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

Not Applicable

Not yet recruiting

• Conditions: Premature Infant; Clustered Care; Developmental Care; Neonatal Intensive Care Unit

• Registration Number: NCT07052786
• Lead Sponsor: KTO Karatay University

Brief 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\<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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-06-23
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-07
• Last Update Posted: 2025-07-07
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Nurse behavior change	within 6 weeks	Measured by test score change from pre- to post-test within 6 weeks

Secondary Outcome Measures

Name	Time	Method
Nurses' opinions on the effectiveness of the clinical guideline	4-6 weeks post-intervention	Evaluation of nurses' perceptions regarding the effectiveness, applicability, and usability of the individualized developmental clustered care guideline.