Protocol summary

Study aim
Self-esteem gradually increases in the pre-adolescent years, and with the onset of adolescence due to abstract thinking about physical interpretation, more thoughts about oneself are observed. Social strength is such as graduating from university, marriage, changing jobs. Diseases that change the structure of the body, such as scoliosis, may also change the mental image of the body
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 60 patients.Excel software rand function was used for randomization.
Settings and conduct
Background: Psychological education of patients with scoliosis Location: Shafa Yahyaian Hospital, Tehran Scope and method of work: Educational package for children Blinding: Yes-patient-physician-statistical researcher
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with idiopathic scoliosis, No need for surgical treatment, Accept brace treatment Age 9-12 years Criteria for non-entry : Congenital scoliosis Secondary scoliosis to other etiologies such as radiotherapy or tumor Age less than 9 and older than 12 years
Intervention groups
The experimental group undergoes 12sessions of 1.5 hours, one session per week for approximately three months under the intervention of self-respect training by a clinical psychologist Demographic, clinical, and radiographic information are obtained using patient records Completion of the body image anxiety questionnaire is done by the participants at the beginning and end of the study at intervals of three months, twice, in both group
Main outcome variables
1. A person's dissatisfaction and embarrassment with his appearance, checking and hiding perceived defects 2. The degree to which anxiety about appearance interferes with a person's social performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210520051351N3
Registration date: 2022-05-14, 1401/02/24
Registration timing: prospective

Last update: 2022-05-14, 1401/02/24
Update count: 0
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Mehdi Mohammadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4448 2494
Email address
mehdi.668491@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of self-esteem and psychological problems educational package in children with scoliosis
Public title
The effectiveness of self-esteem and psychological problems educational package in children with scoliosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with idiopathic scoliosis No need for surgical treatment Accept brace treatment Age 9-12 years
Exclusion criteria:
Congenital scoliosis Secondary scoliosis to other etiologies such as radiotherapy or tumor Age less than 9 and older than 12 years
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method in the present study: simple randomization so that they will be divided into control and intervention groups one by one. Randomization unit: will be individual. Layers of randomization: Using stratified randomization Patients are randomly placed in different groups and random blocks are used for balance in groups. The samples are classified according to the center of the class and then in each class with the help of software to generate a random sequence. Randomization tool: Random number table The method of constructing a random sequence is selected one by one Explanation of allocation concealment: Patients do not know the type of intervention and the person performing the analysis does not know the type of intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant: does not know the type of intervention Clinical caregiver: Knows the type of intervention Researcher: Knows the type of intervention Impact Assessor: Does not know the type of intervention Data Analyzer: Does not know the type of intervention Health personnel (physicians): Do not know the type of intervention Data collectors and those evaluating the outcome: Unaware of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Mojahedin Islam St. Shafa Yahyaian Hospital
City
Tehran
Province
Tehran
Postal code
1157637131
Approval date
2022-04-15, 1401/01/26
Ethics committee reference number
IR.IUMS.REC.1401.040

Health conditions studied

1

Description of health condition studied
Scoliosis
ICD-10 code
M41.11
ICD-10 code description
Juvenile idiopathic scoliosis

Primary outcomes

1

Description
Theoretical questionnaire score from body image.
Timepoint
Evaluation of psychological problems with body image concern questionnaire before and three months after self-esteem training
Method of measurement
Body Image Concern Questionnaire

2

Description
Beck Anxiety Questionnaire score
Timepoint
Evaluation of psychological problems with Beck Anxiety Questionnaire before and after three months of self-esteem training
Method of measurement
Beck Anxiety Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Self-esteem package training - This group, which is tested in 12 sessions of 1.5 hours, one session per week, for approximately three months under the intervention of self-esteem package training, by a clinical psychologist. Collecting demographic, clinical and radiographic information of patients using patient records and completing a body image concern questionnaire is performed by study participants three months apart, twice, once before the start of the package, and once at the end of treatment. Be.
Category
Rehabilitation

2

Description
Control group: Lack of training in your honor package-Control group: Lack of self-esteem training - This group is also patients with scoliosis who are asked to fill out the desired questionnaire twice in three months.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Yahyaian Hospital
Full name of responsible person
Hasan Ghandehari
Street address
Shafa yahyaiehian Educational and Medical Center, Mojahedin-e-Islam St., Baharestan Square,Tehran
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
mehdi.668491@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
سید عباس متولیان
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hasan Ghandehari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Mojahedin-e-Islam Street
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
Ghandhari.h@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Mohammadpour
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Punak Square, Sardar Jangal St., Bahar Sharghi St., Fajr Alley, No. 29, Unit 3, Postal Code 1476954974
City
TEHRAN
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Fax
Email
mehdi.668491@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Mohammadpour
Position
Felloship
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Mojahedin-e-Islam Street
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
mehdi.668491@gmail.com

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
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
All variables and all potential data can be shared after identifying individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic institutions, and people in industry can apply for it.
Under which criteria data/document could be used
The data can be reviewed and used to improve clinical conditions and maintain patient health and perform meta-analyzes.
From where data/document is obtainable
They can request the author's email or from the research center or university.
What processes are involved for a request to access data/document
Apply by email or post to Iran University of Medical Sciences or Shafa Yahyaian Bone and Joint Reconstruction Research Center.
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