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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732964
• Other study ID #: 2015P002043
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: October 26, 2017
• Start date: November 2015
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Hypotension

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal anxiety level, VAS	assessed by VAS questionnaire	prior to surgery
Primary	maternal anxiety level, VAS	assessed by VAS questionnaire	30 minutes after surgery
Secondary	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
Secondary	maternal anxiety level, STAI	assessed by STAI questionnaire	prior to surgery
Secondary	maternal anxiety level, STAI	assessed by STAI questionnaire	30 minutes after surgery
Secondary	Overall patient satisfaction, questionnaire	Assessed by questionnaire on postop day 1	prior to surgery
Secondary	Overall patient satisfaction, questionnaire	Assessed by questionnaire on postop day 1	30 minutes after surgery
Secondary	Overall patient satisfaction, questionnaire	Assessed by questionnaire on postop day 1	postoperative day 1
Secondary	Overall patient satisfaction, pain control	Assessed by pain control/analgesic requirement on postop day 1	prior to surgery
Secondary	Overall patient satisfaction, pain control	Assessed by pain control/analgesic requirement on postop day 1	30 minutes after surgery
Secondary	Overall patient satisfaction, pain control	Assessed by pain control/analgesic requirement on postop day 1	postoperative day 1
Secondary	Vasopressor requirement, phenylephrine	utilization of phenylephrine, micrograms	within 30 minutes of spinal placement
Secondary	Vasopressor requirement, ephedrine	utilization of ephedrine, milligrams	within 30 minutes of spinal placement