NCT06192368

Brief Summary

Background: In the context of neonatal care, the increasing complexity of medical interventions poses challenges to nurses, contributing to elevated workplace stress. This stress can impact the well-being of nurses and the overall quality of patient care. Despite the documented significance of workplace stress, there is a scarcity of research on effective stress management interventions for neonatal care nurses. This pilot study aims to explore the feasibility, acceptability, and preliminary effects of a virtual reality (VR) intervention on stress reduction among nurses in the neonatal intensive care unit (NICU) at CHU Sainte-Justine. Methods: A randomized intra-subject clinical trial will be conducted, involving 30 NICU nurses and nurse assistants. Participants will act as their own controls, receiving both experimental (VR) and control (tablet gaming) interventions in a random sequence. The study will assess the feasibility of the interventions, clinical trial procedures, and participant satisfaction. Stress levels will be measured using the State-Trait Anxiety Inventory (Trait subscale), Nurse Stress Scale, Stress Numerical Rating Scale-11, and salivary alpha-amylase. Additionally, participants will provide sociodemographic information, and the study will evaluate the perceived clinical workload during intervention sessions. Interventions: The study will employ Paperplane Therapeutics' VR program, INSPIRE, designed to offer a multisensory relaxation experience. The control intervention involves tablet gaming during breaks. Both interventions will be 15 minutes in duration, implemented over five weeks. Results: The study aims to provide insights into the feasibility, acceptability, and preliminary effects of VR-based stress management interventions for NICU nurses. Data analysis will involve statistical comparisons of stress measures between VR and control interventions, contributing to the evidence base for implementing workplace stress reduction programs. Conclusion: This research addresses a critical gap in the literature by investigating the potential benefits of VR interventions for stress reduction among NICU nurses. If successful, this approach could enhance workplace well-being, job satisfaction, and overall nursing care quality, leading to broader implications for stress management strategies in healthcare settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

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

December 18, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

June 19, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

December 18, 2023

Last Update Submit

August 18, 2025

Conditions

Keywords

Virtual realityNurseStressAnxiety

Outcome Measures

Primary Outcomes (4)

  • State-Trait Anxiety Inventory (STAI)

    State-Trait Anxiety Inventory allow to measure general anxiety, likert scale (4 points)

    Measured at baseline T0

  • Nurse Stress Scale (NSS)

    Nurse Stress Scale allow to measure hospital related stress, likert scale (4 points)

    Measured at Baseline (T0) and two weeks after (T7)

  • Stress Numerical Rating Scale-11 (SNRS-11)

    0-10 scale to measure immediate stress

    Before and after all the interventions (T0, 20 minutes after intervention-T1, at Day-2 (T2), 20 minutes after intervention-T3, at Day 4 (T4), 20 minutes after intervention-T5, at Day 6 (T6), 20 after minutes intervention-T7)

  • Salivary Alpha-amylase (SAA)

    Physiological measure for psychosocial stress.

    Before the first intervention (T0) and two weeks after (T7)

Study Arms (2)

Sequence of virtual reality followed by tablet game.

OTHER

Over a period of two weeks (weeks 1 and 2), participants randomized to this sequence will be asked to use virtual reality for 15 minutes during four break periods. These two weeks of virtual reality will be followed by a week with no exposure (week 3). In the following two weeks, participants will be asked to play a game on a tablet for 15 minutes during four break periods (weeks 4 and 5).

Device: INSPIREDevice: Tablet

Sequence of tablet game followed by virtual reality:

OTHER

Over a two-week period (weeks 1 and 2), participants randomized to this sequence will be asked to play a game on a tablet for 15 minutes during four break periods. These two weeks of tablet gaming will be followed by a week with no exposure (week 3). In the following two weeks, participants will be asked to use virtual reality for 15 minutes during four break periods (weeks 4 and 5).

Device: INSPIREDevice: Tablet

Interventions

INSPIREDEVICE

Virtual reality application for relaxing.

Sequence of tablet game followed by virtual reality:Sequence of virtual reality followed by tablet game.
TabletDEVICE

Gaming tablet

Sequence of tablet game followed by virtual reality:Sequence of virtual reality followed by tablet game.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Nurses and nursing assistants holding a position or assigned to the neonatology intensive care unit

You may not qualify if:

  • Epilepsy history
  • Recent eye surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.Justine's Hospital

Montreal, Quebec, H1T 3C5, Canada

Location

Related Publications (41)

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MeSH Terms

Conditions

Occupational StressAnxiety Disorders

Interventions

Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsFeminine Hygiene ProductsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 5, 2024

Study Start

June 19, 2024

Primary Completion

March 5, 2025

Study Completion

March 5, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations