- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746379
Investigation of the Relationship Between Sensory Processing and Kinesychophobia in Fibromyalgia Patients
November 16, 2018 updated by: Özgü İNAL, Hacettepe University
Investigation of the Relationship Between Sensory Processing and Kinesychophobia in
Fibromyalgia; is a chronic and rheumatic condition characterized by diffuse pain.
In patients with fibromyalgia syndrome, there is an increase in psychiatric symptoms, especially depression, anxiety, and somatoform disorders.
Kinesophobia is defined as anxiety against pain and pain caused by painful injury and re-injury.
The aim of this study was to investigate the relationship between kinesophobia and sensory processing in patients with fibromyalgia.
Study Overview
Status
Unknown
Conditions
Detailed Description
Fibromyalgia; is a chronic and rheumatic condition characterized by diffuse pain.
In patients with fibromyalgia syndrome, there is an increase in psychiatric symptoms, especially depression, anxiety, and somatoform disorders.
Kinesophobia is defined as anxiety against pain and pain caused by painful injury and re-injury.
The aim of this study was to investigate the relationship between kinesophobia and sensory processing in patients with fibromyalgia.
Study Type
Observational
Enrollment (Anticipated)
82
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with fibromyalgia
Description
Inclusion Criteria:
- 18-65 years old
- Diagnosed by fibromyalgia
- No other known physical, neurological and psychological illness
- Literate
- Volunteers to participate in the study
Exclusion Criteria:
- Not compliant with inclusion criteria
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
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory processing assessed with the Sensory Adolescent / Adult Sensory Profile Questionnaire
Time Frame: at the end of the third month
|
Sensory processing disorder refers to the difficulty of processing the information coming from the sensory organs, and the inefficiency of the normal sensory processing process.For the evaluation of sensory processing; Sensory Adolescent / Adult Sensory Profile questionnaire will be used.
|
at the end of the third month
|
Knesychophobia assessed with the Tampa Kineshiophobia Scale
Time Frame: at the end of the third month
|
Kinezyophobia is defined as anxiety against pain and pain caused by painful injury and re-injury.
For the evaluation of kinesiophobia; Tampa Kineshiophobia Scale will be used.
|
at the end of the third month
|
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 (Anticipated)
December 16, 2018
Primary Completion (Anticipated)
January 17, 2019
Study Completion (Anticipated)
February 18, 2019
Study Registration Dates
First Submitted
November 15, 2018
First Submitted That Met QC Criteria
November 16, 2018
First Posted (Actual)
November 19, 2018
Study Record Updates
Last Update Posted (Actual)
November 19, 2018
Last Update Submitted That Met QC Criteria
November 16, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018/359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.