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Education With Cartoon's Effectiveness on Disease Management of the Children With Asthma

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ClinicalTrials.gov Identifier: NCT04566835
Recruitment Status : Completed
First Posted : September 28, 2020
Last Update Posted : June 29, 2021
Sponsor:
Collaborator:
Koç University
Information provided by (Responsible Party):
Aylin Akça Sümengen, Bahçeşehir University

Brief Summary:

Objective: The aim of this study is to determine the effect of the education program (HPPCA - Health Promotion Program for Children with Asthma), which was developed by using cartoons and comic based on the health promotion model of Nola J Pender and brain-based learning theories, on disease control and life quality in children aged between 7 and 11, and diagnosed with asthma.

Materials and Methods: The sample of the study consisted of 74 children between the ages of 7 and 11, who presented to a respiratory disease unit of a university hospital in Istanbul. Children were randomly assigned to the experimental (38 children) and control (36 children) groups using the Urn method. It was administered to both groups prior to the intervention. After the HPPCA education administered only to the experimental group, both groups were administered two post-tests as a follow-up in the 1st and 3rd months. Standardized sociodemographic question form, Childhood Asthma Control Test (C-ACT) and Paediatric Asthma Quality of Life Questionnaire (PAQLQ) were used for the follow-up. The data were evaluated using statistical parametric tests.


Condition or disease Intervention/treatment Phase
Asthma in Children Other: Standart Care given during normal examination Behavioral: Health Promotion Program with cartoon education for Children with Asthma Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Assignment to the experimental and control groups was made by a person independent of the researcher. Two balls in different colours, red and white, were placed in a black bag. Assignment to the experimental and control groups was performed by randomly selecting the balls. The following steps:

Step 0: the first child selected the white ball and was included in the experimental group.

Step 1: a ball was selected randomly. Step 2: The child was assigned to the experimental group (E) if the ball was white, and to the control group (C) if the ball was red.

Step 3: A ball in the opposite colour of the selected ball was thrown into the bag (For instance; if the selected ball was red, a white ball was thrown into the bag).

Step 4: The process was repeated starting from Step 1. The researcher and the subjects did not know which subjects would fall into which group until the intervention was administered. In this way, the possible bias was prevented.

Primary Purpose: Supportive Care
Official Title: The Evaluation of Education With Cartoon's Effectiveness on Disease Management of the Children With Asthma
Actual Study Start Date : December 21, 2019
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : July 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Education Group
Taking the Health Promotion Program with cartoons and comics for Children with Asthma
Other: Standart Care given during normal examination
This is the standart education given by doctor. The child and his/her parents come to the doctor for normal examination. They take their asthma diagnosis or other information about their condition. and then the doctor explain them about what is asthma, what are the drugs or how should they use them. This is the implementation using for the control group.

Behavioral: Health Promotion Program with cartoon education for Children with Asthma
First of all, the child and their parents take the routine examination as the same as the control group. Then they take the experimental education called Health Promotion Program with cartoon education for Children with Asthma. The children with asthma were educated within the scope of the program in order to demonstrate the effect of the program on asthma management. Children with asthma were educated with the program, which consisted of 4 units, each of 10 minutes, prepared in the light of the literature and with the current guidelines. Each child received the education in a total of 40 minutes. Every unit has its own cartoon video and comic book material. To sum up The Principal Investigator first give the education about asthma management, then makes them watch the Iggy and the Inhalers videos developed for each unit, and does a colouring activity with comic books at the end of each unit.

Control Group
Taking standart care
Other: Standart Care given during normal examination
This is the standart education given by doctor. The child and his/her parents come to the doctor for normal examination. They take their asthma diagnosis or other information about their condition. and then the doctor explain them about what is asthma, what are the drugs or how should they use them. This is the implementation using for the control group.




Primary Outcome Measures :
  1. Paediatric Asthma Quality of Life Questionnaire - PAQLQ [ Time Frame: Pre Test ]
    The questionnaire has three sub-dimensions, which are symptoms, activity limitation and emotional function. The items related to the "Symptoms" sub-dimension are the items 4, 6, 8, 10, 12, 14, 16, 18, 20 and 23. The items 1, 2, 3, 19 and 22 are related to the "Activity Limitation" sub-dimension. Finally, the items 5, 7, 9, 11, 13, 15, 17 and 21 are related to the "Emotional Function" sub-dimension. While applying the questionnaire, the child should be alone. In the questionnaire, the value of each question is between 1 and 7 points, and the score weights of the questions are equal. The lowest score that could be obtained from the scale is 23, and the highest score is 161. The scores of all sub-categories are added together and the mean scores are calculated. Higher score indicates better quality of life

  2. Childhood Asthma Control Test [ Time Frame: Pre Test ]
    The scale consists of two parts. The 4 questions asked in the first part are in VAS (visual analogue scale) type, and have 4 pictorial options. These questions are asked directly to the child and scored between 0 and 3. The remaining 3 questions are 6-Point Likert-type questions. They are reversely scored, from 5 to 0. This part has to be filled out by the parent. A score between 0 and 27 can be obtained on the scale. The cut-off point for the scale is 19. A score of 19 points or less obtained from the scale indicates that the asthma is not under control of the child.

  3. Childhood Asthma Control Test-Change from Pre Test on first month [ Time Frame: 1st month ]
    The scale consists of two parts. The 4 questions asked in the first part are in VAS (visual analogue scale) type, and have 4 pictorial options. These questions are asked directly to the child and scored between 0 and 3. The remaining 3 questions are 6-Point Likert-type questions. They are reversely scored, from 5 to 0. This part has to be filled out by the parent. A score between 0 and 27 can be obtained on the scale. The cut-off point for the scale is 19. A score of 19 points or less obtained from the scale indicates that the asthma is not under control of the child.

  4. Pediatric Asthma Quality of Life Questionnaire - Change from Pre Test on first month [ Time Frame: 1st month ]
    The questionnaire has three sub-dimensions, which are symptoms, activity limitation and emotional function. The items related to the "Symptoms" sub-dimension are the items 4, 6, 8, 10, 12, 14, 16, 18, 20 and 23. The items 1, 2, 3, 19 and 22 are related to the "Activity Limitation" sub-dimension. Finally, the items 5, 7, 9, 11, 13, 15, 17 and 21 are related to the "Emotional Function" sub-dimension. While applying the questionnaire, the child should be alone. In the questionnaire, the value of each question is between 1 and 7 points, and the score weights of the questions are equal. The lowest score that could be obtained from the scale is 23, and the highest score is 161. The scores of all sub-categories are added together and the mean scores are calculated. Higher score indicates better quality of life

  5. Childhood Asthma Control Test-Change from pretest, first month and fourth month [ Time Frame: 4th month ]
    The scale consists of two parts. The 4 questions asked in the first part are in VAS (visual analogue scale) type, and have 4 pictorial options. These questions are asked directly to the child and scored between 0 and 3. The remaining 3 questions are 6-Point Likert-type questions. They are reversely scored, from 5 to 0. This part has to be filled out by the parent. A score between 0 and 27 can be obtained on the scale. The cut-off point for the scale is 19. A score of 19 points or less obtained from the scale indicates that the asthma is not under control of the child.

  6. Pediatric Asthma Quality of Life Questionnaire - Change from pretest, first month and fourth month [ Time Frame: 4th month ]
    The questionnaire has three sub-dimensions, which are symptoms, activity limitation and emotional function. The items related to the "Symptoms" sub-dimension are the items 4, 6, 8, 10, 12, 14, 16, 18, 20 and 23. The items 1, 2, 3, 19 and 22 are related to the "Activity Limitation" sub-dimension. Finally, the items 5, 7, 9, 11, 13, 15, 17 and 21 are related to the "Emotional Function" sub-dimension. While applying the questionnaire, the child should be alone. In the questionnaire, the value of each question is between 1 and 7 points, and the score weights of the questions are equal. The lowest score that could be obtained from the scale is 23, and the highest score is 161. The scores of all sub-categories are added together and the mean scores are calculated. Higher score indicates better quality of life


Secondary Outcome Measures :
  1. Number of School absenteeism [ Time Frame: Pre Test ]
    If child don't go to the school because of the asthma attack. The investigators evaluate it with a question. The investigators' question was; Have participants ever been absent from school due to asthma in the last four weeks' And the child answer it yes or no

  2. Number of Hospital Visits [ Time Frame: Pre Test ]
    unplanned outpatient clinic visits and emergency room visits. The investigators ask a question to parents; Have participants applied for an unplanned hospital admission due to asthma in the last four weeks?

  3. Number of School absenteeism -Change from Pre Test on first month [ Time Frame: 1st month ]
    If child don't go to the school because of the asthma attack. And the investigators evaluate the change for school absenteeism with new question; Have participants ever been absent from school due to asthma in the last eight weeks. And this is a yes or no question.

  4. Number of Hospital Visits -Change from Pre Test on first month [ Time Frame: 1st month ]
    unplanned outpatient clinic visits and emergency room visits.Have participants applied for an unplanned hospital admission due to asthma in the eight weeks? They should answer it yes or no.

  5. Number of School absenteeism -Change from pretest to first month and fourth month [ Time Frame: 4th month ]
    If child don't go to the school because of the asthma attack. The investigators ask the question again; Have participants been absent from school due to asthma in the last four months? And the child should answer it yes or no.

  6. Number of Hospital Visits-Change from pretest, first month and fourth month [ Time Frame: 4th month ]
    unplanned outpatient clinic visits and emergency room visits. The investigators ask them a question; Have participants applied for an unplanned hospital admission due to asthma in the last four months? The investigators expect them to answer it yes or no.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with chronic allergic asthma,
  • Did not have any communication problems,
  • Volunteered to participate in the study,
  • Were not in the active attack period (2 weeks are sufficient if there is an attack history),
  • Were allergic to substances other than pollen or had no allergies
  • Were included in the study after obtaining the informed consent form from their legal guardians.

Exclusion Criteria:

- Opposite of the inclusion criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566835


Locations
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Turkey
Koc University
Istanbul, Zeytinburnu, Turkey, 34010
Sponsors and Collaborators
Bahçeşehir University
Koç University
Investigators
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Study Director: Ayse F Ocakci, Professor Advisor
Additional Information:
Publications of Results:
Abdelsalam, S. (2017). Outcome of Self-Management Training On Quality Of Life And Self-Efficacy In Patients With Bronchial Asthma. 6.
Çinar, S. (2015). Effect of educational on symptom control and quality of life on asthmatic patients
George, D., & Mallery, M. (2010). SPSS for Windows Step BysStep: A Simple Guide and Reference
Jaudes, P. K., Bilaver, L. A., & Champagne, V. (2015). Do children in foster care receive appropriate treatment for asthma? Children and Youth Services Review, 52, 103-109. doi:https://doi.org/10.1016/j.childyouth.2015.03.004
Kocaaslan, E. N. (2016a). Astımlı çocuklarda hastalık yönetimi konusunda verilen eğitimin çocukların yaşam kalitesi ve öz etkililik düzeylerkine etkisi. Trakya Üniversitesi Sağlık Bilimleri Enstitüsü
Rosenberger, W. F., & Lachin, J. M. (2015). Randomization in clinical trials: theory and practice: John Wiley & Sons
Tabachnick, B., Fidell, L., Tabachnick, B., & Fidell, L. (2014). Using multivariate statistics (6th New International ed.). Essex: Pearson, 235, 284.

Other Publications:
Abadoğlu, Ö., Başyiğit, İ., Bavbek, S., Bayındır, Ü., Bayram, H., Bingöl, G., . . . Yüksel, H. (2016). Türk Toraks Derneğİ Astim Tani ve Tedavİ Rehberİ. Official Journal of the Turkish Thoracic Society(17).
Akdeniz, E., & Öncel, S. (2019). Türkiye'de Hemşirelik Alanında Astımlı Çocuklarla İlgili Yapılan Lisansüstü Tezlerin İncelenmesi. Turkiye Klinikleri Hemsirelik Bilimleri, 11(2).
Aktan, Z. D., Berk, H., Erdoğan, F., & Öktem, S. (2019). Relationship Between Serum IgE Level and Anxiety, Depression, Somatization and Quality of Life in Pediatric Asthma. Current Approaches in Psychiatry/Psikiyatride Guncel Yaklasimlar, 11.
Al, S., & Özcebe, H. (2017). Sosyal Güvenlik Kurumu Kayıtlarında 0-18 Yaş Aralığı İçin Astım Hastalığının Analizi. Sosyal Güvence Dergisi, 6(12), 32.
Alkan, H. Ö. (2016). Hasta Eğitimi ve Davranış Değişikliği Geliştirme. Journal of Cardiovascular Nursing, 7(Sup 2), 41-47.
Bozkurt, G., & Yıldız, S. (2004). Astımlı Okul Çocuklarına Hastalığın Yönetimi Konusunda Verilen Eğitimin Yaşam Kalitelerine Etkisi. İstanbul Üniversitesi F.N.H.Y.O. Dergisi, 13(53), 101-113.
Çoruhlu, T. Ş., Nas, S. E., & Keleş, E. J. A. Ü. E. F. D. (2016). Beyin Temelli Öğrenme Yaklaşımına Dayalı Web Destekli Öğretim Materyalinin Etkililiğinin Değerlendirilmesi: Işık ve Ses Ünitesi. 5(1), 104-132.
Çövener, Ç. (2012). Tip 1 Diyabet Yönetiminde Sağlığı Geliştirme Modeli ve Tam öğrenme Kuramına Dayalı Eğitimin Etkisi. (Doctoral Doctoral). Marmara University, Istanbul.
Demirbaş, B. C., Çekiç, Ş., Canıtez, Y., & Sapan, N. (2017). Okul çağındaki astımlı olguların çocukluk çağı astım kontrol testi ile değerlendirilmesi. Güncel Pediatri, 15(3), 11-16.
Hockenberry, M. J., & Wilson, D. (2018). Wong's nursing care of infants and children-E-book: Elsevier Health Sciences.
Hsu, J., Sicrar, K., Herman, E., & Garbe, P. (2018). EXHALE: A Technical Package to Control Asthma
Kanık, E. A., Taşdelen, B., & Erdoğan, S. (2011). Klinik denemelerde randomizasyon.
Karadağ, A., Çalışkan, N., & Baykara, Z. G. (2017). Hemşirelik Teorileri ve Modelleri (Vol. Baskı 1). İstanbul: Akademi Basın ve Yayıncılık

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Responsible Party: Aylin Akça Sümengen, Principal Investigator, Faculty Member in Bahcesehir University School of Health Science, Bahçeşehir University
ClinicalTrials.gov Identifier: NCT04566835    
Other Study ID Numbers: BAU
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators took an informed consent form from parents and declared that never share any personal information about the participants.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aylin Akça Sümengen, Bahçeşehir University:
pediatric asthma
quality of life in children with asthma
cartoon education in asthma
asthma management education
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases