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NCT Number: NCT06747793

Virtual Reality to Reduce the Anxiety in Critically Ill Patient

Anxiety and discomfort generated by repeated medical cares and invasive procedures can induce cognitive disorders in critical illness survivors as post-traumatic stress disorder. For this reason, managing patients' anxiety is particularly important in the intensive care unit. Physicians have recently started using immersive virtual reality (VR), based on real-time interaction with an artificial 360° immersive world, as an adjunctive non-invasive and non-pharmacological anxiolysis technique. The purpose of this project is to assess the virtual reality stimulation to reduce anxiety in Intensive Care Unit (ICU) patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, France

Location contact

Floriane PUEL, MD

CONTACT

Floriane PUEL, MD

PRINCIPAL_INVESTIGATOR

About this study

Physicians have recently started using immersive VR as an adjunctive non-invasive and non-pharmacological pain control and anxiolysis technique, but the literature on this topic in the adult ICU is quite sparse. In a pilot study, Gerber et al showed the feasibility and acceptance of VR stimulation as a new non-pharmacological intervention to comfort patients during their stay in the ICU and the results appear promising [11]. In our view, the management of anxiety related to healthcare interventions remains a major global challenge and it will be interesting to assess the use of VR in a chronic daily use in the ICU adult patients. Our study will be conducted in the adult intensive care unit of the University of Toulouse, France. All patients who meet the inclusion criteria will be randomized. There will be two distinct groups: the control group will receive standard ICU care, whereas the intervention group will, in addition to the standard ICU care, will receive relaxing VR stimulation two times a day. The intervention will be performed by trained ICU nurses. Anxiety will be assessed by the Visual Analogue Scale for Anxiety (VAS-A) twice by day (morning and evening), sleep quality with the Richards-Campbell Sleep Questionnaire (RCSQ) every morning, depression, and anxiety with the Hamilton Depression Rating Scale (HDRS) and the Hamilton Anxiety Rating Scale (HAM-A) at 3-months after the inclusion. Each patient's heart rate, blood pressure, respiration rate, SatO2, and physical or neurocognitive side effects were used to evaluate if the VR sessions will have any effect on physiology.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient
  • Oral consent after free and informed information
  • Hospitalized in the multipurpose intensive care unit of Rangueil hospital with an estimated length of stay greater than 24 hours
  • Conscious (Glasgow Coma Scale > 8) and Richmond Agitation-Sedation Scale (RASS) sedation score between -1 and +1
  • Mechanically ventilated or not
  • Person affiliated to or beneficiary of a social security system.

Exclusion criteria

  • Patient under legal protection (guardianship or curatorship)
  • RASS < -1 or > +1
  • Visual or hearing difficulties preventing the use of the VR headset
  • Severe psychiatric history (severe depression, psychosis, bipolarity), advanced dementia or mental retardation
  • Hemodynamic (Norepinephrine support > 0.5 gamma/kg/min) and/or respiratory instability (invasive mechanical ventilation with FiO2 greater than 80%)
  • Presence of a malformation or cervical or facial trauma that does not allow the application of the VR headset
  • Pregnancy or breastfeeding

Treatment and study plan

Virtual Reality

Other

The intervention will consist of relaxing virtual reality stimulation, which will be started after obtaining informed consent. Immersive 360-degree videos (nature environments) will be played inside a head-mounted display, with the video sound played inside headphones. Each virtual reality video will last 30 minutes. The stimulation will be provided two times per day, morning and evening, every day until the patient ICU discharge, or the maximum of 7 days will be reached. The intervention group will also receive standard intensive care unit care, same as in the control group.

Primary outcomes

  1. Patients' anxiety level after using virtual reality

    Time frame: 7 days

    Visual Analogue Scale for Anxiety (VAS-A) is a scale measuring anxiety from 0 to 100 ; 0: no anxiety, 100: maximum of anxiety

Secondary outcomes

  1. Difference in patient anxiety after using virtual reality

    Time frame: between inclusion and the day 7

    Visual Analogue Scale for Anxiety (VAS-A) variations between inclusion and the day 7. The VAS A is a scale measuring anxiety from 0 to 100 ; 0: no anxiety, 100: maximum of anxiety

  2. Evolution of the psychopathological status: depression

    Time frame: 3 months

    Score to the Hamilton Depression Rating Scale (HDRS) with 16 items from 0 (no symptom) to 4 (high symptom of depression) with a total score from 0 to 30: 0 no depression / 30: depression maximum

  3. Evolution of the psychopathological status: anxiety

    Time frame: 3 months

    Score to the Hamilton Anxiety Rating Scale (HAM-A) with 14 items rom 0 (no symptom) to 4 (high symptom of depression) with a total score from 0 to 56: 0 no anxiety /56: anxiety maximum

  4. Evolution of the Sleep quality

    Time frame: every day through study completion, an average of 5 days

    Score to the Richards-Campbell Sleep Questionnaire (RCSQ) from 0 to 100 (0: worse sleep /100: best sleep

  5. Evaluation of the Safety of using vitural reality in intensive care unit

    Time frame: every day through study completion, an average of 5 days

    Number of side effects that may occur during a VR session

  6. Evaluation of the compliance

    Time frame: 3 months

    Number of virtual reality sessions actually performed by the patient in the intervention group

Study contacts

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

Floriane PUEL, Dr

CONTACT

[email protected]

05 61 32 22 25

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Evaluation of the Use of Virtual Reality to Reduce Anxiety in Intensive Care Patients

Acronym: VRAI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Jan 27, 2025

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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