NCT03398525

Musical Intervention and Patient's Anxiety During Central Venous Catheter Insertion in the Intensive Care Unit

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anxiety
• Pain

Interventions

Type	Name	Description
OTHER	usual care	usual care following local standard operational procedures
OTHER	Musical intervention	Musical intervention using a marketed music program validated for music therapy

Timeline

• Start date: 2018-02-02
• Primary completion: 2019-02-07
• Completion: 2019-02-07
• First posted: 2018-01-12
• Last updated: 2019-05-06

Locations

1 site across 1 country: France