The Effect of Wiping and Swaddling Bath Methods Applied in the Neonatal Intensive Care Unit on Neonatal Comfort: a Randomized Controlled Trial
Launched by GAMZE GOCMEN · Mar 16, 2025
Trial Information
Current as of April 23, 2025
Completed
Keywords
ClinConnect Summary
This study is designed as a randomized controlled trial to compare the effects of swaddled bathing and wipe bathing on neonatal comfort in Neonatal Intensive Care Units (NICUs). The study will be conducted in the NICU of İzmir Tepecik Training and Research Hospital, and after obtaining ethical approval, 64 neonates meeting the inclusion criteria will be enrolled.
As part of the study, the swaddled bath will be applied to the intervention group, while the wipe bath will be applied to the control group. The bathing procedures will be carried out by the researcher according to standard protoc...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Born at 37 weeks of gestation or later
- • Aged between 2 and 7 days
- • Born after 24 hours
- • Stable physiological parameters
- • Spontaneous respiration
- • Birth weight ≥ 2000 grams
- • No skin problems that would prevent the administration of swaddle or wipe bath
- • Both vaginal and cesarean deliveries are accepted
- Exclusion Criteria:
- • Using sedative or muscle relaxant medications
- • Previously exposed to any bath method
- • On mechanical ventilation
- • Diagnosed with sepsis
- • Within the first 78 hours post-operatively
- • Having a central catheter
- • Having disrupted skin integrity
- • Having cranial hemorrhage
- • Major congenital, chromosomal, or neurological anomalies
Trial Officials
Aysun Ekşioğlu, Doç. Dr.
Principal Investigator
Ege University
About Gamze Gocmen
Gamze Gocmen is a dedicated clinical trial sponsor specializing in the advancement of innovative therapeutic solutions. With a strong commitment to rigorous scientific research and patient safety, the organization focuses on conducting high-quality clinical trials across various therapeutic areas. Leveraging a network of experienced professionals and cutting-edge methodologies, Gamze Gocmen aims to accelerate the drug development process while ensuring compliance with regulatory standards. The sponsor is dedicated to fostering collaboration with stakeholders to bring effective treatments to market, ultimately enhancing patient outcomes and contributing to the advancement of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Izmir, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported