NCT07052786 Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT
| NCT ID | NCT07052786 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KTO Karatay University |
| Condition | Premature Infant |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2025-07-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Emine Geçkil, MD, PhD
STUDY DIRECTOR
Necmettin Erbakan University
Frequently Asked Questions
Who can join the NCT07052786 clinical trial?
This trial is open to female participants only, studying Premature Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07052786 currently recruiting?
Yes, NCT07052786 is actively recruiting participants. Contact the research team at tokanftm@gmail.com for enrollment information.
Where is the NCT07052786 trial being conducted?
This trial is being conducted at Konya, Turkey (Türkiye).
Who is sponsoring the NCT07052786 clinical trial?
NCT07052786 is sponsored by KTO Karatay University. The principal investigator is Emine Geçkil, MD, PhD at Necmettin Erbakan University. The trial plans to enroll 44 participants.