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
Among 198 studies in Patient Satisfaction with a site in United States — 30 open to participants now, 35 under way, none of them phase 3. Patient Satisfaction · United States.
Among the 198 studies in Patient Satisfaction with a site in United States, this one is the 137th largest by enrollment of the 162 interventional ones that give a count, is one of 12 that started in 2018, is one of 137 with no phase, and was the 79th registered.
877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.
Browse Patient Satisfaction studies →30 of the 198 studies in Patient Satisfaction with a site in United States are open now. Recruiting first, the newest first:
Montefiore Medical Center · Sites in United States
University of Chicago · Sites in United States
University of California, Los Angeles · Sites in United States
Children's National Research Institute · Sites in United States
VA Office of Research and Development · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 99 Patient Satisfaction studies recruiting now, 61 (62%) set no upper age limit and 30 (30%) stop at 75 or younger; 14 take children under 18; 26 take healthy volunteers.
This study: 18 Years to 50 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
198 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 5 · Phase 3 1 · Phase 4 18
First in 1999; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below the median of 96 across 624 interventional studies indexed under Patient Satisfaction.
Median enrollment 100 across the 162 interventional studies, 160 across the 36 observational. Of the 146 that completed or were terminated, 42 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 198 have an industry lead sponsor. The 10 most frequent:
Tufts Medical Center is the lead sponsor of 200 studies on the registry; 28 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 16 (50%) have results posted.
Tufts Medical Center has 3 studies filed under Patient Satisfaction — fewer than ten, so there is no comparison to draw.
17 of the studies in Patient Satisfaction with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06799052Boston Medical CenterCervical Preparation for Same-Day Dilation & Evacuation | 2026-12 |
| NCT06790043Albany Medical CollegeImpact of Patient Selected Visual Art in the Hospital Room During Antepartum Admission on Hospital Satisfaction Scores and Patient Experience | 2026-12 |
| NCT06975033University of California, San FranciscoEducational Discharge Video Impact on Post-Operative Healthcare Utilization After HoLEP | 2026-12-01 |
| NCT07715591University of California, Los AngelesRandomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery | 2026-12-31 |
| NCT07821476Gebauer CompanyIs Pain Ease (New Formula) Safe and Effective in Reducing Pain Associated With Peripheral Intravenous Cannulation (PIV)? | 2027-01 |
Among the 198 studies in Patient Satisfaction with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Will be shared upon reasonable request.
Supporting information: Study protocol
Time frame: Available for 1 year within publication.
Access criteria: Will need to write a formal request with reason for need to access the data
Ran from Feb 2018 to primary completion in Aug 2019, 17 months.
Results were first posted in Mar 2020, 6 months after primary completion.
Of 368 non-industry interventional studies with no phase under Patient Satisfaction, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 17 months is above that.
Counting every sponsor, half of 370 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.