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

September 22, 2026 updated by: Semanur Bilgiç, Bilecik Seyh Edebali Universitesi

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
341

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: OTHER
  • Time Perspectives: CROSS_SECTIONAL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numerical Rating Scales
Time Frame: 1 days

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
University of Washington Pain-Related Worry Scale
Time Frame: 1 days

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.
1 days
Chronic Pain Acceptance Questionnaire-Short Form
Time Frame: 1 days

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.
1 days
The University of Washington Pain-Related Self-Efficacy Scale-Short Form
Time Frame: 1 days

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
Well-Being in Pain Questionnaire
Time Frame: 1 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bilecik Seyh Edebali Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Kronik Ağrılı Bireyler-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings