RecruitingACTRN12620000222943

Can virtual reality help people to manage their pain after surgery? A pilot study

A pilot randomised controlled trial evaluating the acceptability and effectiveness of a virtual reality intervention for adjunct pain management in adults with acute post-surgical pain

Sponsor

St Vincent's Hospital Sydney

Enrollment

80 participants

Start Date

Jun 17, 2021

Study Type

Interventional

Conditions

Post-surgical pain

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Surgery can be painful, and managing that pain well is important for recovery. This pilot study is exploring whether virtual reality (VR) — using a headset to immerse yourself in a digital environment — can help reduce pain and distress after surgery, alongside standard pain medications. Participants are admitted to hospital after surgery under general anaesthesia. Half are randomly selected to continue with standard pain treatment only, while the other half also participate in four VR sessions over two days. Each session involves wearing a headset and interacting with a virtual world using a handheld controller. Researchers measure pain levels, distress, and heart rate before and after each session, and track how much pain medication is used overall. You may be eligible if you are 18 or older, have had surgery under general anaesthesia, are cognitively able to consent and participate, and can communicate in English. People who are blind, deaf, have an active psychotic illness, use implantable cardiac devices, or have recently had head, neck, or eye surgery cannot take part.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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.

Locations(1)

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

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ACTRN12620000222943