Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 307555 0
None
Universal Trial Number (UTN)
Trial acronym
VrROOM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perceived stress 326995 0
Condition category
Condition code
Mental Health 324182 324182 0 0
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] 324016 0
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] 331994 0
Mental fatigue and workload using the NASA-TLX ( NASA Task Load Index) score will be measured
Timepoint [1] 331994 0
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] 411858 0
Perceived stress scale (PSS)-10
Timepoint [1] 411858 0
At start and end of shift for the duration of this study (4 weeks)
Secondary outcome [2] 411901 0
Multi-dimensional Fatigue Inventory (MFI-20)
Timepoint [2] 411901 0
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
33
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22799 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [2] 22800 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 38085 0
6008 - Subiaco
Recruitment postcode(s) [2] 38086 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 311829 0
Hospital
Name [1] 311829 0
King Edward Memorial Hospital
Country [1] 311829 0
Australia
Funding source category [2] 311865 0
Hospital
Name [2] 311865 0
Perth Children's Hospital
Country [2] 311865 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital
Address
374 Bagot road, Subiaco, Western Australia, 6008
Country
Australia
Secondary sponsor category [1] 313303 0
None
Name [1] 313303 0
None
Address [1] 313303 0
Not applicable
Country [1] 313303 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311272 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 311272 0
Ethics committee country [1] 311272 0
Australia
Date submitted for ethics approval [1] 311272 0
21/07/2022
Approval date [1] 311272 0
01/05/2023
Ethics approval number [1] 311272 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120526 0
Dr Gayatri Jape
Address 120526 0
Neonatal directorate
King Edward Memorial Hospital
374 Bagot road, Subiaco, WA, 6008
Country 120526 0
Australia
Phone 120526 0
+61413441501
Fax 120526 0
Email 120526 0
[email protected]
Contact person for public queries
Name 120527 0
Saumil Desai
Address 120527 0
King Edward Memorial Hospital
374 Bagot road, Subiaco, WA, 6008
Country 120527 0
Australia
Phone 120527 0
+61435170113
Fax 120527 0
Email 120527 0
[email protected]
Contact person for scientific queries
Name 120528 0
Gayatri Jape
Address 120528 0
Neonatal directorate
King Edward Memorial Hospital
374 Bagot road, Subiaco, WA, 6008
Country 120528 0
Australia
Phone 120528 0
+61413441501
Fax 120528 0
Email 120528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
16610Study protocol  [email protected] 384367-(Uploaded-13-07-2022-13-48-17)-Study-related document.docx
16611Informed 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.