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

NCT03924908 | Withdrawn

• 1 other identifier: BurnVR-H
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Burns; Pain, Acute; Anxiety

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")

Secondary Outcomes (4)

• Level of absorption at the moment

  5 minutes after dressing change ("time 1")

• Level of dissociation at the moment

  5 minutes after dressing change ("time 1")

• Time perception

  5 minutes after dressing change ("time 1")

• Change in heart rate

  5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")

Other Outcomes (2)

• Participant's tendency to be absorbed and dissociated

  At inclusion (Day -2)

• Participant's opinion about the tool

  5 minutes after dressing change ("time 1")

Study Arms (2)

VRH

EXPERIMENTAL

Virtual reality hypnosis

Behavioral: VRH

VR

ACTIVE COMPARATOR

Virtual reality

Behavioral: VR

Interventions

VRH BEHAVIORAL

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

VRH

VR BEHAVIORAL

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

VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Burn patient treated as outpatient
• Burn surface area \> or = 5% of the total body surface area
• mainly 2nd degree burn

You may not qualify if:

• Psychiatric antecedents
• Claustrophobia
• Heavy hearing
• Visual impairment
• Face burn
• Conjunctivitis
• Consent not obtained

Sponsors & Collaborators

• University of Liege: lead

MeSH Terms

Conditions

Burns; Acute Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinic, principal investigator

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 23, 2019
• Study Start: January 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share