Clinical trial NCT03924908: Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients
Official title: Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients Treated as Outpatients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burns
Pain, Acute
Anxiety
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in pain perception: Visual Analogical Scale (VAS)
timeFrame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
measure: Change in anxiety: Visual Analogical Scale (VAS)
timeFrame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
measure: Change in fatigue
timeFrame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
measure: Change in relaxation level
timeFrame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Secondary outcomes:
measure: Level of absorption at the moment
timeFrame: 5 minutes after dressing change ("time 1")
measure: Level of dissociation at the moment
timeFrame: 5 minutes after dressing change ("time 1")
measure: Time perception
timeFrame: 5 minutes after dressing change ("time 1")
measure: Change in heart rate
timeFrame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Other outcomes:
measure: Participant's tendency to be absorbed and dissociated
timeFrame: At inclusion (Day -2)
measure: Participant's opinion about the tool
timeFrame: 5 minutes after dressing change ("time 1")
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