NCT07662993

Brief Summary

The aim of this study was to identify factors associated with cognitive skills in female patients with fibromyalgia.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress17%
May 2026Sep 2027

Study Start

First participant enrolled

May 12, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2027

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dynamic Loewenstein Occupational Therapy Cognitive Assessment (DLOTCA)

    DLOTCA assesses the basic cognitive skills of individuals aged 18-69 years using 28 subtests across 7 cognitive domains (Awareness, Orientation, Spatial Perception, Visual Perception, Visual-Motor Structuring, Application, and Thinking Processes) (13). Each subtest has 3 scoring stages: First stage: Pre-mediation scoring (1 point indicates the worst performance). Second stage: Mediation score (a high score (4 or 5) indicates poor performance). Third stage: Post-mediation scoring (1 point indicates the worst performance).

    At baseline (Day 1)

Secondary Outcomes (7)

  • Fibromyalgia Impact Questionnaire

    At Baseline (Day 1)

  • Pressure Pain Threshold Measurements

    At baseline (Day 1)

  • Cognitive Exercise Therapy Approach Scale

    At baseline (Day 1)

  • Tampa Kinesiophobia Scale

    At Baseline (Day 1)

  • Pain Catastrophizing Scale:

    At baseline (Day 1)

  • +2 more secondary outcomes

Eligibility Criteria

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

At least 41 female fibromyalgia patients aged 18-65 years who are followed by Pamukkale University Rheumatology Clinic, diagnosed according to the 2011 American Rheumatology Association Fibromyalgia classification criteria, and who meet the inclusion criteria will be included in the study.

You may qualify if:

  • Being between 18-65 years of age
  • Being female
  • Having been diagnosed with fibromyalgia for at least 6 months, with the appearance of a range of somatic and cognitive symptoms in addition to widespread pain.

You may not qualify if:

  • Having another illness that affects their physical condition
  • Having cognitive impairment to the extent that they cannot cooperate
  • Being pregnant
  • Impaired Turkish language comprehension or speech
  • Concurrent autoimmune or inflammatory disease
  • Diseases affecting the central nervous system (e.g., multiple sclerosis, Parkinson's disease)
  • Serious psychiatric conditions that prevent participation (e.g., psychotic disorders).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start

May 12, 2026

Primary Completion (Estimated)

August 12, 2027

Study Completion (Estimated)

September 12, 2027

Last Updated

June 23, 2026

Record last verified: 2026-06

Locations