Nurse's RoleNCT04396431
The Effect of Nurse Health Education and Follow-up Programme on Sun Protection Behaviors of Children
A study testing education in people with Nurse's Role and Cancer, run by Ege University.
Trial summary
The aim of the study is to determine the effect of nurse health education and follow up program on sun protection behaviors of children. The study as a randomized controlled group was implemented in February- October 2014 in Turkey. Read more about this study
- Who is it for?
- Ages 8 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Cancer
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Sep 2015
- 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 8 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age between 8 and 9
- have the consent of a parent
- Fitzpatrick skin type between 1 and 3
Who cannot join
- Fitzpatrick skin type between 4 and 6
About this study
Official title: The Effect of Nurse Health Education and Follow-up Programme on Sun Protection
The aim of the study is to determine the effect of nurse health education and follow up program on sun protection behaviors of children. The study as a randomized controlled group was implemented in February- October 2014 in Turkey. After obtaining the parents' and the children's written consent, data were collected through face-to-face interviews using, the instruments (stages of change, the decisional balance scale, child and parental sun protection behavior form, self-efficacy form) on sun protection based on the transtheoretical model.
Read the detailed description
Approximately 25% of lifelong sun exposure is formed prior to the age of 18. A significant correlation between exposure to ultraviolet radiation in childhood and skin cancer in adulthood draws attention to the importance of sun protection behaviors to be applied in this period. School-age children are easily reachable to promote preventive health behaviors. The aim of the study is to determine the effect of nurse health education and follow up program on sun protection behaviors of children. The study as a randomized controlled group trial was implemented in February- October 2014. Purposive nonprobability sampling was used to select 25 schools in Izmir Karşıyaka district and research was conducted in two schools where attending the children coming from medium families. Risk assessment for skin cancer was performed by Fitzpatrick classification with 260 children before the study. Out of these children, 144 were found to be risky and were randomized to intervention (n = 40) and control (n = 40) groups according to their age, gender, and skin type. In the survey, the effect size was identified as 0.73 by a 5% error and 80% confidence. After obtaining the parents' and the children's written consent, data were collected through face-to-face interviews using, the instruments (stages of change, the decisional balance scale, child and parental sun protection behavior form, self-efficacy form) on sun protection based on the transtheoretical model. Turkish validity and reliability study of the scale was conducted by Aygün and Ergün (2013). The intervention group was trained about sun protection behaviors in six sessions. Each session lasted 45 minutes. Refresher training was organized on the 15th day, on 1st month 2nd month after the first session. At the beginning and at the end of the program, decisional balance and self-efficacy of children were evaluated. Data were analyzed by frequencies, regression, Wilcoxon signed-rank test, paired-samples t-test, independent samples t-test, Mann-Whitney U test, Friedman's test, and Chi-square test. Written consent was taken from children and their parents, schools, and the local ethics committee.
- Conditions
- Nurse's Role, Cancer
- Being tested
- education
- Keywords
- nursing, Transtheoretical model, sun protection, self-efficacy, decisional balance, prevention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
The intervention group was offered a six-hour training program based on the transtheoretical model in order to promote sun protection behavior and to reinforce self-efficacy. The program was prepared by the researchers in consideration of the SunSmart Program implemented in Australia, the SunWise School Program developed by the United States Environmental Protection Agency. The program included various educational tools such as a sun protection story, activity book, PowerPoint presentations, cartoons, and puzzles.
Refresher training was conducted 15 days, 1 month, and 2 months after the initial training. Sun protection behavior and self-efficacy of the children were evaluated at the beginning of the study and six months after the program. As gifts to support their sun protection behavior, the children were given an FDA-approved sunscreen with 50+ SPF, a white cotton short-sleeved T-shirt as protective clothing, sunglasses with 100% UV protection, and a wide-brimmed hat.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Other | The intervention group was offered a six-hour training program based on the transtheoretical model in order to promote sun protection behavior and to reinforce self-efficacy. Receives: Behavioral: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-efficacy
examines self efficacy regarding protection from the sun. It is also scored on a five-point scale (1 - not at all confident, 2 - not very confident, 3 - moderately confident, 4 - very confident, and 5 - extremely confident)
Measured: 6 months
Secondary outcomes (1)
sun protection behavior
measures the incidence of sun protection behavior when outdoors for periods longer than 15 minutes. It is scored on a five-point scale ranging from 1 to 5 (1 - never, 2 - rarely, 3 - sometimes, 4 - often, and 5 - always)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study startMar 2014
- Primary completionAug 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özüm erkin, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396431
- Sponsor's protocol ID
- 433178
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse Health Education and Follow-up Programme on Sun Protection
- ClinicalTrials.gov ID
- NCT04396431
- Acronym / sponsor ID
- 433178
- Conditions
- Nurse's Role, Cancer
- Keywords
- nursing, Transtheoretical model, sun protection, self-efficacy, decisional balance, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 May 2020 (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.
The aim of the study is to determine the effect of nurse health education and follow up program on sun protection behaviors of children. The study as a randomized controlled group was implemented in February- October 2014 in Turkey. After obtaining the parents' and the children's written consent, data were collected through face-to-face interviews using, the instruments (stages of change, the decisional balance scale, child and parental sun protection behavior form, self-efficacy form) on sun protection based on the transtheoretical model.
Detailed description
Approximately 25% of lifelong sun exposure is formed prior to the age of 18. A significant correlation between exposure to ultraviolet radiation in childhood and skin cancer in adulthood draws attention to the importance of sun protection behaviors to be applied in this period. School-age children are easily reachable to promote preventive health behaviors. The aim of the study is to determine the effect of nurse health education and follow up program on sun protection behaviors of children. The study as a randomized controlled group trial was implemented in February- October 2014. Purposive nonprobability sampling was used to select 25 schools in Izmir Karşıyaka district and research was conducted in two schools where attending the children coming from medium families. Risk assessment for skin cancer was performed by Fitzpatrick classification with 260 children before the study. Out of these children, 144 were found to be risky and were randomized to intervention (n = 40) and control (n = 40) groups according to their age, gender, and skin type. In the survey, the effect size was identified as 0.73 by a 5% error and 80% confidence. After obtaining the parents' and the children's written consent, data were collected through face-to-face interviews using, the instruments (stages of change, the decisional balance scale, child and parental sun protection behavior form, self-efficacy form) on sun protection based on the transtheoretical model. Turkish validity and reliability study of the scale was conducted by Aygün and Ergün (2013). The intervention group was trained about sun protection behaviors in six sessions. Each session lasted 45 minutes. Refresher training was organized on the 15th day, on 1st month 2nd month after the first session. At the beginning and at the end of the program, decisional balance and self-efficacy of children were evaluated. Data were analyzed by frequencies, regression, Wilcoxon signed-rank test, paired-samples t-test, independent samples t-test, Mann-Whitney U test, Friedman's test, and Chi-square test. Written consent was taken from children and their parents, schools, and the local ethics committee.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Other | Behavioral: educationThe intervention group was offered a six-hour training program based on the transtheoretical model in order to promote sun protection behavior and to reinforce self-efficacy. |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between 8 and 9
- have the consent of a parent
- Fitzpatrick skin type between 1 and 3
Key exclusion criteria (1 listed)
- Fitzpatrick skin type between 4 and 6
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 |
|---|---|---|
| educationThe intervention group was offered a six-hour training program based on the transtheoretical model in order to promote sun protection behavior and to reinforce self-efficacy. The program was prepared by the researchers in consideration of the SunSmart Program implemented in Australia, the SunWise School Program developed by the United States Environmental Protection Agency. The program included various educational tools such as a sun protection story, activity book, PowerPoint presentations, cartoons, and puzzles. Refresher training was conducted 15 days, 1 month, and 2 months after the initial training. Sun protection behavior and self-efficacy of the children were evaluated at the beginning of the study and six months after the program. As gifts to support their sun protection behavior, the children were given an FDA-approved sunscreen with 50+ SPF, a white cotton short-sleeved T-shirt as protective clothing, sunglasses with 100% UV protection, and a wide-brimmed hat. | Behavioural | 2 |
Primary outcome
self-efficacy
Time frame: 6 months
examines self efficacy regarding protection from the sun. It is also scored on a five-point scale (1 - not at all confident, 2 - not very confident, 3 - moderately confident, 4 - very confident, and 5 - extremely confident)
1 secondary outcome
sun protection behavior
Time frame: 6 months
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 20 May 2020.
- Individual participant dataSharing planned: No
Related trials for Nurse's Role
Not yet recruiting
The Effect of Creative Drama on the Therapeutic Communication Skills and Empathy Levels of Pediatric Nursing Students: A Randomized Controlled Study
Nurse's Role, Empathy
Active, not recruiting
Advancing Nursing Practices in Hospital Oncology Care
Gastrointestinal Cancer, Gastrointestinal Disease
RecruitingPhase 1
Two Different Therapeutic Interventions Applied During Blood Sampling in Children
Blood Sampling, Child, Only
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Not yet recruitingObservational study
Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS
Experiences, Lived Experiences
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Nurse's Role and Cancer, run by Ege University.
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 3 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 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
self-efficacy (time frame: 6 months). 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 20 May 2020.