Clinical trial NCT03817775: Effect of Music on the Sedative Use During Coronary Angioplasty
Official title: Effect of Music on the Reduction of the Sedative Dose During Coronary Angioplasty: A Control-case Comparison Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Angioplasty
Keywords: Music therapy
sedation
coronary angioplasty
Lead sponsor: Association de Musicothérapie Applications et Recherches Cliniques
Sponsor class: OTHER
Collaborators: name: American Hospital of Paris
First posted: 2019-01-25
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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: Control or music intervention.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a non-blinded, non-randomized controlled pilot study with patients who will be followed during their coronary angiography procedure and 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. It is expected to enroll around 100 patients and this is estimated to be obtained in a period of 2 months approximately. Patients will be placed in the control group, without music intervention, or assigned to the music group. Assignment will be done in this manner due to limited availability of the hardware and software to the investigation team. Patients in both groups will be matched based on age, sex, weight, height, American Society of Anesthesiology (ASA) score, and prior medical history, including diabetes, hypertension, chronic kidney disease and stroke. Each patient will receive a standardized sedation in the traditional manner and at the discretion of the investigator to reach Bispectral index (BIS) score below 90 and sedation score ≤ 1. The primary study end points will be the consumptions in analgesics and hypnotics. Secondary study end points will be pain and anxiety scores as measured the Numeric Rating Scale (NRS), the Visual Analog Scale (VAS) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS).

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.

Primary outcomes:
measure: Dose Use of Midazolam Medication (mg)
timeFrame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
measure: Dose Use of Propofol Medication (mg)
timeFrame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
measure: Dose Use of Sufentanil Medication (ug)
timeFrame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
Secondary outcomes:
measure: Pain Score
timeFrame: From 0 up to 45 minutes.
measure: Anxiety Score (NRS)
timeFrame: From 0 up to 45 minutes.
measure: Satisfaction of the Patient
timeFrame: Right after the end of the procedure in the recovery room.
measure: Effect on Physiological Parameters: BIS
timeFrame: 10 minutes prior to the beginning of the procedure
measure: Effect on Physiological Parameters: Heart Rate
timeFrame: 10 minutes prior to the beginning of the procedure.
measure: Effect on Physiological Parameters: SpO2%
timeFrame: 10 minutes prior to the beginning of the procedure.
measure: Effect on Physiological Parameters: Mean Arterial Blood Pressure
timeFrame: 10 minutes prior to the beginning of the procedure.
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: American Hospital of Paris
Study officials:
affiliation: Department of Anaesthesia and Intensive Care, American Hospital of Paris
name: Gilles BOCCARA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.
citation: Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
citation: Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.
citation: Guetin S, Brun L, Deniaud M, Clerc JM, Thayer JF, Koenig J. Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences. Altern Ther Health Med. 2016 Jul;22(4):60-3.