Determining the effect of using the educational escape room on health literacy and self-efficacy of patients with type 2 diabetes
Design
Randomized controlled clinical trial with time block on about 60 patients
Settings and conduct
The research environment is a specialized parsian diabetes clinic in Mashhad. The content used in the study is diabetes education and self-care training, and at the end, the effect of education on patients' health literacy and self-efficacy is measured by a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness and satisfaction to participate in the study; age 18 to 63 years old; participation in educational programs; diagnosis of type 2 diabetes by a specialist; literacy. Criteria for non-inclusion: dissatisfaction with continuing to participate in the study; occurrence of acute problems such as severe stress or illness.
Intervention groups
In the intervention group, for each group, first a training session is held by lecturing on diabetes control and self-care, then in the educational escape room, they solve problems and puzzles with the participation of each other and using the given trainings. The control group will hold two training sessions by lecturer and in groups with an interval of half an hour by the researcher.
Main outcome variables
Self-efficacy score with questionnaire (CIDS) and health literacy with questionnaire (DHLS) will be measured at the beginning of the study, immediately and two weeks after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200713048090N1
Registration date:2021-10-29, 1400/08/07
Registration timing:prospective
Last update:2021-10-29, 1400/08/07
Update count:0
Registration date
2021-10-29, 1400/08/07
Registrant information
Name
Faezeh Mardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4224 3320
Email address
mardanif971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational escape room on health literacy and self-efficacy of patients with type II diabetes
Public title
Effect of educational escape room on diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness and satisfaction to participate in the study
Living in Mashhad at the time of research
Age 18 to 63 years
Ability to participate in the training program
Diagnosis of type 2 diabetes by a specialist doctor
At least 3 months have passed since the diagnosis of diabetes
Have a minimum literacy rate
No severe complications (nephropathy, retinopathy, vasculopathy and neuropathy)
History of drug treatment of diabetes
Be alert and able to communicate verbally and non-verbally.
Exclusion criteria:
Dissatisfaction with continuing to participate in the study
Absence from any training sessions
Acute problems such as severe stress or illness
Age
From 18 years old to 63 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The time block method is used to allocate research units. Random sequence is pre-determined by SPSS software for at least 20 days and stored in a package. Every morning, the door of the envelope is opened and based on the relevant code, it will be determined in which group all the patients will be in that day.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Central Building Mashhad University of Medical Sciences, Daneshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2020-07-12, 1399/04/22
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.029
Health conditions studied
1
Description of health condition studied
Diabete
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Health literacy score in the comprehensive diabetes health literacy Scale
Timepoint
Before the training session, immediately and two weeks later
Method of measurement
Comprehensive Diabetes Health Literacy Scale
2
Description
Self-efficacy score on the diabetes self-efficacy scale
Timepoint
Before the training session, immediately and two weeks later
Method of measurement
Confidence in Diabetes self-Care Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: to design an educational escape room based on the frameworks presented in the articles, first the educational needs of patients will be examined by reviewing texts, oral questions from officials and patients at the time of completing the personal information questionnaire, and after extracting items and Preparing a checklist, their validity will also be checked and approved. Then learning goals are planned. Based on the needs, educational goals and the level of knowledge and skills of the participants, the subject of education, narration, game structure and puzzles and their level of difficulty are designed. These puzzles will be narrative-based challenges with a linear structure so that all members of the group can work together to solve each problem at the same time. The physical space in a room at the Parsian Diabetes Center in Mashhad is designed based on learning objectives, puzzles and their narration with appropriate visual effects. In order to evaluate the room before the main meetings, the two groups enter the escape room on a trial and consecutive basis, which is ready for the main intervention after making the necessary corrections. In the intervention group, individuals are divided into groups of 4-6 people based on the same age category and by gender. For each group, a training session with a lecture method with slides and questions and answers for 60 minutes on the topic of diabetes control and self-care is held by the researcher. Before entering the educational escape room, explanations about the rules, scenarios and instructions will be given orally in 5 minutes, which are also available in writing in the room. They then work together to solve problems and puzzles in the room for a maximum of 60 minutes using the instructions given to get the final key to leave the room. The observer (the researcher himself, who also teaches the lecture session) is present with the participants in the room to monitor the performance, provide guidance and measure time, and if he sees a performance error, he will not allow progress until it is corrected. Whenever they need help or clues, they can ask the game supervisor, who will be provided with a minute to add time. Also, if they do not make progress in the first 30 minutes, the game supervisor will guide them. After reaching the final key and leaving the meeting room for 20 minutes to provide feedback, explain mistakes, fix problems, express learning experiences and satisfaction of participants in a group discussion and using the evaluation checklist of the escape room, along with The reception will be held and the relevant questionnaires will be completed.
Category
Other
2
Description
Control group: in the control group, two training sessions (45-60 minutes) will be held by the researcher in the form of lectures by presenting slides and questions and answers during a day with an interval of half an hour (for rest and reception) in groups of 8-12 people. The content and educational objectives will be similar to the intervention group. Finally, people's opinions and learning experiences are checked with a checklist
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Parsian Diabetes Clinic in Mashhad
Full name of responsible person
Seyed Reza Mazloum
Street address
Lashgar Intersection، Bahar Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3858 4040
Email
MazlomR@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohsen tafaghodi
Street address
Central Building Mashhad University of Medical Sciences, Daneshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1337
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Faeze Mardani
Position
MSc student in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school, Ebnesina avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mardanif971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Reza Mazloum
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school, Ebnesina avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mazlomr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Faeze Mardani
Position
MSc student in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school, Ebnesina avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 4441 3294
Email
mardanif971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Study protocol that contains questionnaire and study method. Statistical analysis and study results will be shared in general and no decision has yet been made regarding the participants' data file sharing.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
All researchers and students in the private and public sectors
Under which criteria data/document could be used
For use in research and teaching at universities
From where data/document is obtainable
Seyed Reza Maloum
mazlomr@mums.ac.ir
What processes are involved for a request to access data/document