Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT03398525
Study type Interventional
Source Centre Hospitalier Régional d'Orléans
Contact Thierry Boulain, MD
Phone 33 2 38 51 44 46
Status Recruiting
Phase N/A
Start date February 2, 2018
Completion date February 1, 2020

See also
  Status Clinical Trial Phase
Completed NCT01441141 - Genetics and Pain Severity in Sickle Cell Disease
Recruiting NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Recruiting NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
Not yet recruiting NCT03661892 - Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets Early Phase 1
Completed NCT01198197 - PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A Early Phase 1
Enrolling by invitation NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Completed NCT03459872 - Acupuncture Outcomes Based Rehabilitation N/A
Recruiting NCT03256487 - Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department Phase 2
Recruiting NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Not yet recruiting NCT03634306 - Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy N/A
Completed NCT03690609 - CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers N/A
Completed NCT02533908 - Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children Phase 3
Not yet recruiting NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Not yet recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
Recruiting NCT02911168 - Comparison of US-Guided Paravertebral and Proximal Intercostal Nerve Blocks N/A