An interventional study of usual care and Musical intervention in Anxiety and Pain, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-06.
Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Prevention
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Among 482 studies in Pain with a site in France — 75 open to participants now, 79 under way, 8 of them phase 3. Pain · France.
Among the 482 studies in Pain with a site in France, this one is the 193rd largest by enrollment of the 369 interventional ones that give a count, is one of 22 that started in 2018, is one of 225 with no phase, and was the 254th registered.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →75 of the 482 studies in Pain with a site in France are open now. Recruiting first, the newest first:
University Hospital, Angers · Sites in France
Ages 18–120
Farraj Miguel · Sites in France, Belgium
Ages 18+
University Hospital, Toulouse · Sites in France
Ages 18+
University Hospital, Limoges · Sites in France
Ages 18–50 · Women only
Teleflex · Sites in France, United States, Latvia and 1 more country
Ages 18–80
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
482 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 33 · Phase 3 83 · Phase 4 29
First in 2000; this study’s year is marked. 22 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 75 is above the median of 66 across 8,497 interventional studies indexed under Pain.
Median enrollment 80 across the 369 interventional studies, 100 across the 112 observational. Of the 348 that completed or were terminated, 31 (9%) have results posted.
This tab as a report to print or save as PDF → With an account.
68 of 482 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Régional d'Orléans is the lead sponsor of 132 studies on the registry; 32 are open to participants now.
Centre Hospitalier Régional d'Orléans has 4 studies filed under Pain — fewer than ten, so there is no comparison to draw.
25 of the studies in Pain with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06381063Phase 3Centre Hospitalier Universitaire, AmiensNon-steroidal Anti-inflammatory in Cardiac Surgery | 2027-03 |
| NCT06917651Phase 3University Hospital, Clermont-FerrandManagement of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation. | 2027-04-22 |
| NCT05275881Poitiers University HospitalImpact of Virtual Reality in Hematology and Oncology During Invasive Procedures in Children, Adolescents and Young Adults, from 7 to Less Than 25 Years Old | 2026-11-13 |
| NCT07668050University Hospital, Clermont-FerrandA Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology. | 2026-12 |
| NCT06779812Clinique BizetImpact of Auriculotherapy on Postoperative Pain in Patients Undergoing Surgery for SCC | 2026-12 |
Add all 25 to your calendar (.ics) → With an account.
Among the 482 studies in Pain with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
This study's enrollment of 75 is above the median of 66 across 8,497 interventional studies indexed under Pain.
Browse Pain studies →Centre Hospitalier Régional d'Orléans is the lead sponsor of 132 studies on the registry; 32 are open to participants now.
Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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 · Other: Musical intervention
usual care following local standard operational procedures
Musical intervention using a marketed music program validated for music therapy
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")
Time frame: 30 minutes
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")
Time frame: 30 minutes
duration of the catheter insertion
started with local anesthesia and ending with the application of the dressing on catheter insertion site.
Time frame: 10-30 min
Plan to share: No
Ran from Feb 2018 to primary completion in Feb 2019, 12 months.
Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 12 months is above that.
Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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