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Not yet recruiting NCT06990646

VR-ACT After Stroke: a Feasibility Study

No phase Interventional Chronic Pain Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR-ACT, Sham-VR.
Who it may be relevant to
Registry conditions: Chronic Pain, Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Behavioral VR-ACT
    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
  • Behavioral Sham-VR
    8 2D non-immersive distracting video-animations delivered through a VR headset.

Primary outcome measures

  • Pain intensity [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Pain Impact [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Mental Health [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Psychological and Physical Quality of Life [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

  • medical diagnosis of CPSP;
  • age between 18 and 80;
  • implicit de facto internet and computer literacy;
  • willingness to comply with the study procedures.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06990646 · 2023.13402.PEX · 2023.13402.PEX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗