Clinical trial NCT04933708: LaPPS: Labor Podcast for Patient Satisfaction
Official title: The Effect of a Labor Podcast Intervention on Patient Satisfaction and Postpartum Depression in Nulliparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Onset and Length Abnormalities
Pregnancy Related
Keywords: Nulliparity
Podcast
Labor
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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

1. Labor Podcast Group
2. Usual Teaching
Primary purpose: TREATMENT

Brief summary: 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

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.

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

Primary outcomes:
measure: Labor Agentry Scale
timeFrame: 2 days after delivery
Secondary outcomes:
measure: Birth Satisfaction
timeFrame: 2 days after delivery
measure: Edinburgh Postpartum Depression Scale
timeFrame: 7 days postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sindhu Srinivas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.