Musical Intervention and Patient's Anxiety During Central Venous Catheter Insertion in the Intens… (NCT03398525) | Clinical Trial Compass
CompletedNot Applicable
Musical Intervention and Patient's Anxiety During Central Venous Catheter Insertion in the Intensive Care Unit
France75 participantsStarted 2018-02-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
anxiety assessed using a visual analog scale (VAS)