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Not yet recruitingNCT07846514Updated Sep 29, 2026

The Serial Mediating Roles of Pain Acceptance and Pain Self-Efficacy in the Relationship Between Concerns About Pain and Well-Being in Pain Among Individuals With Chronic Pain: A Structural Equation Modeling Study

An observational study in Chronic Pain, sponsored by Bilecik Seyh Edebali Universitesi. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Bilecik Seyh Edebali Universitesi · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
341
Ages
18 Years and older
Sex
All
01

Study summary

This study is a cross-sectional, correlational, and analytical study designed to examine the serial mediating roles of pain acceptance and pain self-efficacy in the relationship between pain-related concerns 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.

Read the detailed description

It is evident that the experience of chronic pain is not limited to pain intensity alone but is also significantly influenced by an individual's cognitive, emotional, and behavioral responses to pain. In this context, it is important to clarify how pain-related concerns affect an individual's well-being and to identify the mechanisms through which protective psychological processes play a role in this relationship. Accordingly, the aim of this planned study is to examine-using structural equation modeling-the serial mediating roles of pain acceptance and pain self-efficacy in the relationship between pain-related concerns and pain-specific well-being among individuals with chronic pain.

02

Conditions studied

  • Chronic Pain

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Keywords

  • Chronic Pain
  • pain-related concerns
  • pain acceptance
  • pain self-efficacy
  • well-being among individuals with chronic pain
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
341 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. 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").

    Time frame: 1 days

  2. University of Washington Pain-Related Worry Scale

    University of Washington Pain-Related Worry Scale: This scale was developed to assess individuals' pain-related worries and their levels of pain catastrophizing. The scale consists of a total of 6 items. The items inquire about the individual's thoughts regarding pain over the past seven days and are rated using a five-point Likert-type scale with the options: "Never" (1 point), "Rarely" (2 points), "Occasionally" (3 points), "Often" (4 points), and "Always" (5 points). Total scores on the scale range from 6 to 30. There are no reverse-scored items or established cut-off points for the scale. A higher total score indicates increased pain-related worry and a higher level of pain catastrophizing. When necessary, the raw total score can be converted to a T-score using the scale's conversion table. In the study regarding the Turkish validity and reliability of the scale, the Cronbach's alpha value was reported as 0.85.

    Time frame: 1 days

  3. Chronic Pain Acceptance Questionnaire-Short Form

    Chronic Pain Acceptance Questionnaire-Short Form: The scale assesses an individual's level of acceptance regarding the pain experience and their ability to maintain daily life in the presence of pain, shifting away from the constant struggle to control or eliminate it. The scale consists of 8 items and encompasses the dimensions of activity engagement and pain willingness/acceptance. The Turkish validity and reliability study of the scale was conducted by Zure et al. in 2022. Cronbach's alpha values for the scale were found to be 0.76 and 0.80, respectively. The scale utilizes a six-point Likert-type format, with scores ranging from 0 to 48. Higher scores indicate that the patient has a greater acceptance of the pain and copes with it more effectively.

    Time frame: 1 days

  4. 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.

    Time frame: 1 days

  5. 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.

    Time frame: 1 days

06

Study locations

1 site
  • Bilecik Seyh Edebali University
    Bilecik, Bilecik 11000, Turkey (Türkiye)
07

Registry details

Key details

Study ID
NCT07846514
Lead sponsor
Bilecik Seyh Edebali Universitesi
Responsible party
Semanur Bilgiç (Research Assistant, Bilecik Seyh Edebali Universitesi) — Principal investigator
First posted
Sep 29, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Semanur Bilgiç
Contact
semanurblgc@gmail.com
05395966328

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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