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The Effect of Video Education on Skin-to-Skin at the Time of Delivery

2019年7月20日 更新者:Catherine Caponero、Kettering Health Network

The main purpose of this study is to determine the effect of prenatal video education on pregnant women's intention to practice and actual practice of skin to skin contact (SSC) after birth. This study hypothesizes that education in video format will increase patients knowledge about skin to skin in a way that will make them consider participating in skin to skin immediately after birth.

Therefore the end point for this study is intention to participate in SCC measured by a single questionnaire item "Do you plan on participating in skin to skin (or kangaroo care) immediately after birth?" Our secondary end-point will measure whether or not the patient was able to participate in skin to skin within five minutes of delivery.

All study participants will complete a short survey about their intention of practicing skin to skin after birth upon admission for delivery. Half of the study participants will only complete the brief survey. The other half of study participants will then watch a short video about skin to skin and complete one follow up question regarding their intention to practice skin to skin at the time of delivery. All patients will be followed until after delivery to determine if they were able to participate in skin to skin after delivery.

研究概览

详细说明

Despite strong support of breastfeeding by organizations such as the American Academy of Pediatrics, the American Congress of Obstetricians and Gynecologists, and the American Academy of Family Physicians, the rate of breastfeeding initiation at the time of delivery and continuation at 6 months postpartum is below the Center of Disease Prevention's Healthy People 2010 goals (1). UNICEF and the World Health Organization (WHO) have estimated that if all babies were breastfed for a minimum of the first six months of their lives, the rate of morbidity and malnutrition would significantly decrease all over the world (2). The benefits of breastfeeding are numerous for both mothers and infants, with infants obtaining optimal nutrition and passive immunity, and mothers obtaining a more rapid return of postpartum uterine tone, postpartum weight loss, delay of ovulation, and decreased risk of breast, ovarian, and endometrial cancers (3). As a result of this information, in 1991 WHO and UNICEF launched the Baby-Friendly Hospital Initiative (BFHI) to encourage proper infant feeding practices starting at birth. It is based on ten steps, which the hospital must meet and maintain to obtain certification. In support of Step Four of the BFHI to "help mothers initiate breastfeeding within one hour of birth," the skin-to-skin variation of Kangaroo Mother Care was initiated (4).

Kangaroo position, or skin to skin contact (SSC) on a mother's chest, provides thermoregulation, physiological stability, appropriate stimulation, and encourages bonding and breastfeeding (5). In fact, early SSC was significantly associated with type of feeding at discharge through 3 months postpartum (6). Regrettably, according to the American Academy of Pediatrics, some obstacles to SSC and breastfeeding include insufficient prenatal education, disruptive obstetrical practices, and a lack of family and societal support (7). Delivery room and postpartum hospital routines may also significantly disrupt early maternal-infant interactions (8). These barriers to breastfeeding and SSC are more prevalent amongst vulnerable groups, which includes low income, low educational level, and black populations. While effective initiatives such as BFHI are present in hospital settings, guidelines for primary care based interventions originating in a clinician's office currently do not exist (3). Through encouraging education regarding SSC before the time of delivery, patients can actively participate in SSC during delivery and advocate for early SSC (9).

Education can easily influence behavior habits and does not need to require special difficulties on behalf of providers (9). In fact, educational programs have the single greatest effect of any single intervention on both initiation and short term duration for breastfeeding (3). Women who attended breastfeeding classes with lactation consultants - with or without video supplementation - had significantly increased breastfeeding at six months when compared to controls (1). Currently, common office practices include provision of written materials and discharge packets. Neither practice has been shown to be effective in increasing rates of breastfeeding. On the contrary, discharge packets have been shown to reduce the rates of breastfeeding (3). Ideally, breastfeeding education would use both individual or group sessions where both benefits of breastfeeding and SSC would be discussed (10). However, in a busy clinic setting filled with a vulnerable patient population, having the ability to get to extra educational classes is not always an option.

Regardless of amount of prenatal education provided, Southview Medical Center will study participating patients at the time of admission for delivery who watch an 8 minutes 52 second patient education DVD titled "Jumping into Kangaroo Care" by the Ohio Department of Health. Of importance, studies so far have shown no clear pattern for the outcome of breastfeeding in respect to intervention timing (7). In an analysis regarding video modeling, patients who viewed videotapes regarding treatment options had a greater understanding of the risks and benefits of those choices and were more apt to be active participants in decision making (11). Audio-visual material can also be entertaining and can be used by those who have limited literacy. Moreover, the information provided to patients on video has the advantage of being repeatable and consistent, which would allow us to provide the same information to all of our patients (12). By educating patients in a video format at the beginning of their delivery admission, patients will have time to formulate questions and opinions to help them engage in an active dialogue with the staff that will be preforming the delivery. The goal of educating mothers is not only to increase their knowledge and skills but also to influence their attitudes (13). By providing a video which models SSC to all non-emergent anticipated vaginal deliveries upon admission to the hospital, the investigators' hope is to encourage patients to actively participate in SSC at the time of delivery and become their own advocates.

The main purpose of this study is to determine the effect of prenatal video education on pregnant women's intention to practice SSC after birth. This study is critical as quality measures for Southview Medical Center for quarter one of 2017 showed that the hospital has only been 50% successful at initiating skin to skin in vaginal deliveries after 37 weeks gestation with a 5 minute APGAR of 7. The hospital's goal per BFHI is 82%. The investigators' hypothesis is that 30% or more women who did not plan to use SCC would indicate their intention to use SSC post-intervention as compared to those who did not receive the intervention.

研究类型

介入性

注册 (实际的)

240

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Centerville、Ohio、美国、45459
        • Southview Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Pregnant women at Southview Medical Center
  • Over the age of 18
  • Anticipating a vaginal delivery within one week of admission to labor and delivery
  • English speaking
  • Greater than 37 weeks gestation

Exclusion Criteria:

  • Not female
  • Not pregnant
  • Less than 37 weeks gestation
  • A scheduled cesarean section
  • Unstable medical status
  • Expecting an unstable baby requiring medical resuscitation
  • Under the age of 18
  • Non-English speaking requiring translation services

If a patient has a baby with a 5 minute APGAR less than 7 at the time of delivery or needs to proceed to the operating room for cesarean delivery, the patient would not be included in data collection regarding skin to skin at the time of delivery. For this group, only intention would be measured

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:Group A - no video group

Group A will be asked a short survey:

  • their intention to practice skin to skin at the time of delivery
  • if they participated in skin to skin in a previous pregnancy
  • if they had any formal education about skin to skin
  • if they did have formal education was it either

    • a.) Provided at a prenatal appointment,
    • b.) A formal class led by either a nurse or a lactation consultant.

We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).

实验性的:Group B - video group

Group B will be asked the same short survey as group A.

The patient would then immediately watch "Jumping into Kangaroo Care", and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.

We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).

The video is 8 minutes and 52 seconds in length. The video discusses the benefits and logistics of Kangaroo Care from professional's perspectives and from new mother's perspectives.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Intention to Practice Skin-to-skin Contact After Birth
大体时间:1 day

Both groups will be asked a short survey at the time of admission:

  • their intention to practice skin to skin at the time of delivery
  • if they participated in skin to skin in a previous pregnancy
  • if they had any formal education about skin to skin
  • if they did have formal education was it either

    • a.) Provided at a prenatal appointment
    • b.) A formal class led by either a nurse or a lactation consultant Group B will watch a short video about skin-to-skin contact and will be then reasked a question regarding their intention to practice skin-to-skin contact after birth. This information will allow us to determine if video education impacts the intention to practice skin-to-skin contact after birth.
1 day
Actual Practice of Skin-to-skin Contact After Birth
大体时间:1 week
For both video and non-video groups, skin to skin duration (minutes) after delivery will be calculated. The time in minutes from delivery to initiation of skin to skin contact is also collected. This information will allow us to determine if video education impacts the actual practice of skin-to-skin contact after birth.
1 week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Catherine M Caponero, DO、Kettering Health Network

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年6月23日

初级完成 (实际的)

2017年10月26日

研究完成 (实际的)

2017年10月26日

研究注册日期

首次提交

2017年6月25日

首先提交符合 QC 标准的

2017年6月25日

首次发布 (实际的)

2017年6月27日

研究记录更新

最后更新发布 (实际的)

2019年8月2日

上次提交的符合 QC 标准的更新

2019年7月20日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1078384-2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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