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Completed

NCT Number: NCT02732964

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pandora Music

Other

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

Other

Patients enrolled will be exposed to Mozart music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.

Primary outcomes

  1. maternal anxiety level, VAS

    Time frame: prior to surgery

    assessed by VAS questionnaire

  2. maternal anxiety level, VAS

    Time frame: 30 minutes after surgery

    assessed by VAS questionnaire

Secondary outcomes

  1. 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

  2. maternal anxiety level, STAI

    Time frame: prior to surgery

    assessed by STAI questionnaire

  3. maternal anxiety level, STAI

    Time frame: 30 minutes after surgery

    assessed by STAI questionnaire

  4. Overall patient satisfaction, questionnaire

    Time frame: prior to surgery

    Assessed by questionnaire on postop day 1

  5. Overall patient satisfaction, questionnaire

    Time frame: 30 minutes after surgery

    Assessed by questionnaire on postop day 1

  6. Overall patient satisfaction, questionnaire

    Time frame: postoperative day 1

    Assessed by questionnaire on postop day 1

  7. Overall patient satisfaction, pain control

    Time frame: prior to surgery

    Assessed by pain control/analgesic requirement on postop day 1

  8. Overall patient satisfaction, pain control

    Time frame: 30 minutes after surgery

    Assessed by pain control/analgesic requirement on postop day 1

  9. Overall patient satisfaction, pain control

    Time frame: postoperative day 1

    Assessed by pain control/analgesic requirement on postop day 1

  10. Vasopressor requirement, phenylephrine

    Time frame: within 30 minutes of spinal placement

    utilization of phenylephrine, micrograms

  11. Vasopressor requirement, ephedrine

    Time frame: within 30 minutes of spinal placement

    utilization of ephedrine, milligrams

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 11, 2016
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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