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

Not Applicable

Completed

• Conditions: Pain; Anxiety
• Interventions: Other: usual care; Other: Musical intervention

• Registration Number: NCT03398525
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-12
• Study Start: 2018-02-02
• Primary Completion: 2019-02-07
• Study Completion: 2019-02-07
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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Exclusion Criteria

• severe hearing loss
• allergy to local anesthetic drug
• pregnancy
• lack of social security number
• patient under guardianship
• previous participation to the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Musical intervention	Musical intervention	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.
Musical intervention	usual care	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.
Usual care	usual care	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CHR d'Orléans; 🇫🇷 Orléans, France