Evaluate the effectiveness of mindfulness-based training to improve the resilience and quality of life in adolescents with idiopathic scoliosis brace treatment and their parents
The purpose of this study was to investigate the effectiveness of bench-based methods on improving resilience and quality of life in adolescents with idiopathic scoliosis treated with brace and their parents.
Design
The plan includes two groups of parents and teens. Which is a case study. Finally, it will be examined whether this training is more effective than adolescents or parents.
Settings and conduct
A cohort of cognitive therapy package for children and adolescents (Sample & Lee, 2007) for adolescent group and parental group also teaches cognitive techniques (Kabat Zein, 1999). The intervention will be held at the Shahid Beheshti University Psychological Consulting and Services Center.
Participants/Inclusion and exclusion criteria
Adolescent group (Entry requirements)
-Does not have any physical and medical illness.
-Have at least 10 years and maximum 18 years of age..
Parents group(Entry requirements)
-Have at least a diploma or higher education.
Adolescent group(Conditions of failure to enter)
-Patient's opposition to cooperation at any time from research.
Intervention groups
This study consists of two groups. A group in which adolescents with scoliosis attend. And the second group, which can include parents whose child was involved in intervention, and can include parents whose son was scoliosis but who did not participate in the intervention.
Main outcome variables
Improve the quality of life and quality of life for teens using brace, as well as their parents. Because the disease and the type of treatment affect the various dimensions of quality of life.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180221038817N1
Registration date:2018-05-29, 1397/03/08
Registration timing:retrospective
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Mehrnaz Tisheh zan
Name of organization / entity
Shahid Beheshti University Of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 41 3544 5244
Email address
m.tishehzan@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effectiveness of mindfulness-based training to improve the resilience and quality of life in adolescents with idiopathic scoliosis brace treatment and their parents
Public title
The Effectiveness of Mindfulness Education in adolescent with scoliosis and their parents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
does not have other physical and medical illness
Use brace and exercise at the same time
At least three months from the start of treatment.
Exclusion criteria:
Age
From 10 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University
Street address
Family Research Institute,Shahid Beheshti University,Shahid shahriari Sq, Yaman St, Shahid Chamran Hwy.
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2016-11-27, 1395/09/07
Ethics committee reference number
850/2/ص
Health conditions studied
1
Description of health condition studied
Idiopathic Scoliosis
ICD-10 code
M41
ICD-10 code description
Scoliosis
Primary outcomes
1
Description
Resonance Score in Conner and Davidson Questionnaire
Timepoint
Prior to training, the resilience score is measured by Conner and Davidson's questionnaire. After one month after completion of the intervention, samples are monitored by measuring instruments.
Method of measurement
Conner and Davidson Suspension Questionnaire
2
Description
The score of the questionnaire (BrQ) measures the quality of life of adolescents with scoliosis who are treated with brace.
Timepoint
Before starting the training, the quality of life score is measured by the Brace Questionnaire and after one month after completion of the intervention, samples are monitored by measuring instruments.
Method of measurement
Brace Questionnaire
3
Description
Quality of Life Score in the WHO Quality of Life Questionnaire for Parents Group
Timepoint
Before starting the training of Mindfulness techniques, the quality of life score is measured by the World Health Organization's Quality of Life questionnaire and after one month after completion of the intervention, samples are monitored by measuring instruments.
Method of measurement
World Health Organization Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: Adolescents with braided Idiopathic scoliosis, Group II: Parents of juvenile idiopathic scoliosis treated with brace
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Technical Orthopedics Dr. Kamyab
Full name of responsible person
Dr. Mojtaba Kamyab
Street address
unit 1,koohe noor building,infront of koohe noor st, motahhari st.
City
Tehran
Province
Tehran
Postal code
97257247294
Phone
+98 21 8832 2078
Fax
+98 21 8831 3769
Email
mehr.tn@gmail.com
2
Recruitment center
Name of recruitment center
Dr. Ganjavian office
Full name of responsible person
Dr. Mohammad Saleh Ganjavian
Street address
2end floor,mahdad medical building,miremad st,motahhari st.
City
tehran
Province
Tehran
Postal code
785525625
Phone
+98 21 8875 3130
Email
mehr.tn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Dr. Babak Shokri
Street address
assistance of Research and Technology, presidential building, Shahid Beheshti University,Evin.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 29901
Email
mehr.tn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
no.320, 3th floor, Faculty of Education and Psychology,Shahid beheshti university,daneshjou blvd,velenjak.
City
tehran
Province
Tehran
Postal code
756555557509
Phone
+98 21 2990 5318
Email
psychology2008@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University Of Tehran
Full name of responsible person
Mehrnaz Tishehzan
Position
M.A student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
no.25, 10 metri 8th, daneshgah alley,Golgasht st.
City
tabriz
Province
East Azarbaijan
Postal code
5165938648
Phone
+98 41 3544 5244
Email
mehr.tn@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After the intervention, the findings of the study were followed up and the results of the questionnaires were distributed to each person participating in this study.Also, techniques that are appropriate to the sample conditions will be selected and implemented, and will also be introduced.
When the data will become available and for how long
Starting the access period from September 2018
To whom data/document is available
All researchers and graduate and postgraduate students whose interventions they use in research are good.
Under which criteria data/document could be used
Only for researchers who work on the field of this research(Scoliosis & Mindfulness)
From where data/document is obtainable
1-send the email to this address: mehr.tn@gmail.com and in the text of the email, mention which parts of the data and the results and what research is required.
What processes are involved for a request to access data/document
After sending the email to mehr.tn@gmail, according to your request, a weekly container will be sent to your email address.