Patient SatisfactionNCT06539754
Patient Satisfaction During Cesarean Delivery
A study testing Music in people with Patient Satisfaction, run by Geisinger Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction of the Environment During Cesarean Delivery
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.
Read the 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.
- Conditions
- Patient Satisfaction
- Being tested
- Music
- Keywords
- Cesarean delivery
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Participants will have bone conducting headphones available to listen to the music of their choice from premade Spotify playlists.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This is collected during the study duration, on average 6 hours.
Secondary outcomes (4)
Support person satisfaction
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.
Measured: This is collected through the duration of the study, on average 6 hours,
Heart rate
Participants heart rate will be recorded at the time of consent and during skin closure.
Measured: This will be collected during the study duration, an average 6 hours.
Music and satisfaction
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)
Measured: This is collected during the study duration, on average 6 hours.
Blood pressure
Participants blood pressure (systolic and diastolic) will be recorded at the time of consent and during skin closure.
Measured: This will be collected during the study duration, an average 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start25 Nov 2024
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Awathif D Mackeen, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539754
- Sponsor's protocol ID
- 2024-0158
- Status last verified
- Nov 2025
- First submitted
- 8 Jul 2024
- Last updated
- 12 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal or identifying information from individual participants will be collected. Aggregate data will thus be reported.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction of the Environment During Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06539754
- Acronym / sponsor ID
- 2024-0158
- Conditions
- Patient Satisfaction
- Keywords
- Cesarean delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No music | No intervention | –Participants who undergo cesarean delivery will not have music available to listen to during the procedure. |
| Music | Experimental | Behavioral: MusicParticipants who undergo cesarean delivery will have music of their choice played through bone conduction headphones. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Singleton pregnancy
- Second or third cesarean delivery
- Scheduled cesarean delivery at Geisinger Medical Center
- Able and willing to provide consent
- English speaking
Key exclusion criteria (6 listed)
- Fetal anomaly
- Multifetal gestation
- Hearing loss requiring a sign interpreter or hearing aids
- Planned general anesthesia
- Intrauterine fetal demise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicParticipants will have bone conducting headphones available to listen to the music of their choice from premade Spotify playlists. | Behavioural | Music |
Primary outcome
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.
4 secondary outcomes
Support person satisfaction
Time frame: 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.
Music and satisfaction
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No. No personal or identifying information from individual participants will be collected. Aggregate data will thus be reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Awathif D Mackeen, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Patient Satisfaction, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant satisfaction (time frame: This is collected during the study duration, on average 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.