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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Cyprus1 site
Eastern Mediterranean University
Famagusta, 99628
RASİHA GÜLER, 1, 05488429441, rasihaguler@gmail.com
HÜLYA FIRAT KILIÇ, 2, 05488588821, hulya.firat@emu.edu.tr
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
- Type of Research The research will be carried out in accordance with the methodological and randomized controlled experimental research design.
- 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.
- 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.
- Conditions
- School Health, Health Literacy
- 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 group | Role | What they receive |
|---|---|---|
| experimental | Experimental | A 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 intervention | No intervention | Power 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.
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
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
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
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.
- First posted2 Apr 2021
- Study start1 Apr 2022 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for School HealthStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasiha Güler, Eastern Mediterranean University
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 10163302Liu 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 30662507Chen 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 30356661Knisel 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 33371224Walker 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of "School Health Nursing Program" Implemented Under the Leadership of Nurse
- ClinicalTrials.gov ID
- NCT04829942
- Acronym / sponsor ID
- easternmediterraneanuniversity
- Conditions
- School Health, Health Literacy
- Keywords
- school health, nursing, leadership, health literacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 2 Apr 2021 (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.
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.
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
- Type of Research The research will be carried out in accordance with the methodological and randomized controlled experimental research design.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: positive health behaviorA 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. |
| no intervention | No intervention | –Power point presentations will be given to the control group |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All male and female students in the 9-11 age group in the two primary schools where the study will be conducted.
Key exclusion criteria (1 listed)
- All male and female students except 9-11 age group
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 |
|---|---|---|
| positive health behaviorTraining on nutrition, physical activity, first aid, individual hygiene, violence and bullying will be provided to the initiative group. | Behavioural | experimental |
Primary outcome
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
power analyze
Nutrition Behavior Scale
Time frame: 6 mounth
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.
Health Perceptions and Health Behaviors Scale in Children
Time frame: 6 Mounth
This scale was developed by Walker Sechrst and Pender to evaluate children's health perceptions and health behaviors
Physical Activity Self-Efficacy Scale for Children
Time frame: 6 Mounth
This scale was developed to evaluate the physical activity and self-efficacy levels of primary school students
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 10163302Edmundson 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.
- Background: PubMed 30662507Liu 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.
- Background: PubMed 30356661Chen 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.
- Background: PubMed 33371224Knisel 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.
- Results publication: PubMed 3644262Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.
- Individual participant dataSharing planned: Yes. statistical analyze
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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?
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.