- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07607899
Virtual Reality for Pain and Well-Being in Older Adults (VitaMove)
Moving Without Fear or Pain: Use of Immersive Virtual Reality to Reduce Pain and Improve Well-Being in Older Adults
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Chronic pain in older adults is a complex and multidimensional condition that affects physical function, emotional well-being, social participation, and overall quality of life. In this population, persistent pain is frequently accompanied by fear of movement and maladaptive beliefs about pain, which can lead to activity avoidance and progressive functional decline. Many older adults reduce their physical activity not only because of pain itself, but because of the anticipation that movement will worsen symptoms or cause injury. Over time, this avoidance can contribute to muscular deconditioning, reduced balance, increased frailty, and greater dependence in daily activities. Contemporary pain science recognizes that chronic pain involves not only peripheral tissue factors but also central nervous system processes, cognitive appraisal, emotional regulation, and learned behavioral patterns. For this reason, rehabilitation approaches that address only the physical dimension of pain may be insufficient.
This study is grounded in the biopsychosocial model of chronic pain, which integrates biological, psychological, and social contributors to the pain experience. The intervention is designed to engage these interacting domains simultaneously. On a biological level, gradual activation of the motor system and re-engagement in movement may help counteract deconditioning. On a psychological level, addressing maladaptive pain beliefs and reducing fear-based avoidance may improve confidence and perceived control. On a social and emotional level, increasing engagement and exposure to meaningful environments may support mood and motivation.
Pain neuroscience education has demonstrated benefits in reducing catastrophizing and improving self-efficacy in individuals with chronic pain. Structured educational programs that explain how chronic pain differs from acute injury and how the nervous system can become sensitized may help individuals reinterpret their symptoms in a less threatening way. When patients better understand that pain does not always indicate tissue damage, they may become more willing to re-engage in movement. The educational component included in this study is intended to provide participants with practical strategies to manage flare-ups, regulate stress responses, and reduce unhelpful thoughts related to pain.
In parallel, immersive virtual reality offers a novel therapeutic platform capable of supporting graded exposure to movement in a controlled and engaging manner. Immersive virtual environments create a strong sense of presence, meaning that users feel situated within the simulated environment rather than observing it from a distance. This immersive quality may increase attentional absorption, reduce pain salience, and enhance emotional engagement. Virtual environments can also provide positive and calming experiences, including exposure to natural landscapes, which have been associated with improved mood and reduced stress. In addition, interactive virtual systems can translate gentle physical movements into forward progression within the environment, allowing participants to experience movement success in a supportive context.
The intervention evaluated in this study integrates structured pain education with immersive virtual reality-supported rehabilitation delivered under clinician supervision. The virtual component is personalized and adapted to the participant's functional capacity, preferences, and rehabilitation goals. The progression within the immersive experience is gradual. Participants may begin with exposure to immersive environments that require no active physical movement, allowing them to become comfortable with the technology and to engage in guided motor imagery. As confidence increases, the intervention may incorporate gentle physical movements that influence navigation within the virtual space. This graded approach is designed to reduce fear while reinforcing positive movement experiences. The immersive environments are selected to promote safety, engagement, and enjoyment, with careful monitoring for tolerability.
The primary purpose of this pilot study is not to establish definitive clinical efficacy, but rather to evaluate feasibility, acceptability, and implementation practicality in older adults with chronic pain. The study seeks to determine whether the combined approach can be delivered safely within clinical and residential care settings, whether participants are willing to engage with immersive technology, and whether clinicians can integrate the intervention into routine workflows. The study also aims to estimate variability in key clinical measures in order to inform sample size calculations for a future larger trial.
Several conceptual mechanisms may contribute to potential benefit. Engagement in immersive environments may reduce attentional focus on pain, temporarily lowering perceived intensity. Guided motor imagery and graded movement may activate motor-related neural networks without triggering excessive threat responses. Repeated positive movement experiences may weaken fear-based associations. Educational content may modify maladaptive beliefs and reduce catastrophizing. Improvements in confidence and perceived control may facilitate behavioral activation and adherence to rehabilitation. Exposure to calming natural environments may influence mood and stress regulation. These interacting processes reflect the integrated biopsychosocial rationale of the intervention.
The pilot design allows systematic documentation of recruitment flow, adherence patterns, participant retention, tolerability of immersive exposure, and practical barriers to implementation. The study also examines whether older adults with varying levels of physical function and technological familiarity can engage with immersive systems when provided appropriate supervision and support. Safety considerations are central, including monitoring for cybersickness symptoms such as dizziness, nausea, or disorientation. The intervention is delivered under trained supervision, and participants may discontinue at any time without impact on usual care.
By focusing on feasibility and implementation in real-world contexts rather than tightly controlled laboratory conditions, the study aims to generate information that is directly relevant to clinical translation. The results will inform refinement of procedures, optimization of session pacing, identification of appropriate safety parameters, and clarification of training needs for clinicians. Ultimately, this pilot phase is intended to support the development of a larger, adequately powered randomized controlled trial designed to evaluate the clinical effectiveness of immersive virtual reality-supported rehabilitation for chronic pain in older adults.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Martine Bordeleau, PhD
- Telefonnummer: 1-581-490-2626
- E-mail: martine.bordeleau@outlook.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Virtual Reality, Pain Education and Usual Care
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.
|
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
Andre navne:
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.
Participants continue to receive their usual care throughout the study period.
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Aktiv komparator: Pain Education and Usual Care
Participants receive the Empowered Relief pain education session and continue usual care.
They do not receive immersive virtual reality sessions during the study period.
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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.
Participants continue to receive their usual care throughout the study period.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Kinesiophobia as Measured by the Tampa Scale of Kinesiophobia (TSK-11)
Tidsramme: 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.
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Baseline (pre-intervention) to post-intervention (after completion of the 8 rehabilitation sessions, approximately 4 weeks)
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Feasibility of the Multimodal Intervention
Tidsramme: Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
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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.
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Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
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Acceptability of the Multimodal Intervention
Tidsramme: Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
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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.
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Throughout the study period (from recruitment through post-intervention assessment, approximately 4-8 weeks)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Fear-Avoidance Beliefs as Measured by the Fear Avoidance Component Scale (FACS)
Tidsramme: Baseline to post-intervention (approximately 4 weeks)
|
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.
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Baseline to post-intervention (approximately 4 weeks)
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Change in Pain Intensity as Measured by the Numeric Rating Scale (NRS 0-10)
Tidsramme: Baseline to post-intervention (approximately 4 weeks)
|
Pain severity and pain interference will be assessed using the Brief Pain Inventory.
The severity subscale ranges from 0 to 40, and the interference subscale ranges from 0 to 70, with higher scores indicating greater pain severity and greater interference with daily functioning.
The outcome measure will evaluate change in BPI scores from baseline to post-intervention.
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Baseline to post-intervention (approximately 4 weeks)
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Change in Emotional State as Measured by the Profile of Mood States (POMS)
Tidsramme: Baseline to post-intervention (approximately 4 weeks)
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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
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Baseline to post-intervention (approximately 4 weeks)
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Change in Pain Catastrophizing as Measured by the Pain Catastrophizing Scale (PCS)
Tidsramme: Baseline to post-intervention (approximately 4 weeks)
|
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.
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Baseline to post-intervention (approximately 4 weeks)
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Self-Reported Percentage of Pain Relief
Tidsramme: Post-intervention (approximately 4 weeks)
|
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.
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Post-intervention (approximately 4 weeks)
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Self-Reported Percentage Reduction in Unhelpful Pain-Related Thoughts
Tidsramme: Post-intervention (approximately 4 weeks)
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Participants will report the percentage reduction in unhelpful thoughts related to pain and movement following the intervention.
Responses will range from 0% (no reduction) to 100% (complete reduction).
This measure captures perceived cognitive improvement.
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Post-intervention (approximately 4 weeks)
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Cybersickness as Measured by the Simulator Sickness Questionnaire (SSQ)
Tidsramme: Assessed during and after virtual reality sessions (up to approximately 4 weeks)
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Tolerance to immersive virtual reality will be assessed using the Simulator Sickness Questionnaire (SSQ), a widely used tool for measuring cybersickness symptoms in virtual environments.
The SSQ assesses three main dimensions: nausea, oculomotor symptoms, such as visual fatigue, and disorientation.
The SSQ includes 16 symptoms, each rated from 0 = none to 3 = severe.
The weighted total score ranges from 0 to 179.52, with higher scores indicating worse outcomes, meaning greater severity of cybersickness symptoms.
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Assessed during and after virtual reality sessions (up to approximately 4 weeks)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Maude Laberge, PhD, Laval University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MP-31-2026-6028
- RQRV (Anden identifikator: Network for Research on Aging)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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