Completed

NCT Number: 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 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.

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Key information

Conditions

Neonatal Care Neonatal Comfort Swaddled Bathing Wipe Bathing

Age range

2 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swaddled Bath Intervention Wipe Bath Intervention

Behavioral

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

Primary outcomes

Newborn comfort (measured with the KONFOR Neo scale)

Time frame: Data collection will include comfort assessments at the 10th and 60th minutes after the bath.

Sponsors and collaborators

Lead sponsor

Gamze Gocmen

Other

Registry information

Official study 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.

Acronym: WS-Bath RCT

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Mar 20, 2025
Registry last updated: Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.