- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06696274
Kinesiophobia, Pain, Balance, Quality of Life and Mental Status in Hemodialysis Patients
November 22, 2024 updated by: Merve Firat, Kirsehir Ahi Evran Universitesi
Investigation of the Relationship Between Kinesiophobia and Pain, Balance, Quality of Life and Mental Status in Hemodialysis Patients
The aim of our study was to investigate the relationship between kinesiophobia and pain, balance, physical performance, quality of life and mental status in patients receiving hemodialysis.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Merve Firat
- Phone Number: +90 850 441 02 44
- Email: mervefirat@ahievran.edu.tr
Study Locations
-
-
-
Kirsehir, Turkey
- Recruiting
- Kirsehir Ahi Evran University
-
Contact:
- Merve Firat
- Phone Number: +90 850 441 02 44
- Email: mervefirat@ahievran.edu.tr
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with end-stage renal disease receiving hemodialysis will be enrolled in the study.
Description
Inclusion Criteria:
- Patients with end stage renal disease receiving hemodialysis
- Receiving hemodialysis for more than 3 months
- Being clinically stable
- Volunteering to participate in this stud
Exclusion Criteria:
-Having musculoskeletal disorders that may affect physical performance
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 |
|---|
|
Hemodialysis patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia
Time Frame: Day 1
|
It will be evaluated with the Tampa Kinesiophobia scale.The total score ranges from 17-68, with a score above 37 indicating a high degree of kinesiophobia.
|
Day 1
|
|
Pain
Time Frame: Day 1
|
Will be evaluated with a numeric rating scale.
Higher scores indicate worse outcomes.
|
Day 1
|
|
Balance
Time Frame: Day 1
|
It will be assessed with a timed up and go test
|
Day 1
|
|
Physical performance
Time Frame: Day 1
|
It will be evaluated with five-repetition sit-to-stand test
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life
Time Frame: Day 1
|
It will be evaluated with the Short Form-36 Quality of Life scale.The subscales rate health from 0 to 100, with 0 indicating poor health and 100 indicating good health.
|
Day 1
|
|
Mental health
Time Frame: Day 1
|
It will be assessed using the Hospital Anxiety and Depression scale.
The lowest score they can get from both subscales is 0 and the highest score is 21.High scores indicate high levels of anxiety and depression
|
Day 1
|
|
Comorbidity level
Time Frame: Day 1
|
It will be evaluated with the Charlson Comorbidity Index.
Total score is between 0-37.
Higher scores indicate worse outcomes and higher risk of death.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yusuf Topal, Kirsehir Ahi Evran University
- Study Chair: Aydin Guclu, Kirsehir Ahi Evran University
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)
November 18, 2024
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
November 6, 2024
First Submitted That Met QC Criteria
November 18, 2024
First Posted (Actual)
November 20, 2024
Study Record Updates
Last Update Posted (Estimated)
November 25, 2024
Last Update Submitted That Met QC Criteria
November 22, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Phobic Disorders
- Anxiety Disorders
- Kinesiophobia
- Kidney Failure, Chronic
Other Study ID Numbers
- 2024-12/101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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