Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Nurse behavior change
研究概览
简要总结
The Individualized Developmental Care (IDC) model was developed to minimize the negative impact of the neonatal intensive care environment and to support infants' physiological stability. It supports the practice of clustered care, which refers to grouping routine medical and nursing procedures into a single care time period to reduce handling and allow the infant uninterrupted rest and maintenance of the sleep-wake cycle.
This study aims to develop a clustered care practice guideline and evaluate its effectiveness. The study was designed as a single-blind randomized controlled trial, where the participating nurses will not be informed about their group allocation (intervention or control) to reduce bias.The study will be conducted between July and September 2025 in the level 2 and 3 NICUs of Necmettin Erbakan University Faculty of Medicine Hospital in Konya, Turkey.
The study population includes all 44 nurses working in these NICUs who meet the inclusion criteria and agree to participate. Since the entire population is accessible, total population sampling will be used. After data collection is completed, a post hoc power analysis will be conducted using G*Power (v3.1.9.2).
Data will be collected using the "Descriptive Information Form for the Infant and the Nurse" and the "Clustered Care Practice Guideline". Pre-test data will be collected before training, and post-test data will be collected 4-6 weeks after the training.
The intervention group will receive the Clustered Care Practice Training Based on Individualized Developmental Care in two in-person sessions (approx. 45 minutes per session), delivered in small groups (11-12 participants). A training booklet prepared by the researchers will be distributed at the end of the sessions.
The normality of the data will be assessed using the Kolmogorov-Smirnov test, normal distribution curves, and skewness-kurtosis values. Parametric tests will be used for normally distributed data; non-parametric tests will be used otherwise. A significance level of P<0.05 will be applied.
Ethical approval was obtained from the Ethics Committee of KTO Karatay University Pharmaceutical and Medical Research (decision no: 2022/014, date: 21.06.2022). Institutional permission was obtained from NEU Faculty of Medicine Hospital. Written informed consent will be obtained from all participating nurses and from parents of the observed infants.
详细描述
Premature infants require intensive care during the early stages of life due to their physiological immaturity and heightened sensitivity to environmental stimuli. Routine care practices commonly performed in neonatal intensive care units (NICUs) may negatively affect the comfort and physiological stability of these infants. Therefore, individualized and developmentally supportive care practices tailored to the specific needs of premature infants have become essential.
This randomized controlled trial aims to evaluate the effectiveness of a clustered care practice guideline developed in accordance with individualized developmental care principles. The study will be conducted with nurses working in a neonatal intensive care unit. Nurses will be randomly assigned to either an intervention group or a control group.
The intervention group will receive training on the use of a clinical guideline designed to implement clustered care based on individualized developmental care, while the control group will continue to provide standard routine care. The effectiveness of the intervention will be assessed through the average scores obtained from the use of the guideline and a qualitative analysis of nurses' perspectives. This study is expected to highlight the importance of developmental care approaches in nursing and contribute to enhancing the overall quality of care provided in NICUs.
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
- Single (Participant)
盲法说明
Single-blind (participant blinding) was applied in this study. In order to prevent sample selection bias, the blocks to be used for randomization will be created by a third party
. The researcher will actively participate in the training and data collection process.
The ideal method is for the randomization list to be concealed from the researcher and nurses, and for the group to which each subject will belong to be disclosed to the researcher only after the participant has been included in the study by a person other than the researcher who has no direct role in the study. To prevent performance bias, nurses who met the inclusion criteria and provided informed consent were assigned to the study and control groups by an independent person according to the randomization list. This ensured the researcher's blinding. Since the researcher provided the training to the intervention group according to the guidelines, blinding of the practitioner was not possible. All participating nurses we
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Working in the NICU of Necmettin Erbakan University Medical Faculty Hospital,
- •Having at least 3 months of experience in the NICU,
- •Volunteering to participate in the research.
排除标准
- •The nurse wanting to leave the study during the study
- •The nurse not participating in the training or not completing the training
- •The nurse not being able to complete the study, including the final
研究组 & 干预措施
Experimental
Individualized developmental care-based group care will be provided to infants according to the guidelines.
干预措施: Infants will receive group care based on individualized developmental care according to the guide. (Behavioral)
Control group
Infants will receive routine care.
干预措施: Standard care (Behavioral)
结局指标
主要结局
Nurse behavior change
时间窗: within 6 weeks
Measured by test score change from pre- to post-test within 6 weeks Research literature generally classifies observation methods into three types: participant observation, non-participant observation, and covert observation. In this study, a structured, direct, non-participant observation method was used to observe the care practices of nurses working in the neonatal intensive care unit in accordance with the developed Clustered Care Implementation Guide. Each nurse was observed twice during the designated care times-once during the pre-test and once during the post-test-with respect to the care practices they performed. To minimize the risk of observer bias, the Clustered Care Implementation Guide was used as a structured observation form. The care stages were predefined according to the routine clinical workflow, and only the practices, behaviours, and responses that were actually observed were recorded in the guide; no subjective interpretations or comments were added. Throughout
次要结局
- Nurses' opinions on the effectiveness of the clinical guideline(4-6 weeks post-intervention)
研究者
Fatma Tokan Özkılıçaslan
Lecturer
KTO Karatay University