Health Literacy and Newborn ScreeningNCT06544356
Health Literacy and Newborn Screenings
An observational study of Health Literacy and Newborn Screening, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Health literacy, the ability to understand and use health information, is crucial in all health processes such as healthy living, disease prevention, diagnosis, treatment, and personal care. The newborn screening program (NSP) helps reduce morbidity and mortality by early diagnosing rare diseases in infants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Health Literacy and Newborn Screening
- How many people
- 425 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Jan 2024
- How long will I take part?
- 1 Month
- 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
- Women only
- Adult, Older adult
Study population: Mothers who gave birth in the hospital, were hospitalised in puerperal wards and met the study criteria.
Who may be able to join
- Mothers who were in the postpartum period, postpartum or hospitalized in the obstetrics surgical ward, had at least one child, were over 18 years of age, were open to communication, and agreed to participate voluntarily in the study were included.
Who cannot join
- Mothers who did not meet the inclusion criteria were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mothers' Health Literacy Levels on Their Knowledge and Attitudes Towards Newborn Screenings
Health literacy, the ability to understand and use health information, is crucial in all health processes such as healthy living, disease prevention, diagnosis, treatment, and personal care. The newborn screening program (NSP) helps reduce morbidity and mortality by early diagnosing rare diseases in infants. Health literacy impacts parents' vaccination choices and attitudes, and higher health literacy is sometimes associated with lower adherence to vaccination protocols. Various studies highlight the significance of health literacy in childhood vaccinations, breastfeeding effectiveness, and attitudes toward YTP, emphasizing parents' lack of knowledge about NSP and the need for education. Notably, parents who give birth outside of hospitals have significant knowledge gaps regarding NSP.
Read the detailed description
Health literacy involves clearly communicating and accurately understanding health information. It is defined as being related to all points in the care process, from promoting and enhancing healthy living to preventing and detecting diseases, diagnosing and decision-making, treating, and personal care.
The newborn screening program (YTP) is defined as the early diagnosis of rare presymptomatic congenital diseases by analyzing blood samples taken from infants' heels. YTP has been stated to significantly reduce morbidity and mortality rates in infants. YTP is used to detect many diseases, including hearing loss, congenital heart defects, endocrine disorders, hemoglobinopathies, congenital metabolic diseases, cystic fibrosis, spinal muscular atrophy, lysosomal storage disorders, and immunodeficiencies.
One study found that communicative health literacy was directly related to vaccination adherence compared to functional and critical health literacy. Parents with higher levels of communicative and critical health literacy were less likely to fully adhere to vaccination protocols. Attitudes towards vaccines and beliefs about the reliability of unofficial vaccine information sources serve as directly related factors in vaccination practices and are reported to mediate the relationship between health literacy and vaccination adherence.
Another study showed that health literacy was related to parents' preferences for the rotavirus vaccine. When vaccines were offered in the free market, parents with higher health literacy were less likely to vaccinate their newborns against rotavirus compared to parents with lower health literacy.
A descriptive study conducted with 279 parents of children aged 0-12 months in the central district of Kırıkkale province found that health literacy was not related to attitudes and behaviors towards childhood vaccinations.
In a study with a Latino population, one-third were found to have inadequate health literacy when measured by reading comprehension, and eight out of ten were inadequate when measured primarily by arithmetic. Furthermore, a significant relationship was reported between limited health literacy levels and lower antibiotic knowledge among Latino parents.
A study found that mothers' health literacy levels and breastfeeding effectiveness were adequate before hospital discharge. The study also indicated that health literacy level served as a protective factor against stopping breastfeeding.
Another study found that most mothers lacked knowledge about blood spots. Additionally, mothers believed that researching dried blood spots was a good thing.
A study evaluating mothers' views on YTP reported that 51.4% of mothers found their knowledge about newborn screening tests partially sufficient and 66.3% wanted information from healthcare personnel. It was also found that 54.8% of mothers knew some diseases could be inherited, 56% knew that genetic diseases were caused by consanguineous marriage, 51.3% knew these diseases could cause irreversible brain damage in infants, 42% knew they could lead to physical growth and development delays, and 48% knew that a diagnosis could be made with two drops of blood taken from the baby's heel. The study emphasized the important roles that nurses and other healthcare professionals should play.
A study evaluating the knowledge and attitudes of midwives and parents who gave birth outside hospitals regarding YTP indicated that midwives informed parents who gave birth in hospitals about YTP. However, parents who gave birth outside hospitals had significant knowledge gaps about YTP and expressed a desire for education on the subject
A study assessing various experiences and attitudes towards YTP found that while parents generally had a positive view of the screening process, some participants experienced significant frustration, particularly regarding how results were received.
- Conditions
- Health Literacy and Newborn Screening
- Being tested
- No intervention, questionnaire filled out
- Keywords
- health literacy, newborn screening programme, mother, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, questionnaire filled outOther
Mother introductory information form, Health Literacy Scale, Knowledge and Attitude Scale about Newborn Screenings were completed.
| Study group | Role | What they receive |
|---|---|---|
| One grups | Mums who've just given birth, Over 18 years of age, literate mothers with at least primary school education Receives: Other: No intervention, questionnaire filled out |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy Scale
The Health Literacy Scale (HLS-14) was used. The scale consists of three sub-dimensions: Functional Health Literacy (5 items), Interactive Health Literacy (5 items), and Critical Health Literacy (4 items). The scale has a maximum score of 70 and a minimum score of 15. The higher the score, the higher the level of health literacy.
Measured: 6 monts
Secondary outcomes (1)
Knowledge and Attitude Scale about Newborn Screening
The Knowledge and Attitude Scale Regarding Newborn Screenings, adapted into was used. The scale has a maximum score of 52 and a minimum score of 0. The higher the score, the lower the level of knowledge and attitudes about newborn screening.
Measured: 6 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Feb 2023
- Primary completion30 Jun 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Literacy and Newborn ScreeningStudies of the same condition, open and under way.
- 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
- 425 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Adiyaman, Yuzuncu Yil University
- Investigators
- Abdullah Adıyaman, Principal investigator, abdullah.adiyaman@erzurum.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544356
- Sponsor's protocol ID
- YuzuncıYıl 2
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2024
- Last updated
- 23 Jun 2026
- 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mothers' Health Literacy Levels on Their Knowledge and Attitudes Towards Newborn Screenings
- ClinicalTrials.gov ID
- NCT06544356
- Acronym / sponsor ID
- YuzuncıYıl 2
- Conditions
- Health Literacy and Newborn Screening
- Keywords
- health literacy, newborn screening programme, mother, newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 9 Aug 2024 (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.
Health literacy, the ability to understand and use health information, is crucial in all health processes such as healthy living, disease prevention, diagnosis, treatment, and personal care. The newborn screening program (NSP) helps reduce morbidity and mortality by early diagnosing rare diseases in infants. Health literacy impacts parents' vaccination choices and attitudes, and higher health literacy is sometimes associated with lower adherence to vaccination protocols. Various studies highlight the significance of health literacy in childhood vaccinations, breastfeeding effectiveness, and attitudes toward YTP, emphasizing parents' lack of knowledge about NSP and the need for education. Notably, parents who give birth outside of hospitals have significant knowledge gaps regarding NSP.
Detailed description
Health literacy involves clearly communicating and accurately understanding health information. It is defined as being related to all points in the care process, from promoting and enhancing healthy living to preventing and detecting diseases, diagnosing and decision-making, treating, and personal care.
The newborn screening program (YTP) is defined as the early diagnosis of rare presymptomatic congenital diseases by analyzing blood samples taken from infants' heels. YTP has been stated to significantly reduce morbidity and mortality rates in infants. YTP is used to detect many diseases, including hearing loss, congenital heart defects, endocrine disorders, hemoglobinopathies, congenital metabolic diseases, cystic fibrosis, spinal muscular atrophy, lysosomal storage disorders, and immunodeficiencies.
One study found that communicative health literacy was directly related to vaccination adherence compared to functional and critical health literacy. Parents with higher levels of communicative and critical health literacy were less likely to fully adhere to vaccination protocols. Attitudes towards vaccines and beliefs about the reliability of unofficial vaccine information sources serve as directly related factors in vaccination practices and are reported to mediate the relationship between health literacy and vaccination adherence.
Another study showed that health literacy was related to parents' preferences for the rotavirus vaccine. When vaccines were offered in the free market, parents with higher health literacy were less likely to vaccinate their newborns against rotavirus compared to parents with lower health literacy.
A descriptive study conducted with 279 parents of children aged 0-12 months in the central district of Kırıkkale province found that health literacy was not related to attitudes and behaviors towards childhood vaccinations.
In a study with a Latino population, one-third were found to have inadequate health literacy when measured by reading comprehension, and eight out of ten were inadequate when measured primarily by arithmetic. Furthermore, a significant relationship was reported between limited health literacy levels and lower antibiotic knowledge among Latino parents.
A study found that mothers' health literacy levels and breastfeeding effectiveness were adequate before hospital discharge. The study also indicated that health literacy level served as a protective factor against stopping breastfeeding.
Another study found that most mothers lacked knowledge about blood spots. Additionally, mothers believed that researching dried blood spots was a good thing.
A study evaluating mothers' views on YTP reported that 51.4% of mothers found their knowledge about newborn screening tests partially sufficient and 66.3% wanted information from healthcare personnel. It was also found that 54.8% of mothers knew some diseases could be inherited, 56% knew that genetic diseases were caused by consanguineous marriage, 51.3% knew these diseases could cause irreversible brain damage in infants, 42% knew they could lead to physical growth and development delays, and 48% knew that a diagnosis could be made with two drops of blood taken from the baby's heel. The study emphasized the important roles that nurses and other healthcare professionals should play.
A study evaluating the knowledge and attitudes of midwives and parents who gave birth outside hospitals regarding YTP indicated that midwives informed parents who gave birth in hospitals about YTP. However, parents who gave birth outside hospitals had significant knowledge gaps about YTP and expressed a desire for education on the subject
A study assessing various experiences and attitudes towards YTP found that while parents generally had a positive view of the screening process, some participants experienced significant frustration, particularly regarding how results were received.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One grups | – | Other: No intervention, questionnaire filled outMums who've just given birth, Over 18 years of age, literate mothers with at least primary school education |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Mothers who gave birth in the hospital, were hospitalised in puerperal wards and met the study criteria.
Key inclusion criteria (1 listed)
- Mothers who were in the postpartum period, postpartum or hospitalized in the obstetrics surgical ward, had at least one child, were over 18 years of age, were open to communication, and agreed to participate voluntarily in the study were included.
Key exclusion criteria (1 listed)
- Mothers who did not meet the inclusion criteria were excluded from the study.
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 |
|---|---|---|
| No intervention, questionnaire filled outMother introductory information form, Health Literacy Scale, Knowledge and Attitude Scale about Newborn Screenings were completed. | Other | One grups |
Primary outcome
Health Literacy Scale
Time frame: 6 monts
The Health Literacy Scale (HLS-14) was used. The scale consists of three sub-dimensions: Functional Health Literacy (5 items), Interactive Health Literacy (5 items), and Critical Health Literacy (4 items). The scale has a maximum score of 70 and a minimum score of 15. The higher the score, the higher the level of health literacy.
1 secondary outcome
Knowledge and Attitude Scale about Newborn Screening
Time frame: 6 monts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- 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.
Abdullah Adıyaman principal investigator
abdullah.adiyaman@erzurum.edu.tr
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 Health Literacy and Newborn Screening, run by Yuzuncu Yil 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 1 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: finished, as of the sponsor's last update on 23 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Literacy Scale (time frame: 6 monts). 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 Jun 2026.