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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anxiety, Pain

Intervention / Treatment
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* Other: usual care
* Other: Musical intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomization with 1:1 allocation ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>After patient information, appropriate skin antisepsis according to local procedures, surgical hand antisepsis by the operator, use of sterile drapes, gowns and gloves, insertion of a central venous catheter after after local anesthesia with 2% lidocaine, using ultrasound guidance. | Other: usual care<br>* usual care following local standard operational procedures<br>|
| Experimental: Musical intervention<br>After patient information, appropriate skin antisepsis according to local procedures, surgical hand antisepsis by the operator, use of sterile drapes, gowns and gloves, insertion of a central venous catheter after after local anesthesia with 2% lidocaine, using ultrasound guidance. In addition, a U-shaped music program (MUSIC CARE, trade mark) will be delivered to the patient through headphones throughout the catheter insertion procedure beginning with the operator's hand washing and ending once the dressing is put on the catheter insertion site. | Other: usual care<br>* usual care following local standard operational procedures<br>Other: Musical intervention<br>* Musical intervention using a marketed music program validated for music therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety assessed using a visual analog scale (VAS) | 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) | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain assessed using a visual analog scale (VAS) | 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) | 30 minutes | 
| duration of the catheter insertion | started with local anesthesia and ending with the application of the dressing on catheter insertion site. | 10-30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central venous catheter, intensive care, music therapy