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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06247618
Other study ID # ppcVirtualReality
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2023
Est. completion date December 1, 2023

Study information

Verified date January 2024
Source Azienda Ospedaliera di Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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; 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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 1, 2023
Est. primary completion date October 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Subject do not sign written consent

Study Design


Related Conditions & MeSH terms


Intervention

Device:
visor
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

Locations

Country Name City State
Italy Hospice Pediatrico- Azienda Ospedale Università Padova Padova PD

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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"). Data collection lasted for four weeks
Primary 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. Data collection lasted for four weeks
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