The Effects of Video-Based and Practical Newborn Bathing Education Provided to Primiparous Pregnant Women During the Third Trimester on Knowledge, Anxiety, and Bonding During the First Bath: a Randomized Controlled Trial (NewbornBathing)

October 25, 2024 updated by: Çağla KILIÇ, Kahramanmaras Sutcu Imam University
This study will be conducted in a randomized controlled experimental research design with pretest, posttest control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 with pretest, posttest control group.

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 (Estimated)

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.
144

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 Locations

  • Turkey
      • Kahramanmaras, Turkey
        • Kahramanmaras Sutcu Imam University

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:

  • Can speak and understand Turkish,
  • 18 years of age or older,
  • Literate,
  • Primiparous,
  • In the third trimester of pregnancy,
  • A singleton pregnancy,
  • No psychiatric illness,
  • Who have not received any training on newborn bathing before,
  • Her baby was not diagnosed with a fetal anomaly,
  • With a smartphone and internet,
  • Residing in the province of Kahramanmaras and
  • Who agreed to participate in the research

Exclusion Criteria:

  • Preterm labor (<37 weeks gestation),
  • Stillbirth,
  • The baby needs intensive care or is hospitalized,
  • The baby has a low birth weight (<2500 grams),
  • The one whose baby's first bath was given by someone else,
  • A newborn bathing program was organized at the pregnancy school.
  • Wishing to leave at any stage of 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 without any other intervention. Pregnant women in this group are verbally informed about bathing during outpatient clinic follow-ups. After completing the post-test questions, the newborn bath application video will be transmitted to the women in this group on their phones and the disadvantageous situation of this group will be tried to be reduced.
Experimental: Intervention group 1
The women assigned to this group will be shown the newborn bath application video prepared by the researchers in groups of 2-4 people in the form of a projection presentation.
Behavioral: Intervention group 1
The women assigned to this group will be shown the newborn bath application video prepared by the researchers in groups of 2-4 people in the form of a projection presentation.
Experimental: Intervention group 2
In groups of 2, the researcher will first explain the stages of newborn bathing application by the researcher in the form of a projection presentation, and then the pregnant women will be provided to perform the newborn bathing application on the newborn bathing model and tools simultaneously with the researcher.
Behavioral: Intervention group 2
In groups of 2, the researcher will first explain the stages of newborn bathing application by the researcher in the form of a projection presentation, and then the pregnant women will be provided to perform the newborn bathing application on the newborn bathing model and tools simultaneously with the researcher.

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
Knowledge Level of Mothers on Newborn Bathing
Time Frame: average 3 months
The Newborn Bathing Knowledge Test was developed by the researchers based on the literature to determine the knowledge levels of mothers about newborn bathing. In the knowledge test, there are a total of 20 questions under 10 main topics including "bath time, bathing materials, ambient temperature, water temperature, umbilical cord care, soap and shampoo use, maintaining newborn body temperature, bathing procedure sequence, safety during bathing, drying after bathing and dressing". The questions were prepared in multiple-choice and true/false design, and each question had only one correct answer. The women's answers to the questions were evaluated after the completion of the test and each correctly answered question was evaluated as five points and the total score ranged from 0-100. The higher the score obtained from the knowledge test, the higher the women's level of knowledge about newborn bathing.
average 3 months
Anxiety level of women
Time Frame: average 3 months
Anxiety level of women will be assessed by using Spielberger's State Anxiety Inventory. The scale was developed to measure the state anxiety levels of normal and abnormal individuals and adapted into Turkish by Öner and Le Compte. It is a self-assessment type scale consisting of short statements. The State Anxiety Inventory was developed to measure a person's anxiety at a specific moment and consists of 20 items. In the evaluation of the scale, it is accepted that those who score below 36 have no anxiety, those who score between 37 and 42 have mild anxiety and those who score 42 and above have high anxiety.
average 3 months
Womens bonding levels
Time Frame: average 3 months
Womens bonding level will be assessed using the Postpartum Bonding Questionnaire (PBQ). The PBQ was first developed to assess mother-infant attachment. It was revised to identify problems in the mother-infant relationship. The scale was adapted into Turkish by Dişsiz et al. in 2024. The six-point Likert-type scale has 21 items to measure the mothers attachment to the infant within a year. As the score obtained from the scale increases, the mothers bonding to the baby decreases.
average 3 months

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.
Kahramanmaras Sutcu Imam University

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 (Estimated)

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.
December 15, 2024

Primary Completion (Estimated)

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.
July 15, 2025

Study Completion (Estimated)

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.
August 15, 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).
September 17, 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.
October 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.
October 28, 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.
October 28, 2024

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.
October 25, 2024

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.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 185
  • TUBITAK or KSU BAP (Other Identifier: TUBITAK or KSU BAP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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