Arthritis, Arthritis/Arthrosis, Arthritis, Rheumatoid, Elderly
Conditions
Keywords
virtual reality, hypnosis, arthritis, pain, quality of life, elderly
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.
Interventions
BEHAVIORALVirtual reality: Beach
Session 1 or 2 (counterbalanced): Exposure to a beach landscape
BEHAVIORALVirtual Reality: Forest
Session 1 or 2 (counterbalanced): Exposure to a forest landscape
BEHAVIORALHypnosis: Magic Hand
Session 3 or 4 (counterbalanced): Exposure to a hypnosis technique: the magic hand
BEHAVIORALHypnosis: Pain Manipulation
Session 3 or 4 (counterbalanced): Exposure to a hypnosis technique: manipulating the pain
BEHAVIORALSession 1bis - 1 week
Repetition of the Session 1 one week after Session 4
BEHAVIORALFollow-up
Repetition of the Session 1 three weeks after Session 4
Sponsors
Ciusss de L'Est de l'Île de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 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). |
| Fatigue | 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) |
| Anxiodepressive symptoms | 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) |
| Perceived changes | 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) |
| Cybersickness | 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) |
| Relaxation | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient demand for medical prescription | 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 |
| Clinical consultations for pain | 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 |
| Respiratory frequence | 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. |
| Prescribed treatment with level 1 or 2 antidepressants (self-reported) | 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 |
| Prescribed treatment with level 1 or 2 anxiolytics (medical record) | 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) |
| Prescribed treatment with level 1 or 2 antidepressants (medical record) | 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) |
| Heart rate | 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 |
| Electrodermal activity | 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 |
| Heart rate variability | 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 |
| Prescribed treatment with level 1 or 2 analgesics (self-reported) | 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 |
| Prescribed treatment with level 1 or 2 analgesics (medical record) | 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) |
| Prescribed treatment with level 1 or 2 anxiolytics (self-reported) | 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 |
Contacts
Primary ContactValentyn Fournier, Ph.D.
Backup ContactDavid Ogez, Ph.D.
Outcome results
None listed