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临床试验/NCT04933708
NCT04933708已完成不适用

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

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
2
主要终点
Labor Agentry Scale

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

盲法说明

Those that provide care for patients on the labor floor will not know if they have had access to labor podcasts or not.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Labor Agentry Scale

时间窗: 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.

次要结局

  • Birth Satisfaction(2 days after delivery)
  • Edinburgh Postpartum Depression Scale(7 days postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fei Cai, MD

Professor of Obstetrics and Gynecology

University of Pennsylvania

研究点 (2)

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