Scoliosis; AdolescenceNCT06429202
The Relationship Between Body Perception and Self-Esteem Level and Quality of Life in Adolescent Idiopathic Scoliosis
An observational study of Scoliosis; Adolescence and Self Esteem, run by Halic University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis; Adolescence, Self Esteem, Quality of Life
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 10 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Having previously undergone spine surgery, having any mental problems, having non-idiopathic scoliosis and orthopedic disease.
- Having a curve of less than 25 degrees
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Scoliosis; Adolescence, Self Esteem, Quality of Life
- Keywords
- idiopathic scoliosis, self esteem, body perception
- Medical subject headings
- Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline
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.
Measured: at baseline
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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 May 2024 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayşenur Çetinkaya, Principal investigator, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429202
- Sponsor's protocol ID
- Acetinkaya003
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Relationship Between Body Perception and Self-Esteem Level and Quality of Life in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06429202
- Acronym / sponsor ID
- Acetinkaya003
- Conditions
- Scoliosis; Adolescence, Self Esteem, Quality of Life
- Keywords
- idiopathic scoliosis, self esteem, body perception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Having previously undergone spine surgery, having any mental problems, having non-idiopathic scoliosis and orthopedic disease.
- Having a curve of less than 25 degrees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşenur Çetinkaya principal investigator
Halic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis; Adolescence and Self Esteem, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur Çetinkaya (+905077218827, fztcetinkaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walter Reed Visual Assessment Scale (time frame: at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.