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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier St Anne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: control comparator.Active comparator 1 intervention
Group B: Arm 1: Experimental (VR)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Level of Anxiety: GAD-7

Interpretation 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety

Time frame
15 months
3

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

Other outcomes

1

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
2

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
3

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
4

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

Locations

This trial has no locations.

Sponsors and contacts

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