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Trial registered on ANZCTR


Registration number
ACTRN12620001350910
Ethics application status
Approved
Date submitted
17/10/2020
Date registered
14/12/2020
Date last updated
21/07/2022
Date data sharing statement initially provided
14/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of Using Virtual Reality Technology for Surgery-related Anxiety among Adults:Protocol for a single-centre randomised controlled trial
Scientific title
The Effectiveness of Using Virtual Reality Technology for Periopeartive Anxiety among Adults undergoing Elective Surgery:Protocol for a single-centre randomised controlled trial
Secondary ID [1] 302406 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periopearative Anxiety 319200 0
Surgery-related Anxiety 319241 0
Condition category
Condition code
Surgery 317168 317168 0 0
Other surgery
Mental Health 317687 317687 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
VIRTUAL REALITY INTERVENTION

The participants will be asked to wear the VR headset for 10 minutes, which has been suggested in the literature to be the optimal time frame for VR without adverse side effects. The participants will be seated in the preoperative holding area while emersed in a VR nature scene with accompanying nature sounds. The preoperative holding area has been selected for administration of the intervention because evidence suggests preoperative anxiety levels among adult surgical patients peak in the preoperative holding area. The VR will be used for relaxation purposes with nine natural scenes combined with natural sounds and music, for the participant to select from: blue moon; red savanna; blue ocean; green meadows; black beginning; white winter; blue deep; red fall, and the orange sunset . The participant's face and forehead will be cleaned using skin-friendly antibacterial cleaning wipes before using the VR device. Disposable hygiene covers will be used to protect the VR device. The researcher will provide the intervention and monitor the participant for adverse side effects such as headache, nausea, vomiting, sweating, fatigue, drowsiness, disorientation, and apathy throughout the session.
Intervention code [1] 318692 0
Treatment: Other
Comparator / control treatment
The control group will receive standard preoperative care only, while the intervention group will receive standard preoperative care plus VR. Standard preoperative care will include preparing the preoperative surgical site, preoperative bathing, preoperative hair removal, wearing theatre gown, removing all jewellery, correct patient ID bracelet, and completing the patient preoperative checklist and health record. .
Control group
Active

Outcomes
Primary outcome [1] 325249 0
Perioperative anxiety as measured by Visual Analog Scale for Anxiety (VAS-A).
Timepoint [1] 325249 0
three-time points
On admission to the preoperative area (T1), immediately before surgery (T2) primary endpoint), and one hour after surgery (T3)
Secondary outcome [1] 387332 0
1. Stress level as measured by:
A) Cortisol levels: will be assessed by using saliva samples.
B) Heart rate (HR): will be assessed manually for 1 minute.
Timepoint [1] 387332 0
Saliva sample two-time points On admission to the preoperative area (T1), immediately before surgery (T2).

Heart rate three-time points On admission to the preoperative area (T1), immediately before surgery (T2), and one hour after surgery (T3)
Secondary outcome [2] 387333 0
2. Postoperative Pain as measured by Visual Analog Scale for Pain (VAS-P).
Timepoint [2] 387333 0
two-time points
On admission to the preoperative area (T1), and one hour after surgery (T3)
Secondary outcome [3] 387334 0
3- Patient satisfaction as measured by the Leiden Perioperative Patient Satisfaction questionnaire (LPPSq).
Timepoint [3] 387334 0
one-time point
24 hours after surgery before they are discharged (T4)
Secondary outcome [4] 387335 0
4- Hospital Length of Stay ( from patient medical records).
Timepoint [4] 387335 0
one-time point (at hospital discharge).
Secondary outcome [5] 387336 0
5- Adverse effect of VR intervention at any time point as measured by the Virtual Reality Symptom Questionnaire (VRSQ).

Possible adverse effects include :
discomfort, headache, stomach awareness, nausea, vomiting, pallor, sweating, fatigue, drowsiness, disorientation, and apathy
Timepoint [5] 387336 0
one-time point
immediately before surgery (T2)

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion if they are 18 years old and over; scheduled for elective surgery; able to understand English and follow instructions.

Screening:
Patients who meet the above inclusion criteria will be screened for their anxiety level using The Amsterdam Preoperative Anxiety and Information score(APAIS). The screening will be done on the day of their surgery in the preoperative holding area. Patients with moderate to high level of preoperative anxiety - defined as a preoperative anxiety score greater than or equal 11 , will be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be eligible for inclusion if they are 18 years old and over, scheduled for elective surgery, can understand English, and can follow instructions. Patients will be excluded if they are scheduled for day surgery; have a history of seizures or motion sickness; or are unable to complete a self-reported questionnaire.

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)
Electronic allocation via an online platform (the REDCap™ randomisation module) will be used to conceal the treatment allocation from the researcher until they have been deemed eligible and screened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to intervention or control via block randomisation on a 1:1 ratio (control: intervention) using a computer-generated random number sequence created by an independent statistician. In addition, randomisation will be stratified by surgery type (i.e. ENT surgery, general surgery, neurosurgery, maxillofacial surgery, urology surgery, vascular surgery, orthopaedics, and other surgeries).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
A two-group parallel Randomised Controlled Trial (RCT) with an allocation ratio of 1:1 will be conducted and reported in accordance with the CONSORT guidelines. A total of 150 patients undergoing elective surgery will be randomised to the control (standard preoperative care) or intervention (standard preoperative care plus VR intervention) groups. The intervention will be delivered using the Oculus Quest 2 Virtual Reality Headset™ fitted with a smartphone. This study will be conducted in the surgical unit of a major Australian metropolitan hospital.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Characteristics of groups will be summarised using counts and percentages for categorical variables and means and standard deviations for continuous variables. The primary outcome will be compared between groups at each follow-up time points using a linear mixed effects regression model, with fixed effects including treatment arm time (categorical), the interaction between treatment and time, and the baseline value of the outcome variable. Differences in mean Visual Analog scale for anxiety(VAS-A) scores between groups at each time point will be presented together with 95% confidence intervals and p-value. Continuous secondary outcomes with repeated measurements will be compared using the same model. Hospital length of stay will be compared using the rank-sum test. Patient satisfaction and the Virtual Reality Symptom Questionnaire (VRSQ) will be compared between groups using an independent sample t-test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/11/2021
Actual
10/11/2021
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
1/11/2022
Actual
Sample size
Target
150
Accrual to date
98
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 38164 0
4029 - Royal Brisbane Hospital
Recruitment outside Australia
Country [1] 23017 0
Saudi Arabia
State/province [1] 23017 0
Jeddah

Funding & Sponsors
Funding source category [1] 306829 0
University
Name [1] 306829 0
The University of Newcastle
Country [1] 306829 0
Australia
Primary sponsor type
University
Name
Umm Al-Qura University
Address
Mecca, Saudi Arabia
PO Box 715
Country
Saudi Arabia
Secondary sponsor category [1] 307388 0
Government body
Name [1] 307388 0
Saudi Arabia Culture Mission
Address [1] 307388 0
16 Watson St, Turner ACT 2612
Country [1] 307388 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306991 0
. The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 306991 0
The university of Newcastle
University Drive
Callaghan NSW 2308
Australia
Ethics committee country [1] 306991 0
Australia
Date submitted for ethics approval [1] 306991 0
28/09/2020
Approval date [1] 306991 0
17/12/2020
Ethics approval number [1] 306991 0
Ethics committee name [2] 311335 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee (RBWH HREC)
Ethics committee address [2] 311335 0
Level 2, Building 34
Royal Brisbane & Women’s Hospital
Butterfield Street, Herston Qld 4029
Australia
Ethics committee country [2] 311335 0
Australia
Date submitted for ethics approval [2] 311335 0
12/04/2021
Approval date [2] 311335 0
21/06/2021
Ethics approval number [2] 311335 0
(HREC/2021/QRBW/74417).

Summary
Brief summary
The purpose of this research is to test if a brief Virtual Reality session reduces anxiety levels in people having elective surgery. Managing anxiety in people having surgery is important because high levels of anxiety can lead to increased pain, surgical infection, poorer wound healing and delayed recovery. Previous research that has used VR has shown that it reduces surgery-related anxiety and leads to better surgical outcomes.

This is a randomised controlled trial which means that participants are randomly allocated to either receive the Virtual Reality session or not.

Everyone who agrees to participate will be asked to:
1- Have heart rate taken at 3 time-point, two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic.

2- Rate your anxiety level on a 100-points scale (zero means you don’t feel anxious, and 100 means you feel extremely anxious) two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic.

3- Provide a saliva sample at 3 time-points to test your stress levels two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. The saliva is taken from your mouth using a cotton swab by yourself, and instruction of use will be provided to you.

4- Rate your pain level on a 100-points scale (zero means you don’t have any pain, and 100 means you feel the worst pain) two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic.

5- Complete a 39 item satisfaction questionnaire before you are discharged from the hospital.

6- Allow the researcher to access your medical record to extract the following information: type of surgery, type of anaesthesia, any medications given before surgery and length of hospital stay.

Those people randomly allocated to receive the Virtual Reality session will be asked to:

1- Use a Virtual Reality device to watch and listen to a nature scene for 5-10 minutes in the waiting area before surgery.

2- Complete a 13 item questionnaire after the virtual reality session asking about any side effects.

Those people randomly allocated to the control group will receive:

1- Routine preoperative care only.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105670 0
Prof Jed Duff
Address 105670 0
Nursing and Midwifery Research Centre | Royal Brisbane and Women’s Hospital

Centre for Clinical Nursing | Building 23, Level 2 | Herston QLD 4029
Country 105670 0
Australia
Phone 105670 0
+61 407 063 138
Fax 105670 0
Email 105670 0
[email protected]
Contact person for public queries
Name 105671 0
Jed Duff
Address 105671 0
Nursing and Midwifery Research Centre | Royal Brisbane and Women’s Hospital

Centre for Clinical Nursing | Building 23, Level 2 | Herston QLD 4029
Country 105671 0
Australia
Phone 105671 0
+61 407 063 138
Fax 105671 0
Email 105671 0
[email protected]
Contact person for scientific queries
Name 105672 0
Jed Duff
Address 105672 0
Nursing and Midwifery Research Centre | Royal Brisbane and Women’s Hospital

Centre for Clinical Nursing | Building 23, Level 2 | Herston QLD 4029
Country 105672 0
Australia
Phone 105672 0
+61 407 063 138
Fax 105672 0
Email 105672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The individual participant data of published results will be shared.
When will data be available (start and end dates)?
The data will be available six months after final data collection for 15 years.
Available to whom?
for participants who wish to receive the result via e-mail.
may presented at a conference or in a scientific publication
Available for what types of analyses?
any purpose.
How or where can data be obtained?
access subject to approvals by Principal Investigator([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9325Study protocol  [email protected] 380653-(Uploaded-29-09-2020-13-52-43)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effectiveness of using virtual reality technology for perioperative anxiety among adults undergoing elective surgery: a randomised controlled trial protocol.2022https://dx.doi.org/10.1186/s13063-022-06908-3
N.B. These documents automatically identified may not have been verified by the study sponsor.