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

NCT ID: NCT03398525

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2019-02-07

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.

Conditions

Anxiety; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: OTHER

usual care following local standard operational procedures

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.

Group Type: EXPERIMENTAL

usual care

Intervention Type: OTHER

usual care following local standard operational procedures

Musical intervention

Intervention Type: OTHER

Musical intervention using a marketed music program validated for music therapy

Interventions

usual care

usual care following local standard operational procedures

Intervention Type: OTHER

Musical intervention

Musical intervention using a marketed music program validated for music therapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mai-Ahn Nay, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Orléans, France

Locations

CHR d'Orléans

Orléans, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35299213 (View on PubMed)

Other Identifiers

IDRCB number: 2017-A02536-47

Identifier Type: OTHER

Identifier Source: secondary_id

CHRO-2017-11

Identifier Type: -

Identifier Source: org_study_id