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

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.

Conditions

• Premature Infant
• Clustered Care
• Neonatal Intensive Care Unit
• Developmental Care

Interventions

BEHAVIORAL

Standard care

Nurses working in the NICU will continue to provide standard care. After the study is completed, nurses in the control group will also receive the same training as the other group.

BEHAVIORAL

Infants will receive group care based on individualized developmental care according to the guide.

A guide to implementing group care based on individualized developmental care will be developed, and nurses working in the NICU will be trained in group care practices and how to use the guide.

Sponsors & Collaborators

• KTO Karatay University

  lead OTHER

Principal Investigators

• Emine Geçkil, MD, PhD · Necmettin Erbakan University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2025-11-01

Completion

2025-12-30

Countries

• Turkey (Türkiye)

Study Locations