Physiotherapy PatientsNCT05926479
Validation And Turkish Cross-Cultural Adaptation of Treatment Expectation Questionnaire (TEX-Q) Tool
An observational study of Physiotherapy Patients, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
The general treatment expectations of patients play a significant role in determining the outcomes of the different treatments they undergo. When it comes to physiotherapy programs, these expectations act as non-specific treatment components, capable of triggering subjective psychological changes and eliciting… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Physiotherapy Patients
- What is being tested?
- Translating the Questionnaire into Turkish and Related Processes, Validity and Reliability
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Individuals who apply to physiotherapy clinic and will receive treatment for any indication
Who may be able to join
- ages between 18-65
- who would receive physiotherapy for at least 2 weeks for any indication
Who cannot join
- insufficient level of Turkish
- having any mental problems that would prevent participation in the study
- receiving another applied treatment other than the physiotherapy program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Bilgi University
Istanbul, Beyoglu, 34340
About this study
The general treatment expectations of patients play a significant role in determining the outcomes of the different treatments they undergo. When it comes to physiotherapy programs, these expectations act as non-specific treatment components, capable of triggering subjective psychological changes and eliciting mechanisms that resemble placebo effects. When theory-based, multidimensional measurement tools that evaluate patients' expectations from various treatments are examined, the Treatment Expectation Questionnaire (TEX-Q) questionnaire stands out. The aim of this study is to ensure the validity and reliability of the Turkish version of this form, which can be answered by every patient receiving various treatments, as an objective alternative and to be included among other treatment expectancy measurement tools.
Read the detailed description
This study includes the translation of the form after obtaining the relevant permissions, examining the internal consistency of the Turkish version, explanatory and confirmatory factor analysis, convergent validity and test-retest reliability processes.
The Turkish version of TEX-Q was applied to 200 patients who applied to the clinic for physiotherapy in the examination of internal consistency and exploratory factor analysis of the questionnaire. For convergent validity, 46 independent participants answered the Turkish version of the TEX-Q, the Positivity Scale, and the Hospital Anxiety and Depression Scale. The test-retest reliability within a 2-weeks interval was analysed in 63 of patients seeking physiotherapy program.
- Conditions
- Physiotherapy Patients
- Being tested
- Translating the Questionnaire into Turkish and Related Processes, Validity, Reliability
- Keywords
- patient, expectation, validity, reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translating the Questionnaire into Turkish and Related ProcessesOther
The first step is the translation from the original language to the other language. The ideal target in the translation phase is to use people who are familiar with the structure of the original language and who are familiar with the language. Two forward translation and one reverse translation methods will be applied after obtaining the written permission of the authors. After the completion of this phase, the terminological differences arising from the translators in the translation process from the original language to Turkish will be collected and discussed on the questions. The cultural adaptation study will be terminated by determining the equivalence between the Turkish version of the index and the English original. The final version of the questionnaire and the necessary changes will be arranged specific to the investigator's society and the authors of the original questionnaire will be consulted and the questionnaire will be finalized.
ValidityOther
The scale will be applied by face-to-face technique and convergent (moderate-high correlation with optimism measure) and distant (low correlation with depression and anxiety measures) validity will be evaluated.
ReliabilityOther
The reliability of the materials will be tested with Cronbach alpha.
| Study group | Role | What they receive |
|---|---|---|
| physiotherapy patient | Not described Receives: Other: Translating the Questionnaire into Turkish and Related Processes; Other: Validity; Other: Reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Expectancy Questionnaire
It is a 21-item questionnaire, originally called the Treatment Expectation Questionnaire, developed by Alberts et al. in 2020, in which treatment expectations for different treatments can be measured in general and comparatively. The participant is asked to mark the number between 0 and 10 that he thinks corresponds to the appropriate value for him. Treatment benefit (items 1-3), positive effect (items 4-6), adverse effects (items 7-9), negative effect (items 10-11), treatment improvement (items 12-13), and behavioral control (items 14). -15) subheadings. Items 7-11 are reverse coded. There are 6 additional items of previous treatment experience. The total score of the questionnaire for the first 15 items is 150.
Measured: Baseline
Secondary outcomes (2)
Positivity Scale
Positivity Scale, directly evaluate the positivity levels of individuals. The original form of the instrument has a five-degree likert-type assessment. The Positivity Scale consists of eight items, one of which is reversed (item 6).
Measured: Baseline
Hospital Anxiety and DepressionScale
The aim of the scale is to determine the severity and severity of the patient by determining the patient's susceptibility to anxiety and depression. The test has a total of 14 questions. Seven of these questions measure anxiety (odd numbers) and the remaining seven measure depression (even numbers). The cut-off points were 10 for anxiety and 7 for depression. Accordingly, those above this score are considered at risk.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start21 Jun 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiotherapy PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Çakır, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926479
- Sponsor's protocol ID
- IstanbulBUFC
- Status last verified
- Sep 2023
- First submitted
- 21 Jun 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation And Turkish Cross-Cultural Adaptation of Treatment Expectation Questionnaire (TEX-Q) Tool
- ClinicalTrials.gov ID
- NCT05926479
- Acronym / sponsor ID
- IstanbulBUFC
- Conditions
- Physiotherapy Patients
- Keywords
- patient, expectation, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general treatment expectations of patients play a significant role in determining the outcomes of the different treatments they undergo. When it comes to physiotherapy programs, these expectations act as non-specific treatment components, capable of triggering subjective psychological changes and eliciting mechanisms that resemble placebo effects. When theory-based, multidimensional measurement tools that evaluate patients' expectations from various treatments are examined, the Treatment Expectation Questionnaire (TEX-Q) questionnaire stands out. The aim of this study is to ensure the validity and reliability of the Turkish version of this form, which can be answered by every patient receiving various treatments, as an objective alternative and to be included among other treatment expectancy measurement tools.
Detailed description
This study includes the translation of the form after obtaining the relevant permissions, examining the internal consistency of the Turkish version, explanatory and confirmatory factor analysis, convergent validity and test-retest reliability processes.
The Turkish version of TEX-Q was applied to 200 patients who applied to the clinic for physiotherapy in the examination of internal consistency and exploratory factor analysis of the questionnaire. For convergent validity, 46 independent participants answered the Turkish version of the TEX-Q, the Positivity Scale, and the Hospital Anxiety and Depression Scale. The test-retest reliability within a 2-weeks interval was analysed in 63 of patients seeking physiotherapy program.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| physiotherapy patient | – | Other: Translating the Questionnaire into Turkish and Related Processes, Other: Validity, Other: Reliability |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals who apply to physiotherapy clinic and will receive treatment for any indication
Key inclusion criteria (2 listed)
- ages between 18-65
- who would receive physiotherapy for at least 2 weeks for any indication
Key exclusion criteria (3 listed)
- insufficient level of Turkish
- having any mental problems that would prevent participation in the study
- receiving another applied treatment other than the physiotherapy program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translating the Questionnaire into Turkish and Related ProcessesThe first step is the translation from the original language to the other language. The ideal target in the translation phase is to use people who are familiar with the structure of the original language and who are familiar with the language. Two forward translation and one reverse translation methods will be applied after obtaining the written permission of the authors. After the completion of this phase, the terminological differences arising from the translators in the translation process from the original language to Turkish will be collected and discussed on the questions. The cultural adaptation study will be terminated by determining the equivalence between the Turkish version of the index and the English original. The final version of the questionnaire and the necessary changes will be arranged specific to the investigator's society and the authors of the original questionnaire will be consulted and the questionnaire will be finalized. | Other | physiotherapy patient |
| ValidityThe scale will be applied by face-to-face technique and convergent (moderate-high correlation with optimism measure) and distant (low correlation with depression and anxiety measures) validity will be evaluated. | Other | physiotherapy patient |
| ReliabilityThe reliability of the materials will be tested with Cronbach alpha. | Other | physiotherapy patient |
Primary outcome
Treatment Expectancy Questionnaire
Time frame: Baseline
It is a 21-item questionnaire, originally called the Treatment Expectation Questionnaire, developed by Alberts et al. in 2020, in which treatment expectations for different treatments can be measured in general and comparatively. The participant is asked to mark the number between 0 and 10 that he thinks corresponds to the appropriate value for him. Treatment benefit (items 1-3), positive effect (items 4-6), adverse effects (items 7-9), negative effect (items 10-11), treatment improvement (items 12-13), and behavioral control (items 14). -15) subheadings. Items 7-11 are reverse coded. There are 6 additional items of previous treatment experience. The total score of the questionnaire for the first 15 items is 150.
2 secondary outcomes
Positivity Scale
Time frame: Baseline
Hospital Anxiety and DepressionScale
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physiotherapy Patients, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Expectancy Questionnaire (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.