Educational intervention for the promote behaviors related to oral health: a randomized trial protocol

doi:10.21203/rs.3.rs-2498842/v1

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Educational intervention for the promote behaviors related to oral health: a randomized trial protocol

https://doi.org/10.21203/rs.3.rs-2498842/v1

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Background: Oral health is an essential part of the overall health in infants, children, and adolescents; because oral diseases have effect on growth performance and quality of life. Given that adolescence is associated with many changes, including physical, sexual and psychosocial changes, and on the other hand, nowadays; many adolescents use mobile applications to monitor their lifestyle behaviors and improve their health. Therefore, the present study will be conducted with the aim of the effect of educational intervention based on self-efficacy theory on promoting adolescent oral health behaviors through the mobile application.

Methods: This is a randomized controlled trial that will be done in two steps. The first stage is related to a descriptive-analytical study; at this stage, determination the current status and educational need assessment of behaviors related to oral health and will be reviewed eligible individuals. The second stage is an experimental study, which is based on the results of a descriptive-analytical study and intervention design. At this stage, eligible adolescents are divided into two groups of intervention and control based on randomized allocation. Then the interventions will be implemented by using of educational strategies based on the self-efficacy theory. Evaluations will be performed with a standard questionnaire of self-efficacy and behaviors related to oral health (knowledge, attitude, behavior), at three points of time (1) Before intervention, (2) one month and (3) three months after the intervention.

Discussion: Adolescents who are in the early stages of permanent teeth; and this unfavorable condition of the mouth and teeth can have negative effects on the longevity of permanent teeth. This study is an attempt to investigate the impact of interventions in promotion behaviors related to oral health of adolescents through the mobile application.

Trial Registration: Iranian Registry of Clinical Trial (IRCT) IRCT20200120046204N1. Registered on 24 September 2022 Ethics code: IR.MODARES.REC.1401.125

Mobile Applications

Self-Efficacy

Oral Health

Health Education

Adolescent

Oral health is an essential part of the overall health in infants, children, and adolescents because oral diseases have effect on growth performance and quality of life [1]. Oral and dental care should be safe, consistent, diverse, accessible, affordable, and high quality that prevents or eliminates disease, pain, and infection. The most important index that shows the level of people suffering from caries is the DMFT index. To calculate the DMFT* of a community, the number of decayed, filled, and missed teeth of the people of that community are counted and its average is calculated [2–6].

Dental caries and other oral health (periodontal) diseases are plaque-associated conditions that have a high global prevalence and are considered an important economic burden [7]. Unlike other infectious diseases, they cannot be stopped by taking antibiotics and can affect a large number of teeth in a short period. The World Health Organization (WHO) considers oral and dental hygiene as a lifelong prerequisite for maintaining public health and emphasizes the importance of this issue more than ever [8, 9].

Adolescence is associated with many changes, including physical, sexual and psycho-social changes, and in this period, unfortunately, neglecting health care, including oral health care, has become commonplace [10, 11]. Adolescents aged 12 to 15 are in the early stages of permanent teeth, and this unfavorable condition of the mouth has negative effects on the longevity of permanent teeth. Therefore, it is very important to develop good oral health habits and lifestyle habits to improve oral health during this period [10, 12]. So that oral health is so important for people that the World Health Organization has declared tooth decay as one of the most important health problems in the world with a prevalence of 60–90% among school students; Also, oral diseases affect nearly 3.5 billion people. [13–15]. In a study conducted in collaboration with the World Health Organization and the Ministry of Health, it showed that the DMFT index in Iran is 67.1%, girls had a higher index than boys, and half of the students refuse to brush their teeth. Another study in Ahvaz showed that tooth decay is more common among girls in Ahvaz and most students, especially boys, are at high risk of tooth decay [16–18].

In addition to non-behavioral factors (shape and form of teeth, placement of teeth, type of teeth, etc.) and genetics, hygiene behaviors in the field of oral health include brushing at least twice a day, using dental floss, using Mouthwash and dental examinations are very important for improving oral health, preventing and controlling tooth decay and other oral health (periodontal) diseases [19–21].

Schools are considered to be the best place to promote health behaviors, including oral health. One of the important health activities of schools is 'health education'. The purpose of health education is to raise the level of health knowledge and finally to create a favorable change in the behavior of students and transfer it to their families [22].

Nowadays, considering that smartphones have become an integral part of daily life and many teenagers are now using mobile apps to monitor their lifestyle behaviors and improve their health, smartphones with content and games related to health behaviors may be a valuable platform to engage children, adolescents, and adults regarding nutritional behaviors, physical activity and prevention of chronic disease risk behaviors [4, 23, 24].

One of the theories of behavior change in the field of health behaviors, especially oral health, is self-efficacy theory. This theory refers to the ability of people to adopt relevant health behaviors to improve indicators and maintain proper health; improving self-efficacy can effectively increase awareness of oral health care and promote good oral health-related behaviors. Self-efficacy theory tells us that people usually only try to do things they believe. They have to do it and if they believe that doing something will lead to failure, they will not try to do it [25]. In this regard, in the studies of Asgari et al. [26], and Fang Keren et al. [27], the role of self-efficacy in protective behaviors and its relationship with the number of times brushing teeth in teenagers have been pointed out, which shows the importance of the variable of self-efficacy and its effect on oral health behavior.

The theory of self-efficacy suggests that the understanding and feeling of efficiency are influenced by 4 factors:

1- Mastery Experience: People believe that they can do new things when they have already done some similar things well. Acquiring such skills is considered the most effective way to strengthen people's self-efficacy (Bandura 1994).

2- Vicarious Experience: Another factor that is effective in understanding and feeling self-efficacy is observational experience, or in other words, observing the successes and failures of others, where you realize the similarity of your experiences and those people. Watching someone like you do something successfully will boost your self-efficacy. Conversely, seeing someone like you fail at something threatens and devalues self-efficacy.

3- Verbal Persuasion: The third factor affecting self-efficacy is verbal persuasion or social influence. When people are verbally encouraged before doing a task, they can gain mastery and skill in doing a task and responsibility and are more likely to do it.

4- Somatic and Emotional States: Physical and emotional states of people when meditation and thinking about doing a task provide clues to the possibility of their failure or success. Stress, anxiety, worry and fear all harm a person's self-efficacy and can lead to a person's prediction and personal estimate of failure or inability to do fearful things (Pajares, 2002).

It has been shown that self-efficacy about oral health is an important variable in predicting successful treatment, preventing health risks and encouraging health-promoting behaviors. In the field of oral health, the use of a self-efficacy scale is very important [28] (Fig. 1).

Therefore, considering the low indicators of oral health behaviors, this study will be conducted with the aim of the effect of educational intervention based on the theory of self-efficacy on the promotion of behaviors related to oral health of adolescents through a mobile application.

This protocol is a randomized clinical trial. The final goal is to investigate the effect of educational intervention based on self-efficacy theory on the promotion of behaviors related to the oral health of adolescents through a mobile application. To achieve this goal, different steps will be taken (Table 1). This study consists of two main phases: The first phase: is a descriptive-analytical cross-sectional study to determine the current situation and educational needs assessment regarding behaviors related to oral health in qualified people. The needs assessment will be evaluated using the standard questionnaire for measuring awareness, attitude and performance [29] of adolescents about oral health and another the standard questionnaire for measuring self-efficacy [30,31] about oral health. The statistical population of Shoushtar schools and the target group are students 13–15-year-old. The sampling method is simple random sampling, which is estimated according to Cochran's formula with a 10% drop in the sample size of 391 people; In this way, 6 urban schools are randomly selected and from each school, according to the statistics of students and the total required sample, a certain number of students will be randomly entered into the descriptive study through their student numbers.

The second phase of the study includes the design and implementation of an educational intervention based on the theory of self-efficacy on the promotion of behaviors related to the oral health of adolescents through a mobile application (Fig. 2).

Table 1: The study overview

Methods

Aim

Phases and participants

Online design of the standard questionnaire

Step 1: Determining the current situation and educational needs assessment regarding behaviors related to oral health

Phase 1

A descriptive-analytical cross-sectional study on adolescents

Based on Mobile app

Questionnaire

Step 1: Intervention group training

Step 2: Transfer educational content to the intervention group

Step 3: Evaluate the program Identify the impact of the program on the intervention group

Phase 2

Design

interventions

researcher

Implementation Adolescent

Intervention evaluation Adolescent

Sampling

At this stage, a list of 27 first-secondary schools in Shoushtar city is prepared. Among the schools, girls' schools are selected and people are randomly assigned to two intervention and control groups. The intervention group receives the training program through the mobile application, while the control group does not receive any training program. Participants are evaluated at three-time points: (1) Before intervention, (2) one month and (3) three months after the intervention.

Calculating Sample Size

In the second phase of calculating the sample size based on a similar study [10] and taking into account the confidence level of 95% and the test power of 80%, the number of samples required for each group (intervention and control) according to the Pocock formula, including 10% drop in number 40 people is allocated for each of the intervention and control groups. so that 4 schools are randomly selected from among 27 city schools; The random allocation of the samples will be done to maintain the balance in the number of people assigned to the two control and test groups and to obtain the maximum power in the study, using the repeated random blocks method with blocks of 4. These repeating random blocks will be done for each floor separately. To implement this method, to maintain the randomness of the allocation of people, before starting the sampling, 6 combinations of four letters A (participant in the test group) and B (participant in the control group) are formed as follows: AABB/ ABAB/ABBA/BABA/BBAA/BAAB.

Finally, by using a six-sided dice with the numbers 1 to 6 on each side, according to the number that appears on the dice each time it is thrown, the order of assigning the participants to the test and control groups on each floor is determined independently.

Consent or assent

An informed consent form will be completed online by all study participants

Inclusion and Exclusion Criteria

The criteria for entering the study include female students 13–15-year-old studying, living in Shoushtar city, not suffering from oral health diseases and underlying diseases, having a smartphone and the ability to use it, and having informed consent to participate in the study. It is a study. Regarding the exit criteria, it can be mentioned the absence of at least one of the above items.

Designing and Developing Educational Intervention Content

The educational content will be compiled after completing the first stage of the study (descriptive-analytical) and evaluating the educational needs through a questionnaire, as well as reviewing past studies related to the areas of awareness, attitude, self-efficacy and performance. The mobile application will consist of different parts (text, game, animation, etc.). The educational content used in the Application will be evaluated by experts and the target group after production. The qualitative validity of the content will be measured by a group of 5-10 experts in the field of health education, dentists and health care workers, as well as 5-10 teenagers similar to the group under study in this research.

The Questionnaire Used and the Scoring Questionnaire in This Study

The data collection tool will be included demographic information, and awareness standard questionnaires, attitude, performance and self-efficacy.

1-Demographic questions include: (age, parents' education, economic status, teeth condition, number of times brushing, flossing and dental plaque).

2- It is a standard questionnaire to measure the knowledge, attitude, and performance of teenagers about oral health. This tool has 36 questions and three areas of awareness (12 questions), attitude (10 questions), and performance (14 questions).

The first part of the questionnaire includes 12 items related to students' knowledge about oral health behaviors, which will be given a score of one for the correct option and zero for the other options. The range of awareness scores is 0-12. A higher score will indicate more awareness in this field.

The second part of the questionnaire contains 10 attitudinal items (alpha coefficient 0.82) and includes a 5-option Likert scale from completely agree (score 5) to completely disagree (score 1). The range of scores for this section is between 10-50 and a higher score will indicate a better attitude of students toward oral health. The last part of the questionnaire contains 14 performance items (alpha coefficient 0.89) which will be measured as options (yes, sometimes and no). The range of scores for this section is between 0-28, and a higher score will indicate a better performance of students regarding oral health. It should be mentioned that two questions were removed from the questions of this section due to the negative correlation between them. The validity and reliability of the questionnaire were also confirmed in the study of Yavari et al [29].

3- It is a standard self-efficacy questionnaire about oral health. This tool includes 3 parts to ensure the ability to brush your teeth, use dental floss and see a dentist.

The self-efficacy questionnaire related to oral and dental hygiene has 3 parts. The first part related to brushing teeth has 10 questions, the second part related to using dental floss has 7 questions and the third part related to see the dentist also has 7 questions.

In the self-efficacy questionnaire, the student is asked to indicate how much she has the ability on a four-point Likert scale (I am completely sure = 4, I am somewhat certain = 3, I am somewhat unsure = 2 and I am not completely sure - 1). He is confident in brushing his teeth, flossing, and to see the dentist in different situations. 10 questionnaire items are related to self-efficacy in brushing teeth (10-40 points), 7 items are related to self-efficacy in flossing (7-28 points) and 7 items are related to self-efficacy in going to the dentist (7-28 points). The reliability and validity of the questionnaire have been confirmed in the study of Carranza et al. [30]. In Iran, its reliability was reported in the study of Ardakani et al. [31] with Cronbach's alpha of 0.79.

It should be noted that the reliability of the tools was also checked and confirmed in the present study (α>0.79).

Follow-up will be done at three points in time;(1) Before intervention, (2) one month and (3) three months after the intervention. According to the research ethics, at the end of the study, the educational content will be provided to the control group.

Public Participation

In this research, the general participation of participants in the descriptive stage will be used to design an educational intervention based on a mobile application and evaluate its impact on promoting preventive behaviors.

Statistical Analysis

Data Management

The obtained data are analyzed in two steps. Phase 1: Analyzing the data from a descriptive-analytical study to determine the current situation and educational needs assessment regarding behaviors related to oral health. Phase 2: Analysis of data obtained from both intervention and control groups at time points before intervention, 1 month, and 3 months after the intervention.

Data Monitoring

The quantitative data in clinical trial will be analyzed using SPSS V22. Descriptive statistics will include frequencies, means and standard deviations. The Kolmogorov-Smirnov test will be used to check the normal distribution of data. Moreover, to compare the means between the two intervention and control groups, T test is used. Paired t-test will be used to compare the means in each group at two points in time, and ANOVA test will be used to compare the means in each group at three points in time. To analyze and evaluate the correlation between demographic variables, correlation tests (Pearson for parametric data and Spearman or Kendall for non-parametric data) and chi-square test will be used.

To analyze the primary outcome (behavior), the linear regression model will be used for predicting variables of awareness, attitude, self-efficacy in brushing teeth, self-efficacy in flossing and self-efficacy in going to the dentist.

This study pays special attention to improving the health of adolescents in schools. This research examines the effects of interventions in improving behaviors related to oral health. The main framework of this study will be to carried out a theory-based intervention using a mobile application to improve the oral health behaviors of adolescents. About this issue, we can refer to the teenage years and the formation of health behaviors such as brushing teeth, feeding, the need for encouragement to believe in their abilities, and also the tendency of teenagers to use mobile phones and various games. Therefore, the present study aims to evaluate the effect of self-efficacy as a predictor of oral health behaviors of adolescents through a mobile application.

Strengths and Weaknesses of the Research

Among the strengths of this research, we can mention the study based on self-efficacy theory as a predictor of health behaviors, interventions based on mobile applications for teenagers, and also the interaction of people with the researcher during the intervention.

One of the weak points of the study is the self-reporting methods of people regarding behaviors related to oral health. Another limitation of the study is the lack of time to collect data on 6 and 12-month follow-ups to determine its lasting effects, which should be considered in future studies.

Trial Status

Date of registration in clinical trial is 2022-10-13. Trial ID is 65599

Expected recruitment start approximate date is 2023-04-08

Expected recruitment end approximate date is 2023-06-09

Ethics and Dissemination

1. Obtaining a license from the Faculty of Medical Sciences of Tarbiat Modares University with ID code (IR.MODARES.REC.1401.125)

2. Registration in Iran Clinical Trial Center with ID code (IRCT20200120046204N1)

3. Obtaining a letter of introduction from of Tarbiat Modares University for the Ministry of Education in Tehran

4. Obtaining a license from the education organization of Khuzestan province, Shoushtar

5. Obtaining informed consent from the participants in the study by the researcher

6. No need to the write first and last name on the questionnaires

7. Assuring participants that their information is confidential

8. Providing educational content to the control group after the end of the research

Dissemination Policy

The publication policy of the project's findings is welcomed in international journals. The authors would like to present the results of the program to teachers, families and other stakeholders in the Ministry of Education of Iran.

Ancillary and Post-Trial Care

A dentist works with the researchers to provide oral care for the students in this study.

Ethics and Dissemination

The Tarbiat Modares University of Ethics Committee for Health Research Ethics (IR.MODARES.REC.1401.125) approved the study. Informed consent will be obtained from all participants. The data (when ready) will be available from the corresponding author on request.

Acknowledgments

This paper is extracted from the Ph.D. thesis in the Department of Health Education and Health Promotion, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. The authors would like to thank the teachers, Students, and staff of potential schools and principals of the education ministry in Shoushtar, Khuzestan, Iran

Authors’ Contributions

Seyedeh Zahra Marashi was the main investigator who collected and analyzed the data and wrote the first draft of the manuscript. Alireza Heidarnia supervised the study and contributed to the writing process. Seyedeh Somayeh Kazemi and Fatemeh Zarei were the study advisor who contributed to the analysis and interpretation and provided the final draft. All authors read and approved the final manuscript.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Availability of Data and Materials

The data will be available from the corresponding author on request.

Ethics Approval and Consent to Participate

Written informed consent was obtained from each participant. The Ethics Committee of Tarbiat Modares University, Tehran, Iran, approved the study. The ethical code is IR.MODARES.REC.1401.125

Consent for Publication

All detailed data publication is most welcome

Competing Interests

The authors declare that they have no competing interests

Author Details

^1,2,4Department of Health Education and Promotion, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.

³Department of Public Health, School of Health, Mazandaran University of Medical Sciences, Sari, Iran

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Educational intervention for the promote behaviors related to oral health: a randomized trial protocol

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