BurnsNCT03924908
Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients
A study testing VRH and VR in people with Burns and Pain, Acute, run by University of Liege.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Pain, Acute, Anxiety
- What is being tested?
- VRH and VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Burn patient treated as outpatient
- Burn surface area > or = 5% of the total body surface area
- mainly 2nd degree burn
Who cannot join
- Psychiatric antecedents
- Claustrophobia
- Heavy hearing
- Visual impairment
- Face burn
- Conjunctivitis
- Consent not obtained
About this study
Official title: Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients Treated as Outpatients
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.
- Conditions
- Burns, Pain, Acute, Anxiety
- Being tested
- VRH, VR
- Medical subject headings
- Burns, Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRHBehavioural
Patients will see a 3D film combined with a hypnotic voice during the entire procedure of dressing change
VRBehavioural
Patients will see a 3D film without any hypnotic voice during the entire procedure of dressing change
| Study group | Role | What they receive |
|---|---|---|
| VRH | Experimental | Virtual reality hypnosis Receives: Behavioral: VRH |
| VR | Active comparator | Virtual reality Receives: Behavioral: VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
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.
Measured: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Change in fatigue
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.
Measured: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Change in relaxation level
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.
Measured: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Secondary outcomes (4)
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.
Measured: 5 minutes after dressing change ("time 1")
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.
Measured: 5 minutes after dressing change ("time 1")
Time perception
We will ask to the patient his perception of time during the session.
Measured: 5 minutes after dressing change ("time 1")
Change in heart rate
Physiological parameter measured using pulse oximeter
Measured: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Why it stopped: Not enough human resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Françoise Rousseau, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924908
- Sponsor's protocol ID
- BurnVR-H
- Status last verified
- Jun 2023
- First submitted
- 11 Apr 2019
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients Treated as Outpatients
- ClinicalTrials.gov ID
- NCT03924908
- Acronym / sponsor ID
- BurnVR-H
- Conditions
- Burns, Pain, Acute, Anxiety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough human resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRH | Experimental | Behavioral: VRHVirtual reality hypnosis |
| VR | Active comparator | Behavioral: VRVirtual reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Burn patient treated as outpatient
- Burn surface area > or = 5% of the total body surface area
- mainly 2nd degree burn
Key exclusion criteria (7 listed)
- Psychiatric antecedents
- Claustrophobia
- Heavy hearing
- Visual impairment
- Face burn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRHPatients will see a 3D film combined with a hypnotic voice during the entire procedure of dressing change | Behavioural | VRH |
| VRPatients will see a 3D film without any hypnotic voice during the entire procedure of dressing change | Behavioural | VR |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Level of absorption at the moment
Time frame: 5 minutes after dressing change ("time 1")
Level of dissociation at the moment
Time frame: 5 minutes after dressing change ("time 1")
Time perception
Time frame: 5 minutes after dressing change ("time 1")
Change in heart rate
Time frame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VRH and VR in people with Burns and Pain, Acute, run by University of Liege.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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")). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.