Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000534886p
Ethics application status
Submitted, not yet approved
Date submitted
27/01/2021
Date registered
6/05/2021
Date last updated
6/05/2021
Date data sharing statement initially provided
6/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Integration of Virtual Reality as analgesia for office based flexible cystoscopy: a randomized prospective study
Scientific title
Effect of Virtual Reality as analgesia for office based flexible cystoscopy on procedural discomfort: a randomized prospective study
Secondary ID [1] 303273 0
None
Universal Trial Number (UTN)
U1111-1264-2733
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 320464 0
Cystoscopy 320465 0
Condition category
Condition code
Renal and Urogenital 318349 318349 0 0
Other renal and urogenital disorders
Surgery 318350 318350 0 0
Surgical techniques
Anaesthesiology 318712 318712 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of a virtual reality headset whilst undertaking office based flexible cystoscopy. Patients will wear a commercially available virtual reality headset for the duration of the procedure. They will receive a short tutorial on how to operate the headset prior to undergoing the procedure. Patient lie on a clinic bed whilst undergoing the procedure, in the outpatient clinic, which is standard practice. The procedure takes about 10 minutes. Patients will watch environmental scenery of a virtual savannah type scene with varied flora and fauna to provide distraction, with natural sounds of these played through the headset. Once the procedure is complete the patient will remove the headset. The headset will be cleaned.
Intervention code [1] 319574 0
Prevention
Intervention code [2] 319575 0
Treatment: Devices
Comparator / control treatment
Standard practice of office based flexible cystoscopy. Patients are seen in the outpatient clinic to undergo flexible cystoscopy. The procedure is verbally explained to patients and any questions they have answered before proceeding. They are able to decline the procedure if they require. Patients will then lie on a clinic bed and expose their genitalia. The skin surrounding the external urethral meatus is cleaned with antiseptic solution, and the patient draped appropriately with sterile drapes.. Sterile anaesthetic gel is then applied to the urethra. The flexible cystoscope is then introduced through the urethra, with irrigation, into the bladder. The entire urethra and bladder is examined. The cystoscope is then removed which concludes the procedure. Patients will often have to pass urine afterwards due to instillation of fluid on entry. Patients in the control group will have the same procedural protocol, but with no virtual reality headset.
Control group
Active

Outcomes
Primary outcome [1] 326320 0
Pain scores from office based flexible cystoscopy. This will be assessed with a study specific questionnaire which uses the visual analog scale for patients to record their responses.
Timepoint [1] 326320 0
Prior to and Immediately after the procedure
Primary outcome [2] 326648 0
Anxiety scores from office based flexible cystoscopy. This will be assessed with a study specific questionnaire which uses the visual analog scale for patients to record their responses.
Timepoint [2] 326648 0
Prior to and immediately after the procedure
Primary outcome [3] 326649 0
Overall satisfaction scores from office based flexible cystoscopy. This will be assessed with a study specific questionnaire which uses the visual analog scale for patients to record their responses.
Timepoint [3] 326649 0
Prior to and immediately after the procedure
Secondary outcome [1] 391052 0
Response to virtual reality headset. This will be assessed with a study specific questionnaire which uses the visual analog scale for patients to record their responses.
Timepoint [1] 391052 0
Immediately after the procedure

Eligibility
Key inclusion criteria
Undergoing flexible cystoscopy in the Urology outpatient clinic at Dunedin Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with vision impairment or significant cognitive impairment.

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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A Sample size has been calculated from existing studies data to be able to detect a statistically significant difference of 1 cm on the visual analog scale. Depending on the distribution of the data, a statistical calculation will be made to calculate the P value of the difference between the two groups. It is likely that the data will be normally distrubted so an ordinary t test could be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/05/2021
Actual
Date of last participant enrolment
Anticipated
1/02/2022
Actual
Date of last data collection
Anticipated
1/02/2022
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 23413 0
New Zealand
State/province [1] 23413 0
Otago

Funding & Sponsors
Funding source category [1] 307683 0
Government body
Name [1] 307683 0
Southern District Health Board
Country [1] 307683 0
New Zealand
Primary sponsor type
University
Name
University Of Otago
Address
201 Great King Street, Dunedin 9011, New Zealand
Country
New Zealand
Secondary sponsor category [1] 308382 0
Government body
Name [1] 308382 0
Southern District Health Board
Address [1] 308382 0
201 Great King Street, Dunedin 9011, New Zealand
Country [1] 308382 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307719 0
Southern Health and Disability Ethics Committee, New Zealand
Ethics committee address [1] 307719 0
133 Molesworth Street, Thorndon, Wellington 6011
Ethics committee country [1] 307719 0
New Zealand
Date submitted for ethics approval [1] 307719 0
25/02/2021
Approval date [1] 307719 0
Ethics approval number [1] 307719 0

Summary
Brief summary
Virtual reality has made an impact in areas of acute and chronic pain as an adjunct to standard analgesia regimes. Research has already shown benefit in areas of paediatric procedures, burn wound debridements and endoscopic gynaecological procedures to manage acute procedural pain. It appears subjective pain scores and anxiety levels may be reduced with this non-pharmacological approach This has not been introduced within the scope of urology procedures.

Flexible cystoscopy is commonly carried out in the outpatient clinic under local anaesthetic. There wide variation in patients experience with this procedure, with a large number tolerating it poorly, which can also detract from the accuracy of the procedure. Integrating Virtual reality as an analgesia for office based flexible cystoscopy may improve patient satisfaction outcomes, and reduce numbers of patients requiring cystoscopy under General Anaesthesia.

Aim:
To determine if virtual reality technology will act as an analgesic aid to improve patient satisfaction following outpatient flexible cystoscopy.

Method:
This will be a single-centre, randomized prospective cohort study conducted within the Urology Department of Dunedin Hospital.

Eligible participants will be patients who present for flexible cystoscopy in the outpatient setting. Patients with vision impairment or significant cognitive impairment will be excluded.

Recruitment will be from the outpatient clinic over a 12-month period. Estimated sample size 200 patients.

Patients will be consented then randomly allocated to Virtual Reality (VR) intervention group or control group. Routine flexible cystoscopy under local anaesthetic will take place with no procedural change in the way samples are collected in both groups. However, the intervention group will wear a VR headset with distraction environment VR software. They will then watch a VR movie for the duration of the procedure. Prior to the procedure in each group, Patients will complete a standardized questionnaire about their expectations of the procedure. This will include questions relating to pain, anxiety and overall expectation. After the procedure, patients will complete the same questionnaire investigating their pain, anxiety, VR response (if applicable) and overall satisfaction.

The primary outcome will be patients’ pain, anxiety and overall satisfaction scores. This will be collected on standardized questionnaires as guided by similar international studies.

Data will then be analysed to see if there is correlation between VR and primary outcome scores. All data collection will be anonymous with no identifiable information collected. No further follow up is required.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108262 0
Dr Thomas Clarkson
Address 108262 0
Southern District Health Board, Dunedin Hospital, 201 Great King Street, Dunedin 9011
Country 108262 0
New Zealand
Phone 108262 0
+64 27 387 3124
Fax 108262 0
Email 108262 0
[email protected]
Contact person for public queries
Name 108263 0
Dr Thomas Clarkson
Address 108263 0
Southern District Health Board, Dunedin Hospital, 201 Great King Street, Dunedin 9011
Country 108263 0
New Zealand
Phone 108263 0
+64 3 434 0999
Fax 108263 0
Email 108263 0
[email protected]
Contact person for scientific queries
Name 108264 0
Dr Thomas Clarkson
Address 108264 0
Southern District Health Board, Dunedin Hospital, 201 Great King Street, Dunedin 9011
Country 108264 0
New Zealand
Phone 108264 0
+64 3 434 0999
Fax 108264 0
Email 108264 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


What supporting documents are/will be available?




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.