Musical Intervention and Patient's Anxiety During Central Venous Catheter Insertion in the Intensive Care Unit (MUSIC-CAT)

May 3, 2019 updated by: Centre Hospitalier Régional d'Orléans

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orléans, France, 45067
        • CHR d'Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Other: usual care
usual care following local standard operational procedures
EXPERIMENTAL: 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.
Other: usual care
usual care following local standard operational procedures
Other: Musical intervention
Musical intervention using a marketed music program validated for music therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anxiety assessed using a visual analog scale (VAS)
Time Frame: 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")
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain assessed using a visual analog scale (VAS)
Time Frame: 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")
30 minutes
duration of the catheter insertion
Time Frame: 10-30 min
started with local anesthesia and ending with the application of the dressing on catheter insertion site.
10-30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Mai-Ahn Nay, MD, CHR Orléans, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2018

Primary Completion (ACTUAL)

February 7, 2019

Study Completion (ACTUAL)

February 7, 2019

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (ACTUAL)

January 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2017-11
  • IDRCB number: 2017-A02536-47 (OTHER: French Government)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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