Empowering Mothers Whose Babies Are Hospitalized in the Neonatal Intensive Care Unit and the Impact of Their Integration Into Their Babies' Care Process on Maternal and Infant Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Parental Stress in the Neonatal Intensive Care Unit
研究概览
简要总结
Family Integrated Care is designed to eliminate the barriers between parents and their infants in the NICU by involving parents of premature infants in their care. Parents are integrated into both the healthcare team and the care of their infant. Through this approach, parents are informed about how they can contribute to their infant's overall development, including neurological and sensory development, motor and behavioral progress, as well as practices such as touch, bonding, skin-to-skin contact, breastfeeding, and increasing breast milk production. They are also educated on general hygiene and care tasks such as diaper changing and body cleaning. This model places importance on the protection and enhancement of both the physical and psychological well-being of the parent and the infant. During this process, parents move beyond being mere "visitors" in the unit to becoming active "participants" and members of the care team. Family integrated care aims to support parents in becoming the primary caregivers for their infants, both during hospitalization and after discharge. This model not only provides education and counseling but also supports the family's comprehensive involvement in the infant's care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The newborn must be premature (gestational age >28 and <34 weeks),
- •The infant must be admitted to the NICU and hospitalized for at least 3 days,
- •The mother must be open to communication and cooperation,
- •The mother must voluntarily agree to participate in the study,
- •The mother must be literate,
- •The mother must be able to speak and understand Turkish,
- •The mother must be primiparous and experiencing motherhood for the first time,
- •The mother must be over 18 years of age,
- •Mothers in the intervention group must be present in the hospital for an average of 6-8 hours per day.
排除标准
- •The newborn has a congenital anomaly (e.g., craniofacial anomalies such as cleft palate, cleft lip, or facial muscle paralysis),
- •The newborn has a diagnosed gastrointestinal, neurological, or genetic disorder (e.g., necrotizing enterocolitis, hydrocephalus, Down syndrome, omphalocele, gastroschisis, short bowel syndrome, or other diseases),
- •The newborn has a congenital heart defect requiring surgical intervention,
- •The mother has a diagnosed psychiatric illness,
- •The mother and/or father do not wish to participate in the study.
- •Withdrawal Criteria:
- •The mother does not attend the training sessions during the study period,
- •The mother fails to maintain cooperation throughout the study,
- •The newborn is transferred to another healthcare center for any reason,
- •The mother wishes to withdraw from the study,
- •The newborn is diagnosed with a chronic illness during the study process.
研究组 & 干预措施
Mother Integrated Care Group
Mothers whose babies are admitted to YYÜ will be contacted within the first 72 hours. Pre-test data (Information Form, Maternal Self-Efficacy, Attachment, Breastfeeding Self-Efficacy, Parental Stress, and Newborn Comfort Scales) will be collected, and the training schedule will be determined through face-to-face interviews.
After the interview with the mother and the pre-test are completed, the training date will be determined in consultation with the researchers. The training, consisting of four stages, is planned to be conducted at a rate of one session per day. Procedures will be demonstrated using mannequins and supported by a PowerPoint presentation and visual materials. A prepared booklet will also be distributed to the mothers. After the training phases are completed, mothers will be encouraged to participate in care as part of a team effort. One day before discharge and one and three months after discharge, survey forms will be completed via WhatsApp.
干预措施: Mother Integrated Care (Behavioral)
Control group
Mothers in this group will receive standard unit care and education. Data collection procedures will be the same as those used in the intervention group. The mother will be contacted within the first 72 hours after admission to the unit, and baseline data will be collected. One day before discharge, and one and three months after discharge, questionnaire forms will be completed via WhatsApp.
结局指标
主要结局
Parental Stress in the Neonatal Intensive Care Unit
时间窗: The mother will be asked to complete the scale form within the first 72 hours of admission to the unit, one day before discharge, and one week after discharge.
The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) will be used to assess the level of parental perception of stressors arising from the physical and psychosocial environment of the intensive care unit. The scale consists of 34 items across three dimensions: Sights and Sounds, Infant Appearance and Behavior, and Parental Role Alteration. Higher scores on the scale indicate higher levels of parental stress (minimum: 0, maximum: 170).
Maternal Attachment
时间窗: The mother will be asked to complete the scale form within the first 72 hours of admission to the unit, one day before discharge, and one week after discharge.
The Maternal Attachment Scale consists of 26 items. The total score can range from 26 to 104. A higher score indicates a higher level of maternal attachment.
Parental Stress in the Neonatal Intensive Care Unit
时间窗: First visit, before discharge
The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) will be used to assess the level of parental perception of stressors arising from the physical and psychosocial environment of the intensive care unit. The scale consists of 34 items across three dimensions: Sights and Sounds, Infant Appearance and Behavior, and Parental Role Alteration. Higher scores on the scale indicate higher levels of parental stress (minimum: 0, maximum: 170).
Maternal Attachment
时间窗: First visit, before discharge, 1 month after discharge, 3 months after discharge
The Maternal Attachment Scale consists of 26 items. The total score can range from 26 to 104. A higher score indicates a higher level of maternal attachment.
The Mother's Perceived Parenting Self-Efficacy
时间窗: First visit, before discharge, 1 month after discharge, 3 months after discharge
The scale was developed to assess the perceived self-efficacy of mothers of premature infants in caring for their babies and understanding their needs. The scale consists of a total of 20 items, and scores range from 20 to 80. A higher score indicates an increase in the mother's perceived parenting self-efficacy.
Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants
时间窗: First visit, before discharge, 1 month after discharge, 3 months after discharge
The scale consists of 18 positive items that assess mothers of preterm infants' perceptions of self-efficacy regarding breastfeeding and milk expression. The total score ranges from 18 to 90, with a high score indicating high breastfeeding self-efficacy.
Newborn Comfort Behavior
时间窗: First visit, before discharge
The scale consists of six behavioral parameters that assess alertness, calmness/agitation, respiratory response or crying, body movements, facial tension, and muscle tone. Each parameter is scored on a scale of 1 to 5, and the total score ranges from 6 to 30. A high score indicates a decreased level of comfort in the newborn.
次要结局
未报告次要终点
研究者
Emel AVÇİN
Assistant Professor
University of Yalova