ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001012763

Ethics application status

Approved

Date submitted

13/07/2022

Date registered

19/07/2022

Date last updated

15/09/2024

Date data sharing statement initially provided

19/07/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of Virtual Reality on Perceived Stress in Neonatal Intensive Care Staff

Scientific title

Effect of using Virtual Reality on Perceived Stress in Neonatal Intensive Care Staff: A Randomized Controlled trial (Virtual Reality fOr Our Minds (VrROOM) Study)

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

VrROOM

Linked study record

Health condition

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

Perceived stress

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be exposed to either virtual relaxation (VR) in the first period, followed by no VR in the second treatment period, or no VR in the first period, followed by VR in the second period.
The participant shall be directed to the respective rooms labelled as intervention or control by a facilitator depending on the allocation.
Participants in the VR immersion (intervention group) will wear the VR headset (Meta Quest 2) and choose one of the following apps: scenic walk, meditation with relaxing music or physical activity (eg: virtual tennis) based on their preferences in a specific room allocated for the study. Considering the short break times during high acuity workload, the participants will experience VR relaxation for 10 minutes per session; and only one session for the duration of their shift. They will be eligible to receive a maximum of 3 sessions per week over the intervention period of 2 weeks. Participants in the control group will have routine breaks without the VR experience.
The enrolled participants will undergo a washout period of two weeks during which they will not be assessed for their stress levels. As part of the crossover design, the participants in the intervention arm shall then be switched over to the control arm and those in the control arm shall then switch over to the intervention arm. They will then be assessed for stress using the same scales and time points as specified for the same shift pattern as in the previous arm.

Intervention code [1]

Treatment: Other

Comparator / control treatment

There will be a two week washout period and the control and intervention groups will swap over since this is a crossover design.
Routine break during shifts with no exposure to VR

Control group

Active

Outcomes

Primary outcome [1]

Mental fatigue and workload using the NASA-TLX ( NASA Task Load Index) score will be measured

Timepoint [1]

Participants will be asked to complete the NASA Task Load Index (NASA-TLX) at the start of their shift (T1) and at the end of their shift (T4) throughout the duration of this study (4 weeks)

Secondary outcome [1]

Perceived stress scale (PSS)-10

Timepoint [1]

At start and end of shift for the duration of this study (4 weeks)

Secondary outcome [2]

Multi-dimensional Fatigue Inventory (MFI-20)

Timepoint [2]

At the start and end of shift for the duration of this study (4 weeks)

Eligibility

Key inclusion criteria

All healthcare providers (HCPs) in the tertiary NICU irrespective of their duration of employment or shift type (day/ night) or shift duration.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

HCPs with photosensitive epilepsy or significant cardiopulmonary disease will be excluded from the study.

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)

Opaque sealed envelope used for allocation concealment

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Using a computer generated randomisation sequence

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

With no prior estimate of within-subject variance available for this study, a standardised approach has been used in the power calculation. There is a total of 73 HCP’s (56 nurses and 17 junior doctors) rostered daily across the three sites. We expect approximately 50 HCP’s to agree to participate in the study. A sample size of 25 in each sequence group (AB/BA) gives 80% power to detect a standardised mean difference of 0.6 using a 2x2 crossover design t-test with a 0.05 two-sided significance level. Based on an expected mean NASA score of 49 and standard deviation of 18, this would equate to an absolute difference of 10.8 (0.6*18) or an approximate 20% decrease in NASA score from 49 to 38. The mean NASA score of 49 and standard deviation of 18 was derived from the recent meta-analysis done by Hertzum. This calculation incorporates sample size inflation for an expected dropout rate of 10%. The sample size calculation was performed with Power and Sample Size (PASS) software (PASS 2019 Power Analysis and Sample Size Software (2019). NCSS, LLC. Kaysville, Utah, USA).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

12/09/2023

Actual

12/09/2024

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

King Edward Memorial Hospital - Subiaco

Recruitment hospital [2]

Perth Children's Hospital - Nedlands

Recruitment postcode(s) [1]

6008 - Subiaco

Recruitment postcode(s) [2]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

King Edward Memorial Hospital

Address [1]

374 Bagot road, Subiaco, WA, 6008

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Perth Children's Hospital

Address [2]

15 Monash avenue, Nedlands, WA, 6009

Country [2]

Australia

Primary sponsor type

Hospital

Name

King Edward Memorial Hospital

Address

374 Bagot road, Subiaco, Western Australia, 6008

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Not applicable

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Child and Adolescent Health Service Human Research Ethics Committee

Ethics committee address [1]

Perth Children's Hospital
15 Hospital avenue, Nedlands, WA, 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/07/2022

Approval date [1]

01/05/2023

Ethics approval number [1]

Summary

Brief summary

Health care professionals (HCP) working in neonatal intensive care units (NICUs) experience high levels of physical and psychological stress. Nijland and colleagues investigated the ease of use and immediate effect of virtual reality relaxation/ VRRelax (360º immersive environments) to reduce perceived stress in intensive care nurses. After using VRelax, stress levels decreased by 40% and 62% of the ICU nurses thought VRelax was helpful in reducing stress. This study concluded that VR is easy to use and is an effective intervention to reduce immediate stress in ICU nurses. Given these potential benefits, we aim to conduct a pilot study to examine the use of VR to reduce perceived stress in our neonatal intensive care staff during their work shifts.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Gayatri Jape

Address

Neonatal directorate
King Edward Memorial Hospital
374 Bagot road, Subiaco, WA, 6008

Country

Australia

Phone

+61413441501

Fax

gayatri.jape@health.wa.gov.au

Contact person for public queries

Name

Saumil Desai

Address

King Edward Memorial Hospital
374 Bagot road, Subiaco, WA, 6008

Country

Australia

Phone

+61435170113

Fax

saumil.desai@health.wa.gov.au

Contact person for scientific queries

Name

Gayatri Jape

Address

Neonatal directorate
King Edward Memorial Hospital
374 Bagot road, Subiaco, WA, 6008

Country

Australia

Phone

+61413441501

Fax

gayatri.jape@health.wa.gov.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

The team is yet undecided regarding data sharing and this may change depending on the recruitment and response

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16610	Study protocol			saumil.desai@health.wa.gov.au		384367-(Uploaded-13-07-2022-13-48-17)-Study-related document.docx
16611	Informed consent form					384367-(Uploaded-13-07-2022-13-48-54)-Study-related document.docx

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.

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