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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Withdrawn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
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 11, 2019
    Last Updated
    June 25, 2023
    Sponsor
    University of Liege
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    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

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

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