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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music | Other | Selections of Mozart piano sonatas |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Anxiety | Change in anxiety before and after surgery using a numeric rating scale from 0 (no anxiety at all) to 10 (greatest anxiety) | Perioperatively |
| Hemodynamic Parameter (Mean Arterial Pressure, MAP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Drzymalski, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15321139 | Background | 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. | |
| 18074473 | Background | Conrad 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. |
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Will be shared upon reasonable request.
Available for 1 year within publication.
Will need to write a formal request with reason for need to access the data
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | no music |
| FG001 | Intervention Group | Music: selections of Mozart piano sonatas |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Parturients scheduled for cesarean delivery
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | no music |
| BG001 | Intervention Group | Music: selections of Mozart piano sonatas |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patients decided to withdraw from the study prematurely |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 Day |
|
24 hours
Adverse events would be tympanic membrane injury. Otherwise, would not differ from the data element definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | no music | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dan Drzymalski, MD | Tufts Medical Center | 617 636 4526 | ddrzymalski@tuftsmedicalcenter.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2017 | Dec 2, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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There will be two arms of this randomized controlled trial as follows:
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This is the post-procedure mean arterial pressure of the patients.
| post procedure |
| 37409839 | Derived | Drzymalski 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. |
| BG002 |
| Total |
Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | patients who were not anlayzed withdrew from the study | Count of Participants | Participants |
|
| Race (NIH/OMB) | those who withdrew early were not analyzed | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Patient Anxiety | Change in anxiety before and after surgery using a numeric rating scale from 0 (no anxiety at all) to 10 (greatest anxiety) | Posted | Mean | Standard Deviation | NRS scale (0-10) | Perioperatively |
|
|
|
| Secondary | Hemodynamic Parameter (Mean Arterial Pressure, MAP) | This is the post-procedure mean arterial pressure of the patients. | Posted | Mean | Standard Deviation | mmHg | post procedure |
|
|
|
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Intervention Group | Music: selections of Mozart piano sonatas | 0 | 11 | 0 | 11 | 0 | 11 |
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| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |