Validation of the Turkish Brief Inventory of Treatment Expectations in Chronic Pain (BITEC-TR)

Turkish Cross-Cultural Adaptation, Validity, and Reliability of the "Brief Inventory of Treatment Expectations in Chronic Pain" (BITEC) Scale

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Survey Assessment Battery

Detailed Description

This study is a methodological and cross-sectional research project aimed at the cultural adaptation and psychometric evaluation of the Brief Inventory of Treatment Expectations in Chronic Pain (BITEC) into Turkish. The study will be conducted at Bingöl University Faculty of Physical Therapy and Rehabilitation and Bingöl State Hospital Physical Medicine and Rehabilitation Outpatient Clinic. Data collection involves no clinical interventions and will be carried out using printed forms and an online survey platform (Kobotoolbox).

Procedure and Stages

The research will be executed in four consecutive stages:

Stage 1 - Cross-Cultural Adaptation: The BITEC will be adapted into Turkish following the ISPOR guidelines. Two independent native Turkish translators (one health professional, one linguist) will perform the forward translation. An expert panel will synthesize these translations into a consensus version. A native English speaker fluent in Turkish and blind to the original scale will perform the backward translation. The back-translated version will be compared with the original scale to eliminate semantic discrepancies.

Stage 2 - Comprehensibility Pre-testing: The provisional Turkish version will be administered to 30-40 volunteers diagnosed with chronic pain. Items will be rated on a scale from 0 (not comprehensible at all) to 10 (completely comprehensible). Items with a mean score below 8 will be revised.

Stage 3 - Main Data Collection: Eligible participants will be recruited to reach a target sample size of 200 to 250 individuals. Participants will complete a battery of assessments, including a sociodemographic and clinical information form, the 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). For test-retest reliability, a subgroup of approximately 60 participants whose clinical status and treatment remain unchanged will recomplete the BITEC-TR 7-10 days after the initial assessment.

Stage 4 - Statistical Analysis: Data analysis will be performed using SPSS software (v.25). Normality will be assessed via the Shapiro-Wilk test. Construct validity will be examined using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), reporting model fit indices such as CFI, NFI, RMSEA, and chi-square/df. Internal consistency will be evaluated using Cronbach's alpha, and test-retest reliability will be measured using the intra-class correlation coefficient (ICC). Measurement error will be calculated using the standard error of measurement (SEM) and minimal detectable change (MDC 95). Convergent, discriminant, and known-groups validities will be analyzed using Spearman correlation analyses based on pre-established hypotheses registered on the Open Science Framework (OSF). Ceiling and floor effects will also be evaluated.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Aybüke Fanuscu; Phone Number: +9004262160012-5548; Email: afanuscu@bingol.edu.tr

Study Locations

• Turkey (Türkiye)
  • Bingoel, Turkey (Türkiye)
    • Bingol University Faculty of Physical Therapy and Rehabilitation
    • Contact: Aybüke Fanuscu; Phone Number: +904262160012-5548; Email: afanuscu@bingol.edu.tr
  • Bingoel, Turkey (Türkiye)
    • Bingol State Hospital, Physical Medicine and Rehabilitation Outpatient Clinic
    • Contact: Mehmet Gök, MD; Phone Number: +904262142217; Email: mgok19866@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Expectations in Chronic Pain Scale	An 18-item scale consisting of two subscales (ideal expectations and predicted expectations) used to assess pain treatment expectations. Each item is rated on a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). Total scores range from 18 to 90, with higher scores indicating higher expectations. It will be used to evaluate the convergent validity of the BITEC-TR.	Baseline (Day 1)
Pain Catastrophizing Scale	A 13-item scale used to evaluate catastrophic thoughts and feelings related to pain across three subscales: rumination, magnification, and helplessness. Items are scored from 0 (not at all) to 4 (all the time), with a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing. It will be used to evaluate the convergent validity of the BITEC-TR.	Baseline (Day 1)
Hospital Anxiety and Depression Scale Score	A 14-item scale assessing anxiety (7 items) and depression (7 items) symptoms. Items are scored from 0 to 3, with subscale scores ranging from 0 to 21. Higher scores indicate higher levels of anxiety or depression. It will be used to evaluate the discriminant validity of the BITEC-TR.	Baseline (Day 1)

Collaborators and Investigators

• Sponsor: Hacettepe University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; validation study; treatment expectation; Cross-Cultural Adaptation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: AF-202601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: o ensure participant privacy and data confidentiality in accordance with national data protection laws (KVKK) and the approved ethical committee protocol, individual participant data will not be shared with third parties.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No