Actively Recruiting
Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT
Led by KTO Karatay University · Updated on 2025-09-15
44
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Premature infants in neonatal intensive care units (NICUs) face challenges due to their immature physiology and sensitivity to environmental factors. This research aims to develop and assess a clustered care practice guideline based on individualized developmental care principles to minimize the negative impact of routine care and support infants' physiological stability. The study is a single-blind randomized controlled trial involving nurses in NICUs to evaluate how clustered care affects nursing practices. The study involves two groups of nurses: an intervention group receiving training on clustered care guidelines tailored to individualized developmental care and a control group continuing standard care practices. The training consists of two in-person sessions lasting about 45 minutes each, with small group sizes and a training booklet. After training, nurses in the control group will also receive the same training once the study concludes. Nurses' behavior changes will be assessed within six weeks after training, along with their opinions on the guideline's effectiveness gathered 4-6 weeks post-intervention. Data collection includes pre- and post-training assessments using descriptive forms and the clustered care guideline. Ethical approval and informed consent from nurses and infant parents have been obtained, ensuring careful monitoring and evaluation throughout the study period from July to September 2025.
CONDITIONS
Brief Title
Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Nurse wanting to leave the study during the study
- Nurse not participating in or not completing the training
- Nurse unable to complete the study, including the final assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 4 to 6 weeks
Participants receive training and implement individualized developmental care-based group care or continue routine care practices in the neonatal intensive care unit.
Regular visits during the 4 to 6 week intervention period
Trial Site Locations
Total: 1 location
1
Meram Faculty of Medicine
Konya, Turkey (Türkiye)
Actively Recruiting
Research Team
F
Fatma Tokan Özkılıçaslan, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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