Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000178741p
Ethics application status
Submitted, not yet approved
Date submitted
29/01/2022
Date registered
2/02/2022
Date last updated
2/02/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Fear of COVID-19, kinesiophobia, number of step, pain, dyspnea and quality of life in individuals with idiopathic scoliosis
Scientific title
Fear of COVID-19, kinesiophobia, number of step, pain, dyspnea and quality of life in individuals with idiopathic scoliosis during the COVID-19 pandemic.
Secondary ID [1] 306314 0
Nil known
Universal Trial Number (UTN)
U1111-1273-7285
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fear of contracting COVID-19 325077 0
Kinesiophobia 325078 0
Low step count 325079 0
Pain perception 325080 0
Dyspnea perception 325081 0
Poor quality of life 325082 0
idiopathic scoliosis 325086 0
Condition category
Condition code
Musculoskeletal 322504 322504 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this study, it was planned to investigate the fear of contracting COVID-19, levels of kinesiophobia, daily number of steps, pain and dyspnea perception, and quality of life in individuals with idiopathic scoliosis. Evaluation of fear of contracting COVID-19, levels of kinesiophobia, daily number of steps, pain and dyspnea perception, and quality of life will be completed within a maximum of one hour at the hospital clinic. Number of steps will be followed-up during 3 days.
Intervention code [1] 322739 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330297 0
The status of quality of life which will be evaluated using Scoliosis Research Society-22 (SRS-22) questionnaire.
Timepoint [1] 330297 0
at survey time
Secondary outcome [1] 405614 0
Fear of contracting COVID-19 which will be evaluated using the Fear of COVID-19 Scale.
Timepoint [1] 405614 0
at survey time
Secondary outcome [2] 405615 0
Presence of kinesiophobia which will be evaluated using Tampa Kinesiophobia Scale.
Timepoint [2] 405615 0
at survey time
Secondary outcome [3] 405616 0
Daily step counts: Daily average step counts during 3 days will be recorded via pedometer applications installed on smartphones. All patients will be asked to carry their smartphones with them during the day and record to their diaries.
Timepoint [3] 405616 0
at survey time, within 3 days after confirming enrolment
Secondary outcome [4] 405617 0
Pain perception which will be evaluated using Numerical Rating Scale
Timepoint [4] 405617 0
At survey time
Secondary outcome [5] 405618 0
Dyspnea perception which will be evaluated using Numerical Rating Scale
Timepoint [5] 405618 0
At survey time

Eligibility
Key inclusion criteria
• Adult individuals aged 18 and over
• Individuals who volunteered to participate in the study
• Individuals diagnosed with idiopathic scoliosis
• Individuals who can walk independently
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals who have undergone scoliosis surgery
• Individuals with mental problems that may affect cooperation
• Individuals with acute or chronic infections that may affect the evaluations to be made within the scope of the study.
• Individuals participating in any professional sporting activity
• Individuals who have undergone any surgery to prevent walking, have chronic illness, physical or mental disability and/or cognitive impairment, orthopedic/neurological/cardiopulmonary disorders
• Individuals who have had COVID-19
• Individuals diagnosed with COVID-19 (Positive Polymerase Chain Reaction (PCR) test results, those with negative PCR test results but compatible with COVID-19 infection with chest X-ray or lung tomography results)
• Individuals with suspected COVID-19
• Pregnant women

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size required for the study was calculated using the Raosoft sample size calculator. Based on the estimated population (98 individuals) and the response distribution of a mean quality of life score of 3.9, the required sample size was found to be at least 58 individuals with a 95% confidence level and a 5% margin of error. At the end of the study, statistical analyzes will be made using the SPSS 15.0 program. By using visual (histogram and probability graphs) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests), the conformity of all variables to normal distribution will be investigated. Descriptive analyzes will be given using frequency (n) and percentage (%) values for categorical variables, median, minimum and maximum values for non-normally distributed variables, mean and standard deviation (×±ss) for normally distributed variables. The Independent Sample t test (Student t test) will be used to compare the variables that fit the normal distribution, the Mann-Whitney U test will be used to compare the data that do not fit, and the Chi-square test will be used to compare the uncountable data. The relationships between the non-normally distributed variables will be determined by Spearman and the relationships between the normally distributed variables will be determined by the Pearson correlation analysis method. The probability of Type I error in statistical analysis will be determined as p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment outside Australia
Country [1] 24531 0
Turkey
State/province [1] 24531 0
Izmir

Funding & Sponsors
Funding source category [1] 310657 0
Hospital
Name [1] 310657 0
Çanakkale Onsekiz Mart Health Practice and Research Hospital, Department of Physical Medicine and Rehabilitation
Country [1] 310657 0
Turkey
Primary sponsor type
Individual
Name
GÜLSAH BARGI
Address
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country
Turkey
Secondary sponsor category [1] 311870 0
Individual
Name [1] 311870 0
Salih BABAOGLU
Address [1] 311870 0
Çanakkale Onsekiz Mart Health Practice and Research Hospital, Department of Physical Medicine and Rehabilitation, Barbaros, Prof. Dr. Sevim Buluç Sokak. Number:2, 17110 Canakkale Center/Canakkale
Country [1] 311870 0
Turkey
Secondary sponsor category [2] 311871 0
Individual
Name [2] 311871 0
Sümeyye Nur ÖZDEN
Address [2] 311871 0
Çanakkale Onsekiz Mart Health Practice and Research Hospital, Department of Physical Medicine and Rehabilitation, Barbaros, Prof. Dr. Sevim Buluç Sokak. Number:2, 17110 Canakkale Center/Canakkale
Country [2] 311871 0
Turkey
Secondary sponsor category [3] 311872 0
Individual
Name [3] 311872 0
Hatice RESORLU
Address [3] 311872 0
Çanakkale Onsekiz Mart Health Practice and Research Hospital, Department of Physical Medicine and Rehabilitation, Barbaros, Prof. Dr. Sevim Buluç Sokak. Number:2, 17110 Canakkale Center/Canakkale
Country [3] 311872 0
Turkey

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310251 0
Izmir Democracy University Non-Interventional Clinical Research of the Ethics Committee
Ethics committee address [1] 310251 0
Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Ethics committee country [1] 310251 0
Turkey
Date submitted for ethics approval [1] 310251 0
14/01/2022
Approval date [1] 310251 0
Ethics approval number [1] 310251 0

Summary
Brief summary
Today, while the negative effects of the COVID-19 pandemic on human health continue to increase, both healthy individuals and individuals with chronic diseases continue to be adversely affected by this process, both psychologically and/or physically, due to the increasing number of cases and the increase in restriction measures. Fear of contracting COVID-19, kinesiophobia, exercise capacity, dyspnea, pain and quality of life, and relationships between these parameters in individuals with scoliosis during the COVID-19 pandemic is still unknown today. Therefore, in our study, we aimed to investigate fear of COVID-19, kinesiophobia, number of steps, pain, dyspnea and quality of life and the relationship between these parameters in individuals with idiopathic scoliosis in the COVID-19 pandemic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117010 0
Dr GÜLSAH BARGI
Address 117010 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 117010 0
Turkey
Phone 117010 0
+905317938766
Fax 117010 0
+90 232 260 1004
Email 117010 0
gulsah.bargi@idu.edu.tr
Contact person for public queries
Name 117011 0
Dr GÜLSAH BARGI
Address 117011 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 117011 0
Turkey
Phone 117011 0
+905317938766
Fax 117011 0
+90 232 260 1004
Email 117011 0
gulsah.bargi@idu.edu.tr
Contact person for scientific queries
Name 117012 0
Dr GÜLSAH BARGI
Address 117012 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 117012 0
Turkey
Phone 117012 0
+905317938766
Fax 117012 0
+90 232 260 1004
Email 117012 0
gulsah.bargi@idu.edu.tr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
I can not share the data of individuals included in the study in our country within the scope of the personal data protection law.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.