NCT Number: NCT07673874
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Observational
Bingol State Hospital, Physical Medicine and Rehabilitation Outpatient Clinic, Bingoel, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Baseline (Day 1) and 7-10 days later for the test-retest subgroup.
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.
Time frame: Baseline (Day 1)
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.
Time frame: Baseline (Day 1)
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.
Time frame: Baseline (Day 1)
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.
Time frame: Baseline (Day 1)
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.
Contact information is provided by the study sponsor or research team.
Hacettepe University
Other
Turkish Cross-Cultural Adaptation, Validity, and Reliability of the "Brief Inventory of Treatment Expectations in Chronic Pain" (BITEC) Scale
Acronym: BITEC-TR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07740681
Chronic Pain, Neurologic Manifestations
View Trial DetailsNCT07696923
Adhesive Capsulitis, Bursitis
Taipei, Taiwan
View Trial DetailsNCT07641504
Back Pain, Chronic Pain
Birmingham, Alabama, United States
View Trial DetailsNCT07717762
Acute Pain, Chronic Pain
Bern, Canton of Bern, Switzerland
View Trial Details