Impact of Music on Satisfaction, Anxiety, and Hemodynamics During Spinal Anesthesia for Cesarean Delivery
Primary Purpose
Anxiety, Hypotension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pandora Music
Mozart Music
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring satisfaction
Eligibility Criteria
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.
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Pandora Music
Mozart Music
Arm Description
baseline hemodynamics and anxiety screen; no music
A study investigator will create a station in the Pandora® music application based on the patient's preferred music genre or artist.
A study investigator will turn on a playlist of pre-selected Mozart music.
Outcomes
Primary Outcome Measures
maternal anxiety level, VAS
assessed by VAS questionnaire
maternal anxiety level, VAS
assessed by VAS questionnaire
Secondary Outcome Measures
Change in maternal blood pressure after spinal anesthesia induction , compared to baseline blood pressure
nadir systolic arterial pressure within 30 minutes of spinal placement
maternal anxiety level, STAI
assessed by STAI questionnaire
maternal anxiety level, STAI
assessed by STAI questionnaire
Overall patient satisfaction, questionnaire
Assessed by questionnaire on postop day 1
Overall patient satisfaction, questionnaire
Assessed by questionnaire on postop day 1
Overall patient satisfaction, questionnaire
Assessed by questionnaire on postop day 1
Overall patient satisfaction, pain control
Assessed by pain control/analgesic requirement on postop day 1
Overall patient satisfaction, pain control
Assessed by pain control/analgesic requirement on postop day 1
Overall patient satisfaction, pain control
Assessed by pain control/analgesic requirement on postop day 1
Vasopressor requirement, phenylephrine
utilization of phenylephrine, micrograms
Vasopressor requirement, ephedrine
utilization of ephedrine, milligrams
Full Information
NCT ID
NCT02732964
First Posted
April 1, 2016
Last Updated
October 26, 2017
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02732964
Brief Title
Impact of Music on Satisfaction, Anxiety, and Hemodynamics During Spinal Anesthesia for Cesarean Delivery
Official Title
Perioperative Music for Patients Undergoing Scheduled Cesarean Delivery: Impact on Satisfaction, Anxiety, and Hemodynamic Response to Spinal Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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:
Control group: baseline hemodynamics and anxiety screen; no music
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Hypotension
Keywords
satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
baseline hemodynamics and anxiety screen; no music
Arm Title
Pandora Music
Arm Type
Experimental
Arm Description
A study investigator will create a station in the Pandora® music application based on the patient's preferred music genre or artist.
Arm Title
Mozart Music
Arm Type
Experimental
Arm Description
A study investigator will turn on a playlist of pre-selected Mozart music.
Intervention Type
Other
Intervention Name(s)
Pandora Music
Intervention Description
Patients enrolled will be exposed to Pandora music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.
Intervention Type
Other
Intervention Name(s)
Mozart Music
Intervention Description
Patients enrolled will be exposed to Mozart music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.
Primary Outcome Measure Information:
Title
maternal anxiety level, VAS
Description
assessed by VAS questionnaire
Time Frame
prior to surgery
Title
maternal anxiety level, VAS
Description
assessed by VAS questionnaire
Time Frame
30 minutes after surgery
Secondary Outcome Measure Information:
Title
Change in maternal blood pressure after spinal anesthesia induction , compared to baseline blood pressure
Description
nadir systolic arterial pressure within 30 minutes of spinal placement
Time Frame
within 30 minutes of spinal placement
Title
maternal anxiety level, STAI
Description
assessed by STAI questionnaire
Time Frame
prior to surgery
Title
maternal anxiety level, STAI
Description
assessed by STAI questionnaire
Time Frame
30 minutes after surgery
Title
Overall patient satisfaction, questionnaire
Description
Assessed by questionnaire on postop day 1
Time Frame
prior to surgery
Title
Overall patient satisfaction, questionnaire
Description
Assessed by questionnaire on postop day 1
Time Frame
30 minutes after surgery
Title
Overall patient satisfaction, questionnaire
Description
Assessed by questionnaire on postop day 1
Time Frame
postoperative day 1
Title
Overall patient satisfaction, pain control
Description
Assessed by pain control/analgesic requirement on postop day 1
Time Frame
prior to surgery
Title
Overall patient satisfaction, pain control
Description
Assessed by pain control/analgesic requirement on postop day 1
Time Frame
30 minutes after surgery
Title
Overall patient satisfaction, pain control
Description
Assessed by pain control/analgesic requirement on postop day 1
Time Frame
postoperative day 1
Title
Vasopressor requirement, phenylephrine
Description
utilization of phenylephrine, micrograms
Time Frame
within 30 minutes of spinal placement
Title
Vasopressor requirement, ephedrine
Description
utilization of ephedrine, milligrams
Time Frame
within 30 minutes of spinal placement
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30880522
Citation
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.
Results Reference
derived
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Impact of Music on Satisfaction, Anxiety, and Hemodynamics During Spinal Anesthesia for Cesarean Delivery
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