ArthritisVRHArthrisisNCT06833905
Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis
A study testing Virtual reality: Beach, Virtual Reality: Forest and Hypnosis: Magic Hand in people with Arthritis and Arthritis/Arthrosis, run by Ciusss de L'Est de l'Île de Montréal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arthritis, Arthritis/Arthrosis, Arthritis, Rheumatoid
- What is being tested?
- Virtual reality: Beach, Virtual Reality: Forest and Hypnosis: Magic Hand
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in French
- Being diagnosed with hand arthrisis
- Reporting an invalidating chronic pain in hand related to the condition
Who cannot join
- Experiencing a medical condition altering the ability to consent or participate in the study
- Experiencing cognitive disorders; Experiencing sensory disorders (deafness, blindness)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis: a Pilot Randomized Clinical Trial
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.
- Conditions
- Arthritis, Arthritis/Arthrosis, Arthritis, Rheumatoid, Elderly
- Being tested
- Virtual reality: Beach, Virtual Reality: Forest, Hypnosis: Magic Hand, Hypnosis: Pain Manipulation, Session 1bis - 1 week
- Keywords
- virtual reality, hypnosis, arthritis, pain, quality of life, elderly
- Medical subject headings
- Arthritis, Osteoarthritis, Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality: BeachBehavioural
Session 1 or 2 (counterbalanced): Exposure to a beach landscape
Virtual Reality: ForestBehavioural
Session 1 or 2 (counterbalanced): Exposure to a forest landscape
Hypnosis: Magic HandBehavioural
Session 3 or 4 (counterbalanced): Exposure to a hypnosis technique: the magic hand
Hypnosis: Pain ManipulationBehavioural
Session 3 or 4 (counterbalanced): Exposure to a hypnosis technique: manipulating the pain
Session 1bis - 1 weekBehavioural
Repetition of the Session 1 one week after Session 4
Follow-upBehavioural
Repetition of the Session 1 three weeks after Session 4
| Study group | Role | What they receive |
|---|---|---|
| Combined virtual reality and hypnosis | Experimental | The intervention consist in 4 different sessions with the VR headset, two consisting in presenting landscapes (i.e., beach, forest) and two consisting in hypnosis techniques (i.e., magic hand, manipulating hand). Receives: Behavioral: Virtual reality: Beach; Behavioral: Virtual Reality: Forest; Behavioral: Hypnosis: Magic Hand; Behavioral: Hypnosis: Pain Manipulation; Behavioral: Session 1bis - 1 week; Behavioral: Follow-up |
| Waiting list | No intervention | The control group consist in a waiting list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived pain
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)
Measured: 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
Secondary outcomes (6)
Anxiodepressive symptoms
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)
Measured: 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
Quality of life
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).
Measured: 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
Fatigue
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)
Measured: From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)
Relaxation
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)
Measured: From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)
Perceived changes
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)
Measured: From Session 2, each week during 5 weeks, Intervention group: Two times per week (before and after each session)
Cybersickness
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)
Measured: From enrollment, each week during 6 weeks, Intervention group: One time per week (after each session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833905
- Sponsor's protocol ID
- 2024-3539
- Acronym
- VRHArthrisis
- Status last verified
- Mar 2025
- First submitted
- 13 Jan 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared in a dedicated OSF repository.
Publications
Fournier V, Simard MF, Yuen SY, Guine J, Rousseaux F, Lebeau J, Jerbi K, Richebe P, Landry M, Rainville P, Ogez D. Combining virtual reality and hypnosis to alleviate chronic pain in elderly with hand arthritis: protocol for a randomised phase II clinical trial. BMJ Open. 2025 Oct 5;15(10):e103841. doi: 10.1136/bmjopen-2025-103841.
PubMed 41047257
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis: a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06833905
- Acronym / sponsor ID
- VRHArthrisis / 2024-3539
- Conditions
- Arthritis, Arthritis/Arthrosis, Arthritis, Rheumatoid, Elderly
- Keywords
- virtual reality, hypnosis, arthritis, pain, quality of life, elderly
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined virtual reality and hypnosis | Experimental | Behavioral: Virtual reality: Beach, Behavioral: Virtual Reality: Forest, Behavioral: Hypnosis: Magic Hand, Behavioral: Hypnosis: Pain Manipulation, Behavioral: Session 1bis - 1 week, Behavioral: Follow-upThe intervention consist in 4 different sessions with the VR headset, two consisting in presenting landscapes (i.e., beach, forest) and two consisting in hypnosis techniques (i.e., magic hand, manipulating hand). |
| Waiting list | No intervention | –The control group consist in a waiting list. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fluent in French
- Being diagnosed with hand arthrisis
- Reporting an invalidating chronic pain in hand related to the condition
Key exclusion criteria (2 listed)
- Experiencing a medical condition altering the ability to consent or participate in the study
- Experiencing cognitive disorders; Experiencing sensory disorders (deafness, blindness)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality: BeachSession 1 or 2 (counterbalanced): Exposure to a beach landscape | Behavioural | Combined virtual reality and hypnosis |
| Virtual Reality: ForestSession 1 or 2 (counterbalanced): Exposure to a forest landscape | Behavioural | Combined virtual reality and hypnosis |
| Hypnosis: Magic HandSession 3 or 4 (counterbalanced): Exposure to a hypnosis technique: the magic hand | Behavioural | Combined virtual reality and hypnosis |
| Hypnosis: Pain ManipulationSession 3 or 4 (counterbalanced): Exposure to a hypnosis technique: manipulating the pain | Behavioural | Combined virtual reality and hypnosis |
| Session 1bis - 1 weekRepetition of the Session 1 one week after Session 4 | Behavioural | Combined virtual reality and hypnosis |
| Follow-upRepetition of the Session 1 three weeks after Session 4 | Behavioural | Combined virtual reality and hypnosis |
Primary outcome
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)
6 secondary outcomes
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
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
Fatigue
Time frame: From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)
Relaxation
Time frame: From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)
Perceived changes
Time frame: From Session 2, each week during 5 weeks, Intervention group: Two times per week (before and after each session)
Cybersickness
Time frame: From enrollment, each week during 6 weeks, Intervention group: One time per week (after each session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 41047257Fournier V, Simard MF, Yuen SY, Guine J, Rousseaux F, Lebeau J, Jerbi K, Richebe P, Landry M, Rainville P, Ogez D. Combining virtual reality and hypnosis to alleviate chronic pain in elderly with hand arthritis: protocol for a randomised phase II clinical trial. BMJ Open. 2025 Oct 5;15(10):e103841. doi: 10.1136/bmjopen-2025-103841.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared in a dedicated OSF repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality: Beach, Virtual Reality: Forest and Hypnosis: Magic Hand in people with Arthritis and Arthritis/Arthrosis, run by Ciusss de L'Est de l'Île de Montréal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentyn Fournier, Ph.D. (438-738-0627, valentyn.fournier.cemtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06833905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.