- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06952322
Kinesiophobia in the Parents of Hemophilia Patients
April 28, 2025 updated by: Erkan KAYA, Bursa City Hospital
Recurrent joint bleedings lead to the development of a debilitating arthropathy in the patients with hemophilia (PwH).
This hemophilic arthropathy (HA) is characterized by chronic pain, periarticular atrophy and a limited range of motion.
HA affects the perceived quality of life in the PwH.
This painful situation can lead to catastrophizing thoughts that movement and physical activity will result in further pain and injury, when that painful situation is perceived as threatening.
One component of this fear-model includes fear of movement, or kinesiophobia (KP).
KP is defined as an irrational and disadvantaging fear of physical movement and activity resulting from feeling vulnerable to painful injury or reinjury.
Patients with KP develop the belief that movements will lead to re-injury and pain.
Over time, this leads to decreased physical activity, avoidance of daily tasks, functional decline, reluctance to use extremities, and in advanced stages, may result in depression and reduced quality of life.
Although factors associated with KP have been examined in various diseases groups such as chronic low back pain, fibromyalgia, osteoarthritis, migraine, coronary artery disease and rheumatoid arthritis, there is limited research on KP and its predictors in PwH.
To the best of our knowledge there is still no any research about effects of HA to the PwH parents' behavior differences especially regarding to KP.
This study aimed to find out whether there is KP or not in the parents of patients with HA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
61
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bursa, Turkey
- Bursa City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Study conducted in parents of PwH from South Marmara region and parents of healthy child from Bursa City Hospital.
Description
Inclusion Criteria:
Parents of PwH and parents of healthy children were included.
Exclusion Criterias:
- Parents who failed to complete evaluation instruments
- Difficulty in understanding and writing the psychosocial evaluation questionnaires themselves
- Parents whose child has another health problem
- Parents who failed to sign the Informed Consent Document
exluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Parents of Children with Hemophilia
|
Questionnaire results of groups will be compared.
|
|
Parents of Healthy Children
|
Questionnaire results of groups will be compared.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Turkish version of the Tampa Scale of Kinesiophobia (TSK-19)
Time Frame: Day 1
|
This self-administered measuring instrument consists of 19 items with a 4-point Likert scale.
The score range is 11-44(a higher score indicates a greater fear of re-injury from movement).
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2024
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
February 1, 2025
Study Registration Dates
First Submitted
April 18, 2025
First Submitted That Met QC Criteria
April 28, 2025
First Posted (Actual)
April 30, 2025
Study Record Updates
Last Update Posted (Actual)
April 30, 2025
Last Update Submitted That Met QC Criteria
April 28, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-PMR-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Upon reasonable request data will be provided by the authors
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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