Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000693426p
Ethics application status
Submitted, not yet approved
Date submitted
12/06/2025
Date registered
1/07/2025
Date last updated
20/07/2025
Date data sharing statement initially provided
1/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Virtual Reality Intervention for Older Adults Living in Aged Residential Care Facilities
Scientific title
Pilot Study Assessing whether an Immersive Nature Virtual Reality Experience Improves Psychological and Physical Well-Being for Older Adults Residing in Aged Residential Care Facilities.
Secondary ID [1] 314469 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Existential distress 337505 0
Depression 337506 0
Anxiety 337778 0
Spiritual well-being 337779 0
Somatic symptoms 337780 0
Condition category
Condition code
Mental Health 333872 333872 0 0
Other mental health disorders
Mental Health 334122 334122 0 0
Depression
Mental Health 334123 334123 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will all experience the same 10-minute nature-based virtual reality session conducted in person at each individual’s rest home facility. They will be fitted with a Meta Quest 3 headset to wear for the 10-minute duration. The VR experience features footage of New Zealand nature scenes accompanied by meditative music blended with the natural sounds of each scene. This footage can be accessed on youtube (https://www.youtube.com/watch?v=pEO4my44oqw). Prior to the VR experience, participants will complete a 40-minute baseline questionnaire and via an iPad watch a 4-minute pre-recorded video introducing and encouraging the experience of awe. Immediately following the VR session, a follow-up questionnaire taking approximately 30 minutes will be completed. Finally, one week later, the final follow-up questionnaire will be completed, taking 35 minutes either in-person or online. The session will be conducted by the student researcher completing her thesis in Health Psychology. The VR experience will be conducted with participants either seated in a sturdy chair or in bed in a sitting-up position. The intervention will be delivered face to face to each participant individually. Adherence to the VR experience will be monitored by direct observation from the researcher.
Intervention code [1] 331092 0
Treatment: Other
Intervention code [2] 331334 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341501 0
Acceptability of study procedures and virtual reality intervention. This will be assessed as a composite outcome.
Timepoint [1] 341501 0
Interviews will be completed at three time points, baseline (T1), immediately post-intervention (T2), and one week post-intervention (T3). Analyses will occur at the completion of all interviews.
Primary outcome [2] 342238 0
Feasibility of the study procedures and virtual reality intervention. This will be assessed as a composite outcome.
Timepoint [2] 342238 0
Analysis will occur at completion of the project.
Secondary outcome [1] 447786 0
Changes in depression.
Timepoint [1] 447786 0
Baseline, immediately after the VR session, and 7 days post.
Secondary outcome [2] 447787 0
Changes in spiritual well-being.
Timepoint [2] 447787 0
Baseline, immediately after the VR session, and 7 days post.
Secondary outcome [3] 448642 0
Change in somatic symptoms.
Timepoint [3] 448642 0
Baseline, and 7 days post the VR session.
Secondary outcome [4] 449027 0
Changes in anxiety.
Timepoint [4] 449027 0
Baseline, immediately after the VR session, and 7 days post.

Eligibility
Key inclusion criteria
Key inclusion criteria are (a) participants are aged 65 years and older, and (b) participants are residing within a residential care facility (rest home setting).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria are (a) participants have a cognitive, visual, or hearing impairment that would limit their ability to provide informed consent, answer questionnaires, and use virtual reality technology, (b) participants have a history of significant motion sickness, current nausea, or are physically unable to tolerate wearing the virtual reality headset for a minimum of a 10-minute duration, and (c) participants are unable to read or speak in English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 25 participants is considered appropriate to assess feasibility and acceptability, and to provide a preliminary indication of intervention effects. This sample size should provide sufficient power to detect a medium effect size for changes between baseline (T1), immediately post-intervention (T2), and one-week follow-up (T3) using a factorial repeated measures within-subject ANOVA analysis.

Descriptive statistics will be used to assess feasibility outcomes, including recruitment, retention, intervention adherence, safety, and data completeness. SPSS software will be used for quantitative analyses. Changes in well-being outcomes (connectedness, spiritual well-being, depression, anxiety, and somatic symptom burden) across three time points (baseline, post-intervention, and one-week follow-up) will be analyzed using repeated measures ANOVA and paired t-tests, with appropriate corrections or non-parametric alternatives applied as needed. Qualitative interview data will be analyzed using directed content analysis based on the Theoretical Framework of Acceptability (TFA) domains.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 27067 0
New Zealand
State/province [1] 27067 0
Waikato

Funding & Sponsors
Funding source category [1] 319006 0
University
Name [1] 319006 0
University of Auckland
Country [1] 319006 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 321472 0
None
Name [1] 321472 0
Address [1] 321472 0
Country [1] 321472 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317619 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 317619 0
Ethics committee country [1] 317619 0
New Zealand
Date submitted for ethics approval [1] 317619 0
15/04/2025
Approval date [1] 317619 0
Ethics approval number [1] 317619 0

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

Contacts
Principal investigator
Name 141586 0
Miss Sophie Mihaljevich
Address 141586 0
Department of Psychological Medicine Level 12, Room 12.101 Support Building Auckland City Hospital 2 Park Road Grafton Auckland 1023, New Zealand
Country 141586 0
New Zealand
Phone 141586 0
+64 0274420993
Fax 141586 0
Email 141586 0
[email protected]
Contact person for public queries
Name 141587 0
Sophie Mihaljevich
Address 141587 0
Department of Psychological Medicine Level 12, Room 12.101 Support Building Auckland City Hospital 2 Park Road Grafton Auckland 1023, New Zealand
Country 141587 0
New Zealand
Phone 141587 0
+64 0274420993
Fax 141587 0
Email 141587 0
[email protected]
Contact person for scientific queries
Name 141588 0
Sophie Mihaljevich
Address 141588 0
Department of Psychological Medicine Level 12, Room 12.101 Support Building Auckland City Hospital 2 Park Road Grafton Auckland 1023, New Zealand
Country 141588 0
New Zealand
Phone 141588 0
+64 0274420993
Fax 141588 0
Email 141588 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 6 years
Where can requests to access individual participant data be made, or data be obtained directly?
• By contacting researcher Dr. Lisa Reynolds [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    Informed Consent Form AHREC.pdf
Study protocol    Study Protocol Pilot VR AHREC.pdf


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.