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Virtual RealityINSPIRENCT06192368

Virtual Reality Program to Reduce Stress in Neonatal Nurses

A study testing INSPIRE and Tablet in people with Virtual Reality and Stress, run by St. Justine's Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Virtual Reality, Stress, Stress, Work Place
What is being tested?
INSPIRE and Tablet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteCanada
Study dates
19 Jun 2024to 5 Mar 2025
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Epilepsy history
  • Recent eye surgery

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St.Justine's Hospital

    Montreal, Quebec, H1T 3C5

Other trials in Canada

About this study

Official title: Acceptability, Feasibility, and Preliminary Effects of a Virtual Reality (VR) Program to Reduce Stress in Neonatal Intensive Care Unit Nurses

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.

Read more

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.

Read the detailed description

INTRODUCTION In 2021-2022, there were 368,792 births in Canada, with 83,300 (22.5%) in Quebec (Canada). At the CHU Sainte-Justine, the neonatal intensive care unit admits 869 babies during the 2021-22 period. Out of these, 385 babies (44%) were born prematurely and 484 (56%) were admitted for perinatal issues or congenital pathologies. Some of these babies had to be hospitalized for several weeks or even months after birth.

The complexity of care for this population is well-documented and has consequences for nurses working daily in neonatal care units. Nurses in these units reportedly experience significant work-related stress from various stressors. Given the impact of stress on the performance of healthcare organizations, it becomes imperative for nursing unit managers, to implement measures to help nurses better manage and reduce stress in the workplace. In this context, the use of virtual reality (VR) has proven effective in stress reduction for caregivers by providing a relaxing experience. VR is a technology that simulates the user's presence in a virtual environment, visualized using a three-dimensional immersive screen inside a virtual reality headset.

To date, no studies have been identified proposing an intervention using VR for the stress management of caregivers during working hours.

AIMS \& OBJECTIVES OF THE STUDY This pilot study aims to test and evaluate the feasibility, acceptability, and preliminary effects of a virtual reality activity on the stress of nursing staff in the neonatal unit at CHU Sainte-Justine during their breaks.

Objectives:

  • Verify the feasibility of the intervention among participants.
  • Evaluate the feasibility of the clinical trial.
  • Verify the acceptability and satisfaction of nurses and nursing assistants regarding the use of VR.
  • Evaluate the preliminary effects of the VR intervention on the stress levels of neonatal intensive care staff.
  • Assess the feasibility of the clinical trial.

METHODS

DESIGN This is a crossover clinical trial with randomized sequences. Each participant will serve as their own control, receiving both an experimental treatment sequence (virtual reality) and a control treatment sequence (tablet game). The order of the sequences will be determined randomly. A period with no intervention (Wash out period) is planned between the two sequences to prevent the effect of the first sequence from influencing the second.

SETTING The study will take place in the neonatal intensive care unit at CHU Sainte-Justine, a reference center and one of the six tertiary and quaternary neonatal critical care units in Quebec, Canada.

INTERVENTIONS CONTROL TREATMENT Tablet gaming sessions where participants will be able to choose from several games installed on a tablet dedicated to the project.

EXPERIMENTAL TREATMENT Virtual reality sessions using the therapeutic virtual reality program INSPIRE.

VARIABLES AND MEASUREMENT INSTRUMENTS

STATE-TRAIT ANXIETY INVENTORY (STAI, TRAIT SUBSCALE ONLY) The State-Trait Anxiety Inventory (STAI) is a tool used to measure general and habitual anxiety. This scale distinguishes anxiety into emotional response (state subscale) and trait anxiety (trait subscale). Trait anxiety is defined as "relatively stable individual differences in the predisposition to perceive several situations as dangerous or threatening and to respond to these situations with an elevation of situational anxiety". The trait subscale consists of a total of 20 items where participants are asked to indicate, using a four-point Likert scale ("almost never" to "almost always"), how often they experience the mentioned emotional state. For statistical analyses, the scale results will be considered on a total of 80 points. The scores assigned to all 20 items will be summed.

NURSE STRESS SCALE (NSS) The Nurse Stress Scale (NSS) is a tool used to measure nursing stress. This questionnaire measures the frequency and sources of stress experienced by nurses during their work on care units. In this research, version 28 of the tool, consisting of 48 items, will be used. The questionnaire was pre-tested with a cohort of nurses and nursing assistants in the neonatology unit.

A 4-point Likert scale is used to indicate the frequency with which nurses experience stress factors, ranging from "never stressful" to "very often stressful." Nurses also have the option to respond N/A (not applicable) if they have never experienced the stressful item in the neonatal unit. For statistical analyses, the total score of this instrument will be considered. The scores assigned to all 43 items will be summed and then divided by the total number of items. A higher score indicates greater stress. The internal consistency of the NSS is very good (Cronbach's alpha 0.89).

An open-ended question at the end of the questionnaire will be added, asking, "In your opinion, are there other elements related to stress that you experience at work that have not been addressed by the scale and would be important to mention?"

STRESS NUMERICAL RATING SCALE-11 (SNRS-11) The perceived level of immediate stress will also be assessed using the Stress Numerical Rating Scale-11 (SNRS-11). This stress scale is a tool used to measure immediate perceived stress on a scale of 0 to 10.

SALIVARY ALPHA-AMYLASE Salivary alpha-amylase is a physiological measure of the psychosocial stress level of a participant. A decrease (or the same value as at T0 or slightly increased) or an increase between two measurement times indicates a reduction or an increase in the perceived stress level.

SOCIODEMOGRAPHIC AND CONTEXTUAL DATA A sociodemographic questionnaire will be completed by the nurses before their first gaming session. This questionnaire will be useful for describing the sample.

INTERVENTION ACCEPTABILITY AND PARTICIPANT SATISFACTION After their final gaming session, participants will be invited to complete a questionnaire regarding their appreciation of virtual reality, the ease of technology use, the support or obstacles they encountered during their participation, and their overall satisfaction with the intervention.

ANALYSES The analyses will be performed using the statistical analysis software SPSS 29th edition, IBM, Armonk, NY, USA. Descriptive statistics will be used to present sociodemographic and contextual data as well as the satisfaction levels of healthcare professionals. To control for intra- and inter-subject variability, the investigators will use RM-Anova for comparison between different stress measurement times.

The investigators will proceed with a subgroup analysis for the number of years of experience in intensive care, as well as by job title. The investigators will use a significance threshold of 0.05, but considering that this project is a pilot study, they do not aim to verify the effectiveness of VR.

ETHICAL CONSIDERATIONS This project was approved by the Research Ethics Board (REB) of CHU Sainte-Justine in Montreal, Canada.

Being tested
INSPIRE, Tablet
Keywords
Virtual reality, Nurse, Stress, Anxiety
Medical subject headings
Occupational Stress, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSPIREDevice

    Virtual reality application for relaxing.

  • TabletDevice

    Gaming tablet

Study groups in NCT06192368
Study groupRoleWhat they receive
Sequence of virtual reality followed by tablet game.OtherOver 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).
Receives: Device: INSPIRE; Device: Tablet
Sequence of tablet game followed by virtual reality:OtherOver 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).
Receives: Device: INSPIRE; Device: Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. State-Trait Anxiety Inventory (STAI)

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

    Measured: Measured at baseline T0

  2. Nurse Stress Scale (NSS)

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

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

  3. Stress Numerical Rating Scale-11 (SNRS-11)

    0-10 scale to measure immediate stress

    Measured: 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)

  4. Salivary Alpha-amylase (SAA)

    Physiological measure for psychosocial stress.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start19 Jun 2024
  3. Primary completion5 Mar 2025
  4. Study completion5 Mar 2025

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06192368
Sponsor's protocol ID
INSPIRE
Acronym
INSPIRE
Status last verified
Aug 2025
First submitted
18 Dec 2023
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andersen S, Mintz-Binder R, Sweatt L, Song H. Building nurse resilience in the workplace. Appl Nurs Res. 2021 Jun;59:151433. doi: 10.1016/j.apnr.2021.151433. Epub 2021 Apr 14.

    PubMed 33947518
  • Bekelepi N, Martin P. Support interventions for nurses working in acute psychiatric units: A systematic review. Health SA. 2022 Apr 29;27:1811. doi: 10.4102/hsag.v27i0.1811. eCollection 2022.

    PubMed 35548058
  • Beverly E, Hommema L, Coates K, Duncan G, Gable B, Gutman T, Love M, Love C, Pershing M, Stevens N. A tranquil virtual reality experience to reduce subjective stress among COVID-19 frontline healthcare workers. PLoS One. 2022 Feb 9;17(2):e0262703. doi: 10.1371/journal.pone.0262703. eCollection 2022.

    PubMed 35139092
  • Bodet-Contentin L, Letourneur M, Ehrmann S. Virtual reality during work breaks to reduce fatigue of intensive unit caregivers: A crossover, pilot, randomised trial. Aust Crit Care. 2023 May;36(3):345-349. doi: 10.1016/j.aucc.2022.01.009. Epub 2022 Mar 1.

    PubMed 35246356
  • Canada, S. (2022). Estimations des composantes de l'accroissement démographique, annuelles https://doi.org/https://doi.org/10.25318/1710000801-fra

  • Crompton, S. (2011). Qu'est-ce qui stresse les stressés? Principales sources de stress des travailleurs https://www150.statcan.gc.ca/n1/fr/pub/11-008-x/2011002/article/11562-fra.pdf?st=CL4LBGSE

  • Currie K, Gupta BV, Shivanand I, Desai A, Bhatt S, Tunuguntla HS, Verma S. Reductions in anxiety, depression and insomnia in health care workers using a non-pharmaceutical intervention. Front Psychiatry. 2022 Sep 6;13:983165. doi: 10.3389/fpsyt.2022.983165. eCollection 2022.

    PubMed 36147990
  • Dyrbye LN, Shanafelt TD, Johnson PO, Johnson LA, Satele D, West CP. A cross-sectional study exploring the relationship between burnout, absenteeism, and job performance among American nurses. BMC Nurs. 2019 Nov 21;18:57. doi: 10.1186/s12912-019-0382-7. eCollection 2019.

    PubMed 31768129
  • Favrod C, Jan du Chene L, Martin Soelch C, Garthus-Niegel S, Tolsa JF, Legault F, Briet V, Horsch A. Mental Health Symptoms and Work-Related Stressors in Hospital Midwives and NICU Nurses: A Mixed Methods Study. Front Psychiatry. 2018 Aug 20;9:364. doi: 10.3389/fpsyt.2018.00364. eCollection 2018.

    PubMed 30177890
  • Fiske E. Nurse Stressors and Satisfiers in the NICU. Adv Neonatal Care. 2018 Aug;18(4):276-284. doi: 10.1097/ANC.0000000000000514.

    PubMed 29933342
  • French SE, Lenton R, Walters V, Eyles J. An empirical evaluation of an expanded Nursing Stress Scale. J Nurs Meas. 2000 Fall-Winter;8(2):161-78.

    PubMed 11227582
  • Gauthier, J., & Bouchard, S. (1993). Adaptation canadienne-française de la forme révisée du State-Trait Anxiety Inventory de Spielberger. Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement, 25(4), 559.

  • Gray-Toft, P., & Anderson, J. G. (1981, 1981/03/01). The Nursing Stress Scale: Development of an instrument. Journal of behavioral assessment, 3(1), 11-23. https://doi.org/10.1007/BF01321348

  • Hannan KE, Bourque SL, Palmer C, Tong S, Hwang SS. Prevalence and Predictors of Medical Complexity in a National Sample of VLBW Infants. Hosp Pediatr. 2021 May;11(5):525-535. doi: 10.1542/hpeds.2020-004945.

    PubMed 33906959
  • Haugland WA, Crenshaw JT, Gilder RE. Implementing a Resilience Bundle for Emergency Nurses: An Evidence-Based Practice Project. J Emerg Nurs. 2023 Jan;49(1):40-49. doi: 10.1016/j.jen.2022.08.009. Epub 2022 Sep 30.

    PubMed 36184334

Questions about this trial

What is this clinical trial studying?

A study testing INSPIRE and Tablet in people with Virtual Reality and Stress, run by St. Justine's Hospital at 1 site in Canada.

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 1 inclusion and 2 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 24 Aug 2025. 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 Canada. 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?

State-Trait Anxiety Inventory (STAI) (time frame: Measured at baseline T0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06192368, which also lists 41 linked publications.

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 24 Aug 2025.

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