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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
I Am Protecting My Child from the Sun and SMS for sun protection
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04251598
Study groupRoleWhat they receive
Education groupExperimentalOnly "I am Protecting my Child From the Sun" program was given.
Receives: Behavioral: I Am Protecting My Child from the Sun
Education + SMS groupExperimentalThe "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 groupNo interventionNo 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted5 Feb 2020
  2. Study start1 Apr 2018
  3. Primary completion15 Jun 2018
  4. Study completion31 Oct 2018

Resources

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)
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

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.

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