Musculoskeletal DisorderNCT04222036
Validity and Reliability of the Expectation Scale in the Treatment of Chronic Pain
An observational study of Musculoskeletal Disorder and Chronic Pain, run by Baskent University at 2 sites in Turkey (Türkiye).
Trial summary
Questionnaires are available to measure expectations based on patient and treatment expectations in musculoskeletal disorders. In order to elucidate the factors that change expectations in the treatment of pain, more valid and reliable measurement tools are needed to measure the expectations of patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Disorder, Chronic Pain
- What is being tested?
- Translating the Questionnaire into Turkish and Related Processes, Validity and Reliability
- How many people
- 198 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Oct 2020to 10 Mar 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who apply to Baskent University Ankara Hospital Physical Medicine and Rehabilitation Department and will receive treatment due to chronic musculoskeletal diseases.
Who may be able to join
- Patients with pain due to chronic musculoskeletal disorders,
- native speakers of Turkish, those over the age of 18 and under 65 a
Who cannot join
- illiterate individuals
- Individuals with neurological disease and no pain problems
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Active, not recruiting
Baskent University
Ankara, 06790
- Recruiting
Baskent University
Ankara, 06810
aydan AYTAR, 05071535028, aytara@baskent.edu.tr
About this study
Official title: Turkish Validity and Reliability of the Expectation Scale in the Treatment of Chronic Pain
Questionnaires are available to measure expectations based on patient and treatment expectations in musculoskeletal disorders. In order to elucidate the factors that change expectations in the treatment of pain, more valid and reliable measurement tools are needed to measure the expectations of patients. The validity and reliability made in Turkey, there is no comprehensive study that measures the expectations of treatment. Therefore, the aim of this study was to test the Turkish validity and characteristics of the Chronic Pain Expectations Scale in patients with pain due to chronic musculoskeletal disorders.
Read the detailed description
Considering the multidimensionality of pain experience, multidisciplinary approaches are accepted as gold standards in the treatment of pain . Pharmacological and non-pharmacological interventions, therapeutic therapies and treatment beliefs are generally considered to be key to these approaches. However, clinically significant pain treatment responses have not yet been clearly defined . Research suggests that their expectations may be one of the key components in the treatment of pain.
Expectation refers to the complex interplay of thoughts, values, and beliefs that are composed of past experiences and represent an assessment of expected outcomes specific to a situation. Four types of expectations have been proposed: ideal (desires and outcome preferences), predicted (expected outcome), normative (what one thinks should be) and unformed (not explicitly expressed). Numerous studies have demonstrated the importance of expectations in pain experience. Expecting pain reduction is usually associated with decreased pain intensity and improved treatment outcomes. In contrast, expecting increased pain is associated with increased pain. Complex and severe expectations may also affect treatment response. A person's level of participation in the treatment plan can be greatly influenced by expectations. Waiting for the full recovery of chronic pain as a result of treatment may pose an obstacle to functioning and quality of life.
Questionnaires are available to measure expectations based on patient and treatment expectations in musculoskeletal disorders. In order to elucidate the factors that change expectations in the treatment of pain, more valid and reliable measurement tools are needed to measure the expectations of patients. The validity and reliability made in Turkey, there is no comprehensive study that measures the expectations of treatment. Therefore, the aim of this study was to test the Turkish validity and characteristics of the Chronic Pain Expectations Scale in patients with pain due to chronic musculoskeletal disorders.
The study will be conducted on 198 volunteer individuals who apply to Baskent University Ankara Hospital Physical Medicine and Rehabilitation Department and will receive treatment due to chronic musculoskeletal diseases. Each individual participating in the study will be informed about the study.
Patients with pain due to chronic musculoskeletal disorders, native speakers of Turkish, those over the age of 18 and under 65 and literate individuals will be included in the study. Individuals with neurological disease and no pain problems will not be included in the study.
Treatment Expectations Scale in Chronic Pain, Positivity Scale, Hospital Anxiety and Depression Scale and Disease Cognition Questionnaire will apply.
- Conditions
- Musculoskeletal Disorder, Chronic Pain
- Being tested
- Translating the Questionnaire into Turkish and Related Processes, Validity, Reliability
- Keywords
- Reliability, Validity, Chronic Pain Treatment Expectations Scale, Turkish
- Medical subject headings
- Musculoskeletal Diseases, Chronic Pain
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Expectations Scale in Chronic Pain
The Chronic Pain Treatment Expectations Scale is a self-report questionnaire that measures the ideal and predicted expectations of patients. The items are designed to measure two aspects of expectations; ie process and result expectations. The instructions are as follows: The following questions are about your expectation for treatment for your chronic pain. For each question, please tick the box that is most appropriate, (1) What do you expect to be ideal during the healthcare appointment (s) (in the ideal world, what do you want it to happen) (2) What do you expect to be realistic during the healthcare appointment (s) (2) in real life, what do you actually expect). For each item, patients are asked to select the extent to which they will participate in an ideal and predicted expectations on a 5-point scale (1 = strongly disagree 5 = strongly agree). Thus, each item is scored twice by the participants.
Measured: baseline
Secondary outcomes (3)
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). internal consistency coefficient was found to be 0.75.
Measured: baseline
Hospital Anxiety and Depression Scale
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
Disease Cognition Questionnaire
Disease Cognition Questionnaire was determine the cognition of individuals. It is advantageous for large-scale operations due to its low cost, validity and reliability and ease of application. The questionnaire contains a list of statements of individuals with long-term illness. The questionnaire consists of 18 statements. Individuals are asked to what extent they accept the statements. 4 points indicate that they agree completely and 1 point indicates that they never agree. The expressions are grouped under 3 headings, 6 in each category;
- Helplessness (concentration on the deterrent aspects of the disease),
- Acceptance (a positive adaptation to chronic disease with emphasis on reducing its negative aspects),
- Perceived benefits (assigning positive meaning to the disease). High scores for the survey indicate that disease awareness is high.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start8 Oct 2020
- Primary completion30 Oct 2020
- Study completion10 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisorderStudies 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
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aydan aytar, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222036
- Sponsor's protocol ID
- KA19/430
- Status last verified
- Mar 2021
- First submitted
- 31 Dec 2019
- Last updated
- 18 Mar 2021
- 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the Expectation Scale in the Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT04222036
- Acronym / sponsor ID
- KA19/430
- Conditions
- Musculoskeletal Disorder, Chronic Pain
- Keywords
- Reliability, Validity, Chronic Pain Treatment Expectations Scale, Turkish
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 10 Mar 2021 (estimated)
- First posted
- 9 Jan 2020 (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.
Questionnaires are available to measure expectations based on patient and treatment expectations in musculoskeletal disorders. In order to elucidate the factors that change expectations in the treatment of pain, more valid and reliable measurement tools are needed to measure the expectations of patients. The validity and reliability made in Turkey, there is no comprehensive study that measures the expectations of treatment. Therefore, the aim of this study was to test the Turkish validity and characteristics of the Chronic Pain Expectations Scale in patients with pain due to chronic musculoskeletal disorders.
Detailed description
Considering the multidimensionality of pain experience, multidisciplinary approaches are accepted as gold standards in the treatment of pain . Pharmacological and non-pharmacological interventions, therapeutic therapies and treatment beliefs are generally considered to be key to these approaches. However, clinically significant pain treatment responses have not yet been clearly defined . Research suggests that their expectations may be one of the key components in the treatment of pain.
Expectation refers to the complex interplay of thoughts, values, and beliefs that are composed of past experiences and represent an assessment of expected outcomes specific to a situation. Four types of expectations have been proposed: ideal (desires and outcome preferences), predicted (expected outcome), normative (what one thinks should be) and unformed (not explicitly expressed). Numerous studies have demonstrated the importance of expectations in pain experience. Expecting pain reduction is usually associated with decreased pain intensity and improved treatment outcomes. In contrast, expecting increased pain is associated with increased pain. Complex and severe expectations may also affect treatment response. A person's level of participation in the treatment plan can be greatly influenced by expectations. Waiting for the full recovery of chronic pain as a result of treatment may pose an obstacle to functioning and quality of life.
Questionnaires are available to measure expectations based on patient and treatment expectations in musculoskeletal disorders. In order to elucidate the factors that change expectations in the treatment of pain, more valid and reliable measurement tools are needed to measure the expectations of patients. The validity and reliability made in Turkey, there is no comprehensive study that measures the expectations of treatment. Therefore, the aim of this study was to test the Turkish validity and characteristics of the Chronic Pain Expectations Scale in patients with pain due to chronic musculoskeletal disorders.
The study will be conducted on 198 volunteer individuals who apply to Baskent University Ankara Hospital Physical Medicine and Rehabilitation Department and will receive treatment due to chronic musculoskeletal diseases. Each individual participating in the study will be informed about the study.
Patients with pain due to chronic musculoskeletal disorders, native speakers of Turkish, those over the age of 18 and under 65 and literate individuals will be included in the study. Individuals with neurological disease and no pain problems will not be included in the study.
Treatment Expectations Scale in Chronic Pain, Positivity Scale, Hospital Anxiety and Depression Scale and Disease Cognition Questionnaire will apply.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who apply to Baskent University Ankara Hospital Physical Medicine and Rehabilitation Department and will receive treatment due to chronic musculoskeletal diseases.
Key inclusion criteria (2 listed)
- Patients with pain due to chronic musculoskeletal disorders,
- native speakers of Turkish, those over the age of 18 and under 65 a
Key exclusion criteria (2 listed)
- illiterate individuals
- Individuals with neurological disease and no pain problems
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 | – |
| 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 | – |
| ReliabilityThe reliability of the materials will be tested with Cronbach alpha. | Other | – |
Primary outcome
Treatment Expectations Scale in Chronic Pain
Time frame: baseline
The Chronic Pain Treatment Expectations Scale is a self-report questionnaire that measures the ideal and predicted expectations of patients. The items are designed to measure two aspects of expectations; ie process and result expectations. The instructions are as follows: The following questions are about your expectation for treatment for your chronic pain. For each question, please tick the box that is most appropriate, (1) What do you expect to be ideal during the healthcare appointment (s) (in the ideal world, what do you want it to happen) (2) What do you expect to be realistic during the healthcare appointment (s) (2) in real life, what do you actually expect). For each item, patients are asked to select the extent to which they will participate in an ideal and predicted expectations on a 5-point scale (1 = strongly disagree 5 = strongly agree). Thus, each item is scored twice by the participants.
3 secondary outcomes
Positivity Scale
Time frame: baseline
Hospital Anxiety and Depression Scale
Time frame: baseline
Disease Cognition Questionnaire
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Disorder and Chronic Pain, run by Baskent University at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Expectations Scale in Chronic Pain (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 18 Mar 2021.