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

NCT04566835 | Completed DMC

• 1 other identifier: BAU
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

pediatric asthma; quality of life in children with asthma; cartoon education in asthma; asthma management education

Outcome Measures

Primary Outcomes (6)

• Paediatric Asthma Quality of Life Questionnaire - PAQLQ

  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

  Pre Test

• Childhood Asthma Control 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.

  Pre Test

• Childhood Asthma Control Test-Change from Pre Test on first 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.

  1st month

• Pediatric Asthma Quality of Life Questionnaire - Change from Pre Test on first 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

  1st month

• Childhood Asthma Control Test-Change from pretest, first month and fourth 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.

  4th month

• Pediatric Asthma Quality of Life Questionnaire - Change from pretest, first month and fourth 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

  4th month

Secondary Outcomes (6)

• Number of School absenteeism

  Pre Test

• Number of Hospital Visits

  Pre Test

• Number of School absenteeism -Change from Pre Test on first month

  1st month

• Number of Hospital Visits -Change from Pre Test on first month

  1st month

• Number of School absenteeism -Change from pretest to first month and fourth month

  4th month

Study Arms (2)

Education Group

EXPERIMENTAL

Taking the Health Promotion Program with cartoons and comics for Children with Asthma

Other: Standart Care given during normal examination; Behavioral: Health Promotion Program with cartoon education for Children with Asthma

Control Group

OTHER

Taking standart care

Other: Standart Care given during normal examination

Interventions

Standart Care given during normal examination OTHER

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.

Control Group; Education Group

Health Promotion Program with cartoon education for Children with Asthma BEHAVIORAL

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.

Education Group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Bahçeşehir University: lead
• Koç University: collaborator

Study Sites (1)

Koc University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

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Study Officials

• Ayse F Ocakci, Professor

  Advisor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Faculty Member in Bahcesehir University School of Health Science

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 28, 2020
• Study Start: December 21, 2019
• Primary Completion: May 1, 2020
• Study Completion: July 8, 2020
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)