Impact of an Interactive Maternal Resuscitation Navigation Application (MARINA) on Mothers' Experience During and After Premature Infant Resuscitation in the Delivery Room
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Impact of Event Scale-Revised
研究概览
简要总结
The purpose of this study is to design, develop, validate and pilot test an interactive Maternal Resuscitation Navigation Application (MARINA) for the purpose of providing information and guidance about the expected events that a premature infant will experience during initial resuscitation upon delivery. This information will be shared via computer app prior to the time that the mother would be in distress due to active labor. The application will be pilot tested for functionality, usability and feasibility of future use and research in clinical settings. Focused aspects of the application will include simulated video of the active delivery environment, explanation of each team member's role in resuscitation and specific activities involved in premature infant resuscitation. To assure the application addresses key information mothers would desire, the application will include content developed with input from a consulting group of mothers who have experienced premature infant resuscitation in the delivery room. Additionally, prior research by the research team will inform the build of this application. The application will have the ability for mothers to choose whether to view close up procedures (bag/mask positive pressure oxygen delivery, intubation, line placement, etc.). She may alternatively select to only view the broader view of the room while listening to the description of activities occurring at that time. The mother will be able to choose her level of interactivity depending on her comfort level. The application will go through multiple levels of testing throughout the development process. After an iterative process, when the research team finds the application acceptable, a small group of consulting parents and experienced clinicians will review the application for functionality (ease of use) and content validity.
Aim 2: To pilot test the functionality, usability and feasibility of the interactive Maternal Resuscitation Navigation Application (MARINA) for future use and research in clinical settings to reduce maternal distress associated with premature infant resuscitation.
详细描述
AT THIS TIME, THE STUDY IS PROCEEDING WITH CONTROL GROUP ONLY. THE INTERVENTION PHASE OF THE STUDY WILL NOT BEGIN UNTIL A MODIFICATION WITH THE COMPLETED MARINA SOFTWARE APPLICATION IS SUBMITTED AND APPROVED BY THE BOARD. The purpose of this study is to design, develop, validate and pilot test an interactive Maternal Resuscitation Navigation Application (MARINA) for the purpose of providing information and guidance concerning premature infant resuscitation prior to the experience in the delivery room. The application will be pilot tested for functionality, usability and feasibility of future use and research in clinical settings.
Methods MARINA will be created by the University of Iowa Custom Solution and Integration (CSI) department, a division within the Information Technology Services. The application will use an interdisciplinary high-fidelity simulation video in a Labor & Delivery room setting as its core. Focused aspects of the video will include descriptions of the active delivery environment, explanation of each team member's role in resuscitation and specific activities involved in premature infant resuscitation. In order to establish content validity, the application will include content developed with input from a consulting group of mothers who have experienced premature infant resuscitation in the delivery room. Additionally, qualitative data and prior research by the research team will inform the build of this application.
The application will have the ability for mothers to choose whether to view close up procedures (bag/mask positive pressure oxygen delivery, intubation, line placement, etc.). She may alternatively select to only view the broader view of the room while listening to the description of activities occurring at that time. The mother will be able to choose her level of interactivity depending on her comfort level. The high-fidelity resuscitation will include voice over narration describing the steps and explaining key processes. By selecting a specific touch screen icon at crucial steps in the resuscitation process, the family can hear additional information from the narration or see additional angles of the procedure. The simulation will encourage the mother to be an active participant during her child's resuscitation with examples of the simulation mother asking question and receiving communication from the healthcare team caring for her infant. In order to evaluate usability and 'dose' of intervention, the application will include functionality to track which segments were accessed and amount of time spent by participant.
The application will go through multiple levels of testing throughout the development process. After an iterative process, when the research team finds the application acceptable, a small group of consulting parents and experienced clinicians will review the application for functionality (ease of use) and content validity.
Aim 2: To pilot test the functionality, usability and feasibility of the interactive Maternal Resuscitation Navigation Application (MARINA) for future use and research in clinical settings to reduce maternal distress associated with premature infant resuscitation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Control group: English-speaking mothers, age 18 or older, delivered a premature infant at UIHC between 24- and 32-weeks and their infant born during this most recent gestation.
排除标准
- •control group: Infant death, mothers who required general anesthesia at the time of delivery, active investigation by Department of Human Services, prisoners, twin gestation
结局指标
主要结局
Impact of Event Scale-Revised
时间窗: Beginning 24 hours after a mother experiences her child's resuscitation until 65 days post the resuscitation.
Impact of Event Scale - Revised (IES-R) is a tool that measures a participants risk for posttraumatic stress after experiencing an event. The IES-R consists of twenty two question items with a five point Likert scale ranging in response from zero to four, zero denotes low stress and four denotes high stress. The range of total scores is 0-88 with higher scores interpreted as a more stressful impact due to a traumatic event. A score of 24 has been determined to indicate a level of posttraumatic stress high enough for clinical concern.
Perinatal Post traumatic Stress Disorder Questionaire-II
时间窗: Beginning 24 hours after a mother experiences her child's resuscitation until 65 days post the resuscitation.
Perinatal Post traumatic Stress Disorder Questionaire-II (PPQ-II) is a 14-item tool measure assessing post-traumatic symptoms related to the childbirth experience, including intrusiveness or re-experiencing, avoidance behaviors and hyperarousal or numbing of responsiveness. The PPQ-II also contains one item pertaining to feelings of guilt. Response options include a five-point likert scale (scored 0 to 4). Mothers were instructed to provide responses that reflected their experience. The total possible score on the modified PPQ-II ranges from 0 to 56 with a higher score indicating a higher level of maternal distress.
次要结局
未报告次要终点
研究者
Stephanie Stewart
Associate Director, Nursing
University of Iowa