Clinical trial NCT04820400: Reducing Pain and Anxiety During Dressing Changes After Burn Surgery Using Virtual Reality
Official title: BURN 360: Reducing Pain and Anxiety During Dressing Changes After Burn Surgery Using Virtual Reality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Trauma
Burns
Keywords: Virtual Reality
Prospective Randomized Controlled Trial
Decreased drug use
Pain management
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The Ross Tilley Burn Centre (RTBC) is the largest burn care centre in Canada, admitting \~300 patients/year. Most of these severely injured patients require numerous dressing changes and skin grafting procedures which cause extensive pain and anxiety in patients already facing potential losses in terms of function and independence. Poorly managed pain can reduce patient engagement and participation in effective rehabilitation, result in chronic opioid dependence, and worsen post-traumatic stress disorder.

While burn health practitioners specialize in the use of multi-modal pharmacological approach in an attempt to reduce patients' reliance on opioid, there is an increasing recognition of the importance of non-pharmacological strategies to reduce painful procedures in hospital. A number of studies have demonstrated reductions in pain, anxiety and analgesic medications with the use of Virtual Reality (VR) during procedures in hospital. VR can be applied in a variety of ways, with considerable variations in terms of cost, efficacy, and applicability. The burn injury VR literature includes predominantly small cases/series and is lacking on using VR-360 videos as a distraction technique in burn patients. Thus, VR remains under-utilized in most burn centres locally and internationally. To address this lack of knowledge, this study proposes to use VR-360 video as a distraction tool in patients during dressing changes after skin graft surgery.

This study aims to improve burn pain management by reducing opioid requirements, pain and anxiety during painful dressing changes, while also improving patient safety and satisfaction.

The study hypothesis is that immersive virtual reality use in the burn centre will reduce the cumulative dosage of analgesia used during the first two dressing changes after skin graft surgery when compared with patients not utilizing the technology.

The primary objective of this study is to evaluate the effect of VR-360 distraction video on opioid analgesic consumption during burn dressing changes.

The secondary objectives are to investigate the effect of VR-360 on pain, requirement for conscious sedation, additive effect of multiple VR exposures, anxiety, dressing change efficiency, patient reported outcome and satisfaction. Finally, patient and staff surveys will be undertaken which will allow iterative adaptation of 3600 immersive videos to the patients' preferences optimal distraction from the painful stimuli during dressing change.

The majority of patients suffering from burn injuries are committed to undergoing long, complex treatment plans that have significant physical and emotional impact. Pain is a challenge within this population and many patients require high doses of opioids. Indeed, a sizable proportion of burn patients may still require opioids as long as three months after discharge, delaying their reintegration into society and increasing the chance of opioid dependence. VR is a strategy that helps patients alter pain behavior. This study will be the first randomized trial to apply practitioner-designed VR-videos with patient input for greatest impact. It will compare opioid use, pain scores and patient satisfaction scores between this new, state of the art intervention, and current standard practice. By demonstrating VR's 'non-pharmacologic' effectiveness to alter pain perception the study team will develop a cost-effective, accessible tool that can align with practice at Sunnybrook. Furthermore, this team-based quality improvement initiative involving nurses, social workers, physio/occupational therapy and physicians aims to introduce VR as an evidence-based innovative non-pharmacological strategy to reduce opioid requirements and optimize the use of resources, workflow, and improve staff experience in burn centres across Canada and internationally

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cumulative opioid analgesia consumption
timeFrame: Peri-procedural (starting 4 hours before and ending 4 hours after the dressing change)
measure: Change in opioid consumption between the first two dressing changes
timeFrame: Peri-procedural (starting 4 hours before and ending 4 hours after the dressing change)
Secondary outcomes:
measure: Pain assessment
timeFrame: Immediately before, during and after each dressing change
measure: Additive effect of VR exposure on pain
timeFrame: 2 dressing changes: Day 1 and Day 2
measure: Anxiety assessment
timeFrame: immediately before dressing change, during and after each dressing change (30 minutes after procedure complete)
measure: Number of participants requiring conscious sedation
timeFrame: assessed during the dressing procedure
measure: Dressing change efficiency
timeFrame: immediately after dressing change procedure on the day of procedure
measure: Patient satisfaction: survey
timeFrame: assessed after 2nd dressing change on the day of procedure
measure: Opioid use at 3 months
timeFrame: Assessed 3 months after the procedure
measure: Post-Traumatic Stress Disorder Assessment
timeFrame: Assessed 1) at baseline 2) after 2nd dressing procedure, 3) at discharge, 4) at 3 month follow up visit
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
Study officials:
affiliation: SHSC
name: Alan D Rogers, MD
role: PRINCIPAL_INVESTIGATOR
References: