Effects of the Close Collaboration With Parents Intervention on Parents of Newborns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quality of family centered care rated by parents
研究概览
简要总结
This prospective non-randomized controlled before-after comparison study aims to evaluate the effects of the Close Collaboration with Parents, a family-centered care intervention for NICU staff, on parents of the newborns in the neonatal intensive care unit (NICU). We focus on (1) family centered care of the NICU rated by parents, (2) parental anxiety symptoms, and (3) their discharge readiness.
The intervention is planned to be implemented between December 2023 and December 2024.
The investigators will collect data from parents whose newborns are admitted to the NICU before and after the intervention and compare the two groups. In most cases, the parents of the two groups belong to different cohorts.
详细描述
Study period Pre-intervention data collection phase: September 2023 - December 2023 (Planned) Intervention phase: January 2024 - December 2024 (Planned) Post-intervention data collection phase: January 2025 - April 2025 (Planned)
Outcome measures Primary outcome: Quality of family centered care rated by parents Secondary outcomes: Parental anxiety symptoms and parental discharge readiness
Data management Eligible infants and their information will be identified and collected by research team members and entered into the excel file (.xlsx). Data will be pseudonymized when the data is entered into the excel file. All electronic data will be destroyed 10 years after the initiation of the study.
The principal investigator will be responsible for managing access to the data. We do not have a plan to make the data open in the future.
Statistical analysis The comparison between two continuous variables will be carried out by the student t test and, additionally, the multiple linear regression model and the logistic regression model to adjust the effect of the potential confounders. The potential confounders included in the models will be the length of stay and parents' previous mental illness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who have been admitted to the NICU for 2 weeks or longer
排除标准
- •Infants whose parent doesn't have Japanese as their mother tongue
- •Infants whose parent needs psychiatric consultation after birth
研究组 & 干预措施
Pre-intervention
The patient and their parents who are admitted to the NICU before the NICU starts implementing the intervention.
Post-intervention
The patient and their parents who are admitted to the NICU after the NICU implements the intervention.
干预措施: Close Collaboration with Parents (Other)
结局指标
主要结局
Quality of family centered care rated by parents
时间窗: at discharge (about 1 month of age)
The family centered care provided by the medical professionals in the NICU is assessed by parents using a questionnaire modified from DigiFCC questions. It consists of 9 questions. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 not applicable). A higher score indicates better family centered care received by parents. The average score of all questions will be used. This is rated by both parents separately.
次要结局
- Parental discharge readiness(at discharge (about 1 month of age))
- Parental anxiety symptoms(at discharge (about 1 month of age))
研究者
Ryo Itoshima
Chief physician
Nagano Children's Hospital