NCT06247618

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 7, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
Last Updated

February 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

September 7, 2023

Last Update Submit

January 30, 2024

Conditions

Keywords

virtual realitypediatric palliative careanxietyburnout

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Virtual reality

EXPERIMENTAL
Device: visor

Interventions

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

Virtual reality

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subject do not sign written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospice Pediatrico- Azienda Ospedale Università Padova

Padua, PD, 35126, Italy

Location

MeSH Terms

Conditions

Occupational StressAnxiety DisordersBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Zanin

    Azienda Ospedale-Università Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN

Study Record Dates

First Submitted

September 7, 2023

First Posted

February 8, 2024

Study Start

September 7, 2023

Primary Completion

October 10, 2023

Study Completion

December 1, 2023

Last Updated

February 8, 2024

Record last verified: 2024-01

Locations