An interventional study of Arm 1: Experimental (VR) Intervention: Virtual reality sessions and Arm 2: Control (No VR / Standard Care) in Sleep Disorder, sponsored by Centre Hospitalier St Anne. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Health services research
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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.
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.
747 studies on the registry are indexed under Sleep Wake Disorders; 182 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 531 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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: 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.
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.
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.
Time frame: 15 months
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
Time frame: 15 months
Level of Anxiety: GAD-7
Interpretation 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety
Time frame: 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
Time frame: 15 months
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 15 months
No study locations are listed for this record.
Plan to share: Yes — Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Supporting information: Study protocol, Informed consent form
Time frame: Two years after the last publication
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.
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Feb 2027, 12 months later.
Of 209 non-industry interventional studies with no phase under Sleep Wake Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 244 studies reached it within 19 months; a quarter within 6 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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