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Electronic Distraction for ICU Patients (CHOISIR)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Adult ICU Patients

Treatments

Other: CHOISIR

Study type

Interventional

Funder types

Other

Identifiers

NCT04017299
RECHMPL18_0218

Details and patient eligibility

About

This is a feasibility study of electronic devices in order to reduce neuro-psychological disorders and suffering in intensive care unit (ICU) patients. A first step study is necessary to define which device is effective and safe to reduce symptom intensities, among music therapy, virtual reality with real pictures, virtual reality with artificial pictures, and common devices (radio or television). If some devices are effective to reduce patients' symptoms, a second step will be to implement and assess the impact of these tools in a multicenter trial.

Full description

Quality of life following intensive care unit discharge is more and more anticipated during the ICU stay. Psychological trauma during ICU stay, related to medical management, can be very deleterious at short and long term, inducing psychological troubles as post-traumatic stress disorder and delaying the return to a normal social and professional life. For this reason, managing patients' distress is particularly important in the intensive care setting. There has been an increasing number of new technologies for the distraction of patients in different settings. a Today, a large amount of electronic distraction is available. TV and radio are available in each ICU, music therapy has already been studied and it is currently used in some ICUs. Virtual reality (VR) is used to improve attention and memory in stroke patients. Furthermore, VR seems to decrease stress post trauma disorders and phobia, as well as pain and anxiety during surgical procedures and physiotherapy. Our first step study will help us to determine which electronic distraction has the most effect on the top five discomfort symptoms frequently observed in ICU: pain, anxiety dyspnea, thirst and sleep privation.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patient admitted in intensive care unit,
  • adult,
  • French speaking,
  • awake (RASS ≥ -1),
  • not delirious (CAM-ICU negative),

Exclusion criteria

  • patient refusal
  • psychosis or preexisting cognitive dysfunction
  • cerebral injury,
  • hygiene/microbiological harm,
  • pregnancy,
  • decision of withdrawal of care

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

60 participants in 4 patient groups

Virtual reality with computer graphics
Active Comparator group
Description:
Use of Virtual reality with computer graphics
Treatment:
Other: CHOISIR
Virtual reality with real movies
Active Comparator group
Description:
Use of Virtual reality with real movies
Treatment:
Other: CHOISIR
Music therapy (dedicated device and music scores)
Active Comparator group
Description:
Use of music therapy (dedicated device and music scores)
Treatment:
Other: CHOISIR
Usual device (TV radio)
Other group
Description:
usual distraction : watching TV
Treatment:
Other: CHOISIR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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