Sleep Quality in Adolescents With Idiopathic Scoliosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-19
SponsorBezmialem Vakif University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 10-19 years
Diagnosed with adolescent idiopathic scoliosis by a specialist physician
Able to read and understand Turkish
Willing to participate voluntarily
Disqualifiers
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
Aged 10-19 years
Trial population
The study population consists of adolescents aged 10-19 years with adolescent idiopathic scoliosis who were previously referred from the Orthopedics and Traumatology Outpatient Clinic to the Orthopedic Training and Research Laboratory, and age- and sex-similar healthy adolescents without known scoliosis or another spinal deformity. Data are collected online from eligible volunteers using Google Forms. Clinical scoliosis-related information is verified from available medical records and radiological reports.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Adolescents With Idiopathic Scoliosis
Group B: Healthy Controls
Trial outcomes
Primary outcomes
1
Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
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.
Time frame
At study enrollment (single cross-sectional assessment)Secondary outcomes
1
Correlation Coefficient Between Sleep Quality and Cobb Angle
The correlation between sleep quality and scoliosis curve magnitude will be evaluated in participants with adolescent idiopathic scoliosis using the Pittsburgh Sleep Quality Index (PSQI) global score and Cobb angle. The PSQI global score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality. Cobb angle will be obtained from the most recent available radiological evaluation and recorded in degrees. The reported outcome will be the Pearson or Spearman correlation coefficient, as appropriate, ranging from -1 to +1.
Time frame
At study enrollment (single cross-sectional assessment)2
Correlation Coefficient Between Sleep Quality and SRS-22 Function/Activity Domain Score
The correlation between sleep quality and physical function will be evaluated in participants with adolescent idiopathic scoliosis using the Pittsburgh Sleep Quality Index (PSQI) global score and the function/activity domain score of the Scoliosis Research Society-22 Questionnaire (SRS-22). The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The SRS-22 function/activity domain score ranges from 1 to 5, with higher scores indicating better function. The relationship will be reported as a Pearson or Spearman correlation coefficient, as appropriate, ranging from -1 to +1.
Time frame
At study enrollment (single cross-sectional assessment)3
Correlation Coefficient Between Sleep Quality and SRS-22 Pain Domain Score
The correlation between sleep quality and pain will be evaluated in participants with adolescent idiopathic scoliosis using the Pittsburgh Sleep Quality Index (PSQI) global score and the pain domain score of the Scoliosis Research Society-22 Questionnaire (SRS-22). The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The SRS-22 pain domain score ranges from 1 to 5, with higher scores indicating less pain and a better health status. The relationship will be reported as a Pearson or Spearman correlation coefficient, as appropriate, ranging from -1 to +1.
Time frame
At study enrollment (single cross-sectional assessment)4
Correlation Coefficient Between Sleep Quality and SRS-22 Self-Image/Appearance Domain Score
The correlation between sleep quality and self-image/appearance will be evaluated in participants with adolescent idiopathic scoliosis using the Pittsburgh Sleep Quality Index (PSQI) global score and the self-image/appearance domain score of the Scoliosis Research Society-22 Questionnaire (SRS-22). The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The SRS-22 self-image/appearance domain score ranges from 1 to 5, with higher scores indicating a better perception of self-image and appearance. The relationship will be reported as a Pearson or Spearman correlation coefficient, as appropriate, ranging from -1 to +1.
Time frame
At study enrollment (single cross-sectional assessment)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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