Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001398291p
Ethics application status
Submitted, not yet approved
Date submitted
14/08/2018
Date registered
20/08/2018
Date last updated
20/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual reality analgesia for post laparoscopic pain
Scientific title
Investigating the effect of virtual reality on post laparoscopy pain scores in women
Secondary ID [1] 295801 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative pain
 309236 0
Post operative opiate analgesia requirements 309237 0
Condition category
Condition code
Anaesthesiology 308112 308112 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women in the comparator group will have a virtual reality headset attached between 10 degrees to 45-degree based on participant discretion. It will be administered for 3 x 10 minute segments seperated by 5 minutes in between for questions by the investigators or clinicians in the recovery area within 15 minutes of commencement of the laparoscopy. The virtual reality will be a through a pair of VR goggles with a VR video playing on it which will place the patient in an immersive environment that resembles an open field viewing stars in the sky.
Intervention code [1] 312134 0
Treatment: Devices
Comparator / control treatment
Patients in the control group will receive routine care as in line with Monash Health guidelines which involves pain medications post operatively
Control group
Active

Outcomes
Primary outcome [1] 307088 0
Change in post operative pain scores post laproscopy with virtual reality use which will be assessed using a visual analog scale (100mm)
Timepoint [1] 307088 0
Post operatively in the post operative care unit within 1 hour of surgery
Primary outcome [2] 307089 0
Change in post operative analgesia requirements post laproscopy form medical records
Timepoint [2] 307089 0
Post operatively in the post operative care unit within 1 hour of surgery
Secondary outcome [1] 350644 0
Patient feedback on device experience using post study questionnaire designed specifically for this study
Timepoint [1] 350644 0
After utilisation of VR headset in intervention group assessed at discharge for post-operative period

Eligibility
Key inclusion criteria
Women Undergoing laparoscopy for any indication with the Gynaecology Unit
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Conversion to laparotomy
Chronic narcotic use / dependence
Pregnancy
Prior history of sensitivity to VR technology, motion sickness, vertigo, seizures, epilepsy and active nausea and vomiting
Women below 18 years of age
Patients with an intellectual or mental impairment
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
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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out via randomised permutated blocks using Microsoft Excel 2016
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the study, a sample size of 50 per treatment arm was estimated as per Amy at el. based on the small standardised effect size of delta = 0.23 from Whitehead et al. in their controlled study of VR for post operative pain relief11 15. This was based on the assumption of a 90% powered main trial with a type 1 error rate of 5%. As such, the total recruitment for the trial will be n=100 with 50 in each arm .
For this study, data will be summarised utilising descriptive statistics.
The normality of the data will then be explored utilising the Shapiro - Wilk and Kolmogorov- Smirnov test.
Within group differences will be compared using the paired t-test . Between group differences ( for pain scores , physiological parameters and opiate administration) will be calculated utilising either the unpaired t- test or Wilcoxson signed rank test depending on the distribution of the data. Chi squared tests will be utilised to compare the number of requests for analgesia during the procedure while utilising and not utilising VR.
Regression analysis (univariate and or multivariate) will then be utilised to explore the relationship between VR ( VR vs no VR) , pain scores and physiological parameters.
The significance level for this study is set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300394 0
University
Name [1] 300394 0
Monash University Department of O&G
Country [1] 300394 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Biorithm
Address
93A Lorong Tanggam
Singapore 798775
Country
Singapore
Secondary sponsor category [1] 299851 0
None
Name [1] 299851 0
Address [1] 299851 0
Country [1] 299851 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301203 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 301203 0
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Ethics committee country [1] 301203 0
Australia
Date submitted for ethics approval [1] 301203 0
15/08/2018
Approval date [1] 301203 0
Ethics approval number [1] 301203 0

Summary
Brief summary
The following study will be a comparative open label randomised human pilot study for patients utilising a novel therapeutic modality technology- virtual reality (VR) - to assess its utility as an analgesic in acute pain post laparoscopy. The following pilot study is aimed at efficacy and will assess:
• The effect of VR on pain scores after laparoscopy
• The effect of VR on opiate analgesia requirements after laparoscopy
• Patient feedback on device experience
This will be achieved by comparing VR to routine care post laparoscopy.
As such, the following study will aid in formulating evidence for utilising VR technology as an analgesia option post laparoscopy and potentially lay the foundations for a larger scale randomised controlled trial (RCT).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86206 0
Dr Vinayak Smith
Address 86206 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country 86206 0
Australia
Phone 86206 0
+61431330754
Fax 86206 0
Email 86206 0
[email protected]
Contact person for public queries
Name 86207 0
Vinayak Smith
Address 86207 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country 86207 0
Australia
Phone 86207 0
+61431330754
Fax 86207 0
Email 86207 0
[email protected]
Contact person for scientific queries
Name 86208 0
Vinayak Smith
Address 86208 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country 86208 0
Australia
Phone 86208 0
+61431330754
Fax 86208 0
Email 86208 0
[email protected]

No information has been provided regarding IPD availability


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.