Virtual Reality for Pain and Well-Being in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorLaval University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality-Supported Rehabilitation
DeviceImmersive 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
Other interventionParticipants continue to receive their usual care throughout the study period.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality and Usual CareExperimental treatment 2 interventions
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (pre-intervention) to post-intervention (after completion of the 8 rehabilitation sessions, approximately 4 weeks)2
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.
Time frame
Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)3
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.
Time frame
Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)Secondary outcomes
1
Change in Fear-Avoidance Beliefs as Measured by the Fear Avoidance Component Scale (FACS)
Fear-avoidance beliefs will be assessed using the Fear Avoidance Component Scale (FACS), a self-reported questionnaire designed to comprehensively measure fear-avoidance components in individuals with painful medical conditions. The FACS includes 20 items, each rated on a Likert scale from 0 = completely disagree to 5 = completely agree. The total score is calculated by summing all item scores and ranges from 0 to 100. Higher scores indicate worse outcomes, namely greater fear-avoidance beliefs and behaviors related to pain and movement. Scores can be categorized into five severity levels: Subclinical = 0 to 20, Mild = 21 to 40, Moderate = 41 to 60, Severe = 61 to 80, and Extreme = 81 to 100.
Time frame
Baseline to post-intervention (approximately 4 weeks)2
Change in Emotional State as Measured by the Profile of Mood States (POMS)
Emotional state will be assessed using the Profile of Mood States (POMS), a self-reported questionnaire that evaluates mood across six domains: tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, vigor-activity, and confusion-bewilderment. The POMS includes 65 items, each rated on a 5-point scale from 0 = not at all to 4 = extremely. The Total Mood Disturbance score is calculated by summing the negative mood subscales - tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, and confusion-bewilderment - and subtracting the vigor-activity score. The possible Total Mood Disturbance score ranges from -32 to 200. Higher Total Mood Disturbance scores indicate worse outcomes, reflecting greater overall emotional distress. For individual subscales, higher scores indicate worse outcomes for the negative mood domains and better outcomes for the vigor-activity domain. Subscale score ranges are as follows: tension-anxiety, 0 to 36; depression-dejection, 0
Time frame
Baseline to post-intervention (approximately 4 weeks)3
Change in Pain Catastrophizing as Measured by the Pain Catastrophizing Scale (PCS)
Pain-related catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS). Total scores range from 0 to 52, with higher scores indicating greater levels of rumination, magnification, and helplessness related to pain. The outcome measure will evaluate change in PCS score from baseline to post-intervention.
Time frame
Baseline to post-intervention (approximately 4 weeks)4
Self-Reported Percentage of Pain Relief
Participants will report the percentage of overall pain relief experienced following the intervention. Responses will range from 0% (no relief) to 100% (complete relief). This measure captures perceived global improvement in pain.
Time frame
Post-intervention (approximately 4 weeks)Sponsors and contacts
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Laval University
Lead sponsor
McGill University
Collaborator
École de technologie supérieure
Collaborator
Université du Québec à Chicoutimi
Collaborator
Université de Sherbrooke
Collaborator
Source ClinicalTrials.gov