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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03924908
• Other study ID #: BurnVR-H
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anxiety
• Anxiety Disorders
• Burns
• Pain, Acute

Intervention

Behavioral:
• VRH
Patients will see a 3D film combined with a hypnotic voice during the entire procedure of dressing change
• VR
Patients will see a 3D film without any hypnotic voice during the entire procedure of dressing change

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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")
Primary	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")
Primary	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")
Primary	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")
Primary	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	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")
Secondary	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")
Secondary	Time perception	We will ask to the patient his perception of time during the session.	5 minutes after dressing change ("time 1")
Secondary	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")