Ireland
--:--IST
Recruiting Not applicable

Virtual Reality for Pain and Well-Being in Older Adults

NCT07607899 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2026-09-14
Last updated
2026-09-10

Condition(s) studied

Chronic PainKinesiophobia (Fear of Movement)

Investigational drug(s) / intervention(s)

Virtual Reality-Supported RehabilitationUsual Care

Virtual Reality-Supported Rehabilitation: 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

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

Study 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 using immersive virtual reality rehabilitation to gradually reintroduce movement in a safe and engaging way.

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 care, and up to eight immersive virtual reality rehabilitation sessions. 2) Control Group: Participants will receive usual care, without virtual reality sessions. The findings will inform a larger future study.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Change in Kinesiophobia as Measured by the Tampa Scale of Kinesiophobia (TSK-11) — Baseline (pre-intervention) to post-intervention (after completion of the 8 rehabilitation sessions, approximately 4 weeks)
    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.
  • Feasibility of the Multimodal Intervention — Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
    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.
  • Acceptability of the Multimodal Intervention — Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
    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.

Trial sites (2)

FacilityCityRegionStatus
CIUSSS de la Capitale-Nationale Québec Quebec Recruiting
CISSS de Chaudière-Appalaches Sainte-Marie Quebec Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07607899 on ClinicalTrials.gov ↗ ← All trials in Canada