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Unspecified Fetal and Neonatal JaundiceNCT05964426

Health Literacy of Parents Regarding Neonatal Jaundice

An observational study of Unspecified Fetal and Neonatal Jaundice, run by Ege University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will be conducted as a relational descriptive study to determine the health literacy level of parents with infants between 0-28 days of age regarding neonatal jaundice. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Unspecified Fetal and Neonatal Jaundice
What is being tested?
Turkey Health Literacy Scale (TSOY-32)
How many people
170 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2024to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: It will be carried out with parents who have a newborn between 0-28 days who applied to Beyşehir State Hospital, Pediatrics Polyclinics.

Who may be able to join

  • Theparent has a baby aged 0-28 days, The parent does not have any speech-vision-hearing disability that would prevent communication,
  • The parent speaks Turkish,
  • Parental literacy
  • It was determined by taking into consideration the criteria of volunteering to participate in the research.

Who cannot join

  • -Parents who do not meet the inclusion criteria will be excluded.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Ege University

    Izmir

    Tuba Gıynaş, 05388806835, tubagiynas@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Health Literacy of Parents Regarding Neonatal Jaundice: A Relational Descriptive Study

This study will be conducted as a relational descriptive study to determine the health literacy level of parents with infants between 0-28 days of age regarding neonatal jaundice. The secondary aim of the study is to examine whether the health literacy levels of the parents differ with parent and infant descriptive characteristics and their knowledge about neonatal jaundice. In this study, answers to the following questions were sought.

  1. What is the level of knowledge about neonatal jaundice among parents with infants between 0-28 days?
  2. What is the level of health literacy of parents with infants between 0-28 days of age and is there a relationship between parent, infant identifying characteristics and knowledge about neonatal jaundice?
Read the detailed description

Objective: This study will be conducted as a relational descriptive study to determine the health literacy level of parents with infants between 0-28 days of age regarding neonatal jaundice. The secondary aim of the study is to examine whether the health literacy levels of the parents differ with parent and infant descriptive characteristics and their knowledge about neonatal jaundice.

Methodology of the research: The research is a descriptive study in relational design. It is a study design in which the relationships between two or more variables are examined, aiming to examine whether one variable causes any change in the other variable.

Population of the Study: Parents with newborn babies aged between 0-28 days who live in Turkey and can be reached.

While determining the sample of the study; using G-Power 3.1.9.7 program; type 1 error (α) 0.05, power (1- β) 80% and Cohen's effect size (δ) 0.2, the sample size to represent the main mass was determined as 156 people for this study. However, when the dropout rate is set as 10% for data loss that may occur in the study, the minimum number to be reached for the study is targeted as 170 people.

Snowball processing method, one of the simple processing methods, will be used to reach the sample size. In this method, a reference person related to the subject of the study is selected and other people are reached through this person.For snowball sampling, we will primarily contact pregnant women over 28 weeks of gestation and mothers with newborns in our area via social media, WhatsApp or e-mail. Then, the sample will be reached in the form of pregnant women and mothers who are known to these pregnant women and mothers. Since the researcher is located in the Central Anatolia Region, the sample density is expected to be from the Central Anatolia region. Surveys will be created with an online survey (Google Form) and sent to pregnant women and mothers via social media, WhatsApp or e-mail.

Independent Variables: The independent variables of the study included age, education level, family type, place of residence, whether the parents had other children, how many days old the baby was, gender of the baby, blood type of the mother, father and baby, whether the baby was given formula in addition, whether the parents had sufficient information about neonatal jaundice, from whom they received the information, what their reaction would be if their baby got jaundice, information about the causes, symptoms and complications of jaundice.

Dependent Variables: The mean score of the health literacy scale of the parents constituted the dependent variables.

The research data will be collected through the 'Introductory Information Form on Mother and Infant', 'Parent Information Form on Neonatal Jaundice' and 'Turkey Health Literacy Scale' which were created by the researcher using the literature.

Data Analysis: Statistical Package for Social Sciences 25.0 package program will be used to analyze the data. Descriptive characteristics of the parents will be given as frequency (f), percentage (%) and mean. Normality distribution will be determined by Shapiro-Wilk test. In the analysis of normally distributed data; t-test will be used to determine whether there is a difference between two independent groups, and one-way ANOVA will be used to determine whether there is a difference between more than two independent groups. In the analysis of non-normally distributed data, Mann Whitney-U will be used to determine whether there is a difference between two independent groups and one-way Kruskal-Wallis will be used to determine whether there is a difference between more than two independent groups. The findings obtained will be evaluated at 95% confidence interval and significance at p<0.05 level.

Being tested
Turkey Health Literacy Scale (TSOY-32)
Keywords
Health literacy, neonatal jaundice, newborn
Medical subject headings
Jaundice, Neonatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Turkey Health Literacy Scale (TSOY-32)Other

    Also called Parent and Infant Information Form, Parent Information Form on Neonatal Jaundice

    A survey will be conducted.

Study groups in NCT05964426
Study groupRoleWhat they receive
Parent and Infant Information FormThis form consists of a total of 19 questions in line with the literature, including the parents' age, education level, family type, place of residence, whether they have other children, how many days their baby is, gender of the baby, maternal blood type, paternal blood type, and whether the baby is given formula in addition.
Receives: Other: Turkey Health Literacy Scale (TSOY-32)
Parent Information Form on Neonatal JaundiceThis form consists of a total of 6 questions in line with the literature, including whether the parent has sufficient information about neonatal jaundice, from whom he/she received the information, what his/her reaction will be if his/her baby gets jaundice, and information about the causes, symptoms and side effects of jaundice.
Receives: Other: Turkey Health Literacy Scale (TSOY-32)
Turkey Health Literacy Scale (TSOY-32)It is a 32-question scale developed based on the Conceptual Framework of the European Health Literacy Scale Study. The Turkish Health Literacy Scale (TSOY-32) was developed to assess health literacy in literate people over the age of fifteen. Unlike the original scale, the scale consists of eight components including two dimensions (treatment and service, disease prevention and health promotion) and four processes (accessing health-related information, understanding health-related information, evaluating health-related information, and using/applying health-related information). The overall internal consistency coefficient of the scale was 0.92. The Cronbach's alpha coefficient of the first dimension 'Treatment and Service Subdimension' is 0.88. The Cronbach's alpha coefficient of the second dimension 'Disease Prevention and Health Promotion Dimension' is 0.86. Permission to use the scale was obtained.
Receives: Other: Turkey Health Literacy Scale (TSOY-32)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. It is planned as a relational descriptive study to determine the level of health literacy of parents with babies between 0-28 days of age regarding neonatal jaundice.

    To determine the health literacy levels of parents with 0-28 days old babies regarding neonatal jaundice. Accordingly, the scores of the Turkish Health Literacy Scale (TSOY-32) are given below.

    • (0-25) points: insufficient health literacy
    • (>25-33) score: problematic - limited health literacy
    • (>33-42) score: adequate health literacy
    • (>42-50) score: excellent health literacy

    Measured: August 1 2024 - December 31 2024

Secondary outcomes (1)
  1. The secondary aim of the study was to examine whether parents' health literacy levels differed with parent and infant descriptive characteristics and knowledge about neonatal jaundice.

    The secondary aim of the study is to examine whether the health literacy levels of the parents [Turkish Health Literacy Scale (TSOY-32)] differ according to their parental and infant descriptive characteristics and their knowledge about neonatal jaundice (significance p<0.05).

    Measured: August 1 2024- December 31 2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start1 Jul 2024
  3. Primary completion20 Jul 2024
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05964426
Sponsor's protocol ID
HealthLiteracy
Status last verified
Jul 2024
First submitted
22 Jun 2023
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Unspecified Fetal and Neonatal Jaundice, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Figen YARDIMCI (05388806835, figenyardimci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

It is planned as a relational descriptive study to determine the level of health literacy of parents with babies between 0-28 days of age regarding neonatal jaundice. (time frame: August 1 2024 - December 31 2024). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.

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