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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06429202
Other study ID # Acetinkaya003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 15, 2024
Est. completion date June 10, 2024

Study information

Verified date May 2024
Source Halic University
Contact Aysenur Çetinkaya
Phone +905077218827
Email fztcetinkaya@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 10, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility 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 Design


Locations

Country Name City State
Turkey Halic University Istanbul Eyupsultan

Sponsors (1)

Lead Sponsor Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Walter Reed Visual Assessment Scale 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
Primary Coopersmith Self-Esteem Inventory (CSEI) 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
Primary Scoliosis Research Society-22 Quality of Life Questionnaire 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
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