NCT02732964

Brief Summary

The aim of this study is to evaluate the effect of perioperative music on maternal anxiety, hemodynamic response to spinal anesthesia, postoperative pain medication requirement, and overall maternal satisfaction. Investigators hypothesize that women exposed to perioperative music will have greater overall satisfaction with the delivery experience. Investigators also hypothesize that perioperative music will lower anxiety levels of women having a scheduled cesarean delivery, result in a less profound degree of spinal-induced hypotension prior to cesarean delivery, and result in a lower requirement of analgesics postpartum.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable anxiety

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

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

April 1, 2016

Last Update Submit

October 26, 2017

Conditions

AnxietyHypotension

Keywords

satisfaction

Outcome Measures

Primary Outcomes (2)

  • maternal anxiety level, VAS

    assessed by VAS questionnaire

    prior to surgery

  • maternal anxiety level, VAS

    assessed by VAS questionnaire

    30 minutes after surgery

Secondary Outcomes (11)

  • Change in maternal blood pressure after spinal anesthesia induction , compared to baseline blood pressure

    within 30 minutes of spinal placement

  • maternal anxiety level, STAI

    prior to surgery

  • maternal anxiety level, STAI

    30 minutes after surgery

  • Overall patient satisfaction, questionnaire

    prior to surgery

  • Overall patient satisfaction, questionnaire

    30 minutes after surgery

  • +6 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

baseline hemodynamics and anxiety screen; no music

Pandora Music

EXPERIMENTAL

A study investigator will create a station in the Pandora® music application based on the patient's preferred music genre or artist.

Other: Pandora Music

Mozart Music

EXPERIMENTAL

A study investigator will turn on a playlist of pre-selected Mozart music.

Other: Mozart Music

Interventions

Pandora MusicOTHER

Patients enrolled will be exposed to Pandora music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.

Pandora Music
Mozart MusicOTHER

Patients enrolled will be exposed to Mozart music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.

Mozart Music

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women
  • years or older
  • scheduled for elective cesarean delivery under spinal anesthesia.

You may not qualify if:

  • absolute contraindications of neuraxial anesthesia including patient refusal
  • uncorrected coagulopathy
  • infection at the skin site of epidural placement
  • increased intracranial pressure, or untreated hemodynamic instability.
  • Patients in active labor, with impaired hearing, or who do not want to participate in the study will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Drzymalski DM, Lumbreras-Marquez MI, Tsen LC, Camann WR, Farber MK. The effect of patient-selected or preselected music on anxiety during cesarean delivery: a randomized controlled trial. J Matern Fetal Neonatal Med. 2020 Dec;33(24):4062-4068. doi: 10.1080/14767058.2019.1594766. Epub 2019 Mar 27.

    PMID: 30880522DERIVED

MeSH Terms

Conditions

Anxiety DisordersHypotensionPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersVascular DiseasesCardiovascular DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 11, 2016

Study Start

November 1, 2015

Primary Completion

September 1, 2016

Study Completion

October 1, 2017

Last Updated

October 30, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)