Quality of life of adolescents with idiopathic scoliosis in Korea
| ISRCTN | ISRCTN78283211 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78283211 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/08/2015
- Registration date
- 20/08/2015
- Last edited
- 20/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
The spine is made up of a series of small bones called vertebrae. Scoliosis is a condition that causes the vertebrae to twist or rotate, causing the spine to curve sideways. There are several different types of scoliosis, however the most common type is known as “idiopathic”, which means that the exact cause is not known. Scoliosis can have a disfiguring effect on appearance. This is a particular problem in young people, who are often more concerned with the way their bodies look than adults, as it is a sensitive stage of development. It is thought that young people will experience a lot of emotional distress because of their condition, which can have an effect on their quality of life. This study aims to see how young people suffering from idiopathic scoliosis feel about their quality of life in relation to the disease characteristics and characteristics of the general population.
Who can participate?
Patients between the ages of 8 and 20 suffering from idiopathic scoliosis.
What does the study involve?
Participants are asked to fill in a questionnaire designed to find out how good they feel their quality of life is. The medical records of the participants are also reviewed by the researchers to collect information about how serious their disease is, the type of treatment they are having, and the age when the disease was first diagnosed.
What are the possible benefits and risks of participating?
There are no benefits of participating in the study other than providing new insight and valuable information of HRQoL of Korean adolescents with idiopathic scoliosis. There are no risks of participating.
Where is the study run from?
1. Severance Hosptial (South Korea)
2. Kangnam Severance Hospital (South Korea)
When is the study starting and how long is it expected to run for?
November 2010 to August 2012
Who is funding the study?
Mo-Im Nursing Research Institute of Yonsei University (South Korea)
Who is the main contact?
Professor Jihea Choi
Contact information
Scientific
Jinri-Hall 402-4
Department of Nursing
Yonsei University Wonju College of Medicine
20 Ilsan-ro
Wonju-si, Gangwon-do
220-701
Korea, South
Study information
| Study design | Multi-centre observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | Health-related quality of life of young adolescents conservatively treated for idiopathic scoliosis in Korea: a cross-sectional study |
| Study objectives | This cross-sectional study aims to describe and compare health-related quality of life (HRQoL) of adolescents with idiopathic scoliosis by disease-related characteristics such as age of diagnosis, type of treatment, severity of idiopathic scoliosis, as well as demographic characteristics. |
| Ethics approval(s) | 1. Institutional Review Board of Gangnam Severance Hospital: 24/11/2010, ref: 3-2010-0172 2. Clinical Trials Center (CTC) of Severance Hospital: 22/12/2011, ref: 4-2011-0682 |
| Health condition(s) or problem(s) studied | Scoliosis |
| Intervention | One hundred and ten adolescents with idiopathic scoliosis were recruited from two tertiary hospital outpatient clinics over 1 year. Health-related quality of life (HRQoL) of participants was measured using the Korean version of the Scoliosis Research Society 22 revision (SRS-22r) questionnaire. In addition, their medical records were reviewed to collect data on severity of scoliosis, type of treatment, and age at which they were first diagnosed with the disease. |
| Intervention type | |
| Primary outcome measure | Health-related quality of life (HRQoL) is measured during clinical visits, measured using the Korean version of the Scoliosis Research Society 22 revision (SRS-22r) questionnaire. The SRS-22r contains 22 questions in five domains: function (5 items), pain (5 items), self-image (5 items), mental health (5 items), and satisfaction with management (2 items). Each item contains 5 response levels from worst (1 point) to best (5 point), and the results are expressed as the mean score of each domain and total score of the scale. A higher total score indicates a higher level of quality of life. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 24/11/2010 |
| Completion date | 30/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 20 Years |
| Sex | Both |
| Target number of participants | One hundred and ten adolescents with idiopathic scoliosis were recruited. |
| Key inclusion criteria | 1. Aged between 8 and 20 years 2. Having a primary diagnosis of idiopathic scoliosis. |
| Key exclusion criteria | Any other diagnosable musculoskeletal disease, except for scoliosis and cognitive impairment. |
| Date of first enrolment | 24/11/2010 |
| Date of final enrolment | 30/08/2012 |
Locations
Countries of recruitment
- Korea, South
Study participating centres
03722
Korea, South
06273
Korea, South
Sponsor information
Hospital/treatment centre
50-1 Yeonsei-Ro, Seodaemun-Gu
Seoul
03722
Korea, South
Industry
211 Eonju-Ro Gangnam-Gu
Seoul
06273
Korea, South
Not defined
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/09/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Intend to submit to the journal "Scoliosis" (http://www.scoliosisjournal.com/) |
| IPD sharing plan |
