Clinical trial NCT06887686: The Effect of Wiping and Swaddling Bath Methods Applied in the Neonatal Intensive Care Unit on Neonatal Comfort: a Randomized Controlled Trial
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Care Neonatal Comfort Swaddled Bathing Wipe Bathing
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Newborn comfort (measured with the KONFOR Neo scale)
timeFrame: Data collection will include comfort assessments at the 10th and 60th minutes after the bath.
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Tepecik Training and Research Hospital
Study officials:
affiliation: Ege University
name: Aysun Ekşioğlu, Doç. Dr.
role: PRINCIPAL_INVESTIGATOR
References: