Compliance to Treatment in Adolescent Girls With Idiopathic Scoliosis: is it Associated With Perception of Appearance, Self-esteem, and Quality of Life?
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ClinicalTrials.gov Identifier: NCT06023992 |
Recruitment Status :
Completed
First Posted : September 5, 2023
Last Update Posted : September 5, 2023
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Condition or disease |
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Adolescent Idiopathic Scoliosis |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 40 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Target Follow-Up Duration: | 3 Months |
Official Title: | Compliance to Treatment in Adolescent Girls With Idiopathic Scoliosis: is it Associated With Perception of Appearance, Self-esteem, and Quality of Life? |
Actual Study Start Date : | February 15, 2016 |
Actual Primary Completion Date : | June 5, 2016 |
Actual Study Completion Date : | June 15, 2016 |
- Walter Reed Visual Assessment (WRVAS) [ Time Frame: Baseline ]It is a valid scale consisting of 7 questions, each of which includes 5 visuals and evaluates the physical deformity perceived by the patients.The selected images are scored as the lowest "1" and the highest "5", and the highest total score is 35 and the lowest is 5. It is accepted that the higher the score, the more negative-evil perception of the deformity.
- Coopersmith Self-Esteem Inventory [ Time Frame: Baseline ]A valid and reliable short form of 25 questions adapted to children in the same age group was used to determine the level of self-esteem. Those who say 'No' to a negative statement and 'Yes' to a positive statement in the inventory get 1 point for each question. The level of self-esteem obtained is determined as "low" or "high" based on the average score of the group in which the person belongs.
- Scoliosis Research Society-22 [ Time Frame: Baseline ]It is a scoliosis-specific, valid and reliable quality of life scale that questions pain, body image perception, function/activity, mental health, and satisfaction with treatment. A minimum of 1 point (worst) and a maximum of 5 points (best) are taken for each question. Scoring is obtained by dividing the total score from each section by the number of questions in that section. As a result of the scoring, it is accepted that the higher the score, the higher the quality of life.
- Scoliosis Treatment Compliance Scale [ Time Frame: Baseline ]It is a scale prepared by us to evaluate compliance with the treatment program and recommended Activities of Daily Living in individuals with scoliosis. The patient can get a total of 28 points, with a minimum of 1 and a maximum of 4 points from each statement in the scale. It is observed that the higher the score, the higher the treatment compliance.
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Ages Eligible for Study: | 12 Years to 17 Years (Child) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | In prevalence studies for AIS, it has been reported that the incidence in girls is higher than in boys. In addition, AIS is more progressive in girls and the need for treatment is greater than in boys. |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Provided that the family and the child volunteer to participate in the study,
- Being diagnosed with idiopathic scoliosis
- Girl gender,
- Be 12 years or older,
- Using and still wearing braces for at least 3 months due to AIS,
- Having been prescribed an exercise program
Exclusion Criteria:
- Having had previous spine surgery,
- Presence of a psychological or psychiatric diagnosis,
- Presence of any neurological, muscular, rheumatic or orthopedic diseases accompanying scoliosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06023992
Principal Investigator: | İrem Çetinkaya, MSc | Haliç University | |
Study Chair: | Hürriyet G Yılmaz, MD | Haliç University | |
Study Director: | Melek G Yavuzer, MD | Haliç University |
Responsible Party: | İrem Çetinkaya, Lecturer, Halic University |
ClinicalTrials.gov Identifier: | NCT06023992 |
Other Study ID Numbers: |
karanki3 |
First Posted: | September 5, 2023 Key Record Dates |
Last Update Posted: | September 5, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Adolescent Idiopathic Scoliosis perception of appearance self-esteem quality of life compliance |
Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases |