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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]

None

Universal Trial Number (UTN)

U1111-1264-2733

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pain

Cystoscopy

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Surgery

Surgical techniques

Anaesthesiology

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]

Prevention

Intervention code [2]

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]

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]

Prior to and Immediately after the procedure

Primary outcome [2]

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]

Prior to and immediately after the procedure

Primary outcome [3]

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]

Prior to and immediately after the procedure

Secondary outcome [1]

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]

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]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Southern District Health Board

Address [1]

Dunedin Hospital, 201 Great King Street, Dunedin 9011, New Zealand

Country [1]

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]

Government body

Name [1]

Southern District Health Board

Address [1]

201 Great King Street, Dunedin 9011, New Zealand

Country [1]

New Zealand

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee, New Zealand

Ethics committee address [1]

133 Molesworth Street, Thorndon, Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

25/02/2021

Approval date [1]

Ethics approval number [1]

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

Dr Thomas Clarkson

Address

Southern District Health Board, Dunedin Hospital, 201 Great King Street, Dunedin 9011

Country

New Zealand

Phone

+64 27 387 3124

Fax

[email protected]

Contact person for public queries

Name

Thomas Clarkson

Address

Southern District Health Board, Dunedin Hospital, 201 Great King Street, Dunedin 9011

Country

New Zealand

Phone

+64 3 434 0999

Fax

[email protected]

Contact person for scientific queries

Name

Thomas Clarkson

Address

Southern District Health Board, Dunedin Hospital, 201 Great King Street, Dunedin 9011

Country

New Zealand

Phone

+64 3 434 0999

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details	Attachment
10362	Study protocol	[email protected]	Can be obtained from Investigator on request - con... [More Details]	381301-(Uploaded-05-05-2021-19-41-26)-Study-related document.docx
10363	Informed consent form	[email protected]	Hard copies provided to participants when enrollin... [More Details]	381301-(Uploaded-02-05-2021-18-01-19)-Study-related document.doc
10807	Ethical approval	[email protected]	Can be obtained from study team on request, contac... [More Details]

Results publications and other study-related documents

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