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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03924908

Recruitment Status Not yet recruiting

First Posted April 23, 2019

Last update posted April 28, 2021

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.

  • Condition or Disease:Anxiety
    Burns
    Pain, Acute
  • Intervention/Treatment: Behavioral: VRH
    Behavioral: VR
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients Treated as Outpatients
  • Estimated Study Start Date: January 2022
  • Estimated Primary Completion Date: June 2025
  • Estimated Study Completion Date: June 2025
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. Change in pain perception: Visual Analogical Scale (VAS) [ Time Frame: 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.
  • 2. Change in anxiety: Visual Analogical Scale (VAS) [ Time Frame: 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.
  • 3. Change in fatigue [ Time Frame: 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 fatigue = 0, maximum fatigue = 10.
  • 4. Change in relaxation level [ Time Frame: 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 relaxation = 0, maximum relaxation = 10.
  • Secondary Outcome Measures: 1. Level of absorption at the moment [ Time Frame: 5 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.
  • 2. Level of dissociation at the moment [ Time Frame: 5 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.
  • 3. Time perception [ Time Frame: 5 minutes after dressing change ("time 1") ]
    We will ask to the patient his perception of time during the session.
  • 4. Change in heart rate [ Time Frame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1") ]
    Physiological parameter measured using pulse oximeter
  • Other Outcome Measures: 1. Participant's tendency to be absorbed and dissociated [ Time Frame: At 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".
  • 2. Participant's opinion about the tool [ Time Frame: 5 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")
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Anne-Françoise Rousseau, PhD +3243667495 afrousseau@chuliege.be

Contact: Audrey Vanhaudenhuyse, PhD avanhaudenhuyse@chuliege.be

Locations
Sponsors and Collaborators

University of Liege

More Information
  • Responsible Party: University of Liege
  • ClinicalTrials.gov Identifier: NCT03924908 History of Changes
  • Other Study ID Numbers: BurnVR-H
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: April 28, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Acute Pain
    Burns
    Anxiety Disorders