness regulation skills; 3 promoting acceptance; 3 focused on behavioral change and commitment to valued action) |
| Sham-VR | Sham comparator | Behavioral: Sham-VR8 2D non-immersive distracting video animations delivered through a VR headset |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- medical diagnosis of CPSP;
- age between 18 and 80;
- implicit de facto internet and computer literacy;
- willingness to comply with the study procedures.
Key exclusion criteria (7 listed)
- currently with active malignancy; -
- severe cognitive impairment;
- currently undergoing any psychological intervention or VR-delivered pain management program;
- current severe psychiatric symptoms (i.e., psychosis; severe depression; non-suicidal self-injury; suicide attempt in the last month);
- language impairment with severe comprehension deficit;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-ACT8 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 | Behavioural | VR-ACT |
| Sham-VR8 2D non-immersive distracting video-animations delivered through a VR headset. | Behavioural | Sham-VR |
Primary outcome
Pain intensity
Time frame: From enrollment to the end of treatment at 8 weeks
- The Numeric Rating Scale (NRS)
Pain Impact
Time frame: From enrollment to the end of treatment at 8 weeks
- Pain Disability Index (PDI)
Mental Health
Time frame: From enrollment to the end of treatment at 8 weeks
Mental Health: - Depression Anxiety and Stress Scale (DASS-21)
Psychological and Physical Quality of Life
Time frame: From enrollment to the end of treatment at 8 weeks
- World Health Organization Quality of Life - Bref (WHOQOL- Bref)
3 secondary outcomes
Mindful Awareness
Time frame: From enrollment to the end of treatment at 8 weeks
Emotional Regulation
Time frame: From enrollment to the end of treatment at 8 weeks
Psychological Flexibility
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 41650200Carvalho SA, Menezes P, Duarte C, Skvarc D, Sousa E Silva AR, Valentim A, Emanuel Diogo J, Sargento-Freitas J, Trindade IA, Castilho P, Lapa T, Andersson G, Castelo-Branco M. 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. JMIR Res Protoc. 2026 Feb 6;15:e80611. doi: 10.2196/80611.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing VR-ACT in people with Chronic Pain and Stroke, run by University of Coimbra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sérgio A Carvalho, PhD (+351 239 851 450, sergiocarvalho@fpce.uc.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06990646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.