Trial Review

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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
ACTRN12624000660583
Ethics application status
Approved
Date submitted
3/04/2024
Date registered
22/05/2024
Date last updated
22/05/2024
Date data sharing statement initially provided
22/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual therapy and yoga training in parents of children diagnosed with cancer
Scientific title
The effects of virtual therapy and yoga training on the quality of life, depression, anxiety, physical activity and sleep quality of parents of children diagnosed with cancer
Secondary ID [1] 311830 0
Nil known
Universal Trial Number (UTN)
U1111-1306-1579
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 333360 0
Quality of life 333743 0
Quality of sleep 333744 0
Depression 333745 0
Anxiety 333746 0
Condition category
Condition code
Mental Health 330043 330043 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 330044 330044 0 0
Depression
Mental Health 330430 330430 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research will be carried out on a group of parents of children diagnosed with lymphoblastic leukemia staying in Przyladek Nadziei in Wroclaw. The subjects will be randomly assigned to a group: with an intervention in the form of virtual therapy, yoga training and a control group.
Virtual therapy using the VRTierOne system will be conducted in Przyladek Nadzei. The program assumes 8 sessions performed in the shortest possible time, which in practice translates into a period of 2-3 weeks. Sessions can take place maximum once a day. The length of the session increases gradually from 5 to 20 minutes of stay in virtual reality. The entire session is conducted in virtual reality. The therapist conducts therapy by talking to them via the VR headset. Participants can't see the therapist. The therapy is not tailored to the participant. It is the same for everyone. A research team trained in the use of the equipment will accompany subjects during each session. Sessions are held in the form of individual meetings, in a room excluded from use for purposes other than scientific and therapeutic during the research period. The session starts with putting on virtual reality (VR) goggles with headphones. After starting the session, the patient is always in the same virtual environment (garden) with various plants, a stone path and a watering can. In some sessions, there is also a mandala drawing, which is filled in with colors by the participant (according to voice instructions). Participant listens to the voice of the therapist conducting therapy in the Ericksonian style, tips on coloring mandala and the sounds of birds. The research team will keep a document containing information about the number of sessions completed, participants' resignation from the study, data necessary to arrange subsequent meetings and an individual code allowing the participant to be identified via VR. After entering the individual code into VR, it recognizes the patient and suggests starting the next session (remembers which session number was last played for a given person).
Yoga training will be conducted by an instructor in a park near the center. They will be held 4 times a week so that parents can participate on the day that suits them best. Each training unit of moderate intensity will last 60 minutes. The intensity of physical exercise during training will be assessed using the Borg scale. The yoga instructor will keep a list of participants' attendance at ech session. The duration of the intervention will be 4 weeks, with a total of 8 meetings. This will be hatha yoga suitable for beginners. Examples of positions used during training: Auspicious Pose (Swastikasana), Cow Face Pose (Gomukhasana), Hero Pose (Virasana) and Lotus Pose (Padmasana). Staying in each position is associated with deep breathing.
Intervention code [1] 328283 0
Prevention
Intervention code [2] 328284 0
Lifestyle
Intervention code [3] 328550 0
Behaviour
Comparator / control treatment
People from control group will also be parents of children diagnosed with lymphoblastic leukemia. They won't get virtual therapy or yoga training as a part of experiment. They will be tested as experimental groups.
Control group
Active

Outcomes
Primary outcome [1] 337803 0
Quality of life
Timepoint [1] 337803 0
Baseline, 2/3 weeks (primary endpoint), 6/7 weeks post-enrollment
Primary outcome [2] 337804 0
Trait anxiety
Timepoint [2] 337804 0
Baseline, 2/3 weeks (primary endpoint), 6/7 weeks post-enrollment
Primary outcome [3] 337805 0
Depression
Timepoint [3] 337805 0
Baseline, 2/3 weeks (primary endpoint), 6/7 weeks post-enrollment
Secondary outcome [1] 433362 0
Quality of sleep
Timepoint [1] 433362 0
Baseline, 2/3 weeks, 6/7 weeks post-enrollment
Secondary outcome [2] 433363 0
Health-related physical activity
Timepoint [2] 433363 0
Baseline, 2/3 weeks, 6/7 weeks post-enrollment
Secondary outcome [3] 433364 0
Daily physical activity
Timepoint [3] 433364 0
Baseline: 168 hours continuous measurement (prior to intervention) 2/3 weeks post-baseline (after completing the intervention): 168 hours continuous measurement

Eligibility
Key inclusion criteria
Voluntary, informed consent to participate in research and publication of results, child undergoing oncological treatment (lymphoblastic leukemia), no contraindications to physical activity.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious chronic diseases and psychiatric treatment in the phase of increasing the dose of the drug.

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 a computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/03/2024
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
100
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 26231 0
Poland
State/province [1] 26231 0
Lower Silesia

Funding & Sponsors
Funding source category [1] 316171 0
University
Name [1] 316171 0
Wroclaw University of Health and Sport Sciences
Country [1] 316171 0
Poland
Primary sponsor type
University
Name
Wroclaw Univeristy of Health and Sport Sciences
Address
Country
Poland
Secondary sponsor category [1] 318406 0
Individual
Name [1] 318406 0
Wroclaw Univeristy of Health and Sport Sciences, Iwona Malicka - promoter
Address [1] 318406 0
Country [1] 318406 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314995 0
Ethical Committee of the University School of Physical Education in Wroclaw
Ethics committee address [1] 314995 0
Ethics committee country [1] 314995 0
Poland
Date submitted for ethics approval [1] 314995 0
26/07/2023
Approval date [1] 314995 0
29/09/2023
Ethics approval number [1] 314995 0
23/2023

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

Contacts
Principal investigator
Name 133362 0
Ms Aleksandra Dabrowska
Address 133362 0
Wroclaw University of Health and Sport Sciences al. I. J. Paderewskiego 35, 51-612 Poland
Country 133362 0
Poland
Phone 133362 0
+48 531419253
Fax 133362 0
Email 133362 0
[email protected]
Contact person for public queries
Name 133363 0
Aleksandra Dabrowska
Address 133363 0
Wroclaw University of Health and Sport Sciences al. I. J. Paderewskiego 35, 51-612 Poland
Country 133363 0
Poland
Phone 133363 0
+48 531419253
Fax 133363 0
Email 133363 0
[email protected]
Contact person for scientific queries
Name 133364 0
Aleksandra Dabrowska
Address 133364 0
Wroclaw University of Health and Sport Sciences al. I. J. Paderewskiego 35, 51-612 Poland
Country 133364 0
Poland
Phone 133364 0
+48 531419253
Fax 133364 0
Email 133364 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:
• Only for researchers who provide a methodologically sound proposal.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Only the overall, statistically information (e.g. sample mean age, BMI, gender, etc.) as well as the questionnaire results (anonymous). Also, all questionnaires are named by participants code, not personal data.

What types of analyses could be done with individual participant data?
• Any purpose.

When can requests for individual participant data be made (start and end dates)?
From:
Only on request. Start date

To:
after analysis, end date - not determined.

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected]).

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


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.