- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06539754
Patient Satisfaction During Cesarean Delivery
Patient Satisfaction of the Environment During Cesarean Delivery
Study Overview
Detailed Description
Currently, our institution does not routinely offer music during cesarean delivery. The goal of this study would be to determine whether the option to listen to music improves patient satisfaction. Also, the study would examine support person satisfaction and changes in maternal vital signs from prior to entering the operating room as compared to prior to exiting the operating room in a sample of patients. If positive satisfaction results are noted in those randomized to the music arm, this would be a low-cost intervention that providers could utilize to increase patient satisfaction during surgery.
This will be a prospective randomized controlled trial to determine whether the option of music being played in the operating room can impact the experience for the patient. Subjects will be randomized via central computer-generated randomization 1:1 to either have music played during their procedure or no music played during their procedure. A per protocol analysis will be performed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Singleton pregnancy
- Second or third cesarean delivery
- Scheduled cesarean delivery at Geisinger Medical Center
- Able and willing to provide consent
- English speaking
- Greater than or equal to 37 weeks' gestation
Exclusion Criteria:
- Fetal anomaly
- Multifetal gestation
- Hearing loss requiring a sign interpreter or hearing aids
- Planned general anesthesia
- Intrauterine fetal demise
- Participants that present in labor or require urgent/emergent cesarean delivery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No music
Participants who undergo cesarean delivery will not have music available to listen to during the procedure.
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Experimental: Music
Participants who undergo cesarean delivery will have music of their choice played through bone conduction headphones.
|
Participants will have bone conducting headphones available to listen to the music of their choice from premade Spotify playlists.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant satisfaction
Time Frame: This is collected during the study duration, on average 6 hours.
|
Visual analog scales from 0-10 (0=extremely unsatisfied, 10=extremely satisfied) will be collected by the patient marking on the line prior to the procedure and during skin closure.
|
This is collected during the study duration, on average 6 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Support person satisfaction
Time Frame: This is collected through the duration of the study, on average 6 hours,
|
Visual analog scales from 0-10 (0=extremely unsatisfied, 10=extremely satisfied) will be collected by the support person marking on a line during the participant's skin closure.
|
This is collected through the duration of the study, on average 6 hours,
|
|
Heart rate
Time Frame: This will be collected during the study duration, an average 6 hours.
|
Participants heart rate will be recorded at the time of consent and during skin closure.
|
This will be collected during the study duration, an average 6 hours.
|
|
Music and satisfaction
Time Frame: This is collected during the study duration, on average 6 hours.
|
Patient's will be asked after their procedure whether they believe music did or would have improved their satisfaction during cesarean delivery using a visual analog scale (0-10)
|
This is collected during the study duration, on average 6 hours.
|
|
Blood pressure
Time Frame: This will be collected during the study duration, an average 6 hours.
|
Participants blood pressure (systolic and diastolic) will be recorded at the time of consent and during skin closure.
|
This will be collected during the study duration, an average 6 hours.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Awathif D Mackeen, MD, Geisinger Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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