Clinical trial NCT06833905: Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis
Official title: Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis: a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthritis
Arthritis/Arthrosis
Arthritis, Rheumatoid
Elderly
Keywords: virtual reality
hypnosis
arthritis
pain
quality of life
elderly
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Perceived pain
timeFrame: 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:
measure: Anxiodepressive symptoms
timeFrame: 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
measure: Quality of life
timeFrame: 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
measure: Fatigue
timeFrame: From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)
measure: Relaxation
timeFrame: From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)
measure: Perceived changes
timeFrame: From Session 2, each week during 5 weeks, Intervention group: Two times per week (before and after each session)
measure: Cybersickness
timeFrame: From enrollment, each week during 6 weeks, Intervention group: One time per week (after each session)
Other outcomes:
measure: Respiratory frequence
timeFrame: 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)
measure: Heart rate
timeFrame: 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)
measure: Electrodermal activity
timeFrame: 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)
measure: Heart rate variability
timeFrame: 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)
measure: Prescribed treatment with level 1 or 2 analgesics (self-reported)
timeFrame: 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
measure: Prescribed treatment with level 1 or 2 analgesics (medical record)
timeFrame: 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
measure: Prescribed treatment with level 1 or 2 anxiolytics (self-reported)
timeFrame: 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
measure: Patient demand for medical prescription
timeFrame: 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
measure: Clinical consultations for pain
timeFrame: 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
measure: Prescribed treatment with level 1 or 2 antidepressants (medical record)
timeFrame: 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
measure: Prescribed treatment with level 1 or 2 antidepressants (self-reported)
timeFrame: 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
measure: Prescribed treatment with level 1 or 2 anxiolytics (medical record)
timeFrame: 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
Locations:
Study officials:
References: