Validation of the Turkish Brief Inventory of Treatment Expectations in Chronic Pain

NCT07673874 | Not Yet Recruiting

• 1 other identifier: AF-202601
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to conduct the Turkish cross-cultural adaptation, validity, and reliability study of the "Brief Inventory of Treatment Expectations in Chronic Pain" (BITEC) scale. Chronic pain is a complex, multidimensional experience that affects a significant portion of the adult population. Treatment expectations play a critical role in predicting clinical outcomes and directly influencing placebo/nocebo responses. While several tools exist to evaluate expectations, there is a lack of a concise, clinician-friendly, and Item Response Theory (IRT)-based instrument adapted for Turkish chronic pain populations. The BITEC is a 9-item scale that evaluates biological, psychological, and social/interactional expectation domains. This methodological and cross-sectional study will be conducted with adult patients diagnosed with chronic pain for at least three months at Bingöl State Hospital. The study will be carried out in four consecutive stages: cross-cultural adaptation (forward and backward translation), comprehensibility pre-testing (with 30-40 volunteers), main data collection (with at least 200 participants), and statistical analyses. Data will be collected through printed forms and an online survey platform (Kobotoolbox), involving no clinical interventions. Participants will complete a sociodemographic information form, the Turkish version of the BITEC (BITEC-TR), the Treatment Expectations in Chronic Pain Scale (TEC-TR), the Pain Catastrophizing Scale (PCS), the Numerical Pain Rating Scale (NPRS), and the Hospital Anxiety and Depression Scale (HADS). Additionally, a subgroup of approximately 60 participants will recomplete the BITEC-TR 7-10 days after the initial session to evaluate test-retest reliability. Psychometric evaluation will include construct validity through exploratory and confirmatory factor analyses, and internal consistency and stability measurements.

Conditions

Chronic Pain

Keywords

treatment expectation; validation study; chronic pain; Cross-Cultural Adaptation

Outcome Measures

Primary Outcomes (2)

• Turkish Brief Inventory of Treatment Expectations in Chronic Pain (BITEC-TR) Score

  The BITEC-TR is a 9-item scale that evaluates biological, psychological, and social/interactional domains of treatment expectations in individuals with chronic pain. Each item is scored on a 4-point category scale (Never, Sometimes, Almost Always, Always). Total scores reflect the patient's level of treatment expectations, with higher scores or specific classification levels indicating higher expectations. It will be used to assess the scale's construct validity, internal consistency, and test-retest reliability.

  Baseline (Day 1) and 7-10 days later for the test-retest subgroup.

• 11-point Numerical Pain Rating Scale Score

  An 11-point segment scale (0 to 10) used to measure average pain intensity over the last week. '0' represents no pain, and '10' represents unbearable pain. It will be used to evaluate the convergent validity of the BITEC-TR.

  Baseline (Day 1)

Secondary Outcomes (3)

• Treatment Expectations in Chronic Pain Scale

  Baseline (Day 1)

• Pain Catastrophizing Scale

  Baseline (Day 1)

• Hospital Anxiety and Depression Scale Score

  Baseline (Day 1)

Study Arms (1)

Patients with Chronic Pain

Adult patients aged 18-70 who have been experiencing non-cancer chronic pain for at least three months, are literate, and are currently receiving medical treatment. Data will be collected through printed forms or the online survey platform Kobotoolbox.

Other: Survey Assessment Battery

Interventions

Survey Assessment Battery OTHER

Participants will complete a comprehensive survey battery including: Sociodemographic and Clinical Information Form Turkish Brief Inventory of Treatment Expectations in Chronic Pain (BITEC-TR) Treatment Expectations in Chronic Pain Scale Pain Catastrophizing Scale (PCS) Numerical Pain Rating Scale (NPRS) Hospital Anxiety and Depression Scale (HADS)

Patients with Chronic Pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients who have been diagnosed with any type of non-cancer chronic pain condition (such as fibromyalgia, nociceptive pain, neuropathic pain, osteoarthritis, rheumatoid arthritis, or chronic headache/migraine) for at least three months, are literate, and are currently undergoing medical treatment. The sample will be recruited from patients admitting to the Physical Medicine and Rehabilitation Outpatient Clinic at Bingöl State Hospital. Data will be collected through both printed forms in the clinical setting and an online survey platform (Kobotoolbox), ensuring representation of both outpatient clinic attendees and accessible chronic pain patient groups.

You may qualify if:

• Aged 18-70 years
• Having chronic pain for at least 3 months according to the International Association for the Study of Pain (IASP) criteria
• Diagnosed with any chronic pain condition (e.g., fibromyalgia, nociceptive pain, neuropathic pain, etc.)
• Being literate
• Currently receiving any medical treatment

You may not qualify if:

• Presence of cancer-related pain
• Diagnosis of acute pain
• Being unable to fill out the questionnaire due to a diagnosed cognitive impairment or psychiatric illness
• Presence of visual or motor disabilities that prevent completing the questionnaire

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (2)

Bingol State Hospital, Physical Medicine and Rehabilitation Outpatient Clinic

Bingoel, Turkey (Türkiye)

Location

Bingol University Faculty of Physical Therapy and Rehabilitation

Bingoel, Turkey (Türkiye)

Location

Related Publications (2)

• Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

  PMID: 15804318 BACKGROUND

• Caumo W, Franca BR, Ehlers J, de Jezus Castro SM, Borges RB, Hirakata VN, Bueno GB, da Torres IL, Fregni F. Development and Validation of the Brief Inventory of Treatment Expectations in Chronic Pain (BITEC). Eur J Pain. 2026 Feb;30(2):e70211. doi: 10.1002/ejp.70211.

  PMID: 41612668 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aybüke Fanuscu

CONTACT

+9004262160012-5548; afanuscu@bingol.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)