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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03924908
Enrollment
0
Registered
2019-04-23
Start date
2023-01-01
Completion date
2025-06-01
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Burns, Pain, Acute

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.

Interventions

BEHAVIORALVRH

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

BEHAVIORALVR

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

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in fatigue5 minutes before dressing change (time 0) and 5 minutes after dressing change (time 1)Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.
Change in anxiety: Visual Analogical Scale (VAS)5 minutes before dressing change (time 0) and 5 minutes after dressing change (time 1)Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.
Change in relaxation level5 minutes before dressing change (time 0) and 5 minutes after dressing change (time 1)Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.
Change in pain perception: Visual Analogical Scale (VAS)5 minutes before dressing change (time 0) and 5 minutes after dressing change (time 1)Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.

Secondary

MeasureTime frameDescription
Change in heart rate5 minutes before dressing change (time 0) and 5 minutes after dressing change (time 1)Physiological parameter measured using pulse oximeter
Level of absorption at the moment5 minutes after dressing change (time 1)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.
Level of dissociation at the moment5 minutes after dressing change (time 1)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.
Time perception5 minutes after dressing change (time 1)We will ask to the patient his perception of time during the session.

Other

MeasureTime frameDescription
Participant's tendency to be absorbed and dissociatedAt inclusion (Day -2)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.
Participant's opinion about the tool5 minutes after dressing change (time 1)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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026