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出境医 / 临床实验 / Electronic Distraction for ICU Patients (CHOISIR)

Electronic Distraction for ICU Patients (CHOISIR)

Study Description
Brief 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, 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.

Condition or disease Intervention/treatment Phase
Adult ICU Patients Other: CHOISIR Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Choose an Electronic Distraction, Faisability and Discomfort Improvement Evaluation by and for ICU Patients : a Cross Over Randomized Controlled Study.
Actual Study Start Date : July 17, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Virtual reality with computer graphics
Use of Virtual reality with computer graphics
 Other: CHOISIR
Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.
Active Comparator: Virtual reality with real movies
Use of Virtual reality with real movies
 Other: CHOISIR
Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.
Active Comparator: Music therapy (dedicated device and music scores)
Use of music therapy (dedicated device and music scores)
 Other: CHOISIR
Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.
Usual device (TV radio)
usual distraction : watching TV
 Other: CHOISIR
Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.
Outcome Measures
Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Variation of Respiratory rate during the use of each device [ Time Frame: up to 20 minutes (after the device use ) ]
    Respiratory rate : c/min

  3. Variation of physiologic Blood pressure during the use of each device [ Time Frame: up to 20 minutes (after the device use ) ]
    Blood pressure : mmHg

  4. Variation of Heart Rate during the use of each device [ Time Frame: up to 20 minutes (after the device use ) ]
    Heart Rate : b/min

  5. 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) ]
    Numeric Rating Scale from 0 to 10

  6. 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 ]
    Numeric Rating Scale from 0 to 10


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
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France
University of Montpellier Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Gérald CHANQUES, PhD University of Montpellier Hospitals
Tracking Information
First Submitted Date  ICMJE July 5, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE July 17, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • 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 ) ]
    Respiratory rate : c/min
  • Variation of physiologic Blood pressure during the use of each device [ Time Frame: up to 20 minutes (after the device use ) ]
    Blood pressure : mmHg
  • Variation of Heart Rate during the use of each device [ Time Frame: up to 20 minutes (after the device use ) ]
    Heart Rate : b/min
  • 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) ]
    Numeric Rating Scale from 0 to 10
  • 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 ]
    Numeric Rating Scale from 0 to 10
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electronic Distraction for ICU Patients
Official Title  ICMJE Choose an Electronic Distraction, Faisability and Discomfort Improvement Evaluation by and for ICU Patients : a Cross Over Randomized Controlled Study.
Brief 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, 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adult ICU Patients
Intervention  ICMJE Other: CHOISIR
Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.
Study Arms  ICMJE
  • Active Comparator: Virtual reality with computer graphics
    Use of Virtual reality with computer graphics
    Intervention: Other: CHOISIR
  • Active Comparator: Virtual reality with real movies
    Use of Virtual reality with real movies
    Intervention: Other: CHOISIR
  • Active Comparator: Music therapy (dedicated device and music scores)
    Use of music therapy (dedicated device and music scores)
    Intervention: Other: CHOISIR
  • Usual device (TV radio)
    usual distraction : watching TV
    Intervention: Other: CHOISIR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04017299
Other Study ID Numbers  ICMJE 7667
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected
Time Frame: 12 months after the main publication
Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gérald CHANQUES, PhD University of Montpellier Hospitals
PRS Account University Hospital, Montpellier
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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