Pain Clinical Trial
Official title:
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
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.
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.
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