Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients

Study Overview
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Brief Summary
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Different non-pharmacological techniques, including hypnosis and virtual reality are currently used as complementary tools in the treatment of pain related to burn injury. A new technique called 'virtual reality hypnosis' (VRH) (Patterson et al., 2004), which encompasses a combination of both tools, is regularly used although its actual function remains unknown to this date. With the goal to improve our understanding of VRH combination effects, it is necessary to elaborate randomized and controlled research studies in order to understand their actual function in individual's perception. 100 patients who are treated as outpatients for burn care will be randomly assigned to virtual reality or VRH. Patients will receive one session of one of these techniques during burn dressing change.Physiological parameters will be recorded during dressing change. Participants will fill in a questionnaire evaluating their tendency to be absorbed and dissociated, and another evaluating their level of perceived immersion. Their level of anxiety, pain, fatigue and relaxation will be evaluated before and after the session. A short interview will also be conducted to give participants the opportunity to openly describe their experience.

Official Title
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Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients Treated as Outpatients

Conditions
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Burns, Pain, Acute, Anxiety

Intervention / Treatment
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* Behavioral: VRH
* Behavioral: VR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Burn patient treated as outpatient Burn surface area > or = 5% of the total body surface area mainly 2nd degree burn Exclusion Criteria: Psychiatric antecedents Claustrophobia Heavy hearing Visual impairment Face burn Conjunctivitis Consent not obtained

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VRH<br>Virtual reality hypnosis | Behavioral: VRH<br>* Patients will see a 3D film combined with a hypnotic voice during the entire procedure of dressing change<br>|
| Active Comparator: VR<br>Virtual reality | Behavioral: VR<br>* Patients will see a 3D film without any hypnotic voice during the entire procedure of dressing change<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain perception: Visual Analogical Scale (VAS) | Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10. | 5 minutes before dressing change (time 0) and 5 minutes after dressing change (time 1) | 
| Change in anxiety: Visual Analogical Scale (VAS) | Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10. | 5 minutes before dressing change (time 0) and 5 minutes after dressing change (time 1) | 
| Change in fatigue | Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10. | 5 minutes before dressing change (time 0) and 5 minutes after dressing change (time 1) | 
| Change in relaxation level | Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10. | 5 minutes before dressing change (time 0) and 5 minutes after dressing change (time 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of absorption at the moment | Absorption will be measured as the two components of hypnosis. We will measure absorption and dissociation using the Visual Analogical Scales (VAS). VAS is from 0 to 10. 0 is not absorbed and 10 is really absorbed. When responding to a VAS item, participants will be asked to specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. | 5 minutes after dressing change (time 1) | 
| Level of dissociation at the moment | Dissociation will be measured as the two components of hypnosis. We will measure absorption and dissociation using the Visual Analogical Scales (VAS). When responding to a VAS item, participants will be asked to specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. | 5 minutes after dressing change (time 1) | 
| Time perception | We will ask to the patient his perception of time during the session. | 5 minutes after dressing change (time 1) | 
| Change in heart rate | Physiological parameter measured using pulse oximeter | 5 minutes before dressing change (time 0) and 5 minutes after dressing change (time 1) |