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

23 juni 2026 bijgewerkt door: Aybüke Fanuscu, Hacettepe University

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

250

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Turkije (Türkiye)
      • Bingoel, Turkije (Türkiye)
        • Bingöl University Faculty of Physical Therapy and Rehabilitation
        • Contact:
      • Bingoel, Turkije (Türkiye)
        • Bingol State Hospital, Physical Medicine and Rehabilitation Outpatient Clinic
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: 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)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Turkish Brief Inventory of Treatment Expectations in Chronic Pain (BITEC-TR) Score
Tijdsspanne: 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.
Baseline (Day 1) and 7-10 days later for the test-retest subgroup.
11-point Numerical Pain Rating Scale Score
Tijdsspanne: 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.
Baseline (Day 1)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Treatment Expectations in Chronic Pain Scale
Tijdsspanne: 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.
Baseline (Day 1)
Pain Catastrophizing Scale
Tijdsspanne: 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.
Baseline (Day 1)
Hospital Anxiety and Depression Scale Score
Tijdsspanne: 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.
Baseline (Day 1)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hacettepe University

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

31 mei 2027

Studie voltooiing (Geschat)

31 augustus 2027

Studieregistratiedata

Eerst ingediend

23 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2026

Eerst geplaatst (Werkelijk)

29 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

23 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AF-202601

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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