Impact of Relaxation Sessions Using a Virtual Reality Application on the Sleep Quality of Caregivers Working Night Shifts (Luciole)

Impact of Using a Virtual Reality Application on the Sleep Quality of Caregivers Working Night Shifts

This project aims to evaluate the impact of relaxation sessions conducted using a virtual reality device on the sleep quality of night-shift healthcare workers. The intervention specifically targets the immediate post-night-shift period, a critical time for recovery, by offering immersive guided relaxation experiences designed to reduce anxiety and promote both mental and physiological relaxation.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disorder
• Intervention / Treatment: Device: Arm 2: Control (No VR / Standard Care); Device: Arm 1: Experimental (VR) Intervention: Virtual reality sessions

Detailed Description

Paramedical staff working night shifts are particularly exposed to sleep disorders and psychological difficulties due to the length and organization of their working hours. The ANSES report highlights the central role of anxiety, both as a consequence of night work and as a factor that worsens sleep disturbances.

In response to this situation, the GHU Directorate of Nursing, in collaboration with Occupational Health, the CHRONOS team, and the pain specialist physician, has initiated a reflection on preventive actions aimed at better addressing the vulnerability of healthcare professionals. The objective is to provide concrete responses to psychological distress and the high levels of stress experienced by healthcare workers, which have been further intensified by the health crisis.

Within this framework, it is proposed to specifically address immediate post-night-shift sleep disturbances by implementing a relaxation program using a virtual reality application. This non-pharmacological approach aims to reduce anxiety and improve recovery among paramedical professionals working night shifts.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre A GEOFFROY, PU-PH; Phone Number: 01.58.11.12.40; Email: pa.geoffroy@ghu-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• State-certified nurse or nursing assistant (GHU, GHPG staff)
• Regularly working night shifts and on duty in the units
• Age 18 years and over
• Informed individuals who have signed written consent
• Individuals affiliated with a social security scheme and must be able to understand and read French.

Exclusion Criteria:

• No possibility of follow-up (subjects on fixed-term contracts, ongoing transfers, student reinforcements, etc.)
• Subjects with insufficient command of the French language, preventing them from taking the tests
• Pregnant or breastfeeding women (disruption of the sleep cycle), or women with young children.
• Individuals with a pacemaker or any other implanted medical device, unless medically advised otherwise (due to the radio-magnetic waves emitted by the virtual reality headset)
• Individuals with epilepsy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control comparator.; The participant receives the actigraph again and maintains their usual bedtime and sleep-onset routine, completing the paper sleep diary for sleep quality after each waking. The PSQI scale is measured on the first day (D1) and again after the last night (D30). The sleep-wake rhythm will be analyzed using an actimeter.	Device: Arm 2: Control (No VR / Standard Care); Intervention: No virtual reality or standard care Description: Participants do not undergo virtual reality sessions during this period. The sleep-wake rhythm will be analyzed using an actimeter.
Experimental: Arm 1: Experimental (VR); Intervention: Virtual reality sessions Description: Participants undergo virtual reality sessions during this period. The sleep-wake rhythm will be analyzed using an actimeter. The sleep-wake rhythm will be analyzed using an actimeter.	Device: Arm 1: Experimental (VR) Intervention: Virtual reality sessions; During the virtual reality period (1 month), the participant receives a VR headset and an actigrapher, provided by a Registered Nurse Practitioner (RNP). A training session is organized and scheduled following enrollment. The participant will keep the VR headset and actigrapher at home for one month. The devices will be collected by the night shift supervisor at the end of the usage period. A paper sleep diary will be provided to assess sleep quality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the evolution of sleep quality of paramedical professionals assessed by the PSQI scale, with or without intervention, (cross-over design).	The PSQI provides a score ranging from 0 to 3 for each of the seven components, as well as an overall sleep quality score ranging from 0 to 21, with higher scores indicating poorer sleep quality. The PSQI self-administered questionnaire is used in research and clinical practice to assess sleep quality before and after pharmacological treatment or behavioral therapy in order to measure the impact of the intervention on individuals' sleep.	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of sleep disorders: ISI,	Score Total: 0 to 28 Interpretation 0-7: No clinically significant insomnia 8-14: Mild insomnia (subthreshold) 15-21: Moderate insomnia 22-28: Severe insomnia	15 months
Level of Anxiety: GAD-7	Interpretation 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety	15 months
Level of anxiety and depression: QIDS	Total: 0 to 27 Interpretation 0-5: No depression 6-10: Mild depression 11-15: Moderate depression 16-20: Severe depression 21-27: Very severe depression	15 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work-related quality of life: PROQOL 5	The scale consists of 30 items, rated on a 5-point Likert scale ranging from 1 (Never) to 5 (Very often). It measures three distinct dimensions (10 items each): Compassion Satisfaction (CS) - Pleasure and fulfillment derived from being able to do one's work well. Burnout (BO) - Feelings of exhaustion, frustration, anger, and depression related to work. Secondary Traumatic Stress (STS) - Work-related exposure to extremely stressful or traumatic events experienced by others. Each subscale is scored separately.	15 months
Overall quality of life: Duke Health Profile	The Duke Health Profile (DUKE) is a generic self-administered questionnaire designed to measure perceived health status and overall quality of life in adults. It is brief, easy to administer, and widely used in clinical and research settings. The questionnaire consists of 17 items, assessing health over the previous week. Responses are scored and transformed to a 0-100 scale.	15 months
Participant satisfaction: Visual Analog Scale (VAS)	Score: 0-100 mm Description: Participant satisfaction is assessed using a Visual Analog Scale (VAS), which consists of a horizontal line, typically 100 mm in length, anchored at each end by two extremes: 0: Not satisfied at all 100: Extremely satisfied Interpretation: Low scores → Low level of satisfaction Intermediate scores → Moderate satisfaction	15 months
Severity of sleep disorders: ESS	Score Total: 0 to 24 Interpretation 0-10: Normal 11-15: Moderate excessive sleepiness ≥16: Severe excessive sleepiness	15 months
Severity of sleep disorders: NSI	Score Total: 0 to 20 Interpretation: Higher scores indicate more frequent and debilitating nightmares. Often used in connection with PTSD, anxiety, and depression.	15 months
Severity of sleep disorders: MCTQ	Content Bedtime, sleep onset time, and wake-up time Distinction between workdays and free days Main score MSF (Mid-Sleep on Free days) MSFsc (Mid-Sleep on Free days, sleep-corrected) Interpretation An earlier MSFsc indicates a morning chronotype	15 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Wake Disorders
• Other Study ID Numbers: D24-P018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
• IPD Sharing Time Frame: Two years after the last publication
• IPD Sharing Access Criteria: Data sharing must be accepted by the sponsor and the PI. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with GDPR.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No