Virtual Reality for Pain and Well-Being in Older Adults

NCT07607899 | Not Yet Recruiting

• 2 other identifiers: MP-31-2026-6028RQRV
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic pain is common among adults aged 65 and older and can reduce mobility, independence, mood, and quality of life. Many older adults also develop a fear of movement because they worry that physical activity will increase their pain or cause injury. This fear can lead to reduced activity, physical deconditioning, and further loss of independence. This study aims to evaluate the feasibility, acceptability, and potential impact of Moving Without Fear or Pain, a program combining structured pain education (Empowered Relief) with immersive virtual reality rehabilitation to gradually reintroduce movement in a safe and engaging way. Empowered Relief is a single-session, two-hour online pain education class delivered by a trained health professional. It explains how chronic pain affects the brain and nervous system and teaches strategies to calm the nervous system, manage pain flare-ups, reduce pain-related worry and catastrophizing, and increase confidence in movement and daily activities. The virtual reality intervention includes up to eight individualized sessions over approximately one month. Sessions last 5 to 30 minutes and are supervised by a trained clinician. Participants wear a virtual reality headset and are immersed in calming or engaging environments, such as nature settings. Depending on their comfort and abilities, sessions may begin with passive guided motor imagery and progress to active movement within interactive virtual environments. Some applications allow participants to control movement in the virtual world through gentle physical activity, such as stepping or upper-body movement. The intervention is personalized to each participant's physical capacity, preferences, and rehabilitation goals. The aim is to reduce fear of movement, increase confidence, and promote safe re-engagement in physical activity. In this pilot randomized controlled trial, 24 older adults with chronic pain will be randomly assigned to one of two groups: 1) Experimental Group: Participants will receive the Empowered Relief pain education course, usual care, and up to eight immersive virtual reality rehabilitation sessions. 2) Control Group: Participants will receive the Empowered Relief pain education course and usual care, without virtual reality sessions. The findings will inform a larger future study.

Conditions

Chronic Pain; Kinesiophobia (Fear of Movement)

Keywords

Chronic Pain; Older Adults; Kinesiophobia; Fear of Movement; Empowered Relief; Biopsychosocial Model; Motor Imagery; Virtual Reality Rehabilitation; Non-Pharmacological Pain Management

Outcome Measures

Primary Outcomes (3)

• Change in Kinesiophobia as Measured by the Tampa Scale of Kinesiophobia (TSK-11)

  Kinesiophobia will be assessed using the 11-item Tampa Scale of Kinesiophobia (TSK-11). Scores range from 11 to 44, with higher scores indicating greater fear of movement. The primary analysis will evaluate change in TSK-11 score from baseline to post-intervention.

  Baseline (pre-intervention) to post-intervention (after completion of the 8 rehabilitation sessions, approximately 4 weeks)

• Feasibility of the Multimodal Intervention

  Feasibility will be evaluated using recruitment rate (proportion of eligible individuals who consent), adherence (proportion of intervention sessions completed), retention/attrition rate (proportion of participants completing the study), and documentation of adverse events and protocol deviations.

  Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)

• Acceptability of the Multimodal Intervention

  Acceptability will be assessed using structured participant and clinician questionnaires administered before and after the intervention, including Likert-scale ratings of satisfaction, perceived usefulness, usability of virtual reality, and perceived barriers to participation.

  Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)

Secondary Outcomes (7)

• Change in Fear-Avoidance Beliefs as Measured by the Fear Avoidance Component Scale (FACS)

  Baseline to post-intervention (approximately 4 weeks)

• Change in Pain Intensity as Measured by the Numeric Rating Scale (NRS 0-10)

  Baseline to post-intervention (approximately 4 weeks)

• Change in Emotional State as Measured by the Profile of Mood States (POMS)

  Baseline to post-intervention (approximately 4 weeks)

• Change in Pain Catastrophizing as Measured by the Pain Catastrophizing Scale (PCS)

  Baseline to post-intervention (approximately 4 weeks)

• Self-Reported Percentage of Pain Relief

  Post-intervention (approximately 4 weeks)

Study Arms (2)

Virtual Reality, Pain Education and Usual Care

EXPERIMENTAL

Participants receive the Empowered Relief pain education session and usual care, plus up to eight individualized immersive virtual reality rehabilitation sessions delivered over approximately one month. Virtual reality sessions are supervised by trained clinicians and may include guided motor imagery, immersive nature environments, and graded interactive movement adapted to participant capacity and goals.

Device: Virtual Reality-Supported Rehabilitation; Behavioral: Pain Education; Other: Usual Care

Pain Education and Usual Care

ACTIVE COMPARATOR

Participants receive the Empowered Relief pain education session and continue usual care. They do not receive immersive virtual reality sessions during the study period.

Behavioral: Pain Education; Other: Usual Care

Interventions

Virtual Reality-Supported Rehabilitation DEVICE

Immersive virtual reality rehabilitation sessions delivered under clinician supervision, using guided motor imagery, immersive natural environments, and graded interactive movement adapted to participant capacity and goals. Following completion of the educational session, participants engage in immersive virtual reality rehabilitation delivered under clinician supervision. The virtual reality component uses a head-mounted display to immerse par

Also known as: VR-Based Rehabilitation

Virtual Reality, Pain Education and Usual Care

Pain Education BEHAVIORAL

A standardized single-session, two-hour online pain neuroscience education course delivered by a trained clinician, including education on chronic pain neurophysiology and self-management strategies.

Pain Education and Usual Care; Virtual Reality, Pain Education and Usual Care

Usual Care OTHER

Participants continue to receive their usual care throughout the study period.

Pain Education and Usual Care; Virtual Reality, Pain Education and Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Able to understand and communicate in French
• Chronic pain lasting 6 months or longer
• Average pain intensity of 3 or greater on a 0-10 Numeric Rating Scale during the week prior to enrollment
• Score greater than 25 on the 11-item Tampa Scale of Kinesiophobia (TSK-11)
• No neurocognitive impairment (Mini-Mental State Examination \[MMSE\] ≥ 24), or mild neurocognitive impairment (MMSE 18-24) with preserved capacity to consent (University of California Brief Assessment of Capacity to Consent \[UBACC\] score ≥ 12)
• Normal or corrected-to-normal visual acuity

You may not qualify if:

• Severe motion sickness or intolerance that would prevent safe use of a virtual reality headset (experimental group only)
• Medical condition that would prevent safe participation in rehabilitation activities
• Presence of open wounds or infection at painful or contralateral sites

Sponsors & Collaborators

• Laval University: lead
• McGill University: collaborator
• École de technologie supérieure: collaborator
• Université du Québec à Chicoutimi: collaborator
• Université de Sherbrooke: collaborator

MeSH Terms

Conditions

Chronic Pain; Kinesiophobia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Maude Laberge, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine Bordeleau, PhD

CONTACT

1-581-490-2626; martine.bordeleau@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed of their group allocation and will be told that the study compares two rehabilitation approaches. The statistician responsible for data analysis will receive anonymized datasets coded without indication of group assignment. Clinicians delivering the intervention cannot be blinded due to the nature of the virtual reality component. No additional parties are masked beyond those specified.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professional - Researcher Profile

Model Details: This is a pilot randomized controlled trial using a parallel assignment design. Participants will be allocated to one of two groups: one group will receive pain education and immersive virtual reality-supported rehabilitation in addition to usual care, while the other group will receive pain education and usual care only. Both groups will be followed over the same study period. Randomization will be performed using a minimization procedure to balance key participant characteristics. The study is double-blind with respect to participants and the statistician analyzing the data

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified individual participant data and the study protocol will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years following publication.
• Access Criteria: De-identified individual participant data and supporting documentation (study protocol) will be made available to qualified researchers upon reasonable request. Access will be granted to researchers who provide a methodologically sound research proposal and who agree to a data use agreement in accordance with institutional, ethical, and legal requirements. Requests will be reviewed by the principal investigator and research team. Data will be shared in de-identified form to protect participant confidentiality.