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 |
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Recruitment Status :
Completed
First Posted : September 5, 2023
Last Update Posted : September 5, 2023
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| Tracking Information | ||||||||||
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| First Submitted Date | August 22, 2023 | |||||||||
| First Posted Date | September 5, 2023 | |||||||||
| Last Update Posted Date | September 5, 2023 | |||||||||
| Actual Study Start Date | February 15, 2016 | |||||||||
| Actual Primary Completion Date | June 5, 2016 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Compliance to Treatment in Adolescent Girls With Idiopathic Scoliosis: is it Associated With Perception of Appearance, Self-esteem, and Quality of Life? | |||||||||
| Official Title | Compliance to Treatment in Adolescent Girls With Idiopathic Scoliosis: is it Associated With Perception of Appearance, Self-esteem, and Quality of Life? | |||||||||
| Brief Summary | Idiopathic scoliosis is a spinal deformity that occurs in adolescent girls and boys and is more progressive in girls. The cosmetic changes caused by the scoliotic spine cause negativity in perception of appearance and psychosocial problems in pubertal individuals, especially in girls. It is thought that brace used in conservative treatment increase this negativity in body image and affect compliance with treatment. In this study, it was aimed to determine whether there is an effect on the individual's compliance with the programmed treatment by investigating the perception of body appearance, self-esteem and quality of life of adolescent girls with idiopathic scoliosis. In this context, forty adolescent girls diagnosed with "idiopathic scoliosis" and followed in the "Formed Healthcare Scoliosis Unit" were included in the study. In the study, Walter Reed Visual Evaluation Scale was used to evaluate perception of appearance, Coopersmith Self-Esteem Inventory to evaluate self-esteem, and SRS-22 Scoliosis Patient Questionnaire to evaluate quality of life. Scoliosis Treatment Compliance Scale, which was developed by us and whose validity and reliability study was planned, was used to evaluate compliance with the treatment program. | |||||||||
| Detailed Description | Scoliosis is a three-dimensional deformity of the spine in which a lateral deviation of more than 10º is observed in the coronal plane. Causes deterioration in sagittal, frontal and transverse planes; In scoliosis with lateral flexion, rotation and shortness components, there is a complex curvature of the spine. The risk of progression, the initial degree of curvature, the age and maturation level of the patient are important for the treatment plan of a patient with AIS. In addition, cosmetic appearance and social factors play a role in the treatment protocol. Methods used in the treatment of scoliosis by considering the progression factor; observation, physiotherapy and specific rehabilitation, brace and surgical treatment. There are studies showing that the results are positively affected if the programmed and recommended conservative treatment methods are complied with, and the importance of compliance to treatment is emphasized. In order for the spinal tissues to respond to the forces created by the trunk orthoses (braces) used in the conservative treatment of AIS, a sufficient time and regular use of the brace is required. Studies have shown that there is non-compliance in the treatment process and that patients do not comply with the treatment, especially by not using their braces for a sufficient time during the day. Exercise therapy has been used for years during follow-up and as a form of conservative therapy. Posture exercises (stabilization exercises) to provide spinal control, exercises to increase spinal flexibility (stretching exercises), exercises to correct muscle strength imbalance and to regulate breathing are applied. It has been reported that compliance with exercise therapy positively affects the treatment results. It is very important to keep the treatment programs at home, to raise the awareness of the person to control the spine in daily life, to integrate the applied exercises into daily life activities and to support the scoliosis with sports activities. It is reported that correctly planned daily life activities and positions and sports activities that do not involve the risk of injury affect the treatment results positively. The long treatment period in scoliosis, especially the use of braces, negatively affects daily life and increases the stress level. In this process, individuals with AIS may experience social isolation, depression, low participation in activities and non-compliance. It is mentioned that in order to achieve real success in treatment, the patient should come to terms with the situation he is in cognitively and psychosocial problems should be taken into account. With the deviations in the frontal, sagittal and transverse planes of the scoliotic spine, the cosmetic effect becomes evident and negatively affects body image perception and psychological health. General physical changes in adolescence are accompanied by a reassessment of the young individual's self-concept. Studies have shown that compliance to treatment in individuals with AIS is associated with body image perceptions and self-esteem. In addition, scoliosis is an important risk factor for poor quality of life in children and adolescents. It has been reported that the quality of life in AIS is significantly affected by the negative perception of the individual on body image, and low quality of life is associated with low self-esteem, especially in adolescent individuals who use braces. When the literature is examined, studies examining the psychosocial effects of individuals with AIS and their relationships with quality of life and compliance to treatment are very limited. When the literature is examined, studies examining the psychosocial effects of individuals with AIS and their relationships with quality of life and compliance to treatment are very limited. When the measurement methods used in studies questioning adherence to treatment in the literature are examined, it is seen that there are limitations in the evaluation of corset and exercise therapy, as well as other treatment components such as daily life and sports activities. Since subjective and objective measurement methods are insufficient to question the treatment as a whole, a scale designed within the scope of this study was also presented to the literature. The aim of the investigators is to solve these limitations in the literature and to determine the effect of perception of deformity, self-esteem and quality of life on the adherence to treatment of the adolescent individual. |
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| Study Type | Observational [Patient Registry] | |||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | 3 Months | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | A clinic where individuals with scoliosis are treated and followed up by specialist physician and physiotherapists, as well as a scoliosis brace production and application center: Formed Healthcare Orthotics and Prosthesis Center - Scoliosis Unit. | |||||||||
| Condition | Adolescent Idiopathic Scoliosis | |||||||||
| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
40 | |||||||||
| Original Actual Enrollment | Same as current | |||||||||
| Actual Study Completion Date | June 15, 2016 | |||||||||
| Actual Primary Completion Date | June 5, 2016 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria: Provided that the family and the child volunteer to participate in the study,
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 12 Years to 17 Years (Child) | |||||||||
| Accepts Healthy Volunteers | Not Provided | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Not Provided | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT06023992 | |||||||||
| Other Study ID Numbers | karanki3 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | İrem Çetinkaya, Halic University | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | Halic University | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | Halic University | |||||||||
| Verification Date | September 2023 | |||||||||