Anxiety, Pain
Conditions
Keywords
central venous catheter, intensive care, music therapy
Brief 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.
Interventions
OTHERusual care
usual care following local standard operational procedures
OTHERMusical intervention
Musical intervention using a marketed music program validated for music therapy
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
randomization with 1:1 allocation ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient hospitalized in the intensive care unit or high-dependency unit * patient for whom a central venous catheter insertion is envisaged * patient capable of hearing and understanding explanations and able to consent
Exclusion criteria
* severe hearing loss * allergy to local anesthetic drug * pregnancy * lack of social security number * patient under guardianship * previous participation to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anxiety assessed using a visual analog scale (VAS) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain assessed using a visual analog scale (VAS) | 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) |
| duration of the catheter insertion | 10-30 min | started with local anesthesia and ending with the application of the dressing on catheter insertion site. |
Countries
France
Outcome results
None listed