Comparison of the effect of pain management training on face-to-face mobile-based methods on pain and quality of life in adolescents with chronic pain in Shiraz (1397)
Design
A clinical trial with two intervention groups and a control group in which 192 patients will be assigned by random numbers.
Blind double-sided.
Settings and conduct
Research Areas: Secondary Schools for Girls and Boys in 4 Education area in Shiraz.
Patients will be randomly assigned to one of the three mobile education groups, face-to-face training, and control group. In the mobile-based education group, the software will provide educational materials to the patients. In face-to-face training, students will attend four sessions. There is no training in the control group. The current study is two-way blind. The companies themselves do not know which group will be placed and the researcher It also does not recognize this issue and is used to help researcher.
Participants/Inclusion and exclusion criteria
inter:
Age between12 to 18 years
Secondary education
Teen Access to Mobile
Having chronic pain diagnosis based on ICD 11 criteria
Exit:
Having other chronic non-painful physical illnesses (such as MS, diabetes, cancer, etc.), according to a person
According to a person, he has chronic mental illness
Intervention groups
Intervention group 1: Mobile education
Intervention group 2: face to face training
Control group: Just fill in the questionnaires without any training.
Main outcome variables
Changes in quality of life score after receiving pain management training in both face-to-face and mobile-based methods, changes in pain severity score from receiving pain management training in both face-to-face and mobile-based methods.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180808040744N2
Registration date:2019-04-12, 1398/01/23
Registration timing:registered_while_recruiting
Last update:2019-04-12, 1398/01/23
Update count:0
Registration date
2019-04-12, 1398/01/23
Registrant information
Name
Zahra Jahandide
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
jahandide@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mobile-based pain management education on the pain and quality of life of adolescents with chronic pain in Shiraz, 1397
Public title
The effect of mobile-based pain control education on the pain and quality of life of adolescents with chronic pain in Shiraz
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 12 to18 years
Secondary education
Access to smart phone
Having chronic pain diagnosis based on ICD 11 criteria
Exclusion criteria:
According to a person, he has chronic mental illness
According to one's own opinion, the presence of other non-painful physical, chronic physical illnesses
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
640
Randomization (investigator's opinion)
Randomized
Randomization description
At first, secondary schools from the four educational districts of Shiraz city are randomly selected, and from each district two girls and boys' state schools will be selected by systematic random sampling and then from each school in a randomized, three classes ( From each base, a class will be selected. After obtaining informed consent, demographic information, pain intensity and quality of life are provided to them, and adolescents who have the criteria for entering the study are selected to enter the study. And these adolescents are randomly assigned to three groups of pain management training in person, mobile education and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
To prevent contamination, all adolescents selected in a school are in the same category. The companies themselves do not know which group will be placed in, and the researcher will also not be aware of this. The purpose of the researcher's assistance is to use it and completely randomly place each sample in one of the intervention groups or control group.
This study is a double-blind study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2019-01-31, 1397/11/11
Ethics committee reference number
IR.SUMS.REC.1398.091
Health conditions studied
1
Description of health condition studied
chronic pain
ICD-10 code
G89.2
ICD-10 code description
Chronic pain, not elsewhere classified
Primary outcomes
1
Description
Quality of life score in pediatrics quality of life questionnaire
Timepoint
At the beginning of the study, immediately and 3 months after the end of the intervention
Method of measurement
Pediatrics Quality of life questionnaire
2
Description
Pain severity score in pain intensity questionnaire
Timepoint
At the beginning of the study, immediately and 3 months after the end of the intervention
Method of measurement
Numeic rating scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In the mobile-based education group, the software will provide educational materials to the patients. For this purpose, patients in this group receive weekly instructional materials and encourages the use of the contents of the educational content provided in the software and will receive educational pamphlets.
Category
Rehabilitation
2
Description
Intervention group: Second intervention group: In face-to-face training, patients will attend four training sessions. These meetings will be held weekly (weekly by one meeting) and each session will last for 60 to 90 minutes. Face-to-face education will be done in groups of 8 to 10 people.
Category
Rehabilitation
3
Description
Control group: The control group will not receive any intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Secondary schools in Shiraz
Full name of responsible person
jahandide zahra
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
zahrajahandide7@gmail.com
Web page address
http://nurs-midwif.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr. ghasemi , younes
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nurs_midwif@sums.ac.ir
Web page address
http://nurs-midwif.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Jahandide zahra
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychiatrics
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nurs_midwif@sums.ac.ir
Web page address
http://nurs-midwif.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
SHAYGAN MARYAM
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nurs_midwif@sums.ac.ir
Web page address
http://nurs-midwif.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jahandide zahra
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychiatrics
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nurs_midwif@sums.ac.ir
Web page address
http://nurs-midwif.sums.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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