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OpenTrials
Completed

NCT Number: NCT03398525

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR d'Orléans

Orléans, 45067, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

usual care following local standard operational procedures

Musical intervention

Other

Musical intervention using a marketed music program validated for music therapy

Primary outcomes

  1. 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")

Secondary outcomes

  1. 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")

  2. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study 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

Acronym: MUSIC-CAT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 12, 2018
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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