Patient Satisfaction During Cesarean Delivery

NCT06539754 | Completed

• 1 other identifier: 2024-0158
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction

Keywords

Cesarean delivery

Outcome Measures

Primary Outcomes (1)

• Participant satisfaction

  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 Outcomes (4)

• Support person satisfaction

  This is collected through the duration of the study, on average 6 hours,

• Heart rate

  This will be collected during the study duration, an average 6 hours.

• Music and satisfaction

  This is collected during the study duration, on average 6 hours.

• Blood pressure

  This will be collected during the study duration, an average 6 hours.

Study Arms (2)

No music

NO INTERVENTION

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

Music

EXPERIMENTAL

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

Behavioral: Music

Interventions

Music BEHAVIORAL

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

Music

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Awathif D Mackeen, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 6, 2024
• Study Start: November 25, 2024
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)