Hemophilic ArthropathyNCT06952322
Kinesiophobia in the Parents of Hemophilia Patients
An observational study of Hemophilic Arthropathy, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemophilic Arthropathy
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study conducted in parents of PwH from South Marmara region and parents of healthy child from Bursa City Hospital.
Who may be able to join
- Parents of PwH and parents of healthy children were included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hemophilic Arthropathy
- Being tested
- Questionnaire and Physical Exam
- Keywords
- Kinesiophobia, hemophilic arthropathy
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
Questionnaire results of groups will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Parents of Children with Hemophilia | Not described Receives: Other: Questionnaire and Physical Exam | |
| Parents of Healthy Children | Not described Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish version of the Tampa Scale of Kinesiophobia (TSK-19)
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Jun 2024
- Primary completion31 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilic ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erkan KAYA, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952322
- Sponsor's protocol ID
- 2025-PMR-2
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request data will be provided by the authors
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophobia in the Parents of Hemophilia Patients
- ClinicalTrials.gov ID
- NCT06952322
- Acronym / sponsor ID
- 2025-PMR-2
- Conditions
- Hemophilic Arthropathy
- Keywords
- Kinesiophobia, hemophilic arthropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents of Children with Hemophilia | – | Other: Questionnaire and Physical Exam |
| Parents of Healthy Children | – | Other: Questionnaire and Physical Exam |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study conducted in parents of PwH from South Marmara region and parents of healthy child from Bursa City Hospital.
Key inclusion criteria (1 listed)
- Parents of PwH and parents of healthy children were included.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamQuestionnaire results of groups will be compared. | Other | Parents of Children with Hemophilia, Parents of Healthy Children |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Undecided. Upon reasonable request data will be provided by the authors
Related trials for Hemophilic Arthropathy
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Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
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Real-World Joint Outcomes After Selective Transition to Low-Dose Emicizumab in Pediatric Hemophilia A
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Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilic Arthropathy, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish version of the Tampa Scale of Kinesiophobia (TSK-19) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.