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Completed NCT07052786

Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT

Conditions: Premature Infant, Clustered Care, Neonatal Intensive Care Unit, Developmental Care

Sex: Female
Healthy volunteers: Yes
Phase: NA
Enrollment: 49
Sponsor: KTO Karatay University

Location: Meram Faculty of Medicine Konya

Summary

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\

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07052786). StuddyBuddy aggregates publicly available trial information.