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).
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
- Recruiting
Ege University
Izmir
Tuba Gıynaş, 05388806835, tubagiynas@gmail.com
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.
- What is the level of knowledge about neonatal jaundice among parents with infants between 0-28 days?
- 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.
- Conditions
- Unspecified Fetal and Neonatal Jaundice
- 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 group | Role | What they receive |
|---|---|---|
| Parent and Infant Information Form | This 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 Jaundice | This 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.
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)
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.
- First posted28 Jul 2023
- Study start1 Jul 2024
- Primary completion20 Jul 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Fetal and Neonatal JaundiceStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Associate Professor Figen YARDIMCI
- Responsible party
- Principal investigator, Tuba GIYNAS, Ege University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy of Parents Regarding Neonatal Jaundice: A Relational Descriptive Study
- ClinicalTrials.gov ID
- NCT05964426
- Acronym / sponsor ID
- HealthLiteracy
- Conditions
- Unspecified Fetal and Neonatal Jaundice
- Keywords
- Health literacy, neonatal jaundice, newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Associate Professor Figen YARDIMCI
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- What is the level of knowledge about neonatal jaundice among parents with infants between 0-28 days?
- 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?
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parent and Infant Information Form | – | Other: Turkey Health Literacy Scale (TSOY-32)This 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. |
| Parent Information Form on Neonatal Jaundice | – | Other: Turkey Health Literacy Scale (TSOY-32)This 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. |
| Turkey Health Literacy Scale (TSOY-32) | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -Parents who do not meet the inclusion criteria will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkey Health Literacy Scale (TSOY-32)Also: Parent and Infant Information Form, Parent Information Form on Neonatal JaundiceA survey will be conducted. | Other | Parent Information Form on Neonatal Jaundice, Parent and Infant Information Form, Turkey Health Literacy Scale (TSOY-32) |
Primary outcome
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
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
1 secondary outcome
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.
Time frame: August 1 2024- December 31 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.