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OpenTrials
Completed

NCT Number: NCT05380700

Virtual Reality on the IMC

The goal of this substudy (main study NCT04498585) is to determine the feasibility of applying virtual reality stimulation to patients in the intermediate care unit. Patients on this ward are generally more awake and alert than patients in the intensive care unit, thereby they are able to provide feedback about their experience. As the intermediate care unit is not without stress, examining the physiological parameters (e.g., heart rate, respiration rate, blood pressure, etc.) could also provide telling information as to the calming effect of virtual reality. The movements of these patients are also recorded using accelerometers which will provide valuable information about the characteristics of the movements that patients make while confined to their beds. These movements can act as a reference for further investigation into movements related to delirium which is a secondary outcome measure of the main study.

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Key information

Conditions

Feasibility of Virtual Reality Stimulation for Critically Ill Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital

Bern, 1010, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent
  • Aged ≥18 years
  • No severe visual or auditory impairments (strabismus, macular degeneration, retinopathy)
  • German or French speaking
  • Estimated length of stay (from time of study inclusion) >24 hours

Exclusion criteria

  • Patients without calotte, with external ventricular drainage or other Intracranial pressure probes
  • Patients with epilepsy
  • Patients with Covid-19

Treatment and study plan

Virtual Reality Stimulation

Device

Participants in the intervention group will be provided with up to 30 minutes of relaxing, 360-degree virtual reality (VR) stimulation and corresponding sounds, twice in 24 hours during their stay on the intermediate care unit.

Other names: Visuo-acoustic stimulation

Primary outcomes

  1. Acceptability of providing virtual reality stimulation

    Time frame: Recorded immediately after every VR stimulation

    To determine the acceptability of providing VR stimulation to patients in the intermediate care (IMC) unit based on 1) the subjective perception of the feedback, and 2) the ability of the stimulation to be maintained for minimum 20 minutes.

  2. Safety of providing virtual reality stimulation

    Time frame: Safety will be determined based on the reporting of adverse or serious adverse events in the 1-hour following the completion of the VR stimulation.

    To determine the safety based on the adverse or serious adverse events reported by the medical staff, or the subjective reporting of the participant who received the VR stimulation.

Secondary outcomes

  1. Heart Rate

    Time frame: Recorded during entire stay in the IMC (up to 24 hours)

    Changes in heart rate (beats per minute) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.

  2. Blood Pressure

    Time frame: Recorded during entire stay in the IMC (up to 24 hours)

    Changes in blood pressure (mmHg) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.

  3. Respiration Rate

    Time frame: Recorded during entire stay in the IMC (up to 24 hours)

    Changes in respiration rate (breaths per minute) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.

  4. Oxygen Saturation

    Time frame: Recorded during entire stay in the IMC (up to 24 hours)

    Changes in oxygen saturation (%) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.

Other outcomes

  1. Movement Patterns before and after VR stimulation

    Time frame: Recorded during entire stay in the IMC (up to 24 hours)

    Movement patterns, measured as acceleration and rotation, will be measured using inertial measurement units. The data will be used to determine if there is a change in pattern between periods before, during, or after stimulation.

  2. Movement Intensity before and after VR stimulation

    Time frame: Recorded during entire stay in the IMC (up to 24 hours)

    Movement intensity, measured as acceleration and rotation, will be measured using inertial measurement units. The data will be used to determine if there is a change in intensity between periods before, during, or after stimulation.

  3. Cognitive Functioning

    Time frame: Recorded during entire stay in the IMC (up to 24 hours)

    Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA).

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern

Registry information

Official study title

Virtual Reality Stimulation on the Intermediate Care Unit

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 19, 2022
Registry last updated
Jun 21, 2022

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.