Sleep Quality and Associated Factors in Adolescents With Idiopathic Scoliosis: A Controlled Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
研究概览
简要总结
This controlled cross-sectional observational study aims to compare sleep quality between adolescents with idiopathic scoliosis and age- and sex-similar healthy controls. Participants aged 10-18 years will complete online questionnaires assessing demographic characteristics and sleep quality. Adolescents with idiopathic scoliosis will also be evaluated for scoliosis-specific quality of life, body image, Cobb angle, curve type, pain, brace use, and daily brace-wearing duration. The study will additionally investigate factors associated with sleep quality in the scoliosis group. The planned enrollment is 100 participants, including 50 adolescents with idiopathic scoliosis and 50 healthy controls.
详细描述
This controlled cross-sectional observational study is designed to evaluate sleep quality in adolescents with idiopathic scoliosis (AIS) and to compare their sleep quality with that of age- and sex-similar healthy controls. The study will include participants aged 10-18 years and will enroll approximately 100 individuals, consisting of 50 adolescents with AIS and 50 healthy controls.
Data will be collected online using Google Forms. All participants will complete a demographic information form and the Pittsburgh Sleep Quality Index (PSQI). The demographic form will include information on age, sex, height, weight, screen time, physical activity level, sleep duration, sleep environment, and sleep habits.
Participants in the AIS group will additionally complete the Scoliosis Research Society-22 Questionnaire (SRS-22). Clinical information specific to scoliosis, including Cobb angle, curve type, pain, brace use, and daily brace-wearing duration, will also be recorded. Cobb angle and curve type will be obtained from available medical records or the most recent radiological evaluation report.
The primary analysis will compare sleep quality between the AIS and healthy control groups. Secondary analyses will investigate relationships between PSQI total score and scoliosis-related, psychosocial, and treatment-related factors, including Cobb angle, pain, scoliosis-specific quality of life, brace use, and daily brace-wearing duration. Correlation analyses and multiple linear regression will be used to identify factors independently associated with sleep quality within the AIS group.
No intervention, medication, radiological imaging, or physical examination will be performed as part of the study. Participation will consist of completing the online questionnaires, while relevant scoliosis-related clinical data will be verified from existing medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for the Adolescent Idiopathic Scoliosis Group:
- •Aged 10-19 years
- •Diagnosed with adolescent idiopathic scoliosis by a specialist physician
- •Able to read and understand Turkish
- •Willing to participate voluntarily
排除标准
- •for the Adolescent Idiopathic Scoliosis Group:
- •Having a type of scoliosis other than adolescent idiopathic scoliosis
- •Previous spinal surgery
- •Presence of a neurological, rheumatological, cardiovascular, or psychiatric condition that may prevent participation in the study
- •Inclusion Criteria for the Healthy Control Group:
- •Aged 10-19 years
- •No known scoliosis or other spinal deformity
- •Able to read and understand Turkish
- •Willing to participate voluntarily
- •Exclusion Criteria for the Healthy Control Group:
- •Presence of a neurological, rheumatological, cardiovascular, or psychiatric condition that may prevent participation in the study
研究组 & 干预措施
Adolescents With Idiopathic Scoliosis
Adolescents aged 10-18 years with a diagnosis of adolescent idiopathic scoliosis. Participants complete a demographic information form, the Pittsburgh Sleep Quality Index, and the Scoliosis Research Society-22 Questionnaire. Scoliosis-related clinical data, including Cobb angle, curve type, pain, brace use, and daily brace-wearing duration, are also recorded. No intervention is assigned.
Healthy Controls
Age- and sex-similar healthy adolescents aged 10-18 years without known scoliosis or another spinal deformity. Participants complete a demographic information form and the Pittsburgh Sleep Quality Index. No intervention is assigned.
结局指标
主要结局
Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
时间窗: At study enrollment (single cross-sectional assessment)
Sleep quality during the previous month will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality. The primary comparison will be the difference in PSQI global scores between adolescents with idiopathic scoliosis and age- and sex-similar healthy controls.
次要结局
- Correlation Coefficient Between Sleep Quality and SRS-22 Self-Image/Appearance Domain Score(At study enrollment (single cross-sectional assessment))
- Correlation Coefficient Between Sleep Quality and Cobb Angle(At study enrollment (single cross-sectional assessment))
- Correlation Coefficient Between Sleep Quality and SRS-22 Function/Activity Domain Score(At study enrollment (single cross-sectional assessment))
- Correlation Coefficient Between Sleep Quality and SRS-22 Pain Domain Score(At study enrollment (single cross-sectional assessment))
- Correlation Coefficient Between Sleep Quality and SRS-22 Mental Health Domain Score(At study enrollment (single cross-sectional assessment))
- Pittsburgh Sleep Quality Index Global Score by Brace Use Status(At study enrollment (single cross-sectional assessment))
- Pittsburgh Sleep Quality Index Global Score by Daily Brace-Wearing Duration(At study enrollment (single cross-sectional assessment))
研究者
Ayşe Sena Manzak
Assitant prof. PT, PhD
Bezmialem Vakif University