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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04396431
Other study ID # 433178
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date September 2015

Study information

Verified date May 2020
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 2015
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 9 Years
Eligibility Inclusion Criteria:

- age between 8 and 9

- have the consent of a parent

- Fitzpatrick skin type between 1 and 3

Exclusion Criteria:

- Fitzpatrick skin type between 4 and 6

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
education
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 6 months
Secondary 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) 6 months
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