Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000216718
Ethics application status
Approved
Date submitted
1/02/2022
Date registered
7/02/2022
Date last updated
11/02/2022
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Reality Analgesia for Post Laparoscopic Pain
Scientific title
An open label randomised controlled trial to investigate the effect of virtual reality on post laparoscopy pain.
Secondary ID [1] 306319 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-laparoscopic gynaecological surgery 325088 0
Pain 325090 0
Condition category
Condition code
Anaesthesiology 322512 322512 0 0
Pain management
Surgery 322513 322513 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will be using virtual reality (VR) technology as our intervention (and adjunct to routine care). This technology is a non-invasive distraction that is achieved through the application of a head-mounted device, that can easily be removed at any time. VR allows for users to be immersed in a three-dimensional virtual environment through multisensorial stimulation.

For this study, commercially available virtual reality headsets containing custom-designed content will be provided to individuals of the intervention group for a duration of 10 minutes. To ensure adherence to the virtual reality headset, the trials will be performed under direct observation by a member of the research team and participants will be required to complete a post-procedure questionnaire.

The content that will be displayed on the virtual reality headset is called "Meridian". In Meridian, the semi-recumbent user is situated in a space environment and will focus their gaze to point a handheld crystal staff towards a high tempo and steady progression of incoming rings which stream towards the user in a diverse range of patterns. This experience takes place against a backdrop of classical music and requires minimal movement from the patient.

VR administration is for one session only, whilst the patient is in recovery.
Intervention code [1] 322747 0
Treatment: Devices
Intervention code [2] 322748 0
Treatment: Other
Comparator / control treatment
The control group will receive routine care. Routine care involves the administration of pain management drugs as per the local hospital protocol at Monash Health Moorabin.
Control group
Active

Outcomes
Primary outcome [1] 330306 0
Between group differences between VR utilisation and standard care with pain scores using an 11-point visual analogue scale.
Timepoint [1] 330306 0
Data is collected at timepoints: 0, 10 (primary timepoint), and 30 minutes after surgery.
Secondary outcome [1] 405687 0
Between group differences for the amount of post-operative opiate analgesia used. This will be monitored by a site team member, patient chart audit, or review of patient medical records.
Timepoint [1] 405687 0
Data is collected at timepoints: 0, 10 (primary timepoint), and 30 minutes after surgery.
Secondary outcome [2] 405688 0
Between group differences in the changes in physiological parameters. Blood pressure and heart rate will be measured via electronic blood pressure machines whilst respiratory rate will be taken manually by the investigator.
Timepoint [2] 405688 0
Data is collected at timepoints: 0, 10 (primary timepoint), and 30 minutes after surgery.
Secondary outcome [3] 405689 0
Between group differences in the side effects experienced by participants. Possible adverse events include nausea, vomiting, dizziness, vertigo, or seizures. These will be assessed using a study-specific questionnaire.
Timepoint [3] 405689 0
Data is collected at timepoints: 0, 10 (primary timepoint), and 30 minutes after surgery.
Secondary outcome [4] 405690 0
Composite outcome: Between group differences in the post-discharge recovery and ambulation. This will be measured using a study-specific questionnaire that will be completed with the patient via a follow-up phone call.
Timepoint [4] 405690 0
Data is collected at timepoint: 24 hours after discharge,
Secondary outcome [5] 405692 0
Patient feedback on device experience. This will be collected using a questionnaire that was designed specifically for this study.
Timepoint [5] 405692 0
Data is collected at timepoint: 30 minutes after surgery.

Eligibility
Key inclusion criteria
The women in the following group:
1. Undergoing laparoscopy for any indication
The following criteria are relevant as:
1. All indication for gynaecological laparoscopy were considered suitable for pain assessment
2. Sufficient English language comprehension
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Conversion to laparotomy
2. Chronic narcotic use / dependence
3. Pregnancy
4. Prior history of sensitivity to VR technology, motion sickness, vertigo, seizures, epilepsy and active nausea and vomiting
5. Women below 18 years of age
6. Patients with an intellectual impairment
7. People in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process
8. People highly dependent on medical care

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
142
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21601 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 36524 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 310666 0
University
Name [1] 310666 0
Monash University
Country [1] 310666 0
Australia
Primary sponsor type
University
Name
Monash University Department of Obstetrics and Gynaecology
Address
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 311881 0
Hospital
Name [1] 311881 0
Monash Health
Address [1] 311881 0
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country [1] 311881 0
Australia
Secondary sponsor category [2] 311882 0
Commercial sector/Industry
Name [2] 311882 0
Liminal VR Pty Ltd
Address [2] 311882 0
Suite 1.04/17-19 Yarra St,
Abbotsford VIC 3067
Country [2] 311882 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310256 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 310256 0
Research Support Services,
Level 2, i Block,
Monash Medical Centre,
246 Clayton Road,
Clayton, VIC, 3168
Ethics committee country [1] 310256 0
Australia
Date submitted for ethics approval [1] 310256 0
Approval date [1] 310256 0
10/02/2022
Ethics approval number [1] 310256 0
RES-20-0000821L 62571

Summary
Brief summary
Laparoscopy is a commonly performed gynaecological procedure. Studies evaluating post-laparoscopic gynaecological surgery pain suggest post-operative pain is experienced by 35–65% of women. One study demonstrated that ~46% of patients post-laparoscopy were in severe pain and required significantly greater amounts of analgesia than patients undergoing laparotomy.

Virtual reality (VR) is a technological medium that is used to create simulated scenarios in which users are immersed and able to interact with through stimulation of the senses. In recent years, there has been a growing interest in medicine for its potential to provide pain relief with positive results being reported. The mechanism responsible for this phenomenon is not yet fully understood, but is attributed to its ability to distract users from perceiving pain and also due to neurophysiological changes that result from long-term use.

Given the potential of VR to facilitate analgesia, this study hypothesises that VR technology can reduce pain and analgesic requirements with minimal side effects to provide a solution to the existing clinical gap.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117030 0
Prof Beverley Vollenhoven
Address 117030 0
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country 117030 0
Australia
Phone 117030 0
+61 03 85722915
Fax 117030 0
Email 117030 0
beverley.vollenhoven@monash.edu
Contact person for public queries
Name 117031 0
Mr Ritesh Warty
Address 117031 0
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country 117031 0
Australia
Phone 117031 0
+61 404222456
Fax 117031 0
Email 117031 0
ritesh.warty1@monash.edu
Contact person for scientific queries
Name 117032 0
Dr Vinayak Smith
Address 117032 0
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country 117032 0
Australia
Phone 117032 0
+61 431 330 754
Fax 117032 0
Email 117032 0
vinayak.smith@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Protection of participant identity and data.


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.