Health TrialsbyHealthPanel

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

ConditionChronic Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorHacettepe University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Survey Assessment Battery

    Other intervention

    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)

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Patients with Chronic Pain1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Day 1) and 7-10 days later for the test-retest subgroup.
2

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.

Time frame
Baseline (Day 1)

Secondary outcomes

1

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.

Time frame
Baseline (Day 1)
2

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.

Time frame
Baseline (Day 1)
3

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.

Time frame
Baseline (Day 1)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hacettepe University

Lead sponsor

Bingol University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: