CHR d'Orléans
Orléans, 45067, France
NCT Number: NCT03398525
Intensive care unit patients who have to undergo central venous catheter insertion and are able to hear explanations and to gave consent, will be randomized to either usual care during catheter insertion or to a musical intervention added to usual care.
The primary objective will be to assess the patient's anxiety just after catheter insertion. Secondary outcome measures will be the patient-reported pain, the duration of catheter insertion, and the need for additional anxiolytic or sedative drugs during catheter insertion.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Orléans, 45067, France
Patient informed consent will be obtained before any other study specific procedure.
Computer-generated randomization with 1:1 allocation ratio will be stratified by the site of catheter insertion (superior vena cava or femoral), and by the ventilatory status (patient mechanically ventilated or not). Block size, not known by the investigators, of 4 or 6 will be used. Randomization group for each patient will be kept concealed into sealed opaque envelops until inclusion once consent obtained.
Anxiety, the primary outcome measure, and pain related to the catheter insertion will be assessed using two distinct Visual Analogic Scales.
In the usual care group, the catheter will be inserted using the Seldinger method, under local anesthesia with 2% lidocaine, with ultrasound guidance, after proper skin antisepsis, surgical operator's hand washing and antisepsis, and use of sterile drapes, gowns and gloves.
In the intervention group, in addition to the usual care procedures as described above, a musical U-shaped session will be delivered to the patient through headphones, using a tablet computer and the "MUSIC CARE" music program, a validated program for use in health care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
usual care following local standard operational procedures
Musical intervention using a marketed music program validated for music therapy
Time frame: 30 minutes
self-reported patient's anxiety assessed using a 100mm-visual analog scale, extending from 0 mm ("no anxiety") to 100 mm ("worst anxiety ever experienced")
Time frame: 30 minutes
self-reported patient's pain assessed using a 100mm-visual analog scale, extending from 0 mm ("no pain") to 100 mm ("the worst pain possible")
Time frame: 10-30 min
started with local anesthesia and ending with the application of the dressing on catheter insertion site.
Centre Hospitalier Régional d'Orléans
Other
Effect of a Musical Intervention in the Intensive Care Unit During the Implantation of a Central Venous Access or a Dialysis Catheter: A Prospective, Randomized Pilot Study
Acronym: MUSIC-CAT
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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