NCT07714993

Brief Summary

Yağmur KİRMİK, Investigation of the Effect of Family Education on Stress, Deformity Perception, Quality of Life, and Treatment Adherence in Individuals with Adolescent Idiopathic Scoliosis, Hasan Kalyoncu University, Graduate Education Institute, Department of Physiotherapy and Rehabilitation, Master's Thesis, Gaziantep 2026. This study was conducted to investigate the effect of individual/family education on stress, deformity perception, quality of life, and exercise adherence in individuals with adolescent idiopathic scoliosis (AIS). A total of 42 individuals with AIS participated in the study. Randomization was performed to create a study group (n=21) and a control group (n=21). The study group received Physiotherapy Scoliosis-Specific Exercises (PSSE) in addition to individual/family education, while the control group received only PSSE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 9, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

scoliosisAdolescence,stressbody image

Outcome Measures

Primary Outcomes (10)

  • Distress-Eustress Scale for Adolescents

    Each item is rated on a scale of 0 to 4. Scores for the distress and eustress dimensions range from 0 to 20. No total score is calculated for the scale. Higher scores on the eustress dimension indicate that stress is perceived as stimulating and motivating, whereas higher scores on the distress dimension indicate that stress is perceived as a source of strain and tension.

    12 weeks

  • axial trunk rotation measurement (ATR)

    ATR is measured using a scoliometer. The scoliometer is a tool designed to measure the prominence (gibbosity) on the back resulting from trunk rotation. Its degree is determined by taking a measurement over the trunk prominence caused by rotation while performing the Adam's forward-bending test.

    12 Weeks

  • Revised Child Anxiety and Depression Scale

    The total scale score is calculated by summing the scores obtained from all items. As the total score increases, the levels of anxiety and depression increase.

    12 weeks

  • Spinal Appearance Questionnaire

    The questionnaire consists of two sub-groups. The "Appearance" sub-group includes visual questions regarding spinal asymmetry, rib prominence, waist prominence, the relationship between the head, rib cage, and pelvis, head-to-pelvis positioning, shoulder level, and scapular rotation. The score for the Appearance sub-group is calculated by summing the scores of questions 1 through 10; higher scores in this sub-dimension indicate a perception of severe deformity. The "Expectation" sub-group contains questions reflecting the individual's expectations regarding their body, such as a desire to be straighter. The score for the Expectation sub-group is calculated by summing the scores from questions 12 through 15.

    12 weeks

  • Walter Reed Visual Assessment Scale

    The survey items are rated on a scale of 1 to 5, with total scores ranging from a minimum of 7 to a maximum of 35. Higher scores reflect a perception of worsening deformity.

    12 weeks

  • Scoliosis-Related Body Image Scale

    Consisting of seven items and a single factor, this scale measures the dissatisfaction experienced by individuals diagnosed with scoliosis regarding the deformity of their bodies. Each item is scored on a scale of 1 to 5. Higher scores indicate severe dissatisfaction with the body deformity.

    12 weeks

  • General Quality of Life Scale for Children

    This is a General Quality of Life scale comprising items related to physical health (8 items), emotional state (5 items), social status (5 items), and school functioning (5 items). The lower the total scale score, the lower the perceived quality of life. Parent forms are available for the scale-tailored to the 8-12 and 13-18 age groups-and are completed separately but simultaneously by the parents of the participating children. The 23-item scale is scored across three dimensions: Total Scale Score (TSS), Physical Health Total Score (PHTS), and Psychosocial Health Total Score (PSTS). Items are scored on a scale of 0 to 100, with response parameters assigned as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. The TSS is calculated by dividing the sum of all scores by 23; the PHTS is calculated by dividing the sum of the scores from the first 8 items by 8; and the PSTS is calculated by dividing the sum of the scores from the remaining 15 items by 15.

    12 weeks

  • Japanese Scoliosis Questionnaire (SJ-27)

    It is a self-administered, disease-specific questionnaire designed to measure quality of life. It comprises four questions regarding pain associated with sitting, standing, and lying down; six questions assessing anxiety and depression related to spinal deformity; six questions addressing body image and self-perception; four questions concerning the difficulty of participating in physical activities; and seven questions regarding discomfort experienced while carrying bags or getting dressed. Each question is scored on a scale of 0 to 4, with higher scores indicating lower quality of life.

    12 weeks

  • Scoliosis Research Society Score (SRS 22)

    The questionnaire consists of 22 items across five sub-domains: perception of body image, pain, function, psychosocial status, and treatment satisfaction. Each item is scored on a scale of 1 to 5, where a score of 1 indicates a worsening condition and a score of 5 indicates a good condition. A higher total score reflects a better quality of life.

    12 weeks

  • Exercise Adherence Rating Scale

    It evaluates the level of adherence to home exercises among patients with chronic diseases. It consists of three sections. Section A comprises six items that can be adapted to individual needs; it is not included in the scoring. Section B describes how the recommended home exercises are performed, while Section C assesses the reasons for adherence or non-adherence to the recommended exercises. The total questionnaire score is calculated by summing the scores from Sections B and C, with values ranging from 0 to 64.

    12 weeks

Study Arms (2)

Working group

EXPERIMENTAL

The study group received additional individual/family education on 'Physiotherapeutic Scoliosis-Specific Exercises'.

Other: PSSEOther: individual/family education

control group

ACTIVE COMPARATOR

Only scoliosis-specific physiotherapeutic exercises were administered.

Other: PSSE

Interventions

PSSEOTHER

While the study group received individual/family education in addition to Physiotherapeutic Scoliosis-Specific Exercises (PSSE), the control group received only PSSE.

Working groupcontrol group

Individual/family education was provided.

Working group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being between the ages of 10 and 18
  • Absence of chest deformity
  • Absence of psychiatric diagnosis and not taking medication
  • Absence of neurological problems
  • No history of spinal surgery

You may not qualify if:

  • \- Having a psychiatric diagnosis
  • Having a neurological problem
  • Having undergone spinal surgery
  • Presence of orthopedic or cognitive problems that would hinder exercise training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universty

Gaziantep, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • YAVUZ Y YAKUT

    Hasan Kalyoncu Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
It was conducted using the sealed-envelope method.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The aim of this study is to examine the effects of additional individual/family education alongside PSSE on stress, anxiety, depression, quality of life, deformity perception, and treatment adherence.The aim of this study is to examine the effects of additional individual/family education alongside PSSE on stress, anxiety, depression, quality of life, deformity perception, and treatment adherence.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 20, 2026

Study Start

September 6, 2025

Primary Completion

May 30, 2026

Study Completion

June 10, 2026

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

patient individual privacy

Locations