- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509737
Evaluation of the Effect of Life With Food Allergy Education
Evaluation of the Effect of Life With Food Allergy Education Based on Pender's Health Promotion Model Given to Parents With Food Allergic Children Face-to-Face and Through Social Media
Purpose of the Study It was aimed to reveal the changes in the knowledge levels of mothers with food allergy with Life with Food Allergy Education based on Pender's Health Promotion Model.
With this research, it is expected that there will be an increase in the knowledge levels, symptom management levels for food allergies, and treatment knowledge levels of the parents of children diagnosed with food allergy with Life with Food Allergy Education based on the Health Promotion Model.In the study, one group of subjects, divided into two groups, will be given face-to-face education on life with food allergy. For the other group, online food allergy and life education will be given with the same content via social media.In the study, one group of subjects, divided into two groups, will be given face-to-face education on life with food allergy. For the other group, online food allergy and life education will be given with the same content via social media.
Research Question
- Is the Life with Food Allergy Training based on Pender's Health Promotion Model given to parents with a child with food allergy effective in increasing the knowledge levels of parents about food allergy?
- Is there a difference between the knowledge levels of the parents who received the Life with Food Allergy Education Based on Pender's Health Promotion Model given to parents with a child with food allergy face-to-face and through social media? Main Hypotheses of the Study H1: Life with Food Allergy Training based on Pender's Health Promotion Model given to parents with children with food allergy is effective in increasing the knowledge levels of parents about food allergy.
H2: There is a significant difference between the knowledge levels of the parents who received the Life with Food Allergy Education Based on Pender's Health Promotion Model given to parents with children with food allergy face-to-face and through social media.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study was to reveal the changes in the knowledge levels of mothers with food allergy through Life with Food Allergy Education based on Pender's Health Promotion Model.
With this research, it is expected to increase the knowledge levels, symptom management levels for food allergies, and treatment knowledge levels of the parents of children diagnosed with food allergy with Life with Food Allergy Education based on the Health Promotion Model.
PURPOSE OF EDUCATION FOR LIFE WITH FOOD ALLERGY 1. Training: General Concepts of Food Allergy Purpose of Training: To ensure that parents have information about food allergy, food allergy symptoms, food allergy diagnosis and treatment process, and anaphylaxis.
Goal of Training: At the end of this training, the parent will
- Knows the definition of food allergy (Question 1).
- Knows what the most common food allergen is (Question 2)
- Knows what the most common and resistant food allergens are (Question 3)
- Knows that medications do not prevent the development of food allergy (4th question)
- Knows what elimination diet is (5th question).
- Knows food allergy diagnostic methods (Question 6).
- Knows not to experiment with food at home during the food allergy treatment process (Question 7)
- Knows that every food can trigger allergies and that different reactions may occur with each encounter. (Questions 8-9)
- Knows the risk factors for food allergy (Question 10).
- Knows what to pay attention to when monitoring food allergy symptoms in babies and children (Question 11).
- Knows the problems that children with severe food allergies may encounter during the treatment process (Question 12)
- He knows to call 112 in case of anaphylaxis (Question 15).
- Knows the foods that most commonly cause food allergies (Question 16).
- Knows the symptoms of food allergy (Question 17).
Training Method:
1st Intervention Group: Web (Social Media) Based Education 2. Intervention Group: Face-to-face Education
Training Material:
- st Intervention Group: Social media videos - Social media posts
- nd Intervention Group: Powerpoint presentation - Booklet brochure 2. Training: Food Allergy Process Management Purpose of Training: To provide parents with information about how to manage the food allergy process, what to pay attention to when preparing food, what cross-contamination is, the importance of reading labels, and protecting the child from food allergies outside the home.
Goal of Training: At the end of this training, the parent will
- Knows the importance of reading labels (Questions 18-19)
- Knows what foods are required to be declared on labels in the Regulation in Turkey (Questions 20-22).
- Knows what cross-contamination means and knows what should be taken into consideration to prevent cross-contamination (questions 23-24).
- Knows what to pay attention to when preparing food to prevent contamination (questions 24-28).
- Knows what needs to be done outside the home to protect the child from food allergies (questions 29-30).
- Knows the situations that need to be taken into consideration in the care and nutrition of my child while managing the food allergy process (questions 30-34).
- Knows that the trace amount warning on labels is important. (Question 35)
Training Method:
- st Intervention Group: Web (Social Media) Based Education
- nd Intervention Group: Face-to-face Education
Training Material:
- st Intervention Group: Social media videos - Social media posts
- nd Intervention Group: Powerpoint presentation - Booklet brochure 3. Training: Treatment of Food Allergy Purpose of Training: To provide parents with information about treatment methods in food allergy, anaphylaxis and anaphylaxis intervention methods, and the use of Penepin.
Goal of Training: At the end of this training, the parent will
- Knows what happens and what to do in case of anaphylaxis (questions 36-37).
- Knows and can count the symptoms of anaphylaxis (Question 38).
- Knows what to pay attention to when prescribing PENEPIN automatic injector (question 39).
- Knows the use of PENEPIN automatic injector (questions 40-43).
- Knows what symptoms to watch for before treating a suspected serious allergic reaction (Question 44).
- Knows that I should always have an emergency action plan and a PENEPIN automatic injector with my child who is at risk of anaphylaxis (Question 45).
- Knows that the prescription and expiration dates of the PENEPIN automatic injector must be followed (Question 46).
- He knows that an anaphylactic reaction may resolve after PENEPIN administration, but symptoms may reoccur after 1-2 hours (Question 48).
- Knows how to obtain reliable information about food allergies (questions 49-50).
Training Method:
- st Intervention Group: Web (Social Media) Based Education
- nd Intervention Group: Face-to-face Education
Training Material:
- st Intervention Group: Social media videos - Social media posts
- nd Intervention Group: Powerpoint presentation - Booklet brochure
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: AYŞE ÖZEFLANİLİ, Lecturer
- Phone Number: +905558402810
- Email: aözeflanili@kastamonu.edu.tr
Study Contact Backup
- Name: SİBEL KÜÇÜK, A.Prf
- Phone Number: +90 535 448 51 33
- Email: sibel_9741@hotmail.com
Study Locations
-
-
-
Kastamonu, Turkey, 37200
- Kastamonu Eğitim Araştirma Hastanesi
-
Contact:
- EREN YILDIZ, A.Prf.
- Phone Number: 3662141053
- Email: yildizee3737@gmail.com
-
-
Merkez
-
Kastamonu, Merkez, Turkey, 37200
- Kastamonu Eğitim Araştirma Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion Criteria for Face-to-Face Training Group Parent
- The child has a diagnosis of Food Allergy
- Ability to write and speak Turkish
- Volunteering to participate in the research Social Media Education Group İnclusion Criteria
- The child has a diagnosis of Food Allergy
- Ability to write and speak Turkish
- Parent's willingness to participate in the study
- Having a desktop, laptop, tablet or smart phone that can be connected to the internet, actively using social media
Exclusion Criteria:
Face-to-Face Education Group Exclusion Criteria
- The parent has a communication barrier (visual, hearing, diagnosed mental and psychological problems)
- The child has additional chronic diseases other than food allergy
- Parents do not speak Turkish
- Lack of up-to-date telephone information of the family Social Media Education Group Exclusion Criteria
- Parental communication impairment (visual, hearing, diagnosed mental and psychological problems)
- The child has additional chronic diseases other than food allergy
- Parents do not speak Turkish
- Not using social media-internet actively-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SOCIAL MEDIA TRAINING INTERVENTION GROUP
Life with Food Allergy Training will be held in 3 face-to-face sessions for the 1st intervention group, and the session titles are determined as follows. 1st Education: Introduction to food allergy, general information 2.Education: Food allergy management, food allergy in school and social environment-use of social support resources 3. Education: Treatment of food allergy, use of adrenaline autoinjectors |
With this research, it is expected that parents' knowledge levels, symptom management levels for food allergies, and treatment knowledge levels will increase in parents of children diagnosed with food allergy by providing Life with Food Allergy Education based on the Health Promotion Model through social media.
Other Names:
|
|
Experimental: CLASSİC FACE TO FACE EDUCATİON GROUP
Life with food allergy training; The 2nd Intervention Group will share videos created by the trainer with the same training content and visuals as the face-to-face training group on the instagram page to be created on social media.
At the same time, it is planned to share posts created from the training content on the actively used page.
The participant parents will be ensured to follow the page actively, it will be confirmed that they see the posts by liking them and the follow-up will be done by the researcher.
|
With this research, it is expected that parents' knowledge levels, symptom management levels for food allergies, and treatment knowledge levels will increase by providing Life with Food Allergy Training based on the Health Promotion Model with face-to-face training in parents of children diagnosed with food allergy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The level of knowledge in mothers before and after receiving education on living with food allergy and the effectiveness of the education will be measured.
Time Frame: From enrollment to the end of treatment at 3 weeks
|
Data; It will be collected by the researcher using the Life with Food Allergy Education Parent Evaluation Form, through face-to-face interviews in the face-to-face education group, and through Google Forms in the social media education group.
No other scale will be used except the PARENT INFORMATION EVALUATION FORM FORM FOR LIFE TRAINING WITH NUTRIENT ALLERGY BASED ON HEALTH IMPROVEMENT MODEL developed by the author with expert approval.
In this scale to be used, an evaluation will be made based on the YES/NO answers to the information questions, which we aim to measure whether the parents know the information in the training content.
The scale consists of 50 questions and correct answers will be evaluated over 50 points by giving 1 point for correct answers and 0 points for wrong answers.
|
From enrollment to the end of treatment at 3 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: AYŞE ÖZEFLANİLİ, Lecturer, Kastamonu University
Publications and helpful links
Helpful Links
- Diagnosis and management of food allergy
- Clinical management of psychosocial concerns related to food allergy. The Journal of Allergy and Clinical Immunology: In Practice, 4(2), 2016: 205-213.
- Motosue MS, Bellolio MF, Van Houten HK, Shah ND, Campbell RL. Increasing emergency department visits for anaphylaxis, 2005-2014. J Allergy Clin Immunol Pract. 2017;5(1):171-175.e3
- Sicherer, S. H., Vargas, P. A., Groetch, M. E., Christie, L., Carlisle, S. K., Noone, S., Jones, S.M.. Development and validation of educational materials for food allergy. The Journal of Pediatrics, 2012:160(4), 651-656.
- National Academies of Sciences, Engineering, and Medicine., Finding a path to safety in food allergy: Assessment of the global burden, causes, prevention, management, and public policy. The National Academies Press,2017.
- Kaya, A., Tutar Güven, Ş. ve İşler Dalgıç, A, Sağlığı geliştirme modeline göre verilen eğitimin Türkiye'deki hemşirelik araştırmalarında kullanımı. Hemşirelikte Eğitim ve Araştırma Dergisi, 2018:15, 195-201.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- AnkaraYBU-HEM-AÖZEFLANİLİ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on FOOD ALLERGY
-
Vilnius UniversityEnrolling by invitationFood Allergy in Children | Food Allergy in InfantsLithuania
-
Vilnius UniversityEnrolling by invitationFood Allergy in Children | Food Allergy in InfantsLithuania
-
Luxembourg Institute of HealthCentre Hospitalier du LuxembourgActive, not recruitingAllergy;Food | Food Allergy | Food Allergy in Children | Food Allergy Peanut | Tree Nut Allergies | Oral Immunotherapy for Food AllergyLuxembourg
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Chinese University of Hong KongActive, not recruiting
-
Murdoch Childrens Research InstituteCompletedFood Allergy | Food Allergy in InfantsAustralia
-
King's College LondonGuy's and St Thomas' NHS Foundation TrustUnknownEgg Allergy | Food Allergy | Food Allergy in Children | Milk Allergy | Food Allergy in Infants | Nut Allergy | Food Allergen SensitisationUnited Kingdom
-
King's College LondonKing's College Hospital NHS Trust; University College London Hospitals; Cambridge... and other collaboratorsRecruitingEgg Allergy | Food Allergy | Food Allergy in Children | Milk Allergy | Food Allergy in Infants | Nut Allergy | Food Allergen SensitisationUnited Kingdom
-
University Hospital PilsenMacroArray Diagnostics GmbHRecruiting
-
University of Puerto RicoGenentech, Inc.Not yet recruitingFood Allergy Proved
Clinical Trials on social mediagroup
-
Cornell UniversityWeill Medical College of Cornell UniversityCompletedChronic Pain, WidespreadUnited States
-
University of PennsylvaniaDeloitteCompletedObesityUnited States
-
Holland Bloorview Kids Rehabilitation HospitalUniversity of Alberta; University of Toronto; Dalhousie University; IWK Health... and other collaboratorsActive, not recruitingAutism Spectrum Disorder | Social Communication Disorder | Autism-Related Speech Delay | Autism Spectrum Disorder With Impaired Functional Language | Autism or Autistic TraitsCanada
-
Hugo W. Moser Research Institute at Kennedy Krieger...HRSA/Maternal and Child Health BureauCompleted
-
University of PennsylvaniaCompleted
-
VA Office of Research and DevelopmentCompleted
-
Unity Health TorontoCanadian Institutes of Health Research (CIHR)Enrolling by invitation
-
Istituto per la Ricerca e l'Innovazione BiomedicaComune di MessinaRecruiting
-
University of PennsylvaniaPennsylvania Department of HealthCompleted
-
University Hospital, GrenobleLaboratoire de Psychologie et NeuroCognitionNot yet recruitingAutism Spectrum Disorder