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

Primary Purpose

Anxiety, Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
usual care
Musical intervention
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring central venous catheter, intensive care, music therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'Orléans

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

Musical intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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")

Secondary Outcome Measures

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")
duration of the catheter insertion
started with local anesthesia and ending with the application of the dressing on catheter insertion site.

Full Information

First Posted
January 8, 2018
Last Updated
May 3, 2019
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT03398525
Brief Title
Musical Intervention and Patient's Anxiety During Central Venous Catheter Insertion in the Intensive Care Unit
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
February 7, 2019 (Actual)
Study Completion Date
February 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain
Keywords
central venous catheter, intensive care, music therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomization with 1:1 allocation ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Musical intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
usual care following local standard operational procedures
Intervention Type
Other
Intervention Name(s)
Musical intervention
Intervention Description
Musical intervention using a marketed music program validated for music therapy
Primary Outcome Measure Information:
Title
anxiety assessed using a visual analog scale (VAS)
Description
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")
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
pain assessed using a visual analog scale (VAS)
Description
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")
Time Frame
30 minutes
Title
duration of the catheter insertion
Description
started with local anesthesia and ending with the application of the dressing on catheter insertion site.
Time Frame
10-30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai-Ahn Nay, MD
Organizational Affiliation
CHR Orléans, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35299213
Citation
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.
Results Reference
derived

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

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