N/A
Completed N=76
Effect of Music on the Sedative Use During Coronary Angioplasty
Coronary Angioplasty
Source: ClinicalTrials.gov NCT03817775 ↗
Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Dose Use of Midazolam Medication (mg) — 3.0; 1.2 mg — p=<0.01
Summary
This is a non-blinded, non-randomized controlled pilot study with no follow-up. Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Use of Midazolam Medication (mg) |
3.0; 1.2 | <0.01 sig |
| PRIMARY Dose Use of Propofol Medication (mg) |
12.8; 52 | <0.01 sig |
| PRIMARY Dose Use of Sufentanil Medication (ug) |
4.9; 5.1 | 0.7215 |
| SECONDARY Pain Score |
0.5; 0.7 | 0.5675 |
| SECONDARY Anxiety Score (NRS) |
4.2; 2.9 | <0.01 sig |
| SECONDARY Satisfaction of the Patient |
4.5; 4.8 | — |
| SECONDARY Effect on Physiological Parameters: BIS |
96.9; 94.9 | — |
| SECONDARY Effect on Physiological Parameters: Heart Rate |
71.3; 65.5 | — |
| SECONDARY Effect on Physiological Parameters: SpO2% |
98.5; 98.9 | — |
| SECONDARY Effect on Physiological Parameters: Mean Arterial Blood Pressure |
104.7; 104.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patient needs a coronary angiography
- Patient gives verbal consent to participation in the study.
Exclusion Criteria
- Patient aged less than 18 years at time of enrollment
- Patient doesn't like music for cultural reason
- Patient with serious psychiatric disorders
- Patient with not paired deafness or paired one with devices that are incompatible with wearing a headset.
Data sourced from ClinicalTrials.gov (NCT03817775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.