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

NCT07052786 | Recruiting

• 1 other identifier: 2022/014
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

clustered care, guideline,nurse, NICU

Outcome Measures

Primary Outcomes (1)

• Nurse behavior change

  Measured by test score change from pre- to post-test within 6 weeks

  within 6 weeks

Secondary Outcomes (1)

• Nurses' opinions on the effectiveness of the clinical guideline

  4-6 weeks post-intervention

Study Arms (2)

Experimental

EXPERIMENTAL

Individualized developmental care-based group care will be provided to infants according to the guidelines.

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

Control group

ACTIVE COMPARATOR

Infants will receive routine care.

Behavioral: Standard care

Interventions

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.

Also known as: Care based on guidelines

Experimental

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.

Control group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Meram Faculty of Medicine

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Emine Geçkil, MD, PhD

  Necmettin Erbakan University

  STUDY DIRECTOR

Central Study Contacts

Fatma Tokan Özkılıçaslan, MSc

CONTACT

+905396997157; tokanftm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 7, 2025
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)