Chronic PainNCT07846514
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 of Chronic Pain, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 341 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Having chronic pain that has persisted or recurred for at least three months
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bilecik Seyh Edebali University
Bilecik, Bilecik, 11000
Semanur Bilgiç, 05395966328, semanurblgc@gmail.com
About this study
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.
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, pain-related concerns, pain acceptance, pain self-efficacy, well-being among individuals with chronic pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 1 days
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.
Measured: 1 days
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.
Measured: 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.
Measured: 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.
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 341 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semanur Bilgiç, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846514
- Sponsor's protocol ID
- Kronik Ağrılı Bireyler-1
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07846514
- Acronym / sponsor ID
- Kronik Ağrılı Bireyler-1
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, pain-related concerns, pain acceptance, pain self-efficacy, well-being among individuals with chronic pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 341 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Having chronic pain that has persisted or recurred for at least three months
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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").
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Semanur Bilgiç (05395966328, semanurblgc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scales (time frame: 1 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.