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Completed

NCT Number: NCT07052786

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

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.

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Key information

Conditions

Premature Infant Clustered Care Developmental Care Female Urogenital Diseases and Pregnancy Complications Neonatal Intensive Care Unit Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Meram Faculty of Medicine

Konya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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.

Other names: Care based on guidelines

Standard Care

Behavioral

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.

Primary outcomes

  1. Nurse behavior change

    Time frame: 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

Secondary outcomes

  1. Nurses' opinions on the effectiveness of the clinical guideline

    Time frame: 4-6 weeks post-intervention

    Evaluation of nurses' perceptions regarding the effectiveness, applicability, and usability of the individualized developmental clustered care guideline.

    The scoring is based on the 4-point Likert-type assessment section of the 55-item Clustered Care Implementation Guide. In the scoring process, the "performed" option is scored as 1, whereas the "not performed despite being required" option is scored as 0. The "not performed because it was not required" and "not applicable" options are marked during care provision but are excluded from the scoring. For example, if five items are marked as "not performed because it was not required" or "not applicable," the total score is calculated based on 50 rather than 55 items. If 48 of the remaining 50 items are scored as 1, the percentage of items marked as "performed" represents the score obtained from the guide.Since this is a clinical practice guide rather than a scale, no cut-off value has been established. A higher total score on the guide.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Acronym: Guideline

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 7, 2025
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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