Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06192368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-18
Brief Title:
Virtual Reality Program to Reduce Stress in Neonatal Nurses
Sponsor:
St Justines Hospital
Organization:
St Justines Hospital
Study Overview
Official Title:
Acceptability Feasibility and Preliminary Effects of a Virtual Reality VR Program to Reduce Stress in Neonatal Intensive Care Unit Nurses
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE
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
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 368792 births in Canada with 83300 225 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 users 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 NA 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 Cronbachs alpha 089
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 005 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
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 users 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 NA 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 Cronbachs alpha 089
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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None