Skin NeoplasmsNCT04251598
I am Protecting my Child From the Sun Program
A study testing I Am Protecting My Child from the Sun and SMS for sun protection in people with Skin Neoplasms and Parents, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Skin Neoplasms, Parents, Behavior and Behavior Mechanisms
- What is being tested?
- I Am Protecting My Child from the Sun and SMS for sun protection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 31 Oct 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Skin cancer diagnosis / history
- Having a family history of skin cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University, Kumluca Faculty of Health Sciences
Antalya, Kumluca, 07350
About this study
Official title: Effect of the "I am Protecting my Child From the Sun" Program Based on Social Cognitive Theory, on Parent Behaviors
This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. The "I Am Protecting My Child from the Sun" program, based on Social Cognitive Theory, and the sending of short reminder messages had positive effects on the parents' behaviors related to protecting themselves and their children from the sun.
Read the detailed description
This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. Organized as a randomized controlled experimental study conducted on three groups with a pre- and post-test follow-up design, the study was carried out in Manavgat between April 2018 and October 2018 and included the participation of 185 parents, of which 63 were in the education group, 62 were in the education+SMS group, and 60 were in the control group. The parents in the intervention group were administered the "I Am Protecting My Child from the Sun" program for a period of six weeks, while the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week. Data were collected using the Parent Information Form, Skin Cancer Risk Perception Form, Skin Cancer and Sun Knowledge Scale, Parental Self-Efficacy Scale, Parental Sun Protection Scales, and Parent Behaviors Regarding Protecting Themselves and Their Children from The Sun Question Form.
- Conditions
- Skin Neoplasms, Parents, Behavior and Behavior Mechanisms, Child Behavior, Health Behavior
- Being tested
- I Am Protecting My Child from the Sun, SMS for sun protection
- Keywords
- Skin Cancer, Sun Protection, Parent Behavior, Social Cognitive Theory, Public Health Nursing
- Medical subject headings
- Skin Neoplasms, Behavior, Child Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I Am Protecting My Child from the SunBehavioural
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.
SMS for sun protectionBehavioural
While the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | Only "I am Protecting my Child From the Sun" program was given. Receives: Behavioral: I Am Protecting My Child from the Sun |
| Education + SMS group | Experimental | 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. Receives: Behavioral: I Am Protecting My Child from the Sun; Behavioral: SMS for sun protection |
| Control group | No intervention | 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.. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Sun Protection Scales
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.
Measured: 9 months
Sun Protection Applications of Parents for Themselves and Child's
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".
Measured: 9 months
Secondary outcomes (4)
Skin Cancer and Sun Knowledge Scale
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.
Measured: 9 months
Skin Cancer Risk Perception
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.
Measured: 9 months
Parental Competence Scale
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.
Measured: 9 months
Skin Self-Examination
Skin self-examination practices were obtained by asking.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Apr 2018
- Primary completion15 Jun 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin NeoplasmsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem SÜMEN, Akdeniz University
- Investigators
- Selma Öncel, PhD, RN, Professor, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251598
- Sponsor's protocol ID
- TDK-2018-3501
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I want to share "I am Protecting my Child From the Sun" program protocol with other researchers.
Publications
Sumen A, Oncel S. The effect of 'I am Protecting my Child from the Sun' programme on parental sun protection behaviours: Randomized controlled trial. J Adv Nurs. 2021 Jan;77(1):387-400. doi: 10.1111/jan.14614. Epub 2020 Oct 22.
PubMed 33089943
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the "I am Protecting my Child From the Sun" Program Based on Social Cognitive Theory, on Parent Behaviors
- ClinicalTrials.gov ID
- NCT04251598
- Acronym / sponsor ID
- TDK-2018-3501
- Conditions
- Skin Neoplasms, Parents, Behavior and Behavior Mechanisms, Child Behavior, Health Behavior
- Keywords
- Skin Cancer, Sun Protection, Parent Behavior, Social Cognitive Theory, Public Health Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 5 Feb 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.
This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. The "I Am Protecting My Child from the Sun" program, based on Social Cognitive Theory, and the sending of short reminder messages had positive effects on the parents' behaviors related to protecting themselves and their children from the sun.
Detailed description
This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. Organized as a randomized controlled experimental study conducted on three groups with a pre- and post-test follow-up design, the study was carried out in Manavgat between April 2018 and October 2018 and included the participation of 185 parents, of which 63 were in the education group, 62 were in the education+SMS group, and 60 were in the control group. The parents in the intervention group were administered the "I Am Protecting My Child from the Sun" program for a period of six weeks, while the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week. Data were collected using the Parent Information Form, Skin Cancer Risk Perception Form, Skin Cancer and Sun Knowledge Scale, Parental Self-Efficacy Scale, Parental Sun Protection Scales, and Parent Behaviors Regarding Protecting Themselves and Their Children from The Sun Question Form.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Behavioral: I Am Protecting My Child from the SunOnly "I am Protecting my Child From the Sun" program was given. |
| Education + SMS group | Experimental | Behavioral: I Am Protecting My Child from the Sun, Behavioral: SMS for sun protectionThe "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. |
| Control group | No intervention | –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.. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Skin cancer diagnosis / history
- Having a family history of skin cancer
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 |
|---|---|---|
| I Am Protecting My Child from the SunThe 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. | Behavioural | Education + SMS group, Education group |
| SMS for sun protectionWhile the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week. | Behavioural | Education + SMS group |
Primary outcome
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.
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".
4 secondary outcomes
Skin Cancer and Sun Knowledge Scale
Time frame: 9 months
Skin Cancer Risk Perception
Time frame: 9 months
Parental Competence Scale
Time frame: 9 months
Skin Self-Examination
Time frame: 9 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 5 Feb 2020.
- Derived from this study: PubMed 33089943Sumen A, Oncel S. The effect of 'I am Protecting my Child from the Sun' programme on parental sun protection behaviours: Randomized controlled trial. J Adv Nurs. 2021 Jan;77(1):387-400. doi: 10.1111/jan.14614. Epub 2020 Oct 22.
- Individual participant dataSharing planned: Yes. I want to share "I am Protecting my Child From the Sun" program protocol with other researchers.
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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.
Selma Öncel, PhD, RN, Professor study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I Am Protecting My Child from the Sun and SMS for sun protection in people with Skin Neoplasms and Parents, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 7 inclusion and 2 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 5 Feb 2020. 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 Turkey (Türkiye). 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?
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?
Parental Sun Protection Scales (time frame: 9 months). The study lists 2 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 NCT04251598, which also lists 1 linked publication.
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 5 Feb 2020.