NCT07846540

Brief Summary

This study is a cross-sectional, correlational, and analytical study designed to examine the parallel mediating roles of pain resilience and pain self-efficacy in the relationship between self-critical rumination and pain-specific well-being in individuals with chronic pain. Structural equation modeling will be used to simultaneously evaluate the direct and indirect relationships between the variables.

Trial Health

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Trial Health Score

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Enrollment
451

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

8 months

First QC Date

September 16, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

Pain ResiliencePain Self-EfficacySelf-Critical RuminationPain-Specific Well-BeingChronic PainStructural Equation Modeling Study

Outcome Measures

Primary Outcomes (5)

  • Numerical Rating Scales

    Numerical Rating Scales (NRS): In alignment with the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11), participants' pain intensity over the past week, the impact of pain on daily activities, and the level of pain-related distress will be assessed separately using 0-10 numerical rating scales. Pain intensity will be rated from 0 ("no pain") to 10 ("worst pain imaginable"); the impact of pain on daily life from 0 ("no impact") to 10 ("completely prevents my activities"); and pain-related distress from 0 ("no distress") to 10 ("extreme distress").

    1 days

  • The University of Washington Pain-Related Self-Efficacy Scale-Short Form

    The University of Washington Pain-Related Self-Efficacy Scale-Short Form is a 6-item scale developed to assess patients' perceptions regarding their self-efficacy-or confidence-in performing daily, social, and personal activities despite pain. Each item is rated on a 5-point Likert-type scale ranging from 1 ("not at all confident") to 5 ("completely confident"). Total scores on the scale range from 6 to 30, with higher scores indicating a higher level of pain-related self-efficacy. The Cronbach's alpha value was reported as 0.87 in the study regarding the Turkish validity and reliability of the scale.

    1 days

  • Self-Critical Rumination Scale

    Self-Critical Rumination Scale: Developed by Smart et al. (2016) to assess ruminative processes associated with self-critical thoughts, this scale consists of 10 items. Respondents rate how well the statements describe them using a 4-point Likert-type scale (1 = does not describe at all, 2 = describes very little, 3 = describes moderately, 4 = describes very well). In the original study examining its psychometric properties, the scale's internal consistency coefficient was found to be .92, and it was determined to have a single-factor structure. It was also reported that the scale shows high correlations with constructs related to both self-criticism and rumination. In the study regarding the Turkish validity and reliability of the scale, the Cronbach's alpha value was reported as 0.89.

    1 days

  • Pain Resilience Scale

    Pain Resilience Scale: This is a 14-item scale that assesses the cognitive, emotional, and behavioral responses individuals exhibit when facing intense or prolonged pain. The scale comprises two sub-dimensions: behavioral persistence (items 1-5) and a positive cognitive-emotional approach (items 6-14). Items are scored on a scale ranging from 0 ("never") to 4 ("always"). In the Turkish version of the PRS, only items 8, 11, and 12 are reverse-scored; for these items, the scoring is reversed from 4 ("always") to 0 ("never"). A high total score on the scale indicates a high level of pain resilience. The Cronbach's alpha value was reported as 0.920 in the study establishing the scale's validity and reliability in Turkish.

    1 days

  • Well-Being in Pain Questionnaire

    This scale was developed to assess well-being in the presence of pain among individuals with chronic pain, as well as the psychological, social, and lifestyle-related characteristics that support such well-being. The scale consists of a total of 11 items rated on a 5-point Likert scale ranging from 0 ("never") to 4 ("almost always"). The total score is calculated by summing the responses to all items and ranges from 0 to 44. Higher scores indicate a higher level of pain-related well-being; a score of 0 represents the minimum level, while a score of 44 represents the maximum level of pain-related well-being. In the study regarding the Turkish validity and reliability of the scale, the Cronbach's alpha value was reported as 0.713.

    1 days

Eligibility Criteria

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

Having chronic pain that has persisted or recurred for at least three months

You may qualify if:

  • Individuals aged 18 years and older,
  • Having chronic pain that has persisted or recurred for at least three months,
  • Being followed up for chronic pain at the Physical Therapy and Rehabilitation Outpatient Clinic,
  • Able to read and understand Turkish and communicate at a level sufficient to complete data collection forms,
  • And agreeing to participate in the research voluntarily will be included.

You may not qualify if:

  • Individuals with pain lasting less than three months or experiencing only acute pain,
  • Individuals with cancer-related pain,
  • Individuals in the palliative or terminal stage,
  • Individuals who have undergone major surgery within the last three months and still experience acute/postoperative pain related to the surgery,
  • Individuals with cognitive or communication impairments that would prevent them from understanding the research questions and independently responding to the data collection instruments will be excluded.

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

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Semanur Bilgiç

CONTACT

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 (Estimated)

October 31, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 29, 2026

Record last verified: 2026-09

Locations