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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorCiusss de L'Est de l'Île de Montréal

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Combined virtual reality and hypnosisExperimental treatment 6 interventions
Group B: Waiting listNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

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

Secondary outcomes

1

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)

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
2

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).

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
3

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)

Time frame
From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)
4

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)

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

Other outcomes

1

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.

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)
2

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

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)
3

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

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)
4

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

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)

Locations

This trial has no locations.

Sponsors and contacts

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