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

Pain Clinical Trial

— MUSIC-CAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398525
• Other study ID #: CHRO-2017-11
• Secondary ID: IDRCB number: 20
• Status: Completed
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: February 7, 2019

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 7, 2019
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Other:
• usual care
usual care following local standard operational procedures
• Musical intervention
Musical intervention using a marketed music program validated for music therapy

Locations

Country	Name	City	State
France	CHR d'Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	duration of the catheter insertion	started with local anesthesia and ending with the application of the dressing on catheter insertion site.	10-30 min