MedTrace Logo

The Effect of Sleep Caps on Sleep and Physiological Parameters in Infants in the Neonatal Intensive Care Unit

NCT07423962 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-02-24

No results posted yet for this study

Summary

This study is a randomized controlled experimental trial designed to evaluate the effects of a researcher-developed sleep cap on the sleep and physiological variables of infants hospitalized in the Neonatal Intensive Care Unit.

Conditions

  • Newborn
  • Neonatal Intensive Care Unit
  • Neonatal Intensive Care
  • Sleep
  • Physiological Parameters
  • Nursing Care
  • Neonatal Care

Interventions

OTHER

Wearing a Sleep Cap

Demographic characteristics, clinical findings, and physiological variables (heart rate, respiratory rate, saturation value, and body temperature) of the infants in the study group were recorded. The newborns in the study group were fitted with sleeping caps for three days between 7:00 PM and 7:00 AM, and the caps were removed when they woke. 12 hours of uninterrupted video recording was conducted during this time. The newborns' sleeping and waking times, as well as the reasons for waking, were recorded. The video recordings were viewed and evaluated by both the researcher and an independent expert (pediatrician) from the study.

Sponsors & Collaborators

  • Aydin Adnan Menderes University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07423962 on ClinicalTrials.gov