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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Halic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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