NCT03746379

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

December 16, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2019

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

1 month

First QC Date

November 15, 2018

Last Update Submit

November 16, 2018

Conditions

Fybromyalgia

Keywords

kinezyhophobiasensory processingfybromyalgia

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    at the end of the third month

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with fibromyalgia

You may qualify if:

  • years old
  • Diagnosed by fibromyalgia
  • No other known physical, neurological and psychological illness
  • Literate
  • Volunteers to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 19, 2018

Study Start

December 16, 2018

Primary Completion

January 17, 2019

Study Completion

February 18, 2019

Last Updated

November 19, 2018

Record last verified: 2018-11