An interventional study of Music in Patient Satisfaction, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by Tufts Medical Center · Not applicable, Interventional, and Supportive care
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:
The two arms of the study are as follows:
Exclusion Criteria:
baseline hemodynamics and anxiety screen; no music. Satisfaction will be measured.
A study investigator will turn on a playlist of pre-selected Mozart music. Hemodynamics and anxiety screen. Satisfaction will be measured.
Other: Music
Selections of Mozart piano sonatas
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.
Time frame: 1 Day
Patient Anxiety
Change in anxiety before and after surgery using a numeric rating scale from 0 (no anxiety at all) to 10 (greatest anxiety)
Time frame: Perioperatively
Hemodynamic Parameter (Mean Arterial Pressure, MAP)
This is the post-procedure mean arterial pressure of the patients.
Time frame: post procedure
| Milestone | Control Group | Intervention Group |
|---|---|---|
| Started | 11 | 11 |
| Completed | 10 | 10 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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.
| units on a scale | Control Group | Intervention Group |
|---|---|---|
| Patient Satisfaction | 120 ± 22.3 | 116 ± 16.4 |
Change in anxiety before and after surgery using a numeric rating scale from 0 (no anxiety at all) to 10 (greatest anxiety)
| NRS scale (0-10) | Control Group | Intervention Group |
|---|---|---|
| Patient Anxiety | 2.5 ± 2.6 | 2.7 ± 2.7 |
This is the post-procedure mean arterial pressure of the patients.
| mmHg | Control Group | Intervention Group |
|---|---|---|
| Hemodynamic Parameter (Mean Arterial Pressure, MAP) | 82.2 ± 24.8 | 80.4 ± 8.4 |
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Intervention Group | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
Parturients scheduled for cesarean delivery
| Age, Continuous(years) | Control Group | Intervention Group | Total |
|---|---|---|---|
| Mean | 36.2 ± 4.2 | 32.1 ± 6.1 | 34.2 ± 5.5 |
| Sex: Female, Male(Participants) | Control Group | Intervention Group | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control Group | Intervention Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 6 | 6 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 3 | 7 |
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Plan to share: Yes — Will be shared upon reasonable request.
Supporting information: Study protocol
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