Patient SatisfactionNCT03412019
Music vs. No Music During Cesarean Delivery on Patient Satisfaction
A study testing Music in people with Patient Satisfaction, run by Tufts Medical Center at 1 site in United States.
Trial summary
Several studies have demonstrated that music can improve various outcomes during labor and delivery. However, many of these studies didn't measure satisfaction rate accurately. This study aim to assess patient satisfaction in the setting of music or no music during the cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 6 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-50 years old
- Scheduled for elective cesarean delivery
- Nulliparity
- Singleton pregnancy
- Full term fetus (≥37.0 weeks gestational age)
- Healthy fetus (no known congenital diseases at the time of surgery)
- Requesting neuraxial anesthesia for the procedure
- Able to provide informed consent
Who cannot join
- Patient refusal
- Prior history of extensive abdominal surgery
- Active labor
- Contraindication to neuraxial anesthesia
- Uncorrected coagulopathy
- Infection at the skin site of epidural placement
Show all 11Show fewer
- Increased intracranial pressure
- Untreated hemodynamic instability
- Known hypersensitivity to local anesthetics (a.k.a. amide or ester allergy)
- Patients with impaired hearing
- Patient on anti-anxiolytic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Music vs. No Music During Cesarean Delivery on Patient Satisfaction
Several studies have demonstrated that music can improve various outcomes during labor and delivery. However, many of these studies didn't measure satisfaction rate accurately. This study aim to assess patient satisfaction in the setting of music or no music during the cesarean delivery. The study will be conducted in the labor and delivery unit and the expected number to enroll and complete the study is 22.
Read the detailed description
Background:
Several studies have demonstrated that music can improve various outcomes during labor and delivery. In particular, patient satisfaction is often measured on a simple VAS scale, where 0 is no satisfaction and 10 is the highest satisfaction. However, patient satisfaction is a complex parameter to measure, and may be affected by a number of different factors. This study will be performed on the labor and delivery unit to assess patient satisfaction with a validated, reliable, 22-question survey in the setting of music or no music during the cesarean delivery.
Although "music" is an all-encompassing term that describes sound with different pitches and rhythms that comes together as a harmonious whole, not all music is the same. Using "music" for therapeutic purposes would be the equivalent of using "antibiotics" to cure an infection; it is too general of a term, and unlikely that such a general use of music would show a valid therapeutic benefit. However, a study demonstrated that specific selections of Mozart piano sonatas, which have a specific rhythm and mode, improve patient anxiety through a biochemical mechanism (changing the plasma levels of IL-6 and epinephrine). Therefore, in this study, the term "music" will specifically means the same Mozart sonatas as described in the prior study.
Objectives:
The objective of this study is to determine the effect of music on patient satisfaction and anxiety during cesarean delivery.
The hypothesis is that parturients exposed to music during cesarean delivery will have greater overall satisfaction and less anxiety.
Study Timelines:
- Participation begins at the time of consultation for cesarean delivery on the day of surgery, where the co-investigator Dr. Dahlawi will approach the participants and ask them to sign the ICF, and it 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 two arms of the study are as follows:
- Control group: baseline hemodynamics and anxiety screen; no music
- Intervention group - Mozart: A study investigator will turn on a playlist of pre-selected Mozart music.
- Conditions
- Patient Satisfaction
- Being tested
- Music
- Keywords
- Music, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Selections of Mozart piano sonatas
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | baseline hemodynamics and anxiety screen; no music. Satisfaction will be measured. |
| Intervention group - Mozart | Experimental | A study investigator will turn on a playlist of pre-selected Mozart music. Hemodynamics and anxiety screen. Satisfaction will be measured. Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
This outcome will be measured using Morgan's "Maternal Satisfaction Scale for Cesarean Section" (MSSCS).
It is a 22-item questionnaire, each item have a Likert scale from 1-7 (1 =strongly disagree, 7=strongly agree), yielding a composite (total) score ranging 22-154, representing lowest to highest satisfaction. The questionnaire will be given to participants on post-operative day one during the hours of 8am-1pm.
Measured: 1 Day
Secondary outcomes (2)
Patient Anxiety
Change in anxiety before and after surgery using a numeric rating scale from 0 (no anxiety at all) to 10 (greatest anxiety)
Measured: Perioperatively
Hemodynamic Parameter (Mean Arterial Pressure, MAP)
This is the post-procedure mean arterial pressure of the patients.
Measured: post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start21 Feb 2018
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two arms of this randomized controlled trial as follows: * Control group: baseline hemodynamics and anxiety screen; no music * Intervention group - Mozart: A study investigator will turn on a playlist of pre-selected Mozart music.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Drzymalski, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412019
- Sponsor's protocol ID
- 12718
- Status last verified
- Feb 2020
- First submitted
- 12 Jan 2018
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be shared upon reasonable request.
Publications
Morgan PJ, Halpern S, Lo J. The development of a maternal satisfaction scale for caesarean section. Int J Obstet Anesth. 1999 Jul;8(3):165-70. doi: 10.1016/s0959-289x(99)80132-0.
PubMed 15321139Conrad C, Niess H, Jauch KW, Bruns CJ, Hartl W, Welker L. Overture for growth hormone: requiem for interleukin-6? Crit Care Med. 2007 Dec;35(12):2709-13. doi: 10.1097/01.ccm.0000291648.99043.b9.
PubMed 18074473Drzymalski DM, Dahlawi M, Hall RR, Ranjan S, Best CL. The effect of Mozart music on patient satisfaction during caesarean delivery: a randomised controlled trial. Anaesthesiol Intensive Ther. 2023;55(2):114-119. doi: 10.5114/ait.2023.129007.
PubMed 37409839
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Music vs. No Music During Cesarean Delivery on Patient Satisfaction
- ClinicalTrials.gov ID
- NCT03412019
- Acronym / sponsor ID
- 12718
- Conditions
- Patient Satisfaction
- Keywords
- Music, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Posted 3 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several studies have demonstrated that music can improve various outcomes during labor and delivery. However, many of these studies didn't measure satisfaction rate accurately. This study aim to assess patient satisfaction in the setting of music or no music during the cesarean delivery. The study will be conducted in the labor and delivery unit and the expected number to enroll and complete the study is 22.
Detailed description
Background:
Several studies have demonstrated that music can improve various outcomes during labor and delivery. In particular, patient satisfaction is often measured on a simple VAS scale, where 0 is no satisfaction and 10 is the highest satisfaction. However, patient satisfaction is a complex parameter to measure, and may be affected by a number of different factors. This study will be performed on the labor and delivery unit to assess patient satisfaction with a validated, reliable, 22-question survey in the setting of music or no music during the cesarean delivery.
Although "music" is an all-encompassing term that describes sound with different pitches and rhythms that comes together as a harmonious whole, not all music is the same. Using "music" for therapeutic purposes would be the equivalent of using "antibiotics" to cure an infection; it is too general of a term, and unlikely that such a general use of music would show a valid therapeutic benefit. However, a study demonstrated that specific selections of Mozart piano sonatas, which have a specific rhythm and mode, improve patient anxiety through a biochemical mechanism (changing the plasma levels of IL-6 and epinephrine). Therefore, in this study, the term "music" will specifically means the same Mozart sonatas as described in the prior study.
Objectives:
The objective of this study is to determine the effect of music on patient satisfaction and anxiety during cesarean delivery.
The hypothesis is that parturients exposed to music during cesarean delivery will have greater overall satisfaction and less anxiety.
Study Timelines:
- Participation begins at the time of consultation for cesarean delivery on the day of surgery, where the co-investigator Dr. Dahlawi will approach the participants and ask them to sign the ICF, and it 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 two arms of the study are as follows:
- Control group: baseline hemodynamics and anxiety screen; no music
- Intervention group - Mozart: A study investigator will turn on a playlist of pre-selected Mozart music.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two arms of this randomized controlled trial as follows: * Control group: baseline hemodynamics and anxiety screen; no music * Intervention group - Mozart: A study investigator will turn on a playlist of pre-selected Mozart music.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –baseline hemodynamics and anxiety screen; no music. Satisfaction will be measured. |
| Intervention group - Mozart | Experimental | Other: MusicA study investigator will turn on a playlist of pre-selected Mozart music. Hemodynamics and anxiety screen. Satisfaction will be measured. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 18-50 years old
- Scheduled for elective cesarean delivery
- Nulliparity
- Singleton pregnancy
- Full term fetus (≥37.0 weeks gestational age)
Key exclusion criteria (11 listed)
- Patient refusal
- Prior history of extensive abdominal surgery
- Active labor
- Contraindication to neuraxial anesthesia
- Uncorrected coagulopathy
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 |
|---|---|---|
| MusicSelections of Mozart piano sonatas | Other | Intervention group - Mozart |
Primary outcome
Patient Satisfaction
Time frame: 1 Day
This outcome will be measured using Morgan's "Maternal Satisfaction Scale for Cesarean Section" (MSSCS). It is a 22-item questionnaire, each item have a Likert scale from 1-7 (1 =strongly disagree, 7=strongly agree), yielding a composite (total) score ranging 22-154, representing lowest to highest satisfaction. The questionnaire will be given to participants on post-operative day one during the hours of 8am-1pm.
2 secondary outcomes
Patient Anxiety
Time frame: Perioperatively
Hemodynamic Parameter (Mean Arterial Pressure, MAP)
Time frame: post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15321139Morgan PJ, Halpern S, Lo J. The development of a maternal satisfaction scale for caesarean section. Int J Obstet Anesth. 1999 Jul;8(3):165-70. doi: 10.1016/s0959-289x(99)80132-0.
- Background: PubMed 18074473Conrad C, Niess H, Jauch KW, Bruns CJ, Hartl W, Welker L. Overture for growth hormone: requiem for interleukin-6? Crit Care Med. 2007 Dec;35(12):2709-13. doi: 10.1097/01.ccm.0000291648.99043.b9.
- Derived from this study: PubMed 37409839Drzymalski DM, Dahlawi M, Hall RR, Ranjan S, Best CL. The effect of Mozart music on patient satisfaction during caesarean delivery: a randomised controlled trial. Anaesthesiol Intensive Ther. 2023;55(2):114-119. doi: 10.5114/ait.2023.129007.
- Individual participant dataSharing planned: Yes. Will be shared upon reasonable request.
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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.
Dan Drzymalski, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Patient Satisfaction, run by Tufts Medical Center 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 8 inclusion and 11 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 3 Mar 2020. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Satisfaction (time frame: 1 Day). 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 NCT03412019, which also lists 3 linked publications.
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 3 Mar 2020.