- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04251598
I am Protecting my Child From the Sun Program
Effect of the "I am Protecting my Child From the Sun" Program Based on Social Cognitive Theory, on Parent Behaviors
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kumluca
-
Antalya, Kumluca, Turkey, 07350
- Akdeniz University, Kumluca Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Volunteering to participate in the research
- Being least literate
- No communication problems in terms of hearing, seeing and understanding
- Being a mobile phone user to receive text messages sent by the researcher
- Living in the same home with the child
- Joining both parents or one of the parents
- No possibility of leaving the region during the research
Exclusion Criteria:
- Skin cancer diagnosis / history
- Having a family history of skin cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Education group
Only "I am Protecting my Child From the Sun" program was given.
|
The parents in the intervention group were administered the "I Am Protecting My Child from the Sun" program for a period of six weeks. Intervention groups received Sun Protection Guide for Parents, Developmental, Characteristics of 3-6 Age Group Children Brochure, Melanoma Brochure, Video, Frame, Key chain, Magnet, Puzzle, Sunscreen product, T-shirt, hat and UV testing wristband. |
EXPERIMENTAL: Education + SMS group
The "I am Protecting my Child From the Sun" program was given.
After the program, an SMS message was sent on Wednesday and Saturday for 12 weeks.
A total of 25 SMS messages were sent to remind the subject and applications.
|
The parents in the intervention group were administered the "I Am Protecting My Child from the Sun" program for a period of six weeks. Intervention groups received Sun Protection Guide for Parents, Developmental, Characteristics of 3-6 Age Group Children Brochure, Melanoma Brochure, Video, Frame, Key chain, Magnet, Puzzle, Sunscreen product, T-shirt, hat and UV testing wristband.
While the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week.
|
NO_INTERVENTION: Control group
No attempt was made by the researcher during the study.
Only data collection was carried out.
At the end of the research, the "I am Protecting my Child From the Sun" program was given..
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental Sun Protection Scales
Time Frame: 9 months
|
The Self-Efficacy of the Use of Sunscreen Products consists of 5 items, Norms/Attitudes for the Use of Sunscreen Products consists of 6 items, Expectancies for the Use of Sunscreen Products consists of 6 items and Impediments to the Use of Sunscreen Products consists of 3 items in products; The Self - Efficacy of Sun Avoidance consists of 5 items, Norms/Attitudes for Sun Avoidance consists of 4 items, Tanning Expectancies consists of 4 items and Expectancies for Sun Avoidance consists of 5 items in Parental Sun Protection Scales.
To calculate the scores of the scale, the items are numbered from 1 to 5. Each subscale will be evaluated within itself in the scales and it is expected that the scales of Impediments to the Use of Sunscreen Products and Tanning Expectancies scales have low scores and the other scales have high scores.
|
9 months
|
Sun Protection Applications of Parents for Themselves and Child's
Time Frame: 9 months
|
The questionnaire is prepared according to the literature and consists of Sun Protection Applications of Parents for Themselves and Sun Protection Applications of Parents for Child's sections and five questions.
It questions the sun protection practices for sunscreen, long-sleeved clothing, hat, sunglasses and shade.
Answers to questions range from "never", " sometimes" and "always".
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin Cancer and Sun Knowledge Scale
Time Frame: 9 months
|
The Skin Cancer and Sun Knowledge Scale consists of 25 items and evaluates information about five fields: the indications of sun protection, suntanning, skin cancer risk factors, prevention of skin cancer, and skin cancer.
The items consist of 15 correct-incorrect and 10 multiple-choice questions.
For each item, correct answers are symbolized by (1) and incorrect by (0).
Total points are 0-25 on the scale.
The higher the score obtained, the higher the knowledge level.
|
9 months
|
Skin Cancer Risk Perception
Time Frame: 9 months
|
In the Skin Cancer Risk Perception questionnaire, there is a question that questions parents' risk of developing skin cancer, and two questions that question the possibility of developing skin cancer over the next 10 years and their lives.
Parents' skin cancer risk perception was grouped between "very low" and "very high" and evaluated between 1 and 10 points, respectively.
The increase in the score obtained is interpreted as high risk perception.
|
9 months
|
Parental Competence Scale
Time Frame: 9 months
|
Parental Competence Scale consists of 11 items and one dimension to evaluate parents' parenting skills.
The lowest 11 points and the highest 77 points can be obtained from the scale.
|
9 months
|
Skin Self-Examination
Time Frame: 9 months
|
Skin self-examination practices were obtained by asking.
|
9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Selma Öncel, PhD, RN, Professor, Akdeniz University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDK-2018-3501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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