Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05566522 |
| Other study ID # |
2021/1781 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 22, 2021 |
| Est. completion date |
February 22, 2023 |
Study information
| Verified date |
July 2022 |
| Source |
Inonu University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The aim of this study is to comprehensively evaluate the fear of movement in different
diseases. Individuals between the ages of 20-75 will be included in the study. Survey
development phase; It consisted of literature review, qualitative research and the creation
of the draft form. The literature review includes the creation of an item pool through a
detailed examination of the studies on scales assessing kinesiophobia and the questionnaires
used. Scale Postural control, balance, pain, anxiety/depression, 5' likert type orientation
with 28 items consisting of sensory and interaction. 0 strongly disagree, 1: disagree, 2: not
sure, 3: have, 4: have. Each section's own score and total score will be calculated out of
100. TAMPA Kinesiophobia Scale will be used to calculate the convergent validity of the
questionnaire.
Description:
The aim of this study is to comprehensively evaluate the fear of movement in different
diseases. Individuals between the ages of 20-75, those with musculoskeletal, and chronic
diseases, individuals with a Standard Mini-Mental Test Score of 24 above, individuals who
voluntarily agreed to participate in the study, and individuals with informed consent will be
included in the study. Individuals with cardiac and pulmonary problems that may hinder the
study, individuals who do not allow mental assessment, individuals who cannot read and write
in Turkish and who cannot answer the questions will not be included in the study. The
deductive/inductive method will be used to create the survey questions. Survey development
phase; It was composed of literature review, qualitative research, and the creation of the
draft form. The literature review includes the creation of an item pool through a detailed
examination of the studies on scales evaluating kinesiophobia and the questionnaires used.
The draft created as a result of the literature review was sent to the linguist, who
evaluated the subject in terms of meaning and grammar. Then, 10 expert opinions were asked to
rate each question in terms of relevance, clarity, simplicity, and specificity, and were
determined as inappropriate, somewhat appropriate, highly relevant, and very appropriate.
Then, a pilot application will be made to evaluate the face validity of the questionnaire. At
this stage, the pilot study of the scale, which has passed the expert opinion, will be
carried out with a small sample. The scale was created in a 5-point Likert type format with
28 items consisting of Postural control/balance, pain, anxiety/depression, sensory and social
interaction sections. 0 strongly disagree, 1: disagree, 2: not sure, 3: agree, 4: completely
agree. The score of each section and the total score will be calculated out of 100. Then,
criterion-based validity (concurrent validity) method will be used to evaluate the validity
of the questionnaire, and at this stage, individuals will be determined from the relevant
population by non-probabilistic sampling method; Groups will be assigned with the stratified
sampling method. In the other stage, TAMPA Kinesiophobia Scale will be used to determine the
convergent validity of the questionnaire. At the last stage, the reliability of the
questionnaire will be evaluated. Its reliability will be evaluated by the test-retest method.
The scale will be administered on the same subjects at two different times (1-3 days apart)
under the same conditions. In our double-blind randomized study, Inter-observer Consistency
will be tested by using Correlation - Kendall's Coefficient of Concordance to calculate the
agreement between independent observers. The same procedures will be done for the healthy
individuals in the control group. The control group will also be selected from the relevant
population with an improbable random method. The Cronbach Alpha Reliability Coefficient will
be used to evaluate the internal consistency of the study.
