Clinical trial NCT03398525: Musical Intervention and Patient's Anxiety During Central Venous Catheter Insertion in the Intensive Care Unit
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Keywords: central venous catheter
intensive care
music therapy
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization with 1:1 allocation ratio
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: anxiety assessed using a visual analog scale (VAS)
timeFrame: 30 minutes
Secondary outcomes:
measure: pain assessed using a visual analog scale (VAS)
timeFrame: 30 minutes
measure: duration of the catheter insertion
timeFrame: 10-30 min
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
affiliation: CHR Orléans, France
name: Mai-Ahn Nay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacquier S, Nay MA, Muller G, Muller L, Mathonnet A, Lefevre-Benzekri D, Bretagnol A, Barbier F, Kamel T, Runge I, Skarzynski M, Sauvage B, Boulain T. Effect of a Musical Intervention During the Implantation of a Central Venous Catheter or a Dialysis Catheter in the Intensive Care Unit: A Prospective Randomized Pilot Study. Anesth Analg. 2022 Apr 1;134(4):781-790. doi: 10.1213/ANE.0000000000005696.