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

NCT03398525 | Completed

• 2 other identifiers: CHRO-2017-11IDRCB number: 2017-A02536-47
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain

Keywords

central venous catheter; intensive care; music therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• pain assessed using a visual analog scale (VAS)

  30 minutes

• duration of the catheter insertion

  10-30 min

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

Musical intervention

EXPERIMENTAL

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; Other: Musical intervention

Interventions

usual care OTHER

usual care following local standard operational procedures

Musical intervention; Usual care

Musical intervention OTHER

Musical intervention using a marketed music program validated for music therapy

Musical intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'Orléans

Orléans, 45067, France

Location

Related Publications (1)

• 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.

  PMID: 35299213 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mai-Ahn Nay, MD

  CHR Orléans, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomization with 1:1 allocation ratio

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 12, 2018
• Study Start: February 2, 2018
• Primary Completion: February 7, 2019
• Study Completion: February 7, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)