Occupational StressPPCVRNCT06247618
Virtual Reality for Pediatric Palliative Care Team
A study testing visor in people with Occupational Stress, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
Is virtual reality a useful and usable tool to improve the psychological well-being of PPC operators? study primary obtv: assessment of occupational psychological well-being (divided into stress, depression, anxiety and risk of burnout) in the population of health professionals working in pediatric palliative care… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress
- What is being tested?
- visor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 7 Sep 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- work within the pediatric hospice of Padua
- Absence of neurological pathologies
- personnel who actively engage in membership/participation during all 4 weeks of the project
Who cannot join
- Subject do not sign written consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Hospice Pediatrico- Azienda Ospedale Università Padova
Padova, PD, 35126
About this study
Official title: Virtual Reality as a Tool to Promote Healthcare Providers Wellbeing in Pediatric Palliative Care
Is virtual reality a useful and usable tool to improve the psychological well-being of PPC operators? study primary obtv: assessment of occupational psychological well-being (divided into stress, depression, anxiety and risk of burnout) in the population of health professionals working in pediatric palliative care; verify if the virtual reality tool leads to an improvement change at the level of the investigated items (feasibility study). The treatment will have a duration of 4 weeks, with the execution of two sessions per week with the use of a viewer positioned on the head that allows users to navigate and interact in real time with a three-dimensional (3D) environment At time zero (T0), the participants will be administered, shortly before the application of virtual reality, the Mini-Z survey 2.0 questionnaires (the single item burnout question), Depression Anxiety Stress Scales 21 (DASS-21), and a demographic questionnaire (gender, age, profession, shift work, years of work in PPCs). At the end of the compilation, two vision treatments will follow, which will take place three to four days apart.
At time T1 (second week) and time T2 (third week) the DASS-21 will initially be administered followed by two weekly treatments with a visor. At the end (T3) the compilation of both tests (Mini-Z survey 2.0-the single item burnout question and the DASS-21) will be repeated following the last two applications of the viewer.
- Conditions
- Occupational Stress
- Being tested
- visor
- Keywords
- virtual reality, pediatric palliative care, anxiety, burnout
- Medical subject headings
- Occupational Stress, Anxiety Disorders, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visorDevice
The treatment will have a duration of 4 weeks, with the execution of two sessions per week with the use of a viewer positioned on the head that allows users to navigate and interact in real time with a three-dimensional (3D) environment
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Not described Receives: Device: visor |
What is being measured
The primary outcome is the main question the study is designed to answer.
the psychological well-being of healthcare providers: risk of burnout
- Mini-Z Survey 2.0 (single-item): examines the risk of burnout among healthcare provides, particularly The Mini-Z responds to the goal of framing/identifying the burnout risk of workers on the pediatric palliative care team. , it was analysed frequencies and percentages of burnout risk based on the analysis criteria identifiable in Nagasaki et al. 2022 (1- "In Total burnout"; 2-"Always has burnout symptoms the burnout symptoms I perceive are persistent"; 3-"Beginning of burnout"; 4-"Under stress"; 5-"Never felt in Burnout").
Measured: Data collection lasted for four weeks
the psychological well-being of healthcare providers: anxiety, depression and stress
- DASS-21(the Depression Anxiety Stress Scales 21) DASS-21 is a psychometric self-assessment test, derived from the Depression Anxiety Stress Scales [22], detecting three constructs: anxiety, depression and stress. It is measured by 21 items on a 4-point Likert scale (from "0-Not at all applies to me" to "3-It applies a lot or most of the time to me"). Cronbach's alpha of .80 is very good evidence of the high reliability of the tool's content.
Measured: Data collection lasted for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start7 Sep 2023
- Primary completion10 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Marinetto, RN, Azienda Ospedaliera di Padova
- Investigators
- Zanin, Principal investigator, Azienda Ospedale-Università Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247618
- Sponsor's protocol ID
- ppcVirtualReality
- Acronym
- PPCVR
- Status last verified
- Jan 2024
- First submitted
- 7 Sep 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Tool to Promote Healthcare Providers Wellbeing in Pediatric Palliative Care
- ClinicalTrials.gov ID
- NCT06247618
- Acronym / sponsor ID
- PPCVR / ppcVirtualReality
- Conditions
- Occupational Stress
- Keywords
- virtual reality, pediatric palliative care, anxiety, burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Is virtual reality a useful and usable tool to improve the psychological well-being of PPC operators? study primary obtv: assessment of occupational psychological well-being (divided into stress, depression, anxiety and risk of burnout) in the population of health professionals working in pediatric palliative care; verify if the virtual reality tool leads to an improvement change at the level of the investigated items (feasibility study). The treatment will have a duration of 4 weeks, with the execution of two sessions per week with the use of a viewer positioned on the head that allows users to navigate and interact in real time with a three-dimensional (3D) environment At time zero (T0), the participants will be administered, shortly before the application of virtual reality, the Mini-Z survey 2.0 questionnaires (the single item burnout question), Depression Anxiety Stress Scales 21 (DASS-21), and a demographic questionnaire (gender, age, profession, shift work, years of work in PPCs). At the end of the compilation, two vision treatments will follow, which will take place three to four days apart.
At time T1 (second week) and time T2 (third week) the DASS-21 will initially be administered followed by two weekly treatments with a visor. At the end (T3) the compilation of both tests (Mini-Z survey 2.0-the single item burnout question and the DASS-21) will be repeated following the last two applications of the viewer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: visor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- work within the pediatric hospice of Padua
- Absence of neurological pathologies
- personnel who actively engage in membership/participation during all 4 weeks of the project
Key exclusion criteria (1 listed)
- Subject do not sign written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visorThe treatment will have a duration of 4 weeks, with the execution of two sessions per week with the use of a viewer positioned on the head that allows users to navigate and interact in real time with a three-dimensional (3D) environment | Device | Virtual reality |
Primary outcome
the psychological well-being of healthcare providers: risk of burnout
Time frame: Data collection lasted for four weeks
- Mini-Z Survey 2.0 (single-item): examines the risk of burnout among healthcare provides, particularly The Mini-Z responds to the goal of framing/identifying the burnout risk of workers on the pediatric palliative care team. , it was analysed frequencies and percentages of burnout risk based on the analysis criteria identifiable in Nagasaki et al. 2022 (1- "In Total burnout"; 2-"Always has burnout symptoms the burnout symptoms I perceive are persistent"; 3-"Beginning of burnout"; 4-"Under stress"; 5-"Never felt in Burnout").
the psychological well-being of healthcare providers: anxiety, depression and stress
Time frame: Data collection lasted for four weeks
- DASS-21(the Depression Anxiety Stress Scales 21) DASS-21 is a psychometric self-assessment test, derived from the Depression Anxiety Stress Scales [22], detecting three constructs: anxiety, depression and stress. It is measured by 21 items on a 4-point Likert scale (from "0-Not at all applies to me" to "3-It applies a lot or most of the time to me"). Cronbach's alpha of .80 is very good evidence of the high reliability of the tool's content.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zanin principal investigator
Azienda Ospedale-Università Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visor in people with Occupational Stress, run by Azienda Ospedaliera di Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the psychological well-being of healthcare providers: risk of burnout (time frame: Data collection lasted for four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.