NCT06990646

Brief 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 (CPSP), in two assessment moments (pre- to post-intervention).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
2mo left

Started Nov 2025

Shorter than P25 for not_applicable chronic-pain

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Nov 2025Jul 2026

First Submitted

Initial submission to the registry

May 9, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 9, 2025

Last Update Submit

May 21, 2025

Conditions

Chronic PainStroke

Keywords

chronic post-stroke paincontextual-behavioral approachesvirtual realityacceptance and commitment therapy

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (3)

  • Mindful Awareness

    From enrollment to the end of treatment at 8 weeks

  • Emotional Regulation

    From enrollment to the end of treatment at 8 weeks

  • Psychological Flexibility

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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)

Behavioral: VR-ACT

Sham-VR

SHAM COMPARATOR

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

Behavioral: Sham-VR

Interventions

VR-ACTBEHAVIORAL

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

VR-ACT
Sham-VRBEHAVIORAL

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

Sham-VR

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PainStroke

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Sérgio A Carvalho, PhD

CONTACT

+351 239 851 450sergiocarvalho@fpce.uc.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 25, 2025

Study Start

November 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share