None listed
Conditions
Brief summary
This pilot randomised controlled trial aims to evaluate the acceptability and clinical efficacy of a novel, immersive virtual reality (VR) intervention as an adjunct form of analgesia to help manage acute post-surgical pain. It will compare two randomly allocated participant groups, with participants recruited 48 hours after undergoing a surgical procedure under general anaesthesia. The control group will receive usual care (standard pain treatment), while the intervention group will receive usual care in addition to the experimental VR intervention. The intervention involves four sessions of immersive VR, delivered over two days. During each session, the participant is immersed into a virtual environment by wearing a head-mounted display while interacting with a novel VR program using a hand-held controller. Scores of pain severity, pain-related distress, heart rate and the incidence of possible side effects (such a nausea, disorientation and dizziness) will be assessed before and after each VR session. At the completion of the study intervention period, participants will complete a study-specific questionnaire rating their satisfaction and acceptability of the intervention. Their use of pharmacological analgesia (as part of usual care) during the two-day study period will also be measured.
Interventions
The intervention group will receive an experimental virtual reality (VR) intervention, in addition to their ongoing usual care. The intervention will take place over two days, and will consist of four virtual reality sessions in total (two per day, for two days). During each session, participants will wear an immersive VR wireless head-mounted display (operated by a smartphone), and engage with a bespoke interactive VR program designed by the project team. The program is interactive and designed
The intervention group will receive an experimental virtual reality (VR) intervention, in addition to their ongoing usual care. The intervention will take place over two days, and will consist of four virtual reality sessions in total (two per day, for two days). During each session, participants will wear an immersive VR wireless head-mounted display (operated by a smartphone), and engage with a bespoke interactive VR program designed by the project team. The program is interactive and designed in four parts (one for each session). The program immerses the user in a virtual environment, where they are required to interact with an avatar character, and complete a series of virtual tasks, using a single hand-held controller. Session 1's task involves using the controller to pick up and move small objects to virtual targets; Session 2's task involves navigating through the virtual environment to find wood, and build a virtual bridge; Session 3's tasks involves navigating through the virtual environment to complete an object recognition/matching task; and Session 4 involves a logic task to navigate across a virtual body of water via stepping stones. Each session will be a minimum of 5 minutes and a maximum of 10 minutes long. All intervention sessions will be delivered by a clinical researcher, who will monitor the participant throughout each session. Participants will remain seated during all VR sessions.
Sponsors
St Vincent's Hospital Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged 18 years or older - Admitted to an acute hospital ward after undergoing a surgical procedure under general anaesthesia - Cognitively competent to provide consent and participate in study activities, assessed as a score of 4 or more on the Six Item Cognitive Screener - Able to communicate in English
Exclusion criteria
- Blind - Deaf - Have an acute psychotic illness - Have an active substance use disorder - Involuntary hospital admission under the Mental Health Act - Underwent head, neck or eye surgery - Infectious illness at the time of screening - Implantable cardiac device or neurostimulator (including pacemaker, defibrillator, ventricular assist device, brain or spinal stimulator) - Experiencing vertigo and/or other vestibular disturbance at the time of screening
Outcome results
None listed