NCT06952322

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

April 18, 2025

Last Update Submit

April 28, 2025

Conditions

Keywords

Kinesiophobiahemophilic arthropathy

Outcome Measures

Primary Outcomes (1)

  • 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).

    Day 1

Study Arms (2)

Parents of Children with Hemophilia

Other: Questionnaire and Physical Exam

Parents of Healthy Children

Other: Questionnaire and Physical Exam

Interventions

Questionnaire results of groups will be compared.

Parents of Children with HemophiliaParents of Healthy Children

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study conducted in parents of PwH from South Marmara region and parents of healthy child from Bursa City Hospital.

You may qualify if:

  • Parents of PwH and parents of healthy children were included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Physical Medicine and Rehabilitation Clinic

Study Record Dates

First Submitted

April 18, 2025

First Posted

April 30, 2025

Study Start

June 1, 2024

Primary Completion

December 31, 2024

Study Completion

February 1, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations