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

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

Sponsors

Lead sponsor: University of Liege

Source University of Liege
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.

Overall Status Not yet recruiting
Start Date June 1, 2019
Completion Date June 1, 2020
Primary Completion Date June 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in pain perception: Visual Analogical Scale (VAS) 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Change in anxiety: Visual Analogical Scale (VAS) 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Change in fatigue 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Change in relaxation level 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Secondary Outcome
Measure Time Frame
Level of absorption at the moment 5 minutes after dressing change ("time 1")
Level of dissociation at the moment 5 minutes after dressing change ("time 1")
Time perception 5 minutes after dressing change ("time 1")
Change in heart rate 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Enrollment 100
Condition
Intervention

Intervention type: Behavioral

Intervention name: VRH

Description: Patients will see a 3D film combined with a hypnotic voice during the entire procedure of dressing change

Arm group label: VRH

Intervention type: Behavioral

Intervention name: VR

Description: Patients will see a 3D film without any hypnotic voice during the entire procedure of dressing change

Arm group label: VR

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Anne-Françoise Rousseau, PhD

Phone: +3243667495

Email: [email protected]

Verification Date

April 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Liege

Investigator full name: Rousseau

Investigator title: Head of Clinic, principal investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: VRH

Arm group type: Experimental

Description: Virtual reality hypnosis

Arm group label: VR

Arm group type: Active Comparator

Description: Virtual reality

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Factorial Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov