- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06429202
The Relationship Between Body Perception and Self-Esteem Level and Quality of Life in Adolescent Idiopathic Scoliosis
May 20, 2024 updated by: Halic University
Examination of the Relationship Between Body Perception and Self-Esteem Level and Quality of Life in Adolescent Idiopathic Scoliosis
Scoliosis is a three-dimensional, multifactorial disease that becomes more prevalent in adolescents, disrupts the three-dimensional mechanism and posture of the vertebra, causes deterioration in the person's body perception and cosmetic perception, and also causes negative effects on social life and quality of life.
Although idiopathic scoliosis is more common during adolescence, its cause is not yet known.
It is divided into three subheadings according to the age of onset.
These are respectively; It is classified as Juvenile Idiopathic Scoliosis (0-3 years), Infantile Idiopathic Scoliosis (4-10 years), Adolescent Idiopathic Scoliosis (10 years and above).
The most common one is Adolescent Idiopathic Scoliosis.
Its incidence in girls is 4 times higher than in boys.
This study aimed to examine the effects of body image and self-esteem on quality of life in idiopathic adolescent scoliosis patients and to determine whether there is a difference between genders.
Additionally, it will be examined what effect the duration of corset use has on these parameters.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Scoliosis is a three-dimensional, multifactorial disease that becomes more prevalent in adolescents, disrupts the three-dimensional mechanism and posture of the vertebra, causes deterioration in the person's body perception and cosmetic perception, and also causes negative effects on social life and quality of life.
Although idiopathic scoliosis is more common during adolescence, its cause is not yet known.
It is divided into three subheadings according to the age of onset.
These are respectively; It is classified as Juvenile Idiopathic Scoliosis (0-3 years), Infantile Idiopathic Scoliosis (4-10 years), Adolescent Idiopathic Scoliosis (10 years and above).
The most common one is Adolescent Idiopathic Scoliosis.
Its incidence in girls is 4 times higher than in boys.
This study aimed to examine the effects of body image and self-esteem on quality of life in idiopathic adolescent scoliosis patients and to determine whether there is a difference between genders.
Additionally, it will be examined what effect the duration of corset use has on these parameters.
Thirty idiopathic adolescent scoliosis patients, boys and girls aged between 10 and 18, will be included in the study.
Coopersmith Self-Esteem Inventory (CSEI) to evaluate body image, Walter Reed Visual Assessment Scale to evaluate body image, Scoliosis Research Society-22 Quality of Life Questionnaire to evaluate the level of quality of life, sociodemographic data form to obtain personal data, Statistical Package to analyze the data.
for Social Science (SPSS) planned to use Windows version 22.0
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayşenur Çetinkaya
- Phone Number: +905077218827
- Email: fztcetinkaya@gmail.com
Study Locations
-
-
Eyupsultan
-
Istanbul, Eyupsultan, Turkey, 2022
- Halic University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
30 individuals between the ages of 10-18 diagnosed with Adolescent Idiopathic Scoliosis.
As a general recommendation, Cohen states that if the d value is less than 0.2, the effect size can be defined as weak, if it is 0.5, it can be defined as medium, and if it is greater than 0.8, it can be defined as strong (Cohen, 1988).
The minimum number of samples was calculated with the G*Power 3.1.9
program.
Accordingly, the minimum number of samples to be included in the study for an effect size of 0.5, statistical power of 80% and margin of error of 0.05 was calculated as 29.
Description
Inclusion Criteria:
- Volunteering to participate in the study and obtaining parental consent
- Being between the ages of 10-18
- Being diagnosed with idiopathic scoliosis
- Using a scoliosis brace for at least 3 months
- Being within the normal range in body mass index
Exclusion Criteria:
- Having previously undergone spine surgery, having any mental problems, having non-idiopathic scoliosis and orthopedic disease.
- Having a curve of less than 25 degrees
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walter Reed Visual Assessment Scale
Time Frame: at baseline
|
Walter Reed Visual Assessment Scale (WRGDS) is an evaluation scale created from visual figures.
It was developed by Pineda et al. in 2006, for use in individuals with scoliosis, to measure how a person thinks about the deformity in their own body and how severe it is perceived.
|
at baseline
|
|
Coopersmith Self-Esteem Inventory (CSEI)
Time Frame: at baseline
|
It is a self-assessment scale developed by Stanley Coopersmith in 1967.
This test aims to measure the individual's thoughts about himself and his general sense of self-esteem.
The form consists of 58 questions and includes 50 self-esteem items and 8 lie items.
|
at baseline
|
|
Scoliosis Research Society-22 Quality of Life Questionnaire
Time Frame: at baseline
|
Scoliosis Research Society-22 is a 22-question quality of life scale specific to scoliosis.
Developed by the Scoliosis Research Society, it has been translated into different languages and shown to be valid and reliable.
|
at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayşenur Çetinkaya, Halic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 15, 2024
Primary Completion (Estimated)
May 30, 2024
Study Completion (Estimated)
June 10, 2024
Study Registration Dates
First Submitted
May 14, 2024
First Submitted That Met QC Criteria
May 20, 2024
First Posted (Actual)
May 24, 2024
Study Record Updates
Last Update Posted (Actual)
May 24, 2024
Last Update Submitted That Met QC Criteria
May 20, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acetinkaya003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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