Mother Providing Recorded Voice to Her Preterm Infant in Incubator Improves Her Own Grief and Emotional Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Maternal response to Depression, Anxiety, and Stress Scale(DASS)
研究概览
简要总结
The early birth of a premature baby can be a devastating and unplanned situation for parents. Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can feel tremendous guilt whenever they are unable to be present at their baby's bedside. The investigators believe that giving parents an opportunity to provide comfort in the form of the mother's voice, pre-recorded and played to her baby, will improve her feeling about her baby in the NICU. The investigators hypothesize that playing the mother's recorded voice to her extremely preterm infant while in the incubator when she cannot be present will improve the depression, anxiety and stress as well as overall feeling about her baby. The investigators will assess the change in depression, anxiety and stress with the use of a validated tool (the DASS21), as a result of the intervention. The investigators will also assess the improvement of her feelings with a questionnaire () to be administered before and after the intervention. The investigators predict that her depression, anxiety and stress as well as positive feeling will increase after the intervention. The investigators also predict that the infant's vital signs will remain stable and/or improve when the recording is played.
详细描述
Background Information and Scientific Rationale The AdventHealth Orlando NICU is the first U.S. hospital to utilize the Babyleo in a clinical setting. Personnel were trained by Dräger representatives and the units have been in use for over 2 years. During that time, personnel have not used the Audio Port, located on the back of the bed. The Audio Port allows sound to be played inside the incubator at no more than 55 dB, which is within the guidelines set forth by the American Academy of Pediatrics for the target population of this project.
The early birth of a premature baby can be a devastating and unplanned situation for parents. Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can feel tremendous guilt whenever they are unable to be present at their baby's bedside.
The investigators will attempt to provide some comfort and control to the parents of premature infants by implementing this project. Research has shown that when used appropriately in the premature to term infant population, specific sounds can result in "a shorter hospital stay, improved feeding skills, improved behavior state and improved physiological status".
The investigators believe that giving parents an opportunity to provide comfort in the form of the mother's voice, pre-recorded and played to her baby, will improve her feeling about her baby in the NICU. As the process of recording the mother's voice will be aided by trained Music Therapists, parents will also gain knowledge about developmentally appropriate methods of interacting with their infant.
Consideration also needs to be given to staff education. It has long been ingrained in staff that "noise" for the premature infant is undesirable and upsetting to their immature nervous system. While this can be true, studies have shown that appropriate sounds, introduced at the right time, can aid in brain development and the later acquisition of language. Babies do not necessarily need to live in a sound-free environment; in the womb, they are continually exposed to sound. However, staff are very protective of keeping premature infants from becoming stressed, and so the mention of introducing sound into their quiet incubator causes a great deal of consternation. Detailed explanation and staff buy-in will be very important for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Commitment to finish all questionnaires and to participate in the creation of a CD to be played to her baby.
- •Older than 18 years of age
- •Gestational age between 26 0/7 and 30 6/7 weeks
排除标准
- •Younger than 18 years
- •Major congenital or chromosomal anomalies
结局指标
主要结局
Maternal response to Depression, Anxiety, and Stress Scale(DASS)
时间窗: Baseline to 23 days
(DASS is a 1-21 questionnaire where a higher score=worse outcome)
次要结局
- Incidence of apneas, bradycardias and desaturation episodes(Up to 23 days)
- Feelings questionnaire(Up to 23 days)
