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

Pain, Postoperative Clinical Trial

— BURN-360  

Official title:

BURN 360: Reducing Pain and Anxiety During Dressing Changes After Burn Surgery Using Virtual Reality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04820400
• Other study ID #: BURN-360
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Alan D Rogers, MD
• Phone: 416 480 6100
• Email: alandavid.rogers[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Pain, Postoperative
• Trauma

Intervention

Other:
• Immersive VR Video
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.

Locations

Country	Name	City	State
Canada	Sunnybrook Research Institute	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Pain assessment	Study participants will rate their pain using the Numeric Rating Scale for Pain (NRS) on a scale of 0-10 (0 for no pain; 10 for unbearable pain)	Immediately before, during and after each dressing change
Secondary	Additive effect of VR exposure on pain	The dose difference in opioid will be calculated and compared between two consequent dressing change events.	2 dressing changes: Day 1 and Day 2
Secondary	Anxiety assessment	Participants will rate their anxiety using the Visual Analogue Scale for anxiety (VASa), a 0-10 scale where 0 is "Not at all anxious" and 10 is "Extremely anxious".	immediately before dressing change, during and after each dressing change (30 minutes after procedure complete)
Secondary	Number of participants requiring conscious sedation	The requirement for additional intravenous sedatives: ketamine (25mg IV q 5mins with no max and/or midazolam 1mg q15min (MD clinical discretion) or fentanyl (25-50 mcg IV q5 min, maximum total dose of 250mcg)	assessed during the dressing procedure
Secondary	Dressing change efficiency	The dressing nurse will complete a standardized workflow questionnaire using a 0-10 Likert scale (0 as not efficient and 10 as very efficient).	immediately after dressing change procedure on the day of procedure
Secondary	Patient satisfaction: survey	Will be assessed with a survey asking patients subjective thoughts on the procedure experience.	assessed after 2nd dressing change on the day of procedure
Secondary	Opioid use at 3 months	This will be a binary outcome. Whether the patient is on prescription opioid analgesics or not at the 3-month follow-up visit.	Assessed 3 months after the procedure
Secondary	Post-Traumatic Stress Disorder Assessment	All participants will be asked to complete the PTSD checklist for DSM-5 (PCL-5), which asks 20 questions related to symptoms of PTSD, each of which is ranked on a 0-4 scale, where 0 is "Not at all" and 4 is "extremely".	Assessed 1) at baseline 2) after 2nd dressing procedure, 3) at discharge, 4) at 3 month follow up visit