Patient Satisfaction During Cesarean Delivery

Not Applicable

Recruiting

• Conditions: Patient Satisfaction

• Registration Number: NCT06539754
• Lead Sponsor: Geisinger Clinic

Brief Summary

The goal of this interventional study is to determine whether the option to listen to music during cesarean delivery increases the participants satisfaction. Participants and their support person will be asked to fill out a short survey and mark their satisfaction on a visual analog scale. Vital signs will be recorded during their procedure.

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 Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-06
• Study Start: 2024-11-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-10
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participant satisfaction	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.

Secondary Outcome Measures

Name	Time	Method
Support person satisfaction	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.
Heart rate	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.
Music and satisfaction	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)
Blood pressure	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.

Trial Locations

Locations (1)

Geisinger; 🇺🇸 Danville, Pennsylvania, United States