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School HealthNCT04829942

Evaluation of the Effectiveness of "School Health Nursing Program" Implemented Under the Leadership of Nurse

A study testing positive health behavior in people with School Health and Health Literacy, run by Eastern Mediterranean University at 1 site in Cyprus.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

It is very important for children to take their own health responsibilities in giving them positive health behavior. The rapid advancement of technology, cultural differences, changing living conditions, and increasing chronic diseases show us that people should have the authority to make decisions about their own… Read more about this study

Who is it for?
Ages 9 to 11 yearsHealthy volunteers can take part
Conditions the study is for
School Health, Health Literacy
What is being tested?
positive health behavior
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCyprus
Study dates
1 Apr 2022to 15 Oct 2022
Phase
Interventional
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 9 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • All male and female students in the 9-11 age group in the two primary schools where the study will be conducted.

Who cannot join

  • All male and female students except 9-11 age group

Trial locations and contacts

1 site in 1 country.

RASİHA GÜLER, 1 contact

05488429441

rasihaguler@gmail.com

HÜLYA FIRAT KILIÇ, 2 contact

05488588821

hulyafirat@emu.edu.tr

Cyprus1 site
  • Eastern Mediterranean University

    Famagusta, 99628

    RASİHA GÜLER, 1, 05488429441, rasihaguler@gmail.com

    HÜLYA FIRAT KILIÇ, 2, 05488588821, hulya.firat@emu.edu.tr

Other trials in Cyprus

About this study

It is very important for children to take their own health responsibilities in giving them positive health behavior. The rapid advancement of technology, cultural differences, changing living conditions, and increasing chronic diseases show us that people should have the authority to make decisions about their own health, starting from primary school and childhood. All these bring the concept of health literacy to the fore. According to WHO, the concept of health literacy is the cognitive and social skills about individuals' ability to access, understand and use information and their desires in order to protect and improve well-being in health. Providing appropriate health education for age groups is very important for the development of health literacy in children. School-based health education is necessary for health promotion in the 21st century. Studies show that children's health literacy levels are low. There are very few scales that measure health literacy in children. Although there are no school health nursing practices in Northern Cyprus, there are no training programs to develop positive health behaviors. With this study we have planned, it is aimed to implement a training program within the scope of the "School Health Nursing Program" in primary schools selected as a pilot in Northern Cyprus and to form the foundations of School health nursing in our country in line with its results. In addition, measurement tools specific to age groups are needed to measure the level of health literacy, especially in school-age children. Therefore, another purpose of this study is to evaluate the effectiveness of this program on children by implementing an education program within the scope of the "School Health Nursing Program", which will be a first in our country, and to develop the "Child Health Literacy Scale" and to make it a significant contribution to science with this scale.

Read the detailed description

Today's health systems are of great importance in protecting and improving the health of children. It is very important for children to take their own health responsibilities in giving them positive health behavior. The rapid advancement of technology, cultural differences, changing living conditions, and increasing chronic diseases show us that people should have the authority to make decisions about their own health, starting from primary school and childhood. All these bring the concept of health literacy to the fore. According to WHO, the concept of health literacy is the cognitive and social skills about individuals' ability to access, understand and use information and their desires in order to protect and improve well-being in health. It is very important to provide health education appropriate to age groups for the development of health literacy in children. School-based health education is necessary for health promotion in the 21st century. In this context, school health nurses gain great importance. School health nursing is of great importance for children to acquire positive health behaviors and to take their own health responsibilities . In addition to the importance of school health nursing, it is also important to know the health literacy levels of children. Studies show that children's health literacy levels are low. There are very few scales that measure health literacy in children. There is no scale developed to measure health literacy in primary school students in the literature. Among the topics given to children in health education, nutrition, physical activity, first aid, individual hygiene, protection from accidents and prevention of violence are among the most important.

In the development of positive health behaviors, healthy nutrition and regular physical activity behaviors, the education given at school age is very important. In this sense, important responsibilities fall on school health nurses. Although there are no school health nursing practices in Northern Cyprus, there are no training programs to develop positive health behaviors. With this study we have planned, it is aimed to implement a training program within the scope of the "School Health Nursing Program" in primary schools selected as a pilot in Northern Cyprus and to form the foundations of School health nursing in our country in line with its results. In addition, measurement tools specific to age groups are needed to measure the level of health literacy, especially in school-age children. Therefore, another purpose of this study is to evaluate the effectiveness of this program on children by implementing an education program within the scope of the "School Health Nursing Program", which will be a first in our country, and to develop the "Child Health Literacy Scale" and to make it a significant contribution to science with this scale.

GOAL

This study was planned to evaluate the effectiveness of the school health nursing program administered to primary school students under the leadership of a nurse and to develop the "Child Health Literacy Scale".

MATERIALS AND METHODS

  1. Type of Research The research will be carried out in accordance with the methodological and randomized controlled experimental research design.
  2. Place and time of the research The research will be carried out in two stages in state primary schools affiliated to the Ministry of National Education and Culture located within the borders of the Turkish Republic of Northern Cyprus, following the approval of the Ethics Committee and institutional permissions.
  3. The universe and sample of the research

The Universe of the research will be formed by the children studying in state primary schools affiliated with the Ministry of National Education and Culture of the Turkish Republic of Northern Cyprus between the dates of the research. The study, which is planned in two stages, will be studied with two sample groups.

In the first stage: 4th grade students of two primary schools in the Kyrenia region will participate in the selection of the school where the "School Health Nursing Application Program", which is included in the first stage of the research, will be applied. In the study, it is expected that there will be a moderate increase in the scale scores of the experimental group children after the education and the effect size is high (d = 0.50) according to the Cohen scale. Accordingly, the sample size required for 80% power at d = 0.50 and α = 0.05 was determined as 30 persons for the experimental group to approach the normal distribution by using G * Power 3.1.9.2 software. Similarly, 30 people will be taken for the control group, and the sample size is 60 people, 30 being experimental and 30 control groups. The experimental and control group students will be determined with the MedCalc software using the block randomization technique.

In the second stage, the development of the "Child Health-Literacy Scale" will be carried out with 6458 students in the 9-11 age group who attend 4th and 5th grades of primary schools. Students will be determined by simple random sampling method among 4th and 5th grade students of primary schools in Kyrenia, Nicosia, Güzelyurt, Famagusta and İskele districts.

Being tested
positive health behavior
Keywords
school health, nursing, leadership, health literacy

What participants receive

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

  • positive health behaviorBehavioural

    Training on nutrition, physical activity, first aid, individual hygiene, violence and bullying will be provided to the initiative group.

Study groups in NCT04829942
Study groupRoleWhat they receive
experimentalExperimentalA 12-week training program will be applied to the experimental group. Pre-tests will be applied before the trainings begin, and height and weight measurement, nutrition, health perception and behavior scale and physical activity scale will be applied to the experimental group and the control group within the 3rd and 6th month after the training program begins. Scale applications will be applied within 2 days, taking into account the attention span of the students.
Receives: Behavioral: positive health behavior
no interventionNo interventionPower point presentations will be given to the control group

What is being measured

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

  1. With the school health nursing program to be implemented within 6 months, a moderate increase in physical activity, nutrition and health perception and behavior scale scores of students is expected.

    power analyze

    Measured: 6 month

  2. Nutrition Behavior Scale

    The scale was developed to determine the nutritional consumption of children. It consists of 14 items. High scores on the scale indicate that the children are healthy.

    Measured: 6 mounth

  3. Health Perceptions and Health Behaviors Scale in Children

    This scale was developed by Walker Sechrst and Pender to evaluate children's health perceptions and health behaviors

    Measured: 6 Mounth

  4. Physical Activity Self-Efficacy Scale for Children

    This scale was developed to evaluate the physical activity and self-efficacy levels of primary school students

    Measured: 6 Mounth

Timeline

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

  1. First posted2 Apr 2021
  2. Study start1 Apr 2022 (estimated)
  3. Primary completion1 Apr 2022 (estimated)
  4. Study completion15 Oct 2022 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
"School Health Nursing Application Program", which is included in the first stage of the research, will be applied. Similarly, 30 people will be taken for the control group, and the sample size is 60 people, 30 being experimental and 30 control groups. In the second stage, the development of the "Child Health-Literacy Scale" will be carried out with 6458 students in the 9-11 age group who attend 4th and 5th grades of primary schools. Students will be determined by simple random sampling method among 4th and 5th grade students of primary schools in Kyrenia, Nicosia, Güzelyurt, Famagusta and İskele districts.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04829942
Sponsor's protocol ID
easternmediterraneanuniversity
Status last verified
Aug 2021
First submitted
22 Mar 2021
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: statistical analyze

Publications

  • Edmundson E, Parcel GS, Perry CL, Feldman HA, Smyth M, Johnson CC, Layman A, Bachman K, Perkins T, Smith K, Stone E. The effects of the child and adolescent trial for cardiovascular health intervention on psychosocial determinants of cardiovascular disease risk behavior among third-grade students. Am J Health Promot. 1996 Jan-Feb;10(3):217-25. doi: 10.4278/0890-1171-10.3.217.

    PubMed 10163302
  • Liu Y, Tang Y, Cao ZB, Zhuang J, Zhu Z, Wu XP, Wang LJ, Cai YJ, Zhang JL, Chen PJ. Results from the China 2018 Report Card on physical activity for children and youth. J Exerc Sci Fit. 2019 Jan;17(1):3-7. doi: 10.1016/j.jesf.2018.10.002. Epub 2018 Nov 26. No abstract available.

    PubMed 30662507
  • Chen P. Physical activity, physical fitness, and body mass index in the Chinese child and adolescent populations: An update from the 2016 Physical Activity and Fitness in China-The Youth Study. J Sport Health Sci. 2017 Dec;6(4):381-383. doi: 10.1016/j.jshs.2017.09.011. Epub 2017 Sep 29. No abstract available.

    PubMed 30356661
  • Knisel E, Rupprich H, Wunram A, Bremer M, Desaive C. Promotion of Elementary School Students' Health Literacy. Int J Environ Res Public Health. 2020 Dec 21;17(24):9560. doi: 10.3390/ijerph17249560.

    PubMed 33371224
  • Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.

    PubMed 3644262

Questions about this trial

What is this clinical trial studying?

A study testing positive health behavior in people with School Health and Health Literacy, run by Eastern Mediterranean University at 1 site in Cyprus.

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: status not confirmed, as of the sponsor's last update on 18 Aug 2021. 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 Cyprus. 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 RASİHA GÜLER, 1 (05488429441, rasihaguler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

With the school health nursing program to be implemented within 6 months, a moderate increase in physical activity, nutrition and health perception and behavior scale scores of students is expected. (time frame: 6 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04829942, which also lists 5 linked publications.

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 18 Aug 2021.

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