Study design
This study will be conducted as a randomized controlled trial according to case and control groups on students of Yazd universities. The studied population is the students who are studying undergraduate in the universities of Yazd city. To implement the educational intervention, after coordinating with the educational vice-chancellor of Yazd universities and obtaining permission, the studied students will be selected using a two-stage random cluster sampling method. After people enter the study, the researcher gives explanations about the objectives, the method of implementing the project and the confidentiality of the information. If they agree and complete the consent form, the required information will be measured by a questionnaire whose validity and reliability will be measured and it will consist of 4 parts: the first part is demographic information, the second part is the hand washing behavior questionnaire, the third part is the behavioral questionnaire. Vaccine acceptance, the fourth part of the mask wearing behavior questionnaire will be collected. It should be noted that the questionnaires are based on the MTM model.
Eligibility criteria
Inclusion criteria: Studying in universities in Yazd, having a smartphone, access to the Internet, having WhatsApp-Telegram applications and being a member of them, undergraduate students.
Exclusion criteria: absence from more than 10% of training sessions, occurrence of severe physical or mental illness and hospitalization, death or traveling for more than 10 days in the intervention group, withdrawal from the virtual group (WhatsApp-Telegram).
Interventions
In the second phase of the study; Pre-examination part: Questionnaire on hand washing behavior, acceptance of vaccine and use of mask will be completed by undergraduate students of Yazd city in two groups of case and control. The data collection will be online and the questionnaire will be designed on the Porsline website and the link will be provided to the students.
Hand washing behavior, acceptance of vaccine and use of mask will be designed. The educational content will be prepared using reliable and up-to-date scientific sources (including the CDC-WHO website, books and related articles). For the case group, after completing the questionnaires, the compiled educational intervention will be implemented. The teaching method will be chosen according to the type of content and access of the audience. Based on the conditions at the time of implementation, the training will be virtual, face-to-face or a combination of both. In the study, blinding is not done. The nature of the study is in the form of an educational program and people find out whether they are being educated or not. And in the control group, no educational intervention will be implemented (table 1).
Table 1.
Table of lesson plans for educational sessions
Structures used :
Collaborative dialogue (behavioral advantages and disadvantages), behavioral trust, change in physical environment, emotional transformation, practice for change, change in social environment
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target group:
1- Primary target group: undergraduate students
2- Secondary target group: family – peers
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General purpose:
Improving the level of awareness, attitudes and preventive behaviors of contracting Covid-19 in the studied population
Special objectives:
Objectives of cognitive domain:
- The person should name the benefits of preventive behaviors against contracting Covid-19.
- The person should name the disadvantages of preventive behaviors against contracting Covid-19.
- The person can name the preventive behaviors of contracting Covid-19.
- The person can express the solutions of not getting infected with Covid-19.
- The person can mention the necessary accesses and facilities to prevent the infection of Kovid-19.
- The person can express the ways of creating interest and motivation in performing preventive behaviors against contracting Covid-19.
- The person can identify the ways to monitor the preventive daily behaviors of getting infected with Covid-19.
- A person can name the influential people in his life who are influential in carrying out preventive activities against contracting Covid-19.
Objectives of the attitude field:
- A person should consider it valuable to overcome the disadvantages of performing preventive behaviors against contracting Covid-19.
- The person should value the strategies to adapt to the preventive behaviors of getting infected with covid-19.
- The person should consider the available facilities and access to prevent the spread of Covid-19 in their living environment as important.
- The person should be interested in the behaviors of compliance with the preventive behaviors of contracting Covid-19.
- The person can be self-motivated towards the behaviors of matching with the preventive behaviors of contracting Covid-19.
- A person should value self-monitoring of daily preventive activities against contracting Covid-19.
- The person should consider the support of his family members and those around him to be important in accordance with preventive behaviors against contracting Covid-19.
Behavioral goals:
- A person can overcome the disadvantages of performing adaptation behaviors with preventive behaviors against getting infected with Covid-19.
- A person can adopt a suitable solution according to the symptoms of Covid-19.
- A person should make good use of the facilities and access he has in his living environment.
- A person can perform the behaviors of compliance with the preventive behaviors of contracting Covid-19 with interest and motivation.
- The person writes down his daily activities in a notebook.
- With the support of his family members and those around him, the person can adopt behaviors that are compatible with preventive behaviors against contracting Covid-19.
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activities:
- Training through PowerPoint and slides
- Show the movie
- Playing a role
-Presenting pamphlets and notebooks to record daily activities
-social networks
- Holding group discussion meetings
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Number and time of meeting:
- Four virtual sessions and one face-to-face session for 20 minutes
Sources:
- Educational aids: whiteboard, video projector, internet, pamphlets
teaching method:
- Speech with PowerPoint, question and answer, group discussion, virtual space
Monitoring and evaluation method:
Questionnaire
Evaluation time:
Before the intervention and one month after the intervention
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In the post-test part: Finally, the changes in behavior are measured 1 month after the implementation of the intervention, using the mentioned questionnaires. The data collection will be online and the questionnaire will be designed on the Porsline website and the link will be provided to the students.
Patient and public involvement
no patient involved on the trial design. The participants of this project were students
Outcome measures:
The present study will be conducted in two phases. So that in the first phase, the considered questionnaires will be psychometric and localized, and in the second phase, an educational intervention study will be conducted (Chart 1).
In the first phase of the study; After obtaining the code of ethics, the standard questionnaire designed by Sharma's study18,44 will be translated from English to Farsi with the standard 'forward-backward' method. Two health professionals will independently translate the items and the other two will They will translate the answer and a temporary version will be prepared. After that, it will be translated back into English, and after a careful cultural adaptation, the final version will be presented. The validity of the form, content, structure and reliability of the final Persian version will be examined by a panel of experts 38-40.
To determine the validity of the content quantitatively, the questionnaire will be provided to the panel of experts and they will be asked to rate the content validity of the questionnaire[1] in three items (necessary, useful but not necessary) according to the purpose of the research (CVR). (not necessary) about the 'necessity' of the items and about the (CVI) content validity index[2] (qualitative) of the questionnaire, comment on the four items 'not relevant, somewhat relevant, relevant and completely relevant'. Also, the validity of the content will be evaluated by 10 experts using a qualitative method (observance of grammar, use of appropriate words, etc.) 41-43 (Table 2).
Table 2. Decision table about the minimum acceptable CVR value based on the number of scoring experts
Number of specialists
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value CVR
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Number of specialists
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value CVR
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Number of specialists
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value CVR
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5
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0/99
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11
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0/59
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25
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0/37
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6
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0/99
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12
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0/56
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30
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0/33
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7
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0/99
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13
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0/54
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35
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0/31
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8
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0/75
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14
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0/51
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40
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0/29
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9
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0/78
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15
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0/49
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10
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0/62
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20
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0/42
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In order to evaluate the face (qualitative) validity, the questionnaire will be given to 10 experts and 20 students similar to the target group to study it and evaluate the items in terms of 'simplicity and fluency', 'relevance or specificity'. and evaluate 'clarity'. After modifying the items based on the respondents' opinions, in the next step, in order to evaluate the face validity (quantitative) and determine the importance of each item, a 5-point Likert scale including: 'It is completely important', 'It is important', 'Very important' Moderately important', 'slightly important' and 'not important at all' are considered 44-48.
Construct validity examines the adequacy of instruments to measure existing constructs. In this study, factor analysis method was used to measure and determine construct validity. In this method, items with consistent correlations were summarized in the form of new variables called factors. In order to determine the reliability of the tool, Cronbach's alpha internal consistency method will be used with a pilot study 49.
The hand washing behavior questionnaire was designed by Sharma and colleagues at Las Vegas University in America 18. This questionnaire contains 36 questions that have a benefit structure with a scale: never (0), almost never (1), sometimes (2), most of the time (3), often (4). Possible range: 0-20, where a high score is associated with the possibility of starting behavior change. Scale structure of disadvantages: never (0), almost never (1), sometimes (2), most of the time (3), often (4). Probability range: 0-20, with a low score associated with the likelihood of initiating behavior change. To calculate the collaborative dialogue construct score, subtract the disadvantage score from the advantage score. A positive score will indicate a change in behavior. Behavioral trust structure with a scale: not at all sure (0), a little sure (1), fairly sure (2), very sure (3), completely sure (4). Possible range: 0-24, where a high score is associated with the probability of starting to change behavior. The structure of changes in the physical environment with a scale: not at all sure (0), a little sure (1), fairly sure (2), very sure (3), completely sure (4). The possible range is 0-12, where a high score is associated with the probability of initiating behavior change. Emotional transformation structure with a scale: not sure at all (0), a little sure (1), fairly sure (2), very sure (3), completely sure (4). The possible range is 0-12, with a high score in relation to the probability of behavior change. Exercise structure for change with scale: not at all sure (0), somewhat sure (1), fairly sure (2), very sure (3), completely sure (4). The possible range is 0-12, where a high score changes in relation to the probability of behavior change. The structure of changes in the social environment with a scale: not sure at all (0), a little sure (1), fairly sure (2), very sure (3), completely sure (4). The possible range is 0-8, where a high score changes in relation to the probability of behavior change. To model the start of the dependent variable can be 35 items: not at all likely (0), somewhat likely (1), very likely (2), very likely (3) and quite likely (4) and multiple regression can be used. Is. For maintenance modeling, the dependent variable can be 36 items: not at all likely (0), somewhat likely (1), very likely (2), very likely (3), and quite likely (4) and multiple regression, can be used.
The vaccine acceptance questionnaire was designed by Sharma and colleagues at Las Vegas University in the United States 31. This questionnaire contains 27 questions that have the structure of advantages: on a scale (0-4) with a score of 0-12 units. Disadvantage structure: on a scale (0-4) with a possible score of 0-12 units. Collaborative dialogue structure: with a possible score of -12 to +12. Behavioral trust structure unit: on a scale (0-4) with a possible score of 0-12 units. The structure of changes in the physical environment: on a scale (0-4) and a possible score of 0-12. Behavior initiation structure: 0-4 scale with a possible score of 0-4 units. It should be noted that this questionnaire has only the beginning of the behavior because the behavior will not be repeated.
Mask use behavior questionnaire was designed by Sharma and colleagues at Las Vegas University in America 32. This questionnaire contains 33 questions. Structure of benefits: Scale: never (0), almost never (1), sometimes (2), most of the time (3), often (4) Possible range: 0 to 20. A high score is associated with the likelihood of initiating behavior change. Disadvantages: Scale: never (0), almost never (1), sometimes (2), mostly (3), often (4) Possible range: 0 to 20. Low score associated with likelihood of initiating behavior change. To calculate the collaborative dialogue construct score, subtract the disadvantage score from the advantage score. A positive score indicates a change in behavior. Structure of behavioral trust: scale: not at all sure (0), somewhat sure (1), fairly sure (2), very sure (3), completely sure (4) possible range 0-16. A high score associated with the likelihood of initiating behavior change. Structure of changes in the physical environment: scale: not at all sure (0), somewhat sure (1), fairly sure (2), very sure (3), completely sure (4) possible range 0-12. A high score associated with the likelihood of initiating behavior change. Structure of emotional transformation: scale: not at all sure (0), somewhat sure (1), fairly sure (2), very sure (3), completely sure (4) possible range 0-12. A high score is related to the probability of maintaining behavior change. Exercise Structure for Change: Scale: Not at all sure (0), Somewhat sure (1), Fairly sure (2), Very sure (3), Completely sure (4) Possible range 0-12. A high score is related to the probability of maintaining behavior change. The structure of changes in the social environment: scale: not at all sure (0), somewhat sure (1), fairly sure (2), very sure (3), completely sure (4) possible range 0-8 high score in connection with the possibility of maintaining Behavior change.
sample size:
The students under study will be selected using a two-stage random cluster sampling method, and the sample size will be based on the confidence level of 95% and the power of 80%, and the standard deviation of the behavior score. Hand washing, vaccine acceptance, wearing a mask and taking into account the difference between the average of this score in the two case groups and the control group, a minimum sample size of 50 samples was considered in each group. The sample size was determined using the following formula and PASS15 software.
Recruitment
The research team will select eligible students to participate in the project.
Data collection
The data collection will be online and the questionnaire will be designed on the Porsline website and the link will be provided to the students.
Data analysis plan
After coding, the collected data will be analyzed using SPSS 24 software. In addition to descriptive statistics indicators (central and dispersion indices), parametric or non-parametric analytical statistics tests will be used after checking the normality or non-normality of the data by the Smirnov Kolmogorov test.
In addition to descriptive statistics (central and dispersion indices), independent t-tests and chi-square tests will be used to compare demographic variables in the case and control groups. Also, repeated measures analysis of variance and Ben Feroni's pairwise comparison test will be used for the changes in the scores of multi-theoretical model constructs in the pre-test and post-test in both case and control groups. In order to compare the average scores of the constructs of several theories of behavior change in the context of preventive behaviors against contracting Covid-19 in two groups of cases and controls, an ANCOVA analysis of covariance test will be used to compare the intervention in the two groups, taking into account the results of the pre-test. Covariance test or multiple regression will be used to adjust the effect of covariances. In this research, p<0.05 will be considered as a significant level.
Data monitoring:
In this study, educational intervention does not pose any danger to people. To monitor the accuracy of the data, people are given a code and they are asked to enter their code at each stage when filling the online questionnaire.
[1] Content Validity Ratio (CVR)
[2] Content Validity Index (CVI)