Impact of Music on Satisfaction, Anxiety, and Hemodynamics During Spinal Anesthesia for Cesarean Delivery

October 26, 2017 updated by: Michaela Kristina Farber, MD, Brigham and Women's Hospital

Perioperative Music for Patients Undergoing Scheduled Cesarean Delivery: Impact on Satisfaction, Anxiety, and Hemodynamic Response to Spinal Anesthesia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Several studies have demonstrated that preoperative anxiety has been associated with more profound hypotension after spinal anesthesia for cesarean delivery. Music has been shown to have a positive impact on hemodynamic response and patient satisfaction.

To investigators knowledge, however, no studies have evaluated the effects of music during the perioperative period for cesarean delivery on patient satisfaction and hemodynamic responses.

The study will be conducted as a randomized unblended controlled trial with three study arms: control (no music), intervention - Pandora® (patient selected music), and intervention - Mozart (pre-selected relaxing music). Eligibility criteria include pregnant women, 18 years or older, scheduled for elective cesarean delivery under spinal anesthesia. Exclusion criteria include 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. All subjects will be recruited from women admitted for scheduled cesarean delivery at Brigham and Women's Hospital. Investigators anticipate enrolling 150 patients, with 50 patients in each arm of the study.

Participation begins at the time of consultation on the day of surgery, and ends after the post-anesthesia check on postoperative day 1. After recruitment and consent, patients will be randomized using a computer-generated randomization scheme will be used to allocate patients to one of the arms of the study.

The three arms of the study are as follows:

  1. Control group: baseline hemodynamics and anxiety screen; no music
  2. Intervention group - Pandora: A study investigator will create a station in the Pandora® music application based on the patient's preferred music genre or artist.
  3. Intervention group - Mozart: A study investigator will turn on a playlist of pre-selected Mozart music.

At the time of recruitment, patient demographic data and vitals signs will be collected. A baseline anxiety screen will be obtained (all groups) using the verbal analog scale (VAS) anxiety score and abbreviated State-Trait Anxiety Inventory (STAI) questionnaire. Thirty minutes prior to spinal anesthesia for cesarean delivery the designated music group will have music initiated, as described above. 30 minutes after completion of spinal placement, patient hemodynamics and vasopressor requirement (phenylephrine, ephedrine) will be evaluated by the co-investigator in 5 minute intervals. Thirty minutes after arrival in the post-anesthesia care unit postpartum, a postpartum anxiety screen will be obtained (all groups) using the VAS and STAI questionnaire. On postpartum day 1, all patients enrolled in this study will be evaluated within 24 hours of the spinal anesthetic.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
baseline hemodynamics and anxiety screen; no music
Experimental: Pandora Music
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
Patients enrolled will be exposed to Pandora music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.
Experimental: Mozart Music
A study investigator will turn on a playlist of pre-selected Mozart music.
Other: Mozart Music
Patients enrolled will be exposed to Mozart music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
maternal anxiety level, VAS
Time Frame: prior to surgery
assessed by VAS questionnaire
prior to surgery
maternal anxiety level, VAS
Time Frame: 30 minutes after surgery
assessed by VAS questionnaire
30 minutes after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in maternal blood pressure after spinal anesthesia induction , compared to baseline blood pressure
Time Frame: within 30 minutes of spinal placement
nadir systolic arterial pressure within 30 minutes of spinal placement
within 30 minutes of spinal placement
maternal anxiety level, STAI
Time Frame: prior to surgery
assessed by STAI questionnaire
prior to surgery
maternal anxiety level, STAI
Time Frame: 30 minutes after surgery
assessed by STAI questionnaire
30 minutes after surgery
Overall patient satisfaction, questionnaire
Time Frame: prior to surgery
Assessed by questionnaire on postop day 1
prior to surgery
Overall patient satisfaction, questionnaire
Time Frame: 30 minutes after surgery
Assessed by questionnaire on postop day 1
30 minutes after surgery
Overall patient satisfaction, questionnaire
Time Frame: postoperative day 1
Assessed by questionnaire on postop day 1
postoperative day 1
Overall patient satisfaction, pain control
Time Frame: prior to surgery
Assessed by pain control/analgesic requirement on postop day 1
prior to surgery
Overall patient satisfaction, pain control
Time Frame: 30 minutes after surgery
Assessed by pain control/analgesic requirement on postop day 1
30 minutes after surgery
Overall patient satisfaction, pain control
Time Frame: postoperative day 1
Assessed by pain control/analgesic requirement on postop day 1
postoperative day 1
Vasopressor requirement, phenylephrine
Time Frame: within 30 minutes of spinal placement
utilization of phenylephrine, micrograms
within 30 minutes of spinal placement
Vasopressor requirement, ephedrine
Time Frame: within 30 minutes of spinal placement
utilization of ephedrine, milligrams
within 30 minutes of spinal placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015P002043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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