The Effect of Wiping Bath Training on Early Bathing, Body Temperature and Umbilical Cord Fall Time in Newborns

May 3, 2026 updated by: Çağla KILIÇ

The Effect of Wiping Bath Training on Early Bathing, Body Temperature and Umbilical Cord Fall Time in Newborns: A Randomized Controlled Trial

The aim of this study is to examine the effects of wiping bath training on early bathing, body temperature and umbilical cord shedding time in newborns. This study was planned in a randomized controlled experimental research design. The study will be conducted with pregnant women who applied to the pregnancy schools of Kahramanmaraş Necip Fazıl City Hospital Gynecology and Obstetrics Additional Service building. When calculating the sample size, a similar study previously conducted on the subject was taken as a reference and the G*Power 3.1.9.7 program was used (Ayyıldız et al, 2015). In the calculation made; the sample size of the study was found to be at least 36, and considering the parametric distribution, it was planned to complete the study with a total of 60 people, 30 in each group. Considering the possible case losses (10%), it is planned to include a total of 66 women (intervention group: 33, control group: 33). In the study, women will be assigned to groups according to the previously determined randomization number sequences, and then the Pregnant Information Form will be filled out by the participants using the face-to-face interview method. The determined practices will be carried out according to the group to which the participants are assigned. The hospital's pregnancy information class will be used for the training, and if there is another planned training in the pregnancy school, an empty room determined by the hospital administration will be used. The pregnant women in the intervention group will be explained the newborn wiping and bathing application stages by the researcher in groups of 2-3 people on a newborn model, and then the pregnant women will be asked to apply the bath individually on the model. The pregnant women in the control group will be subject to routine hospital protocol and no other intervention will be made. After the birth, the participants will be called by phone and the "Newborn Characteristics Information Form" will be filled out by phone and the participants will be asked to provide information by phone message after the umbilical cord falls off. After the umbilical cord falls off, the participants will be called by phone and the first bath time, umbilical cord falling off time and the body temperature of their babies (before the bath, immediately after the bath and 10 minutes after the bath) will be recorded by asking the mothers on the given follow-up form.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be conducted in a randomized controlled experimental research design.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Kahramanmaraş, Turkey (Türkiye)
        • Kahramanmaraş Necip Fazıl City Hospital, Obstetrics and Gynecology Annex Building, Pregnancy School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Infants of women who can speak and understand Turkish,
  • who are literate, who are between 38-40 weeks of gestation,
  • who have a healthy pregnancy,
  • who can be followed up in the postpartum period by obtaining contact information, -who have a thermometer that can measure their baby's temperature at home, ---
  • whose mothers do not have chronic-systemic diseases, hepatitis, acquired immunodeficiency syndrome and genital infections,
  • who voluntarily agree to participate in the study and give written informed consent will be included in the study.

Exclusion Criteria

  • Newborns with a gestational age below 37 weeks,
  • birth weight below 2500 grams,
  • premature rupture of membranes in the mother,
  • congenital defects,
  • need for intensive care or hospitalization,
  • impaired skin integrity or skin problems and newborns whose mothers could not be contacted after birth will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group:
Pregnant women in the control group will be subjected to the routine hospital protocol and will not be subjected to any other intervention. In the pregnancy schools of the hospitals, they are verbally told not to wash and wipe their babies before the umbilical cord falls off. After the training, pregnant women will be given a home follow-up form to record the first bath time of their babies after birth, the umbilical cord fall time and the body temperature of their babies (before bathing, immediately after bathing and 10 minutes after bathing) and will be told how to fill it out.
Experimental: Wipe Bathing
In groups of 2-3 pregnant women in this group, the researcher will explain the stages of newborn wiping bath application on the newborn model, and then the pregnant women will individually apply the bath on the model. The trainings will be held in the pregnant school at the appropriate hours, or in an empty room determined by the hospital administration if there is another planned training in the pregnant school. In the wiping bath training, for genital area cleaning based on the gender of newborns, women will be provided to perform the procedure on the model appropriate to the gender of their babies. After the training, pregnant women will be given a home follow-up form to record the first bath time of their babies after birth, the umbilical cord fall time and the body temperature of their babies (before bathing, immediately after bathing and 10 minutes after bathing) and will be told how to fill it out.
Behavioral: Wipe Bathing
In groups of 2-3 pregnant women in this group, the researcher will explain the stages of newborn wiping bath application on the newborn model, and then the pregnant women will individually apply the bath on the model. The trainings will be held in the pregnant school at the appropriate times, or in an empty room determined by the hospital administration if there is another planned training in the pregnant school. In the wiping bath training, women will be provided to perform the procedure on the model appropriate to the gender of their babies for genital area cleaning based on the gender of newborns. After the training, pregnant women will be given a home follow-up form to record the first bath time of their babies after birth, the umbilical cord fall time and the body temperature of their babies (before bathing, immediately after bathing and 10 minutes after bathing) and will be told how to fill it out.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early Bathing Rate
Time Frame: 2 weeks after birth
Early Bathing Rate will be determined using the Newborn Home Monitoring Form. This form was developed by the researchers to ensure that mothers record information about the newborn regularly at home and to collect the necessary data for the study. The form will be given to the mothers after the bathing training and they will be asked to fill it in at home. Mothers will be asked to record the baby's first bath time on this form. Baths before 24 hours postpartum will be considered early bathing.
2 weeks after birth
Newborn Body Temperature
Time Frame: 2 weeks after birth
The body temperature of the newborn will be determined using the Newborn Home Monitoring Form. This form was developed by the researchers to ensure that mothers record information about the newborn regularly at home and to collect the necessary data for the study. The form will be given to the mothers after the bathing training and they will be asked to fill it in at home. Mothers will be asked to record their body temperature measurements before, immediately after and 10 minutes after the baby's first bath on this form. Body temperature will be calculated as mean±SD.
2 weeks after birth
The duration of umbilical cord fall
Time Frame: 2 weeks after birth
The duration of umbilical cord fall will be determined using the Newborn Home Monitoring Form. This form was developed by the researchers to ensure that mothers record information about the newborn regularly at home and to collect the necessary data for the study. The form will be given to the mothers after the bathing training and they will be asked to fill it in at home. Mothers will be asked to write the date of the umbilical cord drop on this form. Duration of umbilical cord fall will be calculated as mean±SD.
2 weeks after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Çağla KILIÇ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KSÜ MIDWIFERY DEPARTMENT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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