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Trial registered on ANZCTR


Registration number
ACTRN12620000648921
Ethics application status
Approved
Date submitted
24/04/2020
Date registered
4/06/2020
Date last updated
4/06/2020
Date data sharing statement initially provided
4/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Integration of Virtual Reality as analgesia for Trans-rectal Ultrasound prostate biopsy (TRUS): a randomized prospective study
Scientific title
Effect of Virtual Reality as analgesia for Trans-rectal Ultrasound prostate biopsy (TRUS) on pain severity: a randomized prospective study
Secondary ID [1] 301121 0
nil known
Universal Trial Number (UTN)

U1111-1250-0135
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri- Procedural Pain 317215 0
Peri-Procedural Anxiety 317216 0
prostate biopsy 317380 0
Condition category
Condition code
Surgery 315355 315355 0 0
Other surgery
Renal and Urogenital 315484 315484 0 0
Other renal and urogenital disorders
Anaesthesiology 315485 315485 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In an outpatient clinic the patient presenting for a TRUS biopsy will wear a Virtual Reality (VR) headset and watch a movie for the duration of the biopsy preocedure, duration estimated at 10-15minutes. The software for the movie will be a distraction application used on other similar studies. It will not require movement or active particpation in the VR environment, but merely passively watching the VR movie. The procedure will be carried out by a urology consultant or registrar with a urology nurse assisting. The biopsy procedure itself will not alter, it will be a standard ultrasound guided transrectal biopsy of the prostate and use local anesthetic.
Intervention code [1] 317431 0
Behaviour
Intervention code [2] 317524 0
Treatment: Devices
Comparator / control treatment
Undergoing a routine TRUS prostate biopsy without virtual reality distraction - a routine TRUS procedure involves the use of local anesthetic injected at the site of biopsy
Control group
Active

Outcomes
Primary outcome [1] 323617 0
Peri-procedural pain scores on a verified visual analogue scale will be used on the patient questionnaires - the survey was designed specifically for this study based on similar studies.
References:
1. Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun 1;2(2):175-84.
2. Pritchard M. Measuring anxiety in surgical patients using a visual analogue scale. Nursing Standard (through 2013). 2010 Nov 17;25(11):40.
3. Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, DeSocio PA. Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. The Journal of trauma. 2011 Jul;71(1 0):S125.
Timepoint [1] 323617 0
Directly after procedure
Secondary outcome [1] 382363 0
Peri-procedural Anxiety Symptoms Questionnaire that also uses a verified visual analogue scale used in similar studies
Timepoint [1] 382363 0
Directly after procedure
Secondary outcome [2] 382727 0
VR responsiveness Questionnaire that also uses a verified visual analogue scale used in similar studies - the survey was designed specifically for this study based on similar studies.
References:
1. Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun 1;2(2):175-84.
2. Pritchard M. Measuring anxiety in surgical patients using a visual analogue scale. Nursing Standard (through 2013). 2010 Nov 17;25(11):40.
3. Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, DeSocio PA. Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. The Journal of trauma. 2011 Jul;71(1 0):S125.
Timepoint [2] 382727 0
Directly after procedure
Secondary outcome [3] 382728 0
Overall satisfaction Questionnaire that also uses a verified visual analogue scale used in similar studies - the survey was designed specifically for this study based on similar studies.
References:
1. Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun 1;2(2):175-84.
2. Pritchard M. Measuring anxiety in surgical patients using a visual analogue scale. Nursing Standard (through 2013). 2010 Nov 17;25(11):40.
3. Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, DeSocio PA. Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. The Journal of trauma. 2011 Jul;71(1 0):S125.
Timepoint [3] 382728 0
Directly after procedure

Eligibility
Key inclusion criteria
Patient presenting for TRUS biopsy as per New Zealand ministry of health referral guidelines for diagnosing possible prostate cancer i.e raised PSA, abnormal prostate exam
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Severe cognitive impairment, severe visual 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)
randomisation completed by biostatistician, allocation in opaque sealed envelopes, operator will only find out once the nurse has opened the assigned envelope after consent obtained
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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
One group is randomly assigned to receive no intervention
The other group is randomly assigned to receive the intervention
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

A sample of 200 (100 per group) is required to ensure that there is at least 80% power to detect a difference of 1 on the primary outcome pain scale assuming a standard deviation of 2.5 and a 5% significance level. We will recruit 250 people (125 per group) to allow for a 20% drop out rate. This sample size also ensures that there is at least 80% power to detect a 0.4 standard deviation difference in the secondary outcome of anxiety using a 5% significance level.

A regression model (equivalent to an independent samples t-test) will be used to compare the mean level of pain between the intervention and control groups . Potential confounders will be added to this regression model to adjust for any imbalance between the arms. These may include age, chronic pain conditions ……. A similar approach will be undertaken to analyse the secondary outcome of anxiety.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22513 0
New Zealand
State/province [1] 22513 0

Funding & Sponsors
Funding source category [1] 305564 0
University
Name [1] 305564 0
University of Otago
Address [1] 305564 0
Health Research South
201 Great King Street
Dunedin
9016
Country [1] 305564 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Health Research South
201 Great King Street
Dunedin
9016
Country
New Zealand
Secondary sponsor category [1] 305974 0
None
Name [1] 305974 0
Address [1] 305974 0
Country [1] 305974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305870 0
Northern A Health and Disabilities Ethics Committees
Ethics committee address [1] 305870 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 305870 0
New Zealand
Date submitted for ethics approval [1] 305870 0
04/05/2020
Approval date [1] 305870 0
20/05/2020
Ethics approval number [1] 305870 0
20/NTA/60

Summary
Brief summary
Aim:
To determine if virtual reality technology will act as an analgesic aid to improve patient satisfaction during TRUS biopsy

Hypothesis:
If virtual reality technology is used at the time of routine TRUS biopsy procedures, there will be an improved patient levels of pain, anxiety and overall satisfaction.

Brief Method:
Men will be consented then randomly allocated to Virtual Reality (VR) intervention group or control group. Routine TRUS procedure 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, men 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101878 0
Dr Christian Robinson
Address 101878 0
201 Great King Street
General Surgery Department
Dunedin Hospital
Dunedin
9016
Country 101878 0
New Zealand
Phone 101878 0
+64276877939
Fax 101878 0
Email 101878 0
robch829@gmail.com
Contact person for public queries
Name 101879 0
Dr Christian Robinson
Address 101879 0
201 Great King Street
General Surgery Department
Dunedin Hospital
Dunedin
9016
Country 101879 0
New Zealand
Phone 101879 0
+643 474 0999
Fax 101879 0
Email 101879 0
christian.robinson@southerndhb.govt.nz
Contact person for scientific queries
Name 101880 0
Dr Christian Robinson
Address 101880 0
201 Great King Street
General Surgery Department
Dunedin Hospital
Dunedin
9016
Country 101880 0
New Zealand
Phone 101880 0
+64276877939
Fax 101880 0
Email 101880 0
robch829@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Primary and secondary outcome data
When will data be available (start and end dates)?
At the conclusion of the analysis (likely in 2022) data will be available for 5 years until 2027
Available to whom?
To those who request it
Available for what types of analyses?
Further study to progress the research
How or where can data be obtained?
Access via contacting primary investigator christian.robinson@southerndhb.govt.nz
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7776 0
Study protocol
Citation [1] 7776 0
Link [1] 7776 0
Email [1] 7776 0
christian.robinson@southerndhb.govt.nz
Other [1] 7776 0
Attachment [1] 7776 0
Type [2] 7777 0
Informed consent form
Citation [2] 7777 0
Link [2] 7777 0
Email [2] 7777 0
christian.robinson@southerndhb.govt.nz
Other [2] 7777 0
Attachment [2] 7777 0
Type [3] 7778 0
Ethical approval
Citation [3] 7778 0
Link [3] 7778 0
Email [3] 7778 0
christian.robinson@southerndhb.govt.nz
Other [3] 7778 0
Attachment [3] 7778 0
Type [4] 7779 0
Statistical analysis plan
Citation [4] 7779 0
Link [4] 7779 0
Email [4] 7779 0
christian.robinson@southerndhb.govt.nz
Other [4] 7779 0
Attachment [4] 7779 0
Summary results
No Results