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NCT Number: NCT06833905

Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis

The goal of this pilot randomized clinical trial is to test the efficacy of an intervention combining virtual reality and hypnosis on decreasing pain and improving quality of life in elderly patients with hand arthritis. The main questions it aims to answer are:

* Does the intervention allow for an improvement of patient reported outcomes related to pain and quality of life? * Does the intervention allow for an improvement of physiological variables related to pain? Researchers will compare intervention group to a passive control group (i.e., waiting list with treatment as usual).

Participants in the intervention group will be provided a virtual reality headset allowing them to beneficiate from the virtual reality and hypnosis modules.

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Key information

Conditions

Arthritis Arthritis, Rheumatoid Arthritis/Arthrosis Autoimmune Diseases Connective Tissue Diseases Elderly Immune System Diseases Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fluent in French
  • Being diagnosed with hand arthrisis
  • Reporting an invalidating chronic pain in hand related to the condition

Exclusion criteria

  • Experiencing a medical condition altering the ability to consent or participate in the study
  • Experiencing cognitive disorders; Experiencing sensory disorders (deafness, blindness)

Treatment and study plan

Virtual reality: Beach

Behavioral

Session 1 or 2 (counterbalanced): Exposure to a beach landscape

Virtual Reality: Forest

Behavioral

Session 1 or 2 (counterbalanced): Exposure to a forest landscape

Hypnosis: Magic Hand

Behavioral

Session 3 or 4 (counterbalanced): Exposure to a hypnosis technique: the magic hand

Hypnosis: Pain Manipulation

Behavioral

Session 3 or 4 (counterbalanced): Exposure to a hypnosis technique: manipulating the pain

Session 1bis - 1 week

Behavioral

Repetition of the Session 1 one week after Session 4

follow-up

Behavioral

Repetition of the Session 1 three weeks after Session 4

Primary outcomes

  1. Perceived pain

    Time frame: Intervention group: Two times per week (before and after each session)/Control group: One time per week, For all: from enrollment to the end of intervention at 6 weeks and at a 3 weeks follow-up

    Brief Pain Inventory - Short Form (BPI-SF) ; 9 items ; Scores from 0 to 10 ; scores are computed into mean score ; higher scores mean higher levels of pain (negative outcome)

Secondary outcomes

  1. Anxiodepressive symptoms

    Time frame: Intervention group: Two times per week (before and after each session)/Control group: One time per week, For all: from enrollment to the end of intervention at 6 weeks and at a 3 weeks follow-up

    Hospital Anxiety and Depression Scale (HADS) ; 14 items: 7 items for anxiety, 7 items for depression ; Lickert scale from 0 to 3 ; a mean score is computed for each subscale (anxiety, depression) ; Minimum score for each scale: 0 ; Maximum score for each scale: 21 ; Higher scores mean worst symptomatology (negative outcome)

  2. Quality of life

    Time frame: Intervention group: Two times per week (before and after each session)/Control group: One time per week, For all: from enrollment to the end of intervention at 6 weeks and at a 3 weeks follow-up

    Short-Form Health Survey 12 items (SF-12) ; includes 12 items measuring 8 dimensions (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health) ; the physical (PCS-12) and mental (MCS-12) scales are transformed to have a mean of 50 and a standard deviation of 10 in the general U.S. population ; participants' scores represent the difference compared to the population average (measured in standard deviations) ; scores above 50 indicate a better-than-average health-related quality of life (positive outcome), while scores below 50 suggest below-average health-related quality of life (negative outcome).

  3. Fatigue

    Time frame: From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)

    Multidimensional Fatigue Inventory - 10 Items (MFI-10) ; 10 items measuring 5 dimensions (general fatigue, physical fatigue, mental fatigue, reduction in activity and reduction in motivation) ; the Lickert scale ranges from 1 to 5 ; the answer on the scale represents the score of each individual item which is then added up to a sum for each dimension ; scores per dimension can vary between 4 and 20 ; higher scores indicate higher fatigue levels (negative outcome)

  4. Relaxation

    Time frame: From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)

    Relaxation State Questionnaire (RSQ) ; 10 items ; Lickert scales from 1 to 5 ; scores are computed into a mean score; higher scores indicate higher levels of relaxation (positive outcome)

  5. Perceived changes

    Time frame: From Session 2, each week during 5 weeks, Intervention group: Two times per week (before and after each session)

    Three free items evaluating perceived change in pain, anxiodepressive symptoms, and quality of life ; Lickert scale ranging from 1 to 10 ; higher scores indicate greater perceived changes (positive outcome)

  6. Cybersickness

    Time frame: From enrollment, each week during 6 weeks, Intervention group: One time per week (after each session)

    Cybersickness questionnaire ; 16 items including 2 subscales (nausea and oculomotor); Lickert scale ranging from 0 to 3 ; scores for each subscale are summed to give final scores ; higher scores indicate higher levels of cybersickness (negative outcome)

Other outcomes

  1. Respiratory frequence

    Time frame: One time per week, from enrollment to the end of treatment at 6 weeks, during the whole hypnosis session (for Intervention group) or during 15 minutes where the subject is not engaging in any task (for Control group)

    Will be calculated with the XDCF module in BIOPAC MP200-WS (Biopac Systems, Goleta, CA) ; A higher respiratory frequence is a negative outcome as it indicates higher levels of anxiety and lower levels of relaxation.

  2. Heart rate

    Time frame: One time per week, from enrollment to the end of treatment at 6 weeks, during the whole hypnosis session (for Intervention group) or during 15 minutes where the subject is not engaging in any task (for Control group)

    Will be calculated with module RSP & ECG Bionomadix (Amplificator RPEC-R) in BIOPAC MP200-WS (Biopac Systems, Goleta, CA) ; A higher heart rate is a negative outcome as it indicates higher levels of anxiety and lower levels of relaxation

  3. Electrodermal activity

    Time frame: One time per week, from enrollment to the end of treatment at 6 weeks, during the whole hypnosis session (for Intervention group) or during 15 minutes where the subject is not engaging in any task (for Control group)

    Will be calculated with module EDA Bionomadix in BIOPAC MP200-WS (Biopac Systems, Goleta, CA) ; A higher electrodermal activity is a negative outcome as it indicates higher levels of anxiety and lower levels of relaxation

  4. Heart rate variability

    Time frame: One time per week, from enrollment to the end of treatment at 6 weeks, during the whole hypnosis session (for Intervention group) or during 15 minutes where the subject is not engaging in any task (for Control group)

    Will be calculated with module EDA Bionomadix in BIOPAC MP200-WS (Biopac Systems, Goleta, CA) ; A higher heart rate variability is a positive outcome as it indicates lower levels of anxiety and higher levels of relaxation

  5. Prescribed treatment with level 1 or 2 analgesics (self-reported)

    Time frame: The measure will be taken at 3 timepoints: once at enrollment, once at Week 4, and once during the Follow-up session 9 weeks after the enrollment

    Daily frequency intake of prescribed analgesics reported by the patient

  6. Prescribed treatment with level 1 or 2 analgesics (medical record)

    Time frame: The measure will be taken at 3 timepoints: once at enrollment, once at Week 4, and once during the Follow-up session 9 weeks after the enrollment

    Daily frequency intake of prescribed analgesics reported by the patient's medical record (dose written on their prescription)

  7. Prescribed treatment with level 1 or 2 anxiolytics (self-reported)

    Time frame: The measure will be taken at 3 timepoints: once at enrollment, once at Week 4, and once during the Follow-up session 9 weeks after the enrollment

    Daily frequency intake of prescribed anxiolytics reported by the patient

  8. Patient demand for medical prescription

    Time frame: The measure will be taken at 3 timepoints: once at enrollment, once at Week 4, and once during the Follow-up session 9 weeks after the enrollment

    Patient demand for medical prescription (requested dose/intake frequency) retrieved in medical record

  9. Clinical consultations for pain

    Time frame: The measure will be taken at 3 timepoints: once at enrollment, once at Week 4, and once during the Follow-up session 9 weeks after the enrollment

    Frequency of clinical consultations for pain

  10. Prescribed treatment with level 1 or 2 antidepressants (medical record)

    Time frame: The measure will be taken at 3 timepoints: once at enrollment, once at Week 4, and once during the Follow-up session 9 weeks after the enrollment

    Daily frequency intake of prescribed antidepressants reported by the patient's medical record (dose written on their prescription)

  11. Prescribed treatment with level 1 or 2 antidepressants (self-reported)

    Time frame: The measure will be taken at 3 timepoints: once at enrollment, once at Week 4, and once during the Follow-up session 9 weeks after the enrollment

    Daily frequency intake of prescribed antidepressants reported by the patient

  12. Prescribed treatment with level 1 or 2 anxiolytics (medical record)

    Time frame: The measure will be taken at 3 timepoints: once at enrollment, once at Week 4, and once during the Follow-up session 9 weeks after the enrollment

    Daily frequency intake of prescribed anxiolytics reported by the patient's medical record (dose written on their prescription)

Study contacts

Contact information is provided by the study sponsor or research team.

David Ogez, Ph.D.

CONTACT

[email protected]

514-609-4391

Valentyn Fournier, Ph.D.

CONTACT

[email protected]

438-738-0627

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Registry information

Official study title

Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis: a Pilot Randomized Clinical Trial

Acronym: VRHArthrisis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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