NCT07846501

Brief Summary

This study aims to reveal the effects of pain catastrophizing, psychological resilience, and illness perception on the impact level of fibromyalgia in patients with fibromyalgia, to determine the predictive power of these psychosocial variables regarding the impact level of fibromyalgia, and to evaluate their roles in explaining the burden of the disease.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Sep 2026

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Sep 2027

First Submitted

Initial submission to the registry

September 16, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 16, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 16, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

FibromyalgiaResilience PerceptionPain CatastrophizingIllness Perception

Outcome Measures

Primary Outcomes (5)

  • Visual Analog Scale

    VAS (Visual Analog Scale): A scale consisting of a 10 cm horizontal line marked at equal intervals, with one end representing "no pain" and the other "unbearable pain." The patient is asked to mark the point on the line that best represents the intensity of their pain. This distance, measured in millimeters, is interpreted as a "score." Regarding pain intensity, a score of 0 is rated as "no pain," while a score of 10 is rated as "unbearable, worst possible pain."

    1 days

  • Revised Fibromyalgia Impact Questionnaire

    Revised Fibromyalgia Impact Questionnaire (FIQR): This questionnaire was updated by Bennett et al. in 2009. It consists of 21 separate questions, all rated on a scale of 0 to 10; a score of 10 represents the worst possible state, while 0 indicates the absence of the complaint. The questionnaire comprises three sub-dimensions: "function" (9 questions), "overall impact" (2 questions), and "symptoms" (10 questions). The total score for function (range 0-90) is divided by 3, the total score for overall impact (range 0-20) remains unchanged, and the total score for symptoms (range 0-100) is divided by 2. The total questionnaire score (0-100) is the sum of these values. A higher score indicates a high level of impact from the disease. The recommended cut-off points for disease severity are as follows: 0-23, remission; 24-40, mild disease; 41-63, moderate disease; 64-82, severe disease; and 83-100, very severe disease. The Cronbach's alpha for the FIQR is 0.95, and item-total correlations ra

    1 days

  • The Pain Catastrophizing Scale

    The Pain Catastrophizing Scale is a 13-item self-report scale developed by Sullivan et al. to assess the extent to which individuals tend to catastrophize in response to pain; it utilizes a 5-point Likert-type rating system (scoring 0-4). The original form of the scale comprises three sub-dimensions: helplessness, magnification, and rumination. The internal consistency reliability of the Turkish adaptation of the Pain Catastrophizing Scale was found to be very high, with a Cronbach's alpha coefficient of 0.955. Item-total and inter-item correlation coefficients for the scale were determined to range between 0.488 and 0.848.

    1 days

  • Brief Illness Perception Questionnaire

    Brief Illness Perception Questionnaire: Developed by Broadbent et al. in 2006. This scale comprises 8 items plus an additional item investigating causal factors. With the exception of the ninth item regarding causal factors, the eight items on the scale use a Likert-type scoring system ranging from 0 to 10. The first five items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two items assess emotional illness perceptions: concern (Item 6) and emotions (Item 8). One item evaluates illness coherence (Item 7). Causal representation is assessed via an open-ended question asking patients to list the most important causal factors of their illness (Item 9). Scores on the scale indicate the perceived threat of the illness or the individual's level of ease regarding the condition. When calculating the score, the values for items 3, 4, and 7 are reversed and added to the scores of

    1 days

  • Brief Resilience Scale

    Brief Resilience Scale: This scale was developed by Smith et al. (2008) to measure individuals' psychological resilience. It is a 6-item, self-report instrument using a 5-point Likert scale. Items 2, 4, and 6 are reverse-coded. After reversing the scores for these items, high total scores indicate a high level of psychological resilience. The internal consistency reliability of the Turkish adaptation of the scale was found to be .83.

    1 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with fibromyalgia

You may qualify if:

  • Patients diagnosed with fibromyalgia,
  • Aged 18 years or older,
  • Literate in Turkish,
  • And without communication difficulties.

You may not qualify if:

  • Those with a disease causing cognitive impairment who are unable to answer the survey questions,
  • Those with chronic painful medical conditions other than fibromyalgia (e.g., migraine, diabetic neuropathy, rheumatoid arthritis, etc.),
  • Those diagnosed with neurocognitive, mental, or emotional disorders,
  • Patients with multisystemic diseases such as cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilecik Seyh Edebali University

Bilecik, Bilecik, 11000, 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
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 29, 2026

Study Start

September 16, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 29, 2026

Record last verified: 2026-09

Locations