NCT06887686

The Effect of Wiping and Swaddling Bath Methods Applied in the Neonatal Intensive Care Unit on Neonatal Comfort: a Randomized Controlled Trial

This Study Complies with the Requirements of the Final Rule (42 CFR Part 11) for Clinical Trials with a Start Date of January 18, 2017, or Later, Including the Registration and Reporting of Results As Per the Applicable Regulations.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Gamze Gocmen · Academic / Other
• Sex: All
• Age: 2 Days – 7 Days
• Healthy volunteers: Accepted

Summary

This study will be conducted as a randomized controlled trial to examine the effects of different bathing methods on neonatal comfort. The study will take place in the Neonatal Intensive Care Unit (NICU) of İzmir Tepecik Training and Research Hospital, with a total sample size of 64 neonates who meet the inclusion criteria. Neonates born at 37 weeks or later, with stable physiological parameters, and receiving their first bath will be included. Those diagnosed with sepsis, on mechanical ventilation, or with impaired skin integrity will be excluded. The swaddled bath will be applied to the intervention group, while the wipe bath will be applied to the control group. Neonatal comfort levels will be assessed by a second nurse at 10 and 60 minutes after bathing. Data collection will utilize the COMFORT Neo scale, and statistical analyses will be performed using IBM SPSS. T-tests, ANOVA, and correlation tests will be used to compare the effects of bathing methods on neonatal comfort.

Detailed description

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 protocols. Neonatal comfort levels will be assessed by a second nurse working in the NICU at 10 and 60 minutes after bathing, using the COMFORT Neo scale. Data Analysis: Collected data will be analyzed using IBM SPSS Statistical Package Program. Descriptive statistics (mean, percentage, standard deviation) will be calculated, and t-tests, ANOVA, and correlation analysis will be conducted to evaluate differences between the groups. Ethical Considerations: Prior to the study, approval will be obtained from the Non-Interventional Research Ethics Committee of İzmir Tepecik Training and Research Hospital. Additionally, parents of the neonates will be provided with detailed information about the study, and informed consent will be obtained. This study aims to contribute to the standardization of bathing methods in NICUs and to determine the most effective technique for improving neonatal comfort.

Conditions

• Neonatal Care Neonatal Comfort Swaddled Bathing Wipe Bathing

Interventions

Type	Name	Description
BEHAVIORAL	Swaddled Bath Intervention Wipe Bath Intervention	Swaddled Bath Intervention: In the swaddled bath group, infants are gently wrapped in a soft towel or blanket to maintain a flexed position. They are then immersed in warm water at an appropriate temperature to regulate body temperature. This intervention is designed to reduce stress and pain, particularly for premature infants, and helps to relax the baby's muscles, stabilize body temperature, and increase overall comfort. It is expected to show a more significant effect on physiological and behavioral stabilization than less invasive methods. Wipe Bath Intervention: In the wipe bath group, infants are gently wiped with a cloth soaked in warm water. This method is less invasive than the swaddled bath, aiming to maintain body temperature while providing a milder level of relaxation. The wipe bath is effective for skin cleansing but may not provide the same comfort or stress-reducing effects as the swaddled bath. The expected physiological effects, such as body temperature stabilizatio

Timeline

• Start date: 2024-03-04
• Primary completion: 2024-09-04
• Completion: 2025-03-03
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

1 site across 1 country: Turkey (Türkiye)