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

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: Completed
• Conditions: Anxiety; Hypotension
• Intervention / Treatment: Other: Pandora Music; Other: Mozart Music

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: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
maternal anxiety level, VAS	assessed by VAS questionnaire	prior to surgery
maternal anxiety level, VAS	assessed by VAS questionnaire	30 minutes after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maternal blood pressure after spinal anesthesia induction , compared to baseline blood pressure	nadir systolic arterial pressure within 30 minutes of spinal placement	within 30 minutes of spinal placement
maternal anxiety level, STAI	assessed by STAI questionnaire	prior to surgery
maternal anxiety level, STAI	assessed by STAI questionnaire	30 minutes after surgery
Overall patient satisfaction, questionnaire	Assessed by questionnaire on postop day 1	prior to surgery
Overall patient satisfaction, questionnaire	Assessed by questionnaire on postop day 1	30 minutes after surgery
Overall patient satisfaction, questionnaire	Assessed by questionnaire on postop day 1	postoperative day 1
Overall patient satisfaction, pain control	Assessed by pain control/analgesic requirement on postop day 1	prior to surgery
Overall patient satisfaction, pain control	Assessed by pain control/analgesic requirement on postop day 1	30 minutes after surgery
Overall patient satisfaction, pain control	Assessed by pain control/analgesic requirement on postop day 1	postoperative day 1
Vasopressor requirement, phenylephrine	utilization of phenylephrine, micrograms	within 30 minutes of spinal placement
Vasopressor requirement, ephedrine	utilization of ephedrine, milligrams	within 30 minutes of spinal placement

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: satisfaction
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Anxiety Disorders; Hypotension
• Other Study ID Numbers: 2015P002043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO