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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Burns; Anxiety; Pain, Acute
• Intervention / Treatment: Behavioral: VRH; Behavioral: VR

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Audrey Vanhaudenhuyse, PhD; Email: avanhaudenhuyse@chuliege.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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")

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant's tendency to be absorbed and dissociated	Tellegen Absorption Scale (TAS). Participants answer "true" or 'false" at each items (34). The subject's score is simply the number of items marked "true".	At inclusion (Day -2)
Participant's opinion about the tool	Satisfaction questionnaire created by our lab to understand if patients have a good adherence about the tool or not. Some items should be marked as "yes" or "not" and some items are marked from 1 ("not at all") to 7 ("enormously")	5 minutes after dressing change ("time 1")

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Wounds and Injuries; Burns; Anxiety Disorders; Acute Pain
• Other Study ID Numbers: BurnVR-H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No