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NCT Number: NCT07395323

Impact of Relaxation Sessions 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.

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Key information

Conditions

Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arm 1: Experimental (VR) Intervention: Virtual reality sessions

Device

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.

Arm 2: Control (No VR / Standard Care)

Device

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.

Primary outcomes

  1. Compare the evolution of sleep quality of paramedical professionals assessed by the PSQI scale, with or without intervention, (cross-over design).

    Time frame: 15 months

    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.

Secondary outcomes

  1. Severity of sleep disorders: ISI,

    Time frame: 15 months

    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

  2. Level of Anxiety: GAD-7

    Time frame: 15 months

    Interpretation

    0-4: Minimal anxiety

    5-9: Mild anxiety

    10-14: Moderate anxiety

  3. Level of anxiety and depression: QIDS

    Time frame: 15 months

    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

Other outcomes

  1. Work-related quality of life: PROQOL 5

    Time frame: 15 months

    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.

  2. Overall quality of life: Duke Health Profile

    Time frame: 15 months

    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.

  3. Participant satisfaction: Visual Analog Scale (VAS)

    Time frame: 15 months

    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

  4. Severity of sleep disorders: ESS

    Time frame: 15 months

    Score Total: 0 to 24

    Interpretation

    0-10: Normal

    11-15: Moderate excessive sleepiness

    ≥16: Severe excessive sleepiness

  5. Severity of sleep disorders: NSI

    Time frame: 15 months

    Score Total: 0 to 20

    Interpretation: Higher scores indicate more frequent and debilitating nightmares. Often used in connection with PTSD, anxiety, and depression.

  6. Severity of sleep disorders: MCTQ

    Time frame: 15 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre A GEOFFROY, PU-PH

CONTACT

[email protected]

01.58.11.12.40

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study title

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

Acronym: Luciole

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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