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Trial registered on ANZCTR


Registration number
ACTRN12624001490561p
Ethics application status
Submitted, not yet approved
Date submitted
22/11/2024
Date registered
20/12/2024
Date last updated
20/12/2024
Date data sharing statement initially provided
20/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of immersive virtual reality-based nature exposure on the psychological distress of rehabilitation patients
Scientific title
A randomised controlled trial and process analysis to understand the impact and implementation needs of co-designed immersive virtual reality-based nature exposure to reduce the psychological distress of rehabilitation patients
Secondary ID [1] 313427 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 335829 0
Depression 335830 0
Stress 335831 0
Anxiety 335832 0
Spinal cord injury 335834 0
Condition category
Condition code
Stroke 332405 332405 0 0
Ischaemic
Injuries and Accidents 332406 332406 0 0
Other injuries and accidents
Mental Health 332407 332407 0 0
Anxiety
Mental Health 332408 332408 0 0
Depression
Physical Medicine / Rehabilitation 332409 332409 0 0
Other physical medicine / rehabilitation
Public Health 332410 332410 0 0
Health service research
Stroke 332411 332411 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immersive virtual reality-based nature exposure. Using a fully immersive virtual reality headset, 360 videos of significant local natural locations are displayed to patients in hospital inpatient rehabilitation, with the aim of reducing psychological distress (depression, stress, and anxiety). The local nature is a mixture of green and blue spaces, with audio input. In the virtual world, the patient is at a fixed location, which changes every 30 seconds to 1 minute (pending a co-design process and feedback from focus groups of consumer representatives). There will be scope for patients to choose from available locations to visit during the intervention phase. Adherence will be gauged by usage which will be the patients choice each day. A research nurse assists the patient to put on the headset and start the videos, which are around 4 minutes long (pending a co-design process and feedback from focus groups of consumer representatives). The patient does this once each weekday for 2 weeks, at a quiet and suitable location within the hospital ward. Therefore, the patient can also participate in their standard care (see description in control treatment below).
Intervention code [1] 330016 0
Treatment: Devices
Intervention code [2] 330017 0
Rehabilitation
Comparator / control treatment
Control group takes part in standard care. Standard inpatient neurorehabilitation in Australia is a multidisciplinary program. Patients typically receive care from a team of specialists, including neurologists, physiotherapists, occupational therapists, speech pathologists, psychologists, nurses, and social workers. The focus is on restoring physical, cognitive, and emotional function to maximise independence and quality of life. Rehabilitation programs are tailored to each patient’s specific needs, with therapy sessions held daily.
Control group
Active

Outcomes
Primary outcome [1] 339963 0
Psychological distress in the form of subscales of depression, stress, and anxiety
Timepoint [1] 339963 0
Baseline; immediately following 2 weeks of intervention/control (standard care)
Primary outcome [2] 339964 0
Depression
Timepoint [2] 339964 0
Baseline; immediately following 2-week intervention/control (standard care)
Primary outcome [3] 340174 0
Anxiety
Timepoint [3] 340174 0
Baseline; immediately following 2-week intervention/control (standard care)
Secondary outcome [1] 442103 0
Connection to nature
Timepoint [1] 442103 0
Baseline; immediately following 2-week intervention/control (standard care)
Secondary outcome [2] 442104 0
Attitudes and perceptions of the experience - these two outcomes will be assessed as together through the same assessment methods and analysis.
Timepoint [2] 442104 0
Post the experimental period. All surveys and interviews will aim to be competed within 2-weeks of the end of the experimental period. The preference will be for interviews to be completed on the same day as the final day of exeperimental period to reduce chances of missing data collection through discharge.
Secondary outcome [3] 443172 0
Stress (Primary outcome)
Timepoint [3] 443172 0
Baseline; immediately following 2-week intervention/control (standard care)

Eligibility
Key inclusion criteria
1) Aged 18 and over.
2) Ability to provide informed consent and comprehend the iVR task requirements (University of California Brief Assessment of Capacity to Consent (UCBACC)).
3) Inpatient on the relevant hospital wards
4) Clinically stable (i.e., ready for rehabilitation) as judged by attending clinician.
5) Communication skills sufficient to participate in surveys and report their subjective experiences.
6) Expected discharge date of minimum 2 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for patients
1) Cognitive or emotional instability including delirium, confusion, disorientation, mania; to be assessed by a clinician prior to each stage of research (i.e., PICF, VR testing, and control survey collection).
2) Fever, dry cough, and other COVID symptoms.
3) Familial or personal history of epilepsy, photosensitive epilepsy, or seizures.

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)
An off-site researcher will generate the randomisation order which will then be copied and saved into an excel spreadsheet, printed and put into envelopes, and kept with the off-site researcher. Once a patient provides an on-site researcher with informed consent, the off-site researcher opens the envelope and then emails the research nurse to inform them of the allocated condition (i.e., iVR, Control). It is not possible to blind the patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Between participants simple randomisation will be completed using GraphPad (https://tinyurl.com/3ea94xhk).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To provide an estimated required sample size for patients in the RCT, an a-priori power calculation was conducted in the open-source statistical software G*Power (version 3.1.9.6). Based on our statistically significant finding from the pilot study that there were reduced scores on the DASS-21 for our iVR group, this effect size was used to inform the general strength of the statistical effect (hp2 = .57). However, due to the limited number of studies which report an effect size within this research area, and highly nuanced field-specific nature of typical effect sizes, a large partial eta squared (hp2 = .14) was adopted with a model specified with 80% power (b = .80), alpha of 5% (p < .05) and a moderate correlation on the DV (i.e., DASS-21) between timepoints (r = .50). The calculated sample size is 24 (n = 12 for each condition). To further examine effects by injury type (i.e., SCI, ABI), the total sample size required is 48 (N = 60 accounting for 25% attrition). A total sample size of 60 is feasible, based upon the number of beds in the unit, project timeframes (i.e., 6 months data collection) and eligibility criteria.

Psychological distress measures (DASS-21 and PHQ-8) will be taken before and after the testing period. To examine within-subjects (timepoint: baseline, evaluation) and between-subjects (condition: iVR, control) groups differences, a mixed factorial ANOVA will be conducted arithmetic mean scale scores with t-tests used for post-hoc analyses (i.e., paired samples t-tests by timepoint for each condition, independent samples t-tests by condition at each timepoint). Based on literature which suggest potential moderation and mediation effects on iVR nature efficacy or the restorative effects of nature more generally, multivariate regression techniques will be used to explore potentially influential factors to iVR nature efficacy (e.g., connectedness to nature, feeling of being away from the rehabilitation environment, injury type).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
16/02/2026
Actual
Date of last data collection
Anticipated
2/03/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27357 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 43447 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 317860 0
Government body
Name [1] 317860 0
Motor Accident Insurance Commission (MAIC)
Country [1] 317860 0
Australia
Primary sponsor type
Hospital
Name
Logan Hospital
Address
Country
Australia
Secondary sponsor category [1] 320193 0
University
Name [1] 320193 0
Griffith University
Address [1] 320193 0
Country [1] 320193 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316541 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 316541 0
Ethics committee country [1] 316541 0
Australia
Date submitted for ethics approval [1] 316541 0
16/10/2024
Approval date [1] 316541 0
Ethics approval number [1] 316541 0

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

Contacts
Principal investigator
Name 138210 0
Dr Leslie Gan
Address 138210 0
Geriatrics and Rehabilitation, Logan Hospital, Meadowbrook, Queensland, 4131
Country 138210 0
Australia
Phone 138210 0
+61 07 3089 6523
Fax 138210 0
Email 138210 0
leslie.gan@health.qld.gov.au
Contact person for public queries
Name 138211 0
Michael Norwood
Address 138211 0
N23, Nathan Campus, Nathan, Griffith University, Queensland, 4111
Country 138211 0
Australia
Phone 138211 0
+61 0733821191
Fax 138211 0
Email 138211 0
m.norwood@griffith.edu.au
Contact person for scientific queries
Name 138212 0
Michael Norwood
Address 138212 0
N23, Nathan Campus, Nathan, Griffith University, Queensland, 4111
Country 138212 0
Australia
Phone 138212 0
+61 0733821191
Fax 138212 0
Email 138212 0
m.norwood@griffith.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?
De-identified data. Psychological distress scores, moderation/mediation variables (i.e., inclusion of nature in self), non-identifiable demographic data
When will data be available (start and end dates)?
Immediately following publication - no end date determined
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For meta-analysis and to achieve aims related to the approved proposal
How or where can data be obtained?
By contacting the primary university researcher Michael Norwood at m.norwood@griffith.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



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.