Investigating The Effect Of Using Smartphone-Based Home Physical Activity On the level of Anxiety and Depression Of Adolescents With Juvenile Idiopathic Arthritis
Investigating the effect of using smartphone-based physical activity on the level of anxiety and depression of adolescents with juvenile idiopathic arthritis
Design
The intended clinical trial includes two intervention and control groups in parallel through simple randomization using the website (https://www.Randomization.com). This study is done in the form of a blind strain on the evaluators of the results.
Settings and conduct
The study will be conducted at the Akbar Children's Hospital located in Mashhad, on adolescents aged 12-18 years old with JIA. The patients will be randomly divided into two intervention and control groups. In addition to routine care, the intervention group will receive exercise Menzel use a sports software with the permission of a rheumatologist. Finally, the amount of changes in the levels of depression and anxiety of both groups will be analyzed through questionnaires. This study is a blind and the evaluators are in this group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range of 12-18 years, consent of the adolescent and their parents, not being in the acute phase of the disease, involvement of less than 5 joints, obtaining a score of less than 20 from the CDI questionnaire and obtaining a score of less than 78 from the MASC questionnaire in the initial screening.
Exclusu=ion criteria: severe pain when moving
Intervention groups
In addition to routine care, the intervention group will do their exercise regimen at home based on a sports application. The control group will receive routine JIA care as usual.
Main outcome variables
Anxiety score and depression score using MASC and CDI questionnaires respectively
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230511058152N1
Registration date:2023-05-19, 1402/02/29
Registration timing:prospective
Last update:2023-05-19, 1402/02/29
Update count:0
Registration date
2023-05-19, 1402/02/29
Registrant information
Name
Mitra Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3366 8266
Email address
gholamimt3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect Of Using Smartphone-Based Home Physical Activity On the level of Anxiety and Depression Of Adolescents With Juvenile Idiopathic Arthritis
Public title
Investigating The Effect Of Physical Activity On Adolescents With Juvenile Idiopathic Arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Should be in the Age Range of 12-18 Years.
Declare the Consent of Adolescents and their Parents
Patients should not be in the Acute Phase of the Disease.
Patients have less than 5 Joints Involved.
A Smart Mobile Phone with at least Android 4.0 and the Ability to Use It.
Do not have other Underlying Diseases, Including Cardiovascular, Neurological, and Musculoskeletal diseases.
Have Permission to Exercise and Physical Activity from a Rheumatologist.
Having Access to the Internet
Obtaining a Score less than 20 from the CDI Questionnaire and less than 78 from the MASC Questionnaire in the Initial Screening
Exclusion criteria:
Parents or adolescents do not agree to participate in the study.
Intolerance of exercises do to severe pain
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a Simple Way.
Randomization Tool: https://www.Randomization.com
The Randomization Website Will be Used to Perform Simple Randomization. The System Completely Impartially Assigns the Samples to Two Control and Intervention Groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blinding has been done for the data analyst. They are unaware of which group each sample belongs to.
After randomization, the participants will be informed which group they are in and what intervention they will receive.
The main researcher of the project is also fully aware of which group the patients belong to.
The sports doctor and the rheumatologist of the patients are also aware of the grouping of the patients
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice President of Research and Technology, Qurashi building, Next to Hoveizeh cinema, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.015
Health conditions studied
1
Description of health condition studied
Juvenile idiopathic arthritis
ICD-10 code
M08
ICD-10 code description
Juvenile arthritis
Primary outcomes
1
Description
The anxiety score is checked using the Multidimensional Anxiety Scale for Children questionnaire, which includes a total of 39 questions in 4 dimensions of anxiety. The scoring range in this questionnaire is 0 to 117. With the increase in the score, the degree of anxiety disorder will be more likely.
Timepoint
Baseline phase and also with the purpose of screening and then after 8 weeks of intervention
Method of measurement
Multidimensional Anxiety Scale for Children questionnaire
2
Description
The depression score is evaluated using the Children's Depression Inventory questionnaire, which includes 27 items. By answering them, the subject gets a score between 0 and 54. The higher this number, the higher the level of depression
Timepoint
Baseline phase and also with the purpose of screening and then after 8 weeks of intervention
Method of measurement
Children's Depression Inventory questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine care, people in the intervention group will receive a home exercise program based on a smartphone in the context of a sports application. This program uses a pre-designed application called "Sworkit Kids". Teenagers who have received permission to enter the program from their rheumatologist will be visited individually by a sports doctor in the presence of the researcher. For every teenager, a suitable exercise regime will be prepared and adjusted, including the type of movements, the number and time required for each movement. The application suitable for each patient's exercise regimen is adjusted by the researcher and installed on the patient's smartphone, and how to work with it is taught. Finally, after 8 weeks of intervention, depression and anxiety questionnaires will be completed again by both the intervention and control groups.
Category
Rehabilitation
2
Description
Control group: People in this group will receive routine care including drug care, physical therapy and diet.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Mitra Gholami
Street address
Akbar Children's Hospital, In front of 14 Shahid Kaveh St, Shahid Kaveh Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Fax
+98 51 3870 9201
Email
ak.pr@mums.ac.ir
Web page address
https://akbar.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayor Mobarhan
Street address
Vice President of Research and Technology, Qurashi building, Next to Hoveizeh cinema, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٨٨١٣٩۴۴
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
Ramresearch@mums.ac.ir
Web page address
https://v-research.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
Mitra Gholami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctor's Crossroads, Daneshgah St. Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
00985138591511 051
Fax
+98 51 3859 7313
Email
gholamimt3@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mitra Gholami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctor's Crossroads, Daneshgah St. Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
00985138591511 051
Fax
+98 51 3859 7313
Email
gholamimt3@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mitra Gholami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctor's Crossroads, Daneshgah St. Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
00985138591511 051
Fax
+98 51 3859 7313
Email
gholamimt3@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After publishing the results of the research and completing the evaluations, the data of the research, including the level of anxiety and depression in adolescents with idiopathic arthritis of the youth before the intervention and also its changes after the intervention, the difference in the levels of depression and anxiety in male and female patients, the level of adherence to physical activities in Patients with chronic diseases will be published without mentioning the patient's profile.
When the data will become available and for how long
After the end of the study, all the medical data of the patients can be shared.
To whom data/document is available
Researchers working in academic, scientific and industrial institutions
Under which criteria data/document could be used
Other than the main researcher, no one is allowed to use the documents.
From where data/document is obtainable
The desired request should be sent to Ms. Mitra Gholami's email:
gholamimt3@mums.ac.ir
What processes are involved for a request to access data/document
The desired request should be sent to Ms. Mitra Gholami's email:
gholamimt3@mums.ac.ir