About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fluent in French
Being diagnosed with hand arthrisis
Reporting an invalidating chronic pain in hand related to the condition
Disqualifiers
Experiencing a medical condition altering the ability to consent or participate in the study
Experiencing cognitive disorders; Experiencing sensory disorders (deafness, blindness)
Trial design
Parallel
Treatments tested in this trial
Virtual reality: Beach
BehavioralSession 1 or 2 (counterbalanced): Exposure to a beach landscape
Virtual Reality: Forest
BehavioralSession 1 or 2 (counterbalanced): Exposure to a forest landscape
Hypnosis: Magic Hand
BehavioralSession 3 or 4 (counterbalanced): Exposure to a hypnosis technique: the magic hand
Hypnosis: Pain Manipulation
BehavioralSession 3 or 4 (counterbalanced): Exposure to a hypnosis technique: manipulating the pain
Session 1bis - 1 week
BehavioralRepetition of the Session 1 one week after Session 4
Follow-up
BehavioralRepetition of the Session 1 three weeks after Session 4
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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)
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).
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)
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)
Other outcomes
Respiratory frequence
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.
Heart rate
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
Electrodermal activity
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
Heart rate variability
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
Locations
Sponsors and contacts
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