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Patient Satisfaction During Cesarean Delivery

NCT ID: NCT06539754

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2025-11-10

Brief Summary

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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

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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.

Conditions

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Patient Satisfaction

Keywords

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Cesarean delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants will be randomized in 1:1 stratification to receive music during their procedure or not. Participants will not be aware of the intervention. If a patient is randomized into music, they will be offered headphones to listen to during their procedure.

Study Groups

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No music

Participants who undergo cesarean delivery will not have music available to listen to during the procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Music

Participants who undergo cesarean delivery will have music of their choice played through bone conduction headphones.

Group Type EXPERIMENTAL

Music

Intervention Type BEHAVIORAL

Participants will have bone conducting headphones available to listen to the music of their choice from premade Spotify playlists.

Interventions

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Music

Participants will have bone conducting headphones available to listen to the music of their choice from premade Spotify playlists.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Geisinger Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Awathif D Mackeen, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

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Geisinger

Danville, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2024-0158

Identifier Type: -

Identifier Source: org_study_id