VR-ACT After Stroke: a Feasibility Study

ConditionsChronic Pain Stroke

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorUniversity of Coimbra

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

medical diagnosis of CPSP;

age between 18 and 80;

implicit de facto internet and computer literacy;

willingness to comply with the study procedures.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: VR-ACTExperimental treatment 1 intervention

Group B: Sham-VRSham comparator 1 intervention

Trial outcomes