Adult ICU PatientsCHOISIRNCT04017299
Electronic Distraction for ICU Patients
A study testing CHOISIR in people with Adult ICU Patients, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult ICU Patients
- What is being tested?
- CHOISIR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient admitted in intensive care unit,
- adult,
- French speaking,
- awake (RASS ≥ -1),
- not delirious (CAM-ICU negative),
Who cannot join
- patient refusal
- psychosis or preexisting cognitive dysfunction
- cerebral injury,
- hygiene/microbiological harm,
- pregnancy,
- decision of withdrawal of care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Choose an Electronic Distraction, Faisability and Discomfort Improvement Evaluation by and for ICU Patients : a Cross Over Randomized Controlled Study.
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.
Read the detailed 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.
- Conditions
- Adult ICU Patients
- Being tested
- CHOISIR
- Keywords
- ICU, Pain, Anxiety, Thirst, Dyspnea, Sleep, Discomfort, Distress, Virtual Reality, Music Therapy
- Medical subject headings
- Pain, Anxiety Disorders, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOISIROther
Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality with computer graphics | Active comparator | Use of Virtual reality with computer graphics Receives: Other: CHOISIR |
| Virtual reality with real movies | Active comparator | Use of Virtual reality with real movies Receives: Other: CHOISIR |
| Music therapy (dedicated device and music scores) | Active comparator | Use of music therapy (dedicated device and music scores) Receives: Other: CHOISIR |
| Usual device (TV radio) | Other | usual distraction : watching TV Receives: Other: CHOISIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of intensity of the 5 discomfort symptoms (pain, anxiety, thirst, dyspnea, insomnia) assessed by a self-report 0-10 visually enlarged numeric rating scale
Measured: Just after the use of each device (up to 20 minutes)
Secondary outcomes (6)
Variation of physiologic parametres (Heart Rate, Blood pressure, Respiratory rate and Analgesia nociception Index), evaluation of feasibility and feelings concerning the distraction devices.
Measured: ICU discharge (up to Day 28)
Variation of Respiratory rate during the use of each device
Respiratory rate : c/min
Measured: up to 20 minutes (after the device use )
Variation of physiologic Blood pressure during the use of each device
Blood pressure : mmHg
Measured: up to 20 minutes (after the device use )
Variation of Heart Rate during the use of each device
Heart Rate : b/min
Measured: up to 20 minutes (after the device use )
evaluation of feasibility assessed by the Numeric Rating Scale from 0 to 10
Numeric Rating Scale from 0 to 10
Measured: just after the use of each device (up to 20 minutes)
Evaluation of the feelings concerning the distraction devices assessed by the Numeric Rating Scale from 0 to 10
Numeric Rating Scale from 0 to 10
Measured: ICU discharge or up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start17 Jul 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gérald CHANQUES, PhD, Principal investigator, University of Montpellier Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017299
- Sponsor's protocol ID
- RECHMPL18_0218
- Acronym
- CHOISIR
- Status last verified
- Sep 2025
- First submitted
- 5 Jul 2019
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choose an Electronic Distraction, Faisability and Discomfort Improvement Evaluation by and for ICU Patients : a Cross Over Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04017299
- Acronym / sponsor ID
- CHOISIR / RECHMPL18_0218
- Conditions
- Adult ICU Patients
- Keywords
- ICU, Pain, Anxiety, Thirst, Dyspnea, Sleep, Discomfort, Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Virtual reality with computer graphics | Active comparator | Other: CHOISIRUse of Virtual reality with computer graphics |
| Virtual reality with real movies | Active comparator | Other: CHOISIRUse of Virtual reality with real movies |
| Music therapy (dedicated device and music scores) | Active comparator | Other: CHOISIRUse of music therapy (dedicated device and music scores) |
| Usual device (TV radio) | Other | Other: CHOISIRusual distraction : watching TV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient admitted in intensive care unit,
- adult,
- French speaking,
- awake (RASS ≥ -1),
- not delirious (CAM-ICU negative),
Key exclusion criteria (6 listed)
- patient refusal
- psychosis or preexisting cognitive dysfunction
- cerebral injury,
- hygiene/microbiological harm,
- pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHOISIREvery patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes. | Other | Music therapy (dedicated device and music scores), Usual device (TV radio), Virtual reality with computer graphics, Virtual reality with real movies |
Primary outcome
Variation of intensity of the 5 discomfort symptoms (pain, anxiety, thirst, dyspnea, insomnia) assessed by a self-report 0-10 visually enlarged numeric rating scale
Time frame: Just after the use of each device (up to 20 minutes)
6 secondary outcomes
Variation of physiologic parametres (Heart Rate, Blood pressure, Respiratory rate and Analgesia nociception Index), evaluation of feasibility and feelings concerning the distraction devices.
Time frame: ICU discharge (up to Day 28)
Variation of Respiratory rate during the use of each device
Time frame: up to 20 minutes (after the device use )
Variation of physiologic Blood pressure during the use of each device
Time frame: up to 20 minutes (after the device use )
Variation of Heart Rate during the use of each device
Time frame: up to 20 minutes (after the device use )
evaluation of feasibility assessed by the Numeric Rating Scale from 0 to 10
Time frame: just after the use of each device (up to 20 minutes)
Evaluation of the feelings concerning the distraction devices assessed by the Numeric Rating Scale from 0 to 10
Time frame: ICU discharge or up to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes. identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gérald CHANQUES, PhD principal investigator
University of Montpellier Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHOISIR in people with Adult ICU Patients, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of intensity of the 5 discomfort symptoms (pain, anxiety, thirst, dyspnea, insomnia) assessed by a self-report 0-10 visually enlarged numeric rating scale (time frame: Just after the use of each device (up to 20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.