Clinical trial NCT06192368: Virtual Reality Program to Reduce Stress in Neonatal Nurses
Official title: Acceptability, Feasibility, and Preliminary Effects of a Virtual Reality (VR) Program to Reduce Stress in Neonatal Intensive Care Unit Nurses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Stress
Stress, Work Place
Keywords: Virtual reality
Nurse
Stress
Anxiety
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Epilepsy history
* Recent eye surgery

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Measured at baseline T0
measure: Nurse Stress Scale (NSS)
timeFrame: Measured at Baseline (T0) and two weeks after (T7)
measure: Stress Numerical Rating Scale-11 (SNRS-11)
timeFrame: 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)
measure: Salivary Alpha-amylase (SAA)
timeFrame: Before the first intervention (T0) and two weeks after (T7)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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