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.
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
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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | baseline hemodynamics and anxiety screen; no music |
| Pandora Music | Experimental | A 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 Music | Experimental | A 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.
maternal anxiety level, VAS
assessed by VAS questionnaire
Measured: prior to surgery
maternal anxiety level, VAS
assessed by VAS questionnaire
Measured: 30 minutes after surgery
Secondary outcomes (11)
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
maternal anxiety level, STAI
assessed by STAI questionnaire
Measured: prior to surgery
maternal anxiety level, STAI
assessed by STAI questionnaire
Measured: 30 minutes after surgery
Overall patient satisfaction, questionnaire
Assessed by questionnaire on postop day 1
Measured: prior to surgery
Overall patient satisfaction, questionnaire
Assessed by questionnaire on postop day 1
Measured: 30 minutes after surgery
Overall patient satisfaction, questionnaire
Assessed by questionnaire on postop day 1
Measured: postoperative day 1
Overall patient satisfaction, pain control
Assessed by pain control/analgesic requirement on postop day 1
Measured: prior to surgery
Overall patient satisfaction, pain control
Assessed by pain control/analgesic requirement on postop day 1
Measured: 30 minutes after surgery
Overall patient satisfaction, pain control
Assessed by pain control/analgesic requirement on postop day 1
Measured: postoperative day 1
Vasopressor requirement, phenylephrine
utilization of phenylephrine, micrograms
Measured: within 30 minutes of spinal placement
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.
- First posted11 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionSep 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michaela Kristina Farber, MD, Brigham and Women's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Music for Patients Undergoing Scheduled Cesarean Delivery: Impact on Satisfaction, Anxiety, and Hemodynamic Response to Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02732964
- Acronym / sponsor ID
- 2015P002043
- Conditions
- Anxiety, Hypotension
- Keywords
- satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –baseline hemodynamics and anxiety screen; no music |
| Pandora Music | Experimental | Other: Pandora MusicA study investigator will create a station in the Pandora® music application based on the patient's preferred music genre or artist. |
| Mozart Music | Experimental | Other: Mozart MusicA study investigator will turn on a playlist of pre-selected Mozart music. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pregnant women
- 8 years or older
- scheduled for elective cesarean delivery under spinal anesthesia.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pandora MusicPatients enrolled will be exposed to Pandora music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery. | Other | Pandora Music |
| Mozart MusicPatients enrolled will be exposed to Mozart music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery. | Other | Mozart Music |
Primary outcome
maternal anxiety level, VAS
Time frame: prior to surgery
assessed by VAS questionnaire
maternal anxiety level, VAS
Time frame: 30 minutes after surgery
assessed by VAS questionnaire
11 secondary outcomes
Change in maternal blood pressure after spinal anesthesia induction , compared to baseline blood pressure
Time frame: within 30 minutes of spinal placement
maternal anxiety level, STAI
Time frame: prior to surgery
maternal anxiety level, STAI
Time frame: 30 minutes after surgery
Overall patient satisfaction, questionnaire
Time frame: prior to surgery
Overall patient satisfaction, questionnaire
Time frame: 30 minutes after surgery
Overall patient satisfaction, questionnaire
Time frame: postoperative day 1
Overall patient satisfaction, pain control
Time frame: prior to surgery
Overall patient satisfaction, pain control
Time frame: 30 minutes after surgery
Overall patient satisfaction, pain control
Time frame: postoperative day 1
Vasopressor requirement, phenylephrine
Time frame: within 30 minutes of spinal placement
Vasopressor requirement, ephedrine
Time frame: within 30 minutes of spinal placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Derived from this study: PubMed 30880522Drzymalski 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.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.