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AnxietyNCT02732964

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

A study testing Pandora Music and Mozart Music in people with Anxiety and Hypotension, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Anxiety, Hypotension
What is being tested?
Pandora Music and Mozart Music
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
Nov 2015to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Anxiety, Hypotension
Being tested
Pandora Music, Mozart Music
Keywords
satisfaction
Medical subject headings
Anxiety Disorders, Hypotension, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT02732964
Study groupRoleWhat they receive
ControlNo interventionbaseline hemodynamics and anxiety screen; no music
Pandora MusicExperimentalA study investigator will create a station in the Pandora® music application based on the patient's preferred music genre or artist.
Receives: Other: Pandora Music
Mozart MusicExperimentalA study investigator will turn on a playlist of pre-selected Mozart music.
Receives: Other: Mozart Music

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maternal anxiety level, VAS

    assessed by VAS questionnaire

    Measured: prior to surgery

  2. maternal anxiety level, VAS

    assessed by VAS questionnaire

    Measured: 30 minutes after surgery

Secondary outcomes (11)
  1. Change in maternal blood pressure after spinal anesthesia induction , compared to baseline blood pressure

    nadir systolic arterial pressure within 30 minutes of spinal placement

    Measured: within 30 minutes of spinal placement

  2. maternal anxiety level, STAI

    assessed by STAI questionnaire

    Measured: prior to surgery

  3. maternal anxiety level, STAI

    assessed by STAI questionnaire

    Measured: 30 minutes after surgery

  4. Overall patient satisfaction, questionnaire

    Assessed by questionnaire on postop day 1

    Measured: prior to surgery

  5. Overall patient satisfaction, questionnaire

    Assessed by questionnaire on postop day 1

    Measured: 30 minutes after surgery

  6. Overall patient satisfaction, questionnaire

    Assessed by questionnaire on postop day 1

    Measured: postoperative day 1

  7. Overall patient satisfaction, pain control

    Assessed by pain control/analgesic requirement on postop day 1

    Measured: prior to surgery

  8. Overall patient satisfaction, pain control

    Assessed by pain control/analgesic requirement on postop day 1

    Measured: 30 minutes after surgery

  9. Overall patient satisfaction, pain control

    Assessed by pain control/analgesic requirement on postop day 1

    Measured: postoperative day 1

  10. Vasopressor requirement, phenylephrine

    utilization of phenylephrine, micrograms

    Measured: within 30 minutes of spinal placement

  11. Vasopressor requirement, ephedrine

    utilization of ephedrine, milligrams

    Measured: within 30 minutes of spinal placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionSep 2016
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02732964
Sponsor's protocol ID
2015P002043
Status last verified
Oct 2017
First submitted
1 Apr 2016
Last updated
30 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 30880522

Questions about this trial

What is this clinical trial studying?

A study testing Pandora Music and Mozart Music in people with Anxiety and Hypotension, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maternal anxiety level, VAS (time frame: prior to surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02732964, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.

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