NCT04251598

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 30, 2020

Last Update Submit

January 30, 2020

Conditions

Keywords

Skin CancerSun ProtectionParent BehaviorSocial Cognitive TheoryPublic Health Nursing

Outcome Measures

Primary Outcomes (2)

  • 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.

    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".

    9 months

Secondary Outcomes (4)

  • Skin Cancer and Sun Knowledge Scale

    9 months

  • Skin Cancer Risk Perception

    9 months

  • Parental Competence Scale

    9 months

  • Skin Self-Examination

    9 months

Study Arms (3)

Education group

EXPERIMENTAL

Only "I am Protecting my Child From the Sun" program was given.

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.

Behavioral: I Am Protecting My Child from the SunBehavioral: 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..

Interventions

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.

Education + SMS groupEducation group

While the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week.

Education + SMS group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Skin cancer diagnosis / history
  • Having a family history of skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University, Kumluca Faculty of Health Sciences

Antalya, Kumluca, 07350, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Skin NeoplasmsBehaviorChild BehaviorHealth Behavior

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Selma Öncel, PhD, RN, Professor

    Akdeniz University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

April 1, 2018

Primary Completion

June 15, 2018

Study Completion

October 31, 2018

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

I want to share "I am Protecting my Child From the Sun" program protocol with other researchers.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
The study is completed
Access Criteria
After the study is published as an article

Locations