Effect of Music on the Sedative Use During Coronary Angioplasty

NCT03817775 | Completed Results

• 1 other identifier: MusicSeda
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Angioplasty

Keywords

Music therapy; sedation; coronary angioplasty

Outcome Measures

Primary Outcomes (3)

• Dose Use of Midazolam Medication (mg)

  The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg.

  Between 10 minutes prior to the beginning of the procedure up to 45 minutes.

• Dose Use of Propofol Medication (mg)

  The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg.

  Between 10 minutes prior to the beginning of the procedure up to 45 minutes.

• Dose Use of Sufentanil Medication (ug)

  The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug.

  Between 10 minutes prior to the beginning of the procedure up to 45 minutes.

Secondary Outcomes (7)

• Pain Score

  From 0 up to 45 minutes.

• Anxiety Score (NRS)

  From 0 up to 45 minutes.

• Satisfaction of the Patient

  Right after the end of the procedure in the recovery room.

• Effect on Physiological Parameters: BIS

  10 minutes prior to the beginning of the procedure

• Effect on Physiological Parameters: Heart Rate

  10 minutes prior to the beginning of the procedure.

Study Arms (2)

Control

NO INTERVENTION

The control group will undergo coronary angiography without music intervention.

Music therapy

EXPERIMENTAL

The intervention group will also undergo coronary angiography and will administer music therapy between 10 minutes prior to the beginning of the procedure until its end.

Other: Music therapy

Interventions

Music therapy OTHER

The intervention group will administer "U" sequence between 10 minutes prior to the beginning of the procedure until its end.

Music therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient needs a coronary angiography
• Patient gives verbal consent to participation in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Association de Musicothérapie Applications et Recherches Cliniques: lead
• American Hospital of Paris: collaborator

Study Sites (1)

American Hospital of Paris

Neuilly-sur-Seine, 92200, France

Location

Related Publications (4)

• 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.

  PMID: 17085009 BACKGROUND

• 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.

  PMID: 22001666 BACKGROUND

• 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.

  PMID: 27618935 BACKGROUND

• 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.

  PMID: 27548494 BACKGROUND

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr Gilles BOCCARA
• Organization: • Department of Anaesthesia and Intensive Care, American Hospital of Paris

gilles.boccara@ahparis.org

+33 1 46 41 25 25

Study Officials

• Gilles BOCCARA, PhD

  Department of Anaesthesia and Intensive Care, American Hospital of Paris

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2019
• First Posted: January 25, 2019
• Study Start: January 31, 2019
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: October 21, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)