The Effect of Umbilical Cord Care Training on Cord Falling Time

July 11, 2023 updated by: Özlem Selime MERTER, Firat University

Investigation of the Effect of Umbilical Cord Care Training Given to Primiparous Mothers on Cord Duration: A Randomized Controlled Study

Under normal conditions, the umbilical cord is removed 5-15 days after birth. It dries up and falls within days. It is extremely important to determine the factors that cause the prolongation of the falling time of the cord, which poses a serious risk for infection. The aim of this study is to determine the effect of umbilical cord care training given to primiparous mothers on the duration of cord fall. It is a randomized controlled type of research. The population of the research will be primiparous mothers who gave birth in the obstetrics clinic of a university hospital. A pilot study will be conducted to determine the number of samples. As a result of the pilot study, power analysis will be performed and the number of samples will be determined. Inclusion criteria of mothers in the study; Data collection tools: "Descriptive Questionnaire" and "Questionnaire for Umbilical Cord Care" will be used to collect research data. Randomization will be done as odd days of the week and even days of the week for sample selection in the study. Primiparous mothers giving birth on odd days of the week will form the group that will receive umbilical cord training, while primiparous mothers giving birth on even days of the week will form the group that does not receive training. The research will be carried out in two stages. In the first stage of the research, after informing the mothers about the study, they will be invited to the research. Written consent will be obtained from mothers who volunteered to participate in the study. Then, the "Descriptive Questionnaire" prepared to describe mothers and babies will be filled. In the second stage of the research: the mothers will be called 15-20 days after the first interview and the "Question Form Regarding Umbilical Cord Care" will be filled.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Under normal conditions, the umbilical cord is removed 5-15 days after birth. It dries up and falls within days. It is extremely important to determine the factors that cause the prolongation of the falling time of the cord, which poses a serious risk for infection. The aim of this study is to determine the effect of umbilical cord care training given to primiparous mothers on the duration of cord fall. It is a randomized controlled type of research. The population of the research will be primiparous mothers who gave birth in the obstetrics clinic of a university hospital.

A pilot study will be conducted to determine the number of samples. As a result of the pilot study, power analysis will be performed and the number of samples will be determined.

Data Collection:

Stage 1: A pilot study will be conducted with 10 mothers in order to evaluate the appropriateness of the forms and scales used before the research.

Stage 2: The purpose of the research and how to record the data will be explained to the mothers. The mothers in the sample group will be informed about the path followed in practice and the research, and their verbal and written consent will be obtained.

Stage 3:The mothers who meet the sample selection criteria will be randomly and equally distributed into 2 groups through a program in the computer environment, and randomization will be provided.(http://www1.assumption.edu/users/avadum/applets/RandAssign/ GroupGen.html) (1st experimental education group, 2nd control group).

Stage 4: Then, the "Descriptive Questionnaire" prepared to describe mothers and babies will be filled. In the second stage of the research: the mothers will be called 15-20 days after the first interview and the "Question Form Regarding Umbilical Cord Care" will be filled. Umbilical care training will be given to primiparous mothers who give birth on odd days of the week and meet the research criteria, and the training brochure will be printed out and given to mothers. The training will be given face-to-face during the postpartum period when the mother is stabilized. In order to increase the effectiveness of the training, the content of the training will be reinforced by making mutual questions and answers.

The control group will be given routine clinic care. Stage 5: The time of fall of the umbilical cord will be recorded in the data collection form.

Stage 6:The analysis and reporting of the obtained data will be done.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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
      • Elazığ, Turkey
        • Fırat university
      • Elazığ, Turkey
        • Fırat Univesity

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:Inclusion criteria of mothers in the study;

  • Knowing the last menstrual period (SAT),
  • Gestational week (GH) interval is due (38-42 GH)
  • Able to speak and understand Turkish,
  • Not having any chronic disease (diabetes, hypertension, hyper/hypotroid etc.),
  • Over 18 years old,
  • Normal vaginal delivery
  • First born

Exclusion Criteria:

Exclusion criteria for newborns;

  • Umbilical cord anomaly (long cord, cord entanglement etc.),
  • Needing resuscitation or having a fifth-minute APGAR score of less than 7,
  • Birth weight below 2500 g,
  • Rh, ABO incompatibility
  • Newborns whose umbilical cord does not fall on the postpartum 20th day

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
Intervention / Treatment
Experimental: Group Receiving Umbilical Cord Training
Oral umbilical care training will be given to the primiparous mothers who gave birth on odd days of the week and met the research criteria, and the training brochure will be printed out and given to the mothers. The training will be given face-to-face during the postpartum period when the mother is stabilized. In order to increase the effectiveness of the training, the content of the training will be reinforced by making mutual questions and answers.
Other: education
education about ubilical cord care
No Intervention: Group Without Umbilical Cord Training
The routine operation of the clinic will be carried out without any intervention for primiparous mothers who gave birth on even days of the week and met the research criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QUESTION FORM FOR UMBLIKAL CORD CARE
Time Frame: 1 day

It was prepared by researchers in line with the literature in order to evaluate the umbilical cord and care of the baby and to investigate the umbilical fall time. Expert opinion will be taken for the suitability of the form. There are no minimum and maximum scores in the prepared form. The questionnaire are:

  1. Has your baby's umbilical cord fallen off?
  2. Did you close the umbilical cord? 3- Did you bathe your baby before the umbilical cord fell off? 4- If you gave your baby a bath, how did you do it? 5- Have you used any product (alcohol, tenderdiode, ointment, powder, etc.) for your baby's belly care? 6- When tying your baby's diaper, did you pay attention to keep the umbilical cord outside? 7- Has the umbilical cord been in contact with urine or stool? 8- What type of diaper do you use for your baby? 9- Have you had any traditional practices regarding your baby's navel care? 10- What is the baby's diet?
1 day

Collaborators and Investigators

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

Sponsor

Firat University

Investigators

  • Principal Investigator: Atiye Karakul, Tarsus
  • Principal Investigator: Duygu Karaarslan, Manisa

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)

December 30, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022/ 05- 35

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

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.

Clinical Trials on Infant Conditions

Clinical Trials on education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe