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Trial registered on ANZCTR


Registration number
ACTRN12620000222943
Ethics application status
Approved
Date submitted
12/02/2020
Date registered
24/02/2020
Date last updated
5/08/2021
Date data sharing statement initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Can virtual reality help people to manage their pain after surgery? A pilot study
Scientific title
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
Secondary ID [1] 300493 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-surgical pain 316173 0
Condition category
Condition code
Anaesthesiology 314465 314465 0 0
Pain management
Surgery 314466 314466 0 0
Other surgery
Physical Medicine / Rehabilitation 314467 314467 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 316802 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care. This may include standard pharmacological analgesia and ward based allied health interventions (such as physiotherapy), as deemed necessary and prescribed by their treating clinicians.
Control group
Active

Outcomes
Primary outcome [1] 322795 0
Severity of participants pain, assessed using the Numerical Pain Rating Scale (scored from 0-10).
Timepoint [1] 322795 0
Assessed immediately before and immediately after each VR session
Primary outcome [2] 322843 0
Levels of participant acceptance and satisfaction with the VR intervention, assessed using a study-specific questionnaire
Timepoint [2] 322843 0
Assessed after completion of the study intervention (immediately after completion of the fourth and final VR session)
Secondary outcome [1] 379825 0
Participant's level of pain-related distress, assessed using a Visual Analogue Scale (0-10)
Timepoint [1] 379825 0
Assessed immediately before and immediately after each VR session
Secondary outcome [2] 379992 0
Changes in heart rate (beats per minute), assessed using a pulse oximeter
Timepoint [2] 379992 0
Assessed immediately before and immediately after each VR session
Secondary outcome [3] 379993 0
Proportion of participants who report nausea during the study intervention period
Timepoint [3] 379993 0
Assessed four times, at the time of each VR session (or equivalent time-point during usual care, for control group)
Secondary outcome [4] 379994 0
Proportion of participants who report disorientation and/or dizziness during the study intervention period
Timepoint [4] 379994 0
Assessed four times, at the time of each VR session (or equivalent time-point during usual care, for control group)
Secondary outcome [5] 379995 0
The amount of pharmacological analgesia used by participants during the two-day study period, as determined by review of medication charts and quantified as oral morphine equivalent daily dose (milligrams)
Timepoint [5] 379995 0
Assessed after completion of the study intervention (after completion of the fourth and final VR session)
Secondary outcome [6] 379997 0
Brief Pain Inventory, to assess the severity of pain and the degree to which it interferes with daily activities
Timepoint [6] 379997 0
Assessed at baseline (immediately after enrolment into the study and prior to randomisation), and again at study completion (after completion of the fourth and final VR session, two days after study enrolment)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation will be arranged in sealed envelopes, prepared by a staff member with no role in the study procedures or clinical care of participants. Allocation will occur in random permuted blocks (4 blocks, 20 participants per block), such that after every block, the experimental and control groups will contain equal numbers. Randomisation will be concealed and will occur after a participant completes their baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a web-based, random number sequence generator (available at www.randomization.com), with 1:1 group allocation, and 4 permuted blocks. Concealed envelopes will be prepared using this allocation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics including mean, range, standard deviation, 95% confidence intervals and proportions will be used to describe the study population. Analyses of variance with factors of time and group will be used to examine the effect of the VR intervention on outcomes measures (including pain scores, pain-related distress scores, HR, and oral morphine equivalents), and to investigate group-by-time interactions . Analyses will be conducted using an intention-to-treat approach. Satisfaction and acceptability data will be reported descriptively.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/03/2021
Actual
17/06/2021
Date of last participant enrolment
Anticipated
1/03/2022
Actual
Date of last data collection
Anticipated
8/03/2022
Actual
Sample size
Target
80
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15819 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 29255 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 304910 0
Charities/Societies/Foundations
Name [1] 304910 0
St Vincent's Curran Foundation
Country [1] 304910 0
Australia
Funding source category [2] 304944 0
Commercial sector/Industry
Name [2] 304944 0
Samsung Electronics Australia
Country [2] 304944 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria St
Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 305257 0
None
Name [1] 305257 0
Address [1] 305257 0
Country [1] 305257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305319 0
St Vincent's Hospital Sydney Human Research Ethics Comittee
Ethics committee address [1] 305319 0
St Vincent's Hospital Translational Research Centre
97-105 Boundary St, Darlinghurst, NSW 2010
Ethics committee country [1] 305319 0
Australia
Date submitted for ethics approval [1] 305319 0
Approval date [1] 305319 0
10/05/2019
Ethics approval number [1] 305319 0
2019/ETH00423

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99982 0
A/Prof Steven Faux
Address 99982 0
Department of Rehabilitation and Pain Medicine, St Vincent's Hospital Sydney
170 Darlinghurst Rd, Darlinghurst NSW 2010
Country 99982 0
Australia
Phone 99982 0
+61 2 8382 9516
Fax 99982 0
Email 99982 0
[email protected]
Contact person for public queries
Name 99983 0
Steven Faux
Address 99983 0
Department of Rehabilitation and Pain Medicine, St Vincent's Hospital Sydney
170 Darlinghurst Rd, Darlinghurst NSW 2010
Country 99983 0
Australia
Phone 99983 0
+61 2 8382 9516
Fax 99983 0
Email 99983 0
[email protected]
Contact person for scientific queries
Name 99984 0
Steven Faux
Address 99984 0
Department of Rehabilitation and Pain Medicine, St Vincent's Hospital Sydney
170 Darlinghurst Rd, Darlinghurst NSW 2010
Country 99984 0
Australia
Phone 99984 0
+61 2 8382 9516
Fax 99984 0
Email 99984 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be made available for sharing, in accordance with the ethically approved study protocol


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.