LaPPS: Labor Podcast for Patient Satisfaction (LaPPS)

April 22, 2025 updated by: Fei Cai, MD, University of Pennsylvania

The Effect of a Labor Podcast Intervention on Patient Satisfaction and Postpartum Depression in Nulliparous Women

Patients will be enrolled at 28w0d-36w0d. Randomized to one of two arms:

  1. Labor podcasts - Seven labor podcasts that can be downloaded for any podcast app
  2. Usual care

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Objectives Overall objectives To assess the effect of listening to physician-created podcasts of common labor topics on patient satisfaction and perception of their birth experience Primary outcome variable(s) Patient satisfaction as measured by LAS + 2 satisfaction questions Secondary outcome variable(s) Edinburgh Postpartum Depression Scale (EPDS) scores Logistic regression for multivariate analysis with regards to demographics and other birth outcomes

Background Recently, podcasts have been used for both undergraduate and graduate medical education, with studies showing that they are feasible, acceptable, and effective. Learners appear to enjoy podcast learning because they increased efficiency by allowing listeners to multitask, made listeners keep up to date with medical literature, and increased overall knowledge. However, podcast learning has not been as widespread for patient education. There have been some studies that showed that podcast patient education is feasible, and one small study showed increased knowledge scores after listening to podcasts.

To our knowledge, podcast learning has never been studied in the obstetric population. Labor and delivery is usually a time that is fraught with questions from first time mothers, and more education may increase these women's perception of control and satisfaction overall with birth and the postpartum period. The Labor Agentry Scale (LAS)-10 is a validated instrument measuring expectancies and experiences of personal control during childbirth. The Edinburgh Postnatal Depression Scale (EPDS) is also a validated scale that measures levels of postpartum depression that is commonly used at our institution both immediately postpartum and at the postpartum visit 4-6 weeks after delivery.

Study Design Design Pregnant patients between 28w0d - 36w0d will be randomized to one of the following study arms upon enrollment. Patients will be approached after 20 weeks for consent and randomized after they reach 28 weeks. The study will be done in an intent-to-treat fashion. Due to the nature of the study, blinding will not be possible.

Study Arms 1) Labor Podcast Group - Women randomized to this arm will receive access to a link to download seven HUP physician created labor podcasts in addition to usual care during labor, delivery, and postpartum

o Podcast topics: Labor Anesthesia, Induction of Labor, Second Stage of Labor, Reasons for Cesarean Section, Postpartum Recovery, Complications of Labor and Birth, Normal Labor

  • LAS-10 and Birth Satisfaction survey - Women will be sent these surveys on postpartum day 2 via method they indicated they desire (either email or text message)
  • EPDS - Women will receive this survey on postpartum day 7 via method they desire

    2. Usual care Women randomized to this arm will receive usual care during labor, delivery, and postpartum with the following exceptions:

  • LAS-10 and Birth Satisfaction survey Women will be sent these surveys on postpartum day 2 via method they indicated they desire (either email or text message)
  • EPDS Women will receive this survey on postpartum day 7 via method they desire

Study duration Estimated length of time to enroll all subjects and complete the study Length of a subject's participation time in study Project date of the proposed study

Estimated length of time to enroll all subjects and complete study:

Based on previous studies using the LAS-10, average score ranged between 45-53/70, with standard deviations ranging from 6-12. Therefore, we would estimate that the LAS score in the usual care group to be approximately 50. To be able to detect an effect size of 4, with a standard deviation of 9, and to achieve a power of 0.8 and alpha of 0.05, we would need a sample size of approximately 79 subjects per group. Calculating for a 20% loss to follow-up rate, we would anticipate recruiting 95 subjects per group.

Our city has an average of 16% preterm birth rate. Our hospital averages 1400 nulliparous deliveries/year. We would conservatively estimate approaching 50% of these women in the prenatal period for enrollment. If we assume a 75% consent rate for the RCT, which is standard for our center, we anticipate enrolling 30-36 women per month in our study. We would therefore anticipate it taking 6 months before we reach our target sample size.

We would then require an additional 6 months to compile and analyze the data.

Length of subject's participation:

Women will be followed from time of consent until 7 days postpartum Women will be followed from time of consent until 7 days postpartum.

Project date of the proposed study:

Proposed to start April 2021 for recruitment and enrollment. We anticipate enrolling all patients by end of September 2021. We would likely be able to conclude the study by April 2022.

Resources necessary for human research protection Subjects will be recruited from looking at antepartum clinic charts and messaged via MPM once they are deemed eligible. This can be one by Dr. Cai and Dr. Srinivas. Both will be trained in the study protocol prior to enrolling subjects.

The research staff will also distribute information regarding the study to the aforementioned prenatal clinics so that written information can be handed out by providers to patients. This will allow for patients to be aware of the study. However, only study personnel will be able to consent and enroll patients.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Nulliparous
  • Singleton pregnancy
  • English-speaking
  • Age 18-50
  • Own a smart phone or device capable of downloading podcasts
  • Reached at least 36w0d of gestation
  • Willing and able to sign consent form

Exclusion Criteria:

  • Planned cesarean delivery
  • Complication in pregnancy including:

    • Placenta accrete spectrum
    • Vasa previa
    • Intrauterine fetal demise
    • Known major fetal anomaly
  • Delivery planned at location other than the Hospital of the University of Pennsylvania

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Labor Podcast Group

1) Labor Podcast Group - Women randomized to this arm will receive access to a link to download six HUP physician created labor podcasts in addition to usual care during labor, delivery, and postpartum

o Podcast topics: Labor Anesthesia, Induction of Labor, Second Stage of Labor, Reasons for Cesarean Section, Postpartum Recovery, Complications of Labor and Birth

  • LAS-10 and Birth Satisfaction survey - Women will be sent these surveys on postpartum day 2 via method they indicated they desire (either email or text message)
  • EPDS - Women will receive this survey on postpartum day 7 via method they desire

Listening to podcasts.

Topics include:

Labor Anesthesia, Induction of Labor, Second Stage of Labor, Reasons for Cesarean Section, Postpartum Recovery, Complications of Labor and Birth

No Intervention: Usual Care

2. Usual care Women randomized to this arm will receive usual care during labor, delivery, and postpartum with the following exceptions:

  • LAS-10 and Birth Satisfaction survey Women will be sent these surveys on postpartum day 2 via method they indicated they desire (either email or text message)
  • EPDS Women will receive this survey on postpartum day 7 via method they desire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labor Agentry Scale
Time Frame: 2 days after delivery
Subjects will complete the labor agentry scale after delivery. Score on labor agentry scale will be compared between groups. Score range: 10-70. Higher scores indicate more agentry, which we consider to be better for this study.
2 days after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postpartum Depression Scale
Time Frame: 7 days postpartum
Subjects will complete the EPDS 7 days postpartum. Scores will be compared between the two groups. Score range: 0-30. Higher scores indicate more risk of depression
7 days postpartum
Birth Satisfaction
Time Frame: 2 days after delivery
Subjects will also complete a birth satisfaction survey after delivery. Score on birth satisfaction will be compared between two groups. Score range: 3 - 21. Higher scores indicate higher satisfaction.
2 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sindhu Srinivas, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

June 13, 2021

First Submitted That Met QC Criteria

June 13, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 848622

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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