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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05617638




Registration number
NCT05617638
Ethics application status
Date submitted
8/11/2022
Date registered
15/11/2022

Titles & IDs
Public title
Impact of Virtual Reality (e-Nature VR) During Hospitalization in Adult Intensive Care Unit
Scientific title
Impact of Virtual Reality (e-Nature VR) During Hospitalization in Adult Intensive Care Unit
Secondary ID [1] 0 0
e-Nature VR - ICU
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Intervention

No intervention: Control Group - The control group will not have access to VR.

Active comparator: Intervention Group - Participants in the intervention group will use VR for 20 minutes for 2 consecutive days.


BEHAVIORAL: Intervention
Participants will watch nature images in virtual reality from the e-Natureza VR Database for 20 minutes for 2 consecutive days.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline Oxygen Saturation Percentage at post intervention.
Timepoint [1] 0 0
Immediately post-intervention for 2 consecutive days.
Primary outcome [2] 0 0
Change from Baseline Blood Pressure Values at post intervention.
Timepoint [2] 0 0
Immediately post-intervention for 2 consecutive days.
Primary outcome [3] 0 0
Change from Baseline Respiratory Rate Values at pos intervention.
Timepoint [3] 0 0
Immediately post-intervention for 2 consecutive days.
Primary outcome [4] 0 0
Change from Baseline Heart Rate Values at pos intervention.
Timepoint [4] 0 0
Immediately post-intervention for 2 consecutive days.
Primary outcome [5] 0 0
Change from Baseline Pain Perception at pos intervention.
Timepoint [5] 0 0
Immediately post-intervention for 2 consecutive days.
Primary outcome [6] 0 0
Change from Baseline Affective States pos intervention.
Timepoint [6] 0 0
Immediately post-intervention for 2 consecutive days.
Secondary outcome [1] 0 0
Change in length of stay in the intensive care unit pos intervention
Timepoint [1] 0 0
Immediately post-intervention for 2 consecutive days.

Eligibility
Key inclusion criteria
* individuals of both sexes;
* without communication, vision, hearing or intellectual disabilities;
* capable of mental to fill in the questionnaires;
* who watch at least 5 minutes of the video, minimum physiological immersion time.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* use of sedatives;
* those who experience considerable discomfort possibly caused by virtual reality such as nausea, dizziness or headache, with a history of vertigo, nausea, vomiting;
* convulsion, labyrinthitis, epilepsy, dementia, mental confusion, psychomotor agitation;
* claustrophobia or expressing a desire to discontinue the study;
* patients who use anticholinergic drugs (antipsychotics and benzodiazepines);
* delirium;
* clinical worsening.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
São Paulo

Funding & Sponsors
Primary sponsor type
Other
Name
Hospital Israelita Albert Einstein
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Beneficência Portuguesa de São Paulo
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Eliseth R Leão, PhD
Address 0 0
Hospital Israelita Albert Einstein
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05617638