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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Periopearative Anxiety

Surgery-related Anxiety

Condition category

Condition code

Surgery

Other surgery

Mental Health

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]

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]

Perioperative anxiety as measured by Visual Analog Scale for Anxiety (VAS-A).

Timepoint [1]

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]

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]

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]

2. Postoperative Pain as measured by Visual Analog Scale for Pain (VAS-P).

Timepoint [2]

two-time points
On admission to the preoperative area (T1), and one hour after surgery (T3)

Secondary outcome [3]

3- Patient satisfaction as measured by the Leiden Perioperative Patient Satisfaction questionnaire (LPPSq).

Timepoint [3]

one-time point
24 hours after surgery before they are discharged (T4)

Secondary outcome [4]

4- Hospital Length of Stay ( from patient medical records).

Timepoint [4]

one-time point (at hospital discharge).

Secondary outcome [5]

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]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Recruitment outside Australia

Country [1]

Saudi Arabia

State/province [1]

Jeddah

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Newcastle

Address [1]

University Dr, Callaghan NSW 2308

Country [1]

Australia

Primary sponsor type

University

Name

Umm Al-Qura University

Address

Mecca, Saudi Arabia
PO Box 715

Country

Saudi Arabia

Secondary sponsor category [1]

Government body

Name [1]

Saudi Arabia Culture Mission

Address [1]

16 Watson St, Turner ACT 2612

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

. The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

The university of Newcastle 
University Drive
Callaghan NSW 2308
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/09/2020

Approval date [1]

17/12/2020

Ethics approval number [1]

Ethics committee name [2]

Royal Brisbane & Women's Hospital Human Research Ethics Committee (RBWH HREC)

Ethics committee address [2]

 Level 2, Building 34
Royal Brisbane & Women’s Hospital
Butterfield Street, Herston Qld 4029
Australia

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

12/04/2021

Approval date [2]

21/06/2021

Ethics approval number [2]

(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

Prof Jed Duff

Address

Nursing and Midwifery Research Centre | Royal Brisbane and Women’s Hospital

Centre for Clinical Nursing | Building 23, Level 2 | Herston QLD 4029

Country

Australia

Phone

+61 407 063 138

Fax

j2.duff@qut.edu.au

Contact person for public queries

Name

Jed Duff

Address

Nursing and Midwifery Research Centre | Royal Brisbane and Women’s Hospital

Centre for Clinical Nursing | Building 23, Level 2 | Herston QLD 4029

Country

Australia

Phone

+61 407 063 138

Fax

j2.duff@qut.edu.au

Contact person for scientific queries

Name

Jed Duff

Address

Nursing and Midwifery Research Centre | Royal Brisbane and Women’s Hospital

Centre for Clinical Nursing | Building 23, Level 2 | Herston QLD 4029

Country

Australia

Phone

+61 407 063 138

Fax

j2.duff@qut.edu.au

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(Jed.duff@newcastle.edu.au)

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9325	Study protocol			Salihah.asiri@uon.edu.au		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

Source	Title	Year of Publication	DOI
Embase	The effectiveness of using virtual reality technology for perioperative anxiety among adults undergoing elective surgery: a randomised controlled trial protocol.	2022	https://dx.doi.org/10.1186/s13063-022-06908-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

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