NCT03412019

Brief Summary

Several studies have demonstrated that music can improve various outcomes during labor and delivery. However, many of these studies didn't measure satisfaction rate accurately. This study aim to assess patient satisfaction in the setting of music or no music during the cesarean delivery. The study will be conducted in the labor and delivery unit and the expected number to enroll and complete the study is 22.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

February 21, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 3, 2020

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

January 12, 2018

Results QC Date

December 2, 2019

Last Update Submit

February 18, 2020

Conditions

Patient Satisfaction

Keywords

MusicPatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    This outcome will be measured using Morgan's "Maternal Satisfaction Scale for Cesarean Section" (MSSCS). It is a 22-item questionnaire, each item have a Likert scale from 1-7 (1 =strongly disagree, 7=strongly agree), yielding a composite (total) score ranging 22-154, representing lowest to highest satisfaction. The questionnaire will be given to participants on post-operative day one during the hours of 8am-1pm.

    1 Day

Secondary Outcomes (2)

  • Patient Anxiety

    Perioperatively

  • Hemodynamic Parameter (Mean Arterial Pressure, MAP)

    post procedure

Study Arms (2)

Control group

NO INTERVENTION

baseline hemodynamics and anxiety screen; no music. Satisfaction will be measured.

Intervention group - Mozart

EXPERIMENTAL

A study investigator will turn on a playlist of pre-selected Mozart music. Hemodynamics and anxiety screen. Satisfaction will be measured.

Other: Music

Interventions

MusicOTHER

Selections of Mozart piano sonatas

Intervention group - Mozart

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-50 years old
  • Scheduled for elective cesarean delivery
  • Nulliparity
  • Singleton pregnancy
  • Full term fetus (≥37.0 weeks gestational age)
  • Healthy fetus (no known congenital diseases at the time of surgery)
  • Requesting neuraxial anesthesia for the procedure
  • Able to provide informed consent

You may not qualify if:

  • Patient refusal
  • Prior history of extensive abdominal surgery
  • Active labor
  • Contraindication to neuraxial anesthesia
  • Uncorrected coagulopathy
  • Infection at the skin site of epidural placement
  • Increased intracranial pressure
  • Untreated hemodynamic instability
  • Known hypersensitivity to local anesthetics (a.k.a. amide or ester allergy)
  • Patients with impaired hearing
  • Patient on anti-anxiolytic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (3)

  • Morgan PJ, Halpern S, Lo J. The development of a maternal satisfaction scale for caesarean section. Int J Obstet Anesth. 1999 Jul;8(3):165-70. doi: 10.1016/s0959-289x(99)80132-0.

    PMID: 15321139BACKGROUND

  • Conrad C, Niess H, Jauch KW, Bruns CJ, Hartl W, Welker L. Overture for growth hormone: requiem for interleukin-6? Crit Care Med. 2007 Dec;35(12):2709-13. doi: 10.1097/01.ccm.0000291648.99043.b9.

    PMID: 18074473BACKGROUND

  • Drzymalski DM, Dahlawi M, Hall RR, Ranjan S, Best CL. The effect of Mozart music on patient satisfaction during caesarean delivery: a randomised controlled trial. Anaesthesiol Intensive Ther. 2023;55(2):114-119. doi: 10.5114/ait.2023.129007.

    PMID: 37409839DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dan Drzymalski, MD
Organization
Tufts Medical Center
ddrzymalski@tuftsmedicalcenter.org
617 636 4526

Study Officials

  • Dan Drzymalski, MD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There will be two arms of this randomized controlled trial as follows: * Control group: baseline hemodynamics and anxiety screen; no music * Intervention group - Mozart: A study investigator will turn on a playlist of pre-selected Mozart music.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 26, 2018

Study Start

February 21, 2018

Primary Completion

August 6, 2019

Study Completion

August 6, 2019

Last Updated

March 3, 2020

Results First Posted

March 3, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Will be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
Available for 1 year within publication.
Access Criteria
Will need to write a formal request with reason for need to access the data

Locations

US(1)