FybromyalgiaNCT03746379
Investigation of the Relationship Between Sensory Processing and Kinesychophobia in Fibromyalgia Patients
An observational study of Fybromyalgia, run by Hacettepe University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fybromyalgia
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2018to 18 Feb 2019
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients with fibromyalgia
Who may be able to join
- 18-65 years old
- Diagnosed by fibromyalgia
- No other known physical, neurological and psychological illness
- Literate
- Volunteers to participate in the study
Who cannot join
- Not compliant with inclusion criteria
About this study
Official title: 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.
Read the 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.
- Conditions
- Fybromyalgia
- Keywords
- kinezyhophobia, sensory processing, fybromyalgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory processing assessed with the Sensory Adolescent / Adult Sensory Profile Questionnaire
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.
Measured: at the end of the third month
Knesychophobia assessed with the Tampa Kineshiophobia Scale
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.
Measured: at the end of the third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start16 Dec 2018 (estimated)
- Primary completion17 Jan 2019 (estimated)
- Study completion18 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FybromyalgiaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgü İNAL, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746379
- Sponsor's protocol ID
- 2018/359
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Sensory Processing and Kinesychophobia in
- ClinicalTrials.gov ID
- NCT03746379
- Acronym / sponsor ID
- 2018/359
- Conditions
- Fybromyalgia
- Keywords
- kinezyhophobia, sensory processing, fybromyalgia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 16 Dec 2018 (estimated)
- Primary completion
- 17 Jan 2019 (estimated)
- Study completion
- 18 Feb 2019 (estimated)
- First posted
- 19 Nov 2018 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with fibromyalgia
Key inclusion criteria (5 listed)
- 18-65 years old
- Diagnosed by fibromyalgia
- No other known physical, neurological and psychological illness
- Literate
- Volunteers to participate in the study
Key exclusion criteria (1 listed)
- Not compliant with inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Fybromyalgia
Enrolling by invitationObservational study
Assessment of Pain Experience in Fibromyalgia
Pain, Fybromyalgia
Not yet recruiting
Interventional Study on the Effects of Forest Therapy in Fibromyalgia Patients
Fybromyalgia, Fibromyalgia (FM)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fybromyalgia, run by Hacettepe University.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Sensory processing assessed with the Sensory Adolescent / Adult Sensory Profile Questionnaire (time frame: at the end of the third month). The study lists 2 primary outcomes in all. 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 19 Nov 2018.