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LaPPS: Labor Podcast for Patient Satisfaction (LaPPS)

Primary Purpose

Labor Onset and Length Abnormalities, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Labor Podcast
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Onset and Length Abnormalities focused on measuring Nulliparity, Podcast, Labor

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Labor Podcast Group

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Labor Agentry Scale
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.

Secondary Outcome Measures

Birth Satisfaction
Subjects will also complete a birth satisfaction survey after delivery. Score on birth satisfaction will be compared between two groups. Score range: 2 - 14. Higher scores indicate higher satisfaction.
Edinburgh Postpartum Depression Scale
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

Full Information

First Posted
June 13, 2021
Last Updated
October 6, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04933708
Brief Title
LaPPS: Labor Podcast for Patient Satisfaction
Acronym
LaPPS
Official Title
The Effect of a Labor Podcast Intervention on Patient Satisfaction and Postpartum Depression in Nulliparous Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients will be enrolled at 28w0d-36w0d. Randomized to one of two arms: Labor podcasts - Seven labor podcasts that can be downloaded for any podcast app Usual care
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Onset and Length Abnormalities, Pregnancy Related
Keywords
Nulliparity, Podcast, Labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 Labor Podcast Group Usual Teaching
Masking
Care Provider
Masking Description
Those that provide care for patients on the labor floor will not know if they have had access to labor podcasts or not.
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Labor Podcast Group
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Labor Podcast
Intervention Description
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
Primary Outcome Measure Information:
Title
Labor Agentry Scale
Description
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.
Time Frame
2 days after delivery
Secondary Outcome Measure Information:
Title
Birth Satisfaction
Description
Subjects will also complete a birth satisfaction survey after delivery. Score on birth satisfaction will be compared between two groups. Score range: 2 - 14. Higher scores indicate higher satisfaction.
Time Frame
2 days after delivery
Title
Edinburgh Postpartum Depression Scale
Description
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
Time Frame
7 days postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sindhu Srinivas, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30592144
Citation
Lee SC, Huang H, Minard CG, Schackman J, Rajagopalan S. The use of podcast videos for airway skills. Clin Teach. 2019 Dec;16(6):585-588. doi: 10.1111/tct.12984. Epub 2018 Dec 27.
Results Reference
background
PubMed Identifier
32595856
Citation
Cai F, Burns RN, Kelly B, Hampton BS. CREOGs Over Coffee: Feasibility of an Ob-Gyn Medical Education Podcast by Residents. J Grad Med Educ. 2020 Jun;12(3):340-343. doi: 10.4300/JGME-D-19-00644.1.
Results Reference
background
PubMed Identifier
32709568
Citation
Young B, Pouw A, Redfern A, Cai F, Chow J. Eyes for Ears-A Medical Education Podcast Feasibility Study. J Surg Educ. 2021 Jan-Feb;78(1):342-345. doi: 10.1016/j.jsurg.2020.06.041. Epub 2020 Jul 21.
Results Reference
background
PubMed Identifier
31538949
Citation
Malecki SL, Quinn KL, Zilbert N, Razak F, Ginsburg S, Verma AA, Melvin L. Understanding the Use and Perceived Impact of a Medical Podcast: Qualitative Study. JMIR Med Educ. 2019 Sep 19;5(2):e12901. doi: 10.2196/12901.
Results Reference
background
PubMed Identifier
29464137
Citation
Chin A, Helman A, Chan TM. Podcast Use in Undergraduate Medical Education. Cureus. 2017 Dec 9;9(12):e1930. doi: 10.7759/cureus.1930.
Results Reference
background

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LaPPS: Labor Podcast for Patient Satisfaction

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