Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000435583
Ethics application status
Approved
Date submitted
16/01/2024
Date registered
9/04/2024
Date last updated
9/04/2024
Date data sharing statement initially provided
9/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual Reality and Savoring to Promote Well-being of Patients With Chronic Respiratory Diseases: a Randomized Controlled Trial
Scientific title
Virtual Reality and Savoring to Promote Well-being of Patients With Chronic Respiratory Diseases: a Randomized Controlled Trial
Secondary ID [1] 311332 0
None
Universal Trial Number (UTN)
Trial acronym
oVeRcomING CRDs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic respiratory diseases 332587 0
emotional well-being 332588 0
psychological well-being 332589 0
Condition category
Condition code
Respiratory 329283 329283 0 0
Other respiratory disorders / diseases
Mental Health 329284 329284 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Together with the 3-week traditional pulmonary rehabilitation in the hospital, the experimental group took part in the VR-based enhanced with savoring intervention. It lasted two weeks and included four 25-minute sessions, with two sessions per week. In each session, the experimental group experienced a 10-minute relaxing virtual scenario using the Oculus Quest 2 headset integrated with a narrative voice. The content of the narrative voiceover was not created specifically for this intervention. Moreover, participants completed a savoring exercise proposed through pre-recorded 5-minute audio after each virtual scenario to consolidate and amplify the positive emotions generated by the VR experience. Sessions usually took place on Mondays and Thursdays, starting in the second week of traditional pulmonary rehabilitation. They were administered by the researchers and occurred one-on-one. Direct observation was used to assess adherence to the intervention. The baseline assessment was done in a separate session earlier to avoid overloading the patients and occurred in the same week as starting the traditional pulmonary rehabilitation.
In each session, participants were asked to sit down in a chair and experience the VR scenario and the following savoring exercise. In the first session, patients explored "the secret garden," guided by a relaxing narrative through a peaceful Japanese garden, including crossing a peaceful pond and passing cherry blossom trees. Following this, participants engaged in a savoring exercise, recalling positive emotions from the VR experience and savoring a positive memory where they felt similar emotions.
The second session involved watching "the waterfall in the prairie," where patients enjoyed the sights and sounds of nature, including colorful flowers, quiet lakes, and distant village voices. After this, they were invited to recall the positive emotions felt in the VR experience and to savor a positive past event shared with a loved one.
In the third session, participants were guided by the narrative voice along "the beach at sunset," observing the beauty of the sand, sea, and sunset hues, accompanied by the soothing sounds of waves and gentle wind. They were then prompted to recall positive emotions felt during the VR experience and imagine and savor a personal place connected to these emotions.
Lastly, in the fourth session, patients chose and experienced their favorite scenario from previous sessions. Following that, they were guided through the exercises completed in the previous sessions to consolidate them.
Intervention code [1] 327777 0
Treatment: Other
Intervention code [2] 327778 0
Rehabilitation
Intervention code [3] 328135 0
Treatment: Devices
Comparator / control treatment
Together with the 3-week traditional pulmonary rehabilitation in the hospital, the active control group listened to relaxing music (with a low pitch and a tempo of 60 to 72 beats per minute) in four 25-minute sessions, with two sessions per week. The music was selected from previous studies that have already used it with patients with chronic respiratory diseases, and it varied for each session. Sessions usually took place on Mondays and Thursdays, starting in the second week of traditional pulmonary rehabilitation. They were administered by the researchers and occurred one-on-one. Direct observation was used to assess adherence to the intervention. The baseline assessment was done in a separate session earlier to avoid overloading the patients and occurred in the same week as starting the traditional pulmonary rehabilitation.
Control group
Active

Outcomes
Primary outcome [1] 337103 0
Emotional well-being and psychological well-being
Timepoint [1] 337103 0
Baseline (T0), immediately after the completion of all four sessions (T1, primary timepoint), and in the one-month follow-up (T2) for both groups
Primary outcome [2] 337105 0
Positive affect and negative affect
Timepoint [2] 337105 0
Baseline (T0), immediately after the completion of all four sessions (T1, primary timepoint), and in the one-month follow-up (T2) for both groups
Primary outcome [3] 337106 0
Relaxation
Timepoint [3] 337106 0
Baseline (T0), immediately after the completion of all four sessions (T1, primary timepoint), and in the one-month follow-up (T2) for both groups
Secondary outcome [1] 430726 0
Sense of presence in the virtual environment
Timepoint [1] 430726 0
Immediately after the completion of all four sessions (T1)
Secondary outcome [2] 430727 0
VR acceptance
Timepoint [2] 430727 0
Immediately after the completion of all four sessions (T1)
Secondary outcome [3] 432461 0
Relaxation
Timepoint [3] 432461 0
Immediately before and after each of the four sessions
Secondary outcome [4] 432462 0
Peripheral oxygen saturation (SpO2)
Timepoint [4] 432462 0
Immediately before and after each of the four sessions

Eligibility
Key inclusion criteria
- Age 18 years and over
- A diagnosis of chronic respiratory disease according to European Respiratory Society (ERS)/American Thoracic Society (ATS) criteria
- Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of dementia or cognitive impairment reported within the medical records
- Mini Mental State Examination score of < 26
- Pre-existing medical conditions that preclude the use of the Oculus Quest 2 headset, such as (1) the presence of binocular vision abnormalities, (2) a positive history of seizures and epileptic conditions, (3) the presence of cardiac pacemakers, defibrillators, or implanted devices, and (4) the presence of hearing aids

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization. A label of A or B (A=intervention, B=control) was assigned to each group (block size=4). Free online software (Research Randomizer 4.0) was used to generate the randomization list.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/01/2023
Date of last participant enrolment
Anticipated
Actual
31/07/2023
Date of last data collection
Anticipated
Actual
15/09/2023
Sample size
Target
46
Accrual to date
Final
52
Recruitment outside Australia
Country [1] 26081 0
Italy
State/province [1] 26081 0

Funding & Sponsors
Funding source category [1] 315589 0
Hospital
Name [1] 315589 0
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) INRCA (Italian National Research Centre on Aging) Casatenovo
Country [1] 315589 0
Italy
Funding source category [2] 315591 0
University
Name [2] 315591 0
Università Cattolica del Sacro Cuore di Milano
Country [2] 315591 0
Italy
Primary sponsor type
Hospital
Name
IRCCS INRCA (Italian National Research Centre on Aging) Casatenovo
Address
Via Monteregio 13, Casatenovo, 23880, Lecco
Country
Italy
Secondary sponsor category [1] 317682 0
University
Name [1] 317682 0
Università Cattolica del Sacro Cuore di Milano
Address [1] 317682 0
Largo Gemelli 1, 20123, Milano
Country [1] 317682 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314481 0
Comitato Etico INRCA
Ethics committee address [1] 314481 0
Ethics committee country [1] 314481 0
Italy
Date submitted for ethics approval [1] 314481 0
22/12/2022
Approval date [1] 314481 0
19/01/2023
Ethics approval number [1] 314481 0
3739_2023

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

Contacts
Principal investigator
Name 131738 0
Mrs Alessia Fumagalli
Address 131738 0
IRCCS INRCA Casatenovo, Via Monteregio, 13, 23880 Casatenovo, Lecco
Country 131738 0
Italy
Phone 131738 0
+39 3468298601
Fax 131738 0
Email 131738 0
[email protected]
Contact person for public queries
Name 131739 0
Elisa Pancini
Address 131739 0
Università Cattolica del Sacro Cuore di Milano, Largo Gemelli 1, 20123, Milano
Country 131739 0
Italy
Phone 131739 0
+39 0272342585
Fax 131739 0
Email 131739 0
[email protected]
Contact person for scientific queries
Name 131740 0
Elisa Pancini
Address 131740 0
Università Cattolica del Sacro Cuore di Milano, Largo Gemelli 1, 20123, Milano
Country 131740 0
Italy
Phone 131740 0
+39 0272342585
Fax 131740 0
Email 131740 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


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.