Reducing Pain and Anxiety During Dressing Changes After Burn Surgery Using Virtual Reality

NCT04820400 | Active Not Recruiting

• 1 other identifier: BURN-360
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Burn injury and its treatment is an intensely painful experience. Most severely injured patients require numerous dressing changes and skin grafting procedures (removing skin from healthy part of the body and moving it to damaged area of the body). This procedure cause extensive pain and anxiety and many patients can become dependent on pain killers during their hospital stay and throughout rehabilitation. This can delay reintegration into society and increase the chance of opioid dependence. An effective pain management plan plays a large role in patient recovery. In addition to the physical pain experienced by these patients, burn injury is an intensely stressful and emotional life experience. This study will use a non-drug approach to reduce pain and extensive use of pain killers (opioids) during dressing changes. In particular, the study will use an immersive (allows to experience computer-generated environment as a real world) Virtual reality (VR) distraction tool during dressing change after skin graft surgery. Individuals who will decide to participate in this study will be asked to wear headgear to view immersive 360 videos specially designed by the study team. Before and after this exposure participants will be asked to complete a measurement of their anxiety level (VAS) and rate their pain. This study will help to determine if using VR as a distraction tool during painful dressing changes will reduce pain and anxiety, and therefore opioid medications requirements, and will rely on participants experience and adapt VR videos according to participants' response.

Conditions

Pain, Postoperative; Trauma; Burns

Keywords

Virtual Reality; Prospective Randomized Controlled Trial; Decreased drug use; Pain management

Outcome Measures

Primary Outcomes (2)

• Cumulative opioid analgesia consumption

  Cumulative opioid dose (i.e. fentanyl, hydromorphone, etc.) during the first 2 dressing change sessions in intravenous morphine equivalents (IME).

  Peri-procedural (starting 4 hours before and ending 4 hours after the dressing change)

• Change in opioid consumption between the first two dressing changes

  Opioid consumption over the first 2 dressing changes will be assessed between the two groups and differences will be compared between two consequent dressing change events (Dressing Change Day 1 and Dressing Change Day 2). We will also compare the cumulative doses for both dressing events.

  Peri-procedural (starting 4 hours before and ending 4 hours after the dressing change)

Secondary Outcomes (8)

• Pain assessment

  Immediately before, during and after each dressing change

• Additive effect of VR exposure on pain

  2 dressing changes: Day 1 and Day 2

• Anxiety assessment

  immediately before dressing change, during and after each dressing change (30 minutes after procedure complete)

• Number of participants requiring conscious sedation

  assessed during the dressing procedure

• Dressing change efficiency

  immediately after dressing change procedure on the day of procedure

Study Arms (2)

VR-360 group (VR-group)

EXPERIMENTAL

Patients will watch a VR-360 distraction video during dressing change. The patient will be asked or helped to wear the HMD write in full at the onset of a procedure and watch the VR-360 video during the dressing change procedure. When experiencing pain, the patient may indicate the need for further analgesic medication during the procedure, the patient will be asked to push a button in their hand that will trigger a light-based signal for the nurse to provide further analgesic medication. Should their hands both be involved in the burn injury, the patient will indicate the same verbally.

Other: Immersive VR Video

Control Group (standard treatment)

NO INTERVENTION

The patients will receive standard treatment and will be instructed to use the same button to indicate their pain.

Interventions

Immersive VR Video OTHER

The VR-360 video will be custom-made for the burn patient population. Through a review of current evidence for video scenarios/patients surveys, the study team will define and implement the key components appropriate for acute procedural pain such as type, duration and severity in this patient population. Next, patients will be asked about preferred pain relief elements (e.g. individual colours, geographical locations, sounds, etc.) that would help to design a video scenario. Finally, using a Likert pain scale, patients will be asked to rate each individual descriptor that exacerbates or alleviates pain. For instance, the colour red may be associated with 'flames', 'heat' and 'burns', and thus elevated pain, the colour blue may have the opposite effect, representing 'cooling' or 'cold'. Combined, this information will be used to create a VR-360 video geared towards alleviating acute procedural pain in patients with burn injuries undergoing dressing changes after skin graft.

VR-360 group (VR-group)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Patients anticipated to receive only one skin autograft surgery for acute burn injury at RTBC (patients may have received an allograft skin procedure prior to the autograft)
• Patients who will require inpatient stay for at least two consecutive daily dressing changes
• Patients alert and oriented, and able to watch immersive video and respond to questions

You may not qualify if:

• Patients on mechanical ventilation
• Patients receiving intravenous sedation
• Patients with significant face, neck or scalp burn wounds
• Patients with confirmed resistant bacteria (MRSA, CPE, VRE)
• Patients with history of significant motion sickness (i.e. occur during exposure to physical, visual and virtual motion, cybersickness, etc.) verbally declared by patient
• Patients unable to communicate

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Research Institute

Toronto, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Wounds and Injuries; Burns; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Alan D Rogers, MD

  SHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: March 29, 2021
• Study Start: March 24, 2021
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CA (1)