Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients
Primary Purpose
Burns, Pain, Acute, Anxiety
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VRH
VR
Sponsored by
About this trial
This is an interventional treatment trial for Burns
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VRH
VR
Arm Description
Virtual reality hypnosis
Virtual reality
Outcomes
Primary Outcome Measures
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.
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.
Change in fatigue
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.
Change in relaxation level
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.
Secondary Outcome Measures
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.
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.
Time perception
We will ask to the patient his perception of time during the session.
Change in heart rate
Physiological parameter measured using pulse oximeter
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03924908
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Not enough human resources
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Pain, Acute, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VRH
Arm Type
Experimental
Arm Description
Virtual reality hypnosis
Arm Title
VR
Arm Type
Active Comparator
Arm Description
Virtual reality
Intervention Type
Behavioral
Intervention Name(s)
VRH
Intervention Description
Patients will see a 3D film combined with a hypnotic voice during the entire procedure of dressing change
Intervention Type
Behavioral
Intervention Name(s)
VR
Intervention Description
Patients will see a 3D film without any hypnotic voice during the entire procedure of dressing change
Primary Outcome Measure Information:
Title
Change in pain perception: Visual Analogical Scale (VAS)
Description
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.
Time Frame
5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Title
Change in anxiety: Visual Analogical Scale (VAS)
Description
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.
Time Frame
5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Title
Change in fatigue
Description
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.
Time Frame
5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Title
Change in relaxation level
Description
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.
Time Frame
5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Secondary Outcome Measure Information:
Title
Level of absorption at the moment
Description
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.
Time Frame
5 minutes after dressing change ("time 1")
Title
Level of dissociation at the moment
Description
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 Frame
5 minutes after dressing change ("time 1")
Title
Time perception
Description
We will ask to the patient his perception of time during the session.
Time Frame
5 minutes after dressing change ("time 1")
Title
Change in heart rate
Description
Physiological parameter measured using pulse oximeter
Time Frame
5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Other Pre-specified Outcome Measures:
Title
Participant's tendency to be absorbed and dissociated
Description
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".
Time Frame
At inclusion (Day -2)
Title
Participant's opinion about the tool
Description
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")
Time Frame
5 minutes after dressing change ("time 1")
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients
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