The Evaluation of Education With Cartoon's Effectiveness on Disease Management of the Children With Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Pediatric Asthma Quality of Life Questionnaire - Change from pretest, first month and fourth month
Study Overview
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.
Detailed Description
All guidelines, protocols and recommendations prepared in pediatric asthma emphasize the importance of therapeutic education in asthma management and control. The therapeutic education of children with asthma should be carried out both for skill development and for behavioural changes. Changing the behaviours of individuals is the most difficult part of therapeutic education. Children with asthma should be educated with therapeutic methods and proven nursing models in order to learn disease management and carry out their own asthma control. This model, which targets behavioural changes, has been considered as Pender's Health Promotion Model. The stages of promoting health have been presented clearly; however, the method to be used as a teaching technique in practice has not been clarified. Therefore, it has been suggested in the literature that the model should be used with different training techniques. Looking at the current education and training techniques, the brain-based teaching model, which has been used frequently in educational science in recent years, draws attention. This theory, also known as the neurophysiological theory, was proposed by Donald Olding Hebb in 1951 and developed by Caine & Caine in 1995. With the neurophysiological theory, it has been advocated that the symptom management skills of children with asthma could be made permanent through a good education plan and remindful education methods. The symptoms of asthma are alleviated as the anatomical airway differences disappear when children reach adolescence. They can control asthma better than the young children Therefore, the asthma education is mostly required by the school-age children.
The Health Promotion Model and Brain-Based Training Model in asthma education can best be synthesized with multimedia. The education given with multimedia has been found to be more effective compared to the education given with printed materials. Therefore, the aim of this study is to ensure that the children aged between 7 and 11 learn about disease control and improve their quality of life with an education program (HPPCA - Health Promotion Program for Children with Asthma) developed based on a health promotion model and brain-based learning theories using cartoon and comic book materials.
Trial Design The type of the study is the Randomized Controlled Study, which is one of the quantitative research types. Subjects were assigned to the groups randomly. Pulmonary Function Tests were administered to the children at the beginning of the study, and PFT data were also an outcome. However, when the COVID 19 Pandemic started, current guidelines placed patients with asthma into the risk group and banned PFTs all over the world to prevent the rate of virus spread.
Participants The population of the present study consisted of 653.417 children, which was reported as the total number of children with asthma between 0-18 years in Turkey (who were diagnosed with asthma and prescribed) by Al et al. The study group consisted of 386 children with asthma aged between 7 and 11, who presented to the hospital with asthma according to hospital records after March 2019.
The Place and Time of the Study The pilot study was carried out in the Paediatric Allergy Immunology Outpatient Clinic of a private hospital in Turkey; and the study was carried out in the Paediatric Pulmonology Outpatient Clinic of a state hospital in Turkey. The intervention stages of the study should be carried out in the winter months in terms of the frequency of symptoms of asthma; and the follow-up should be carried out in the spring months, which may increase the atopy and frequency of the symptoms. Therefore, the intervention and follow-up stages of the study were carried out between December 2019 and May 2019.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- 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.
Eligibility Criteria
- Ages
- 7 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Education Group
Taking the Health Promotion Program with cartoons and comics for Children with Asthma
Intervention: Standart Care given during normal examination (Other)
Education Group
Taking the Health Promotion Program with cartoons and comics for Children with Asthma
Intervention: Health Promotion Program with cartoon education for Children with Asthma (Behavioral)
Control Group
Taking standart care
Intervention: Standart Care given during normal examination (Other)
Outcomes
Primary Outcomes
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
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.
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
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.
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
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.
Secondary Outcomes
- Number of School absenteeism(Pre Test)
- Number of School absenteeism -Change from pretest to first month and fourth month(4th month)
- Number of School absenteeism -Change from Pre Test on first month(1st month)
- Number of Hospital Visits-Change from pretest, first month and fourth month(4th month)
- Number of Hospital Visits(Pre Test)
- Number of Hospital Visits -Change from Pre Test on first month(1st month)
Investigators
Aylin Akça Sümengen
Principal Investigator, Faculty Member in Bahcesehir University School of Health Science
Bahçeşehir University