Pain, ChronicNCT06052228
Turkish Version of the Worry About Pain Questionnaire
An observational study of Pain, Chronic and Musculoskeletal Pain, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Pain is one of the main complaints that causes people to apply to health institutions. Pain is seen as a passive warning signal of an underlying disease process; When it becomes chronic, it is considered a disease on its own. Pain that persists longer than the expected recovery time is defined as chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic, Musculoskeletal Pain
- What is being tested?
- Assessment Group
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2023to 20 Feb 2024
- 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 with Musculoskeletal Pain
Who may be able to join
- Being able to read and write in Turkish
- Not having any cognitive impairment
- Having chronic musculoskeletal pain
- Being over 18 years of age
- Being willing and volunteer to work
Who cannot join
- Having a complaint of pain in the musculoskeletal system due to cancer, fracture or surgery within the last 6 months.
- Having severe cognitive impairment
- Having a systemic disease such as rheumatoid arthritis, diabetes mellitus
- Having any neuromuscular disease (such as MS, myopathy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cultural Adaptation and Turkish Version of the Worry About Pain Questionnaire in Individuals With Musculoskeletal Pain: Reliability and Validity Study
Pain is one of the main complaints that causes people to apply to health institutions. Pain is seen as a passive warning signal of an underlying disease process; When it becomes chronic, it is considered a disease on its own. Pain that persists longer than the expected recovery time is defined as chronic pain.
Pain is associated with a number of psychological, physical, and social factors. Clinical observations report that various psychological problems, especially anxiety, and depression, accompany chronic pain, and the long-term persistence of pain significantly impacts a patient's quality of life. Chronic musculoskeletal pain causes fatigue, sleep disruption, and activity and participation restrictions. Therefore, evaluation of pain originating from the musculoskeletal system and factors that cause and increase pain need to be addressed from a biopsychosocial perspective. Chronic pain is an ideal environment for anxiety to develop. If the person's chronic pain cannot be resolved, anxiety increases and the anxiety becomes excessive, the person may lose the ability to distinguish what is dangerous from what is not, as he cannot evaluate pain-related cues properly. Anxiety and depression scales are often used to assess the long-term psychosocial consequences of chronic musculoskeletal pain. However, these scales are inadequate to explain the relationship between pain and anxiety. The Worry About Pain Questionnaire is a self-report scale of 15 items specifically developed to assess pain-related pressure.
To our knowledge, there is no standard, valid, and reliable Turkish questionnaire in the literature that evaluates the pain-related concerns of individuals with musculoskeletal pain and takes into account the cultural differences of Turkish patients. For this reason, our study aims to translate and culturally adapt the Worry About Pain Questionnaire into Turkish in individuals with chronic musculoskeletal pain and to examine the psychometric properties of the Turkish Worry About Pain Questionnaire.
- Conditions
- Pain, Chronic, Musculoskeletal Pain
- Being tested
- Assessment Group
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment GroupOther
Evaluation forms will be applied to the participant who meets the inclusion criteria by face-to-face interview method. The sociodemographic information of the participants and the time taken to answer the questions in the questionnaires will vary according to each participants but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Assessment Group | Evaluation forms will be applied to the participant who meets the inclusion criteria by face-to-face interview method. The sociodemographic information of the participants and the time taken to answer the questions in the questionnaires will vary according to each participants but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1-week intervals. Receives: Other: Assessment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Worry About Pain Questionnaire
The Worry About Pain Questionnaire will be used to evaluate participants' pain-related anxiety levels. Worry About Pain Questionnaire is a Likert-type survey consisting of a total of 15 items. Each question in the survey is scored from 0 (never) to 10 (always). Questions 1, 2, 4, 5, 6, 7, 8, 10, 11, 12 assess the impact of worrying about pain. Questions 3, 9, 13, 14, 15 assess concern about the ability to manage pain.
Measured: 4 weeks
Fear of Pain Scale III
Fear of Pain Scale III, which is used to evaluate the participants' fear of pain, consists of a total of 30 items. A Turkish validity and reliability study was conducted by Ünver et al. in 2018.
Measured: 4 weeks
Short Form McGill Pain Scale
The McGill Pain Scale Short Form combines the features of the standard McGill Pain Questionnaire and is used to evaluate pain caused by chronic cancer pain, chronic back pain, fibromyalgia syndrome, osteoarthritis pain, neuropathic pain, mastalgia and rheumatoid arthritis. Turkish validity and reliability study was conducted by Yakut et al. in 2007.
Measured: 4 weeks
Pain Pressure Threshold
Pressure algometer (dolorimeter) will be used to evaluate sensitivity to pain and determine pressure perception. Pressure algometers have proven useful in assessing fibrositis and hypersensitive points, trigger points, arthritis activation, and visceral pain-pressure sensitivity. For this reason, in our study, the pain pressure threshold will be determined from the trigger points in the upper, middle and lower fibers of the trapezius muscle.
Measured: 4 weeks
Secondary outcomes (5)
Beck Depression Inventory,
Beck Depression Inventory, which is among the most used scales to measure depression all over the world, consists of a total of 21 questions. Each item receives points between 0-3. 11-17 points indicate mild depression, 18-29 points indicate moderate depression, and 30-63 points indicate severe depression. The scale is one of the most widely used depression scales in clinics in Turkey.
Measured: 4 weeks
Beck Anxiety Inventory
Beck Anxiety Inventory, which is used to evaluate the anxiety symptoms experienced by individuals due to social isolation, consists of 21 items and is scored between 0-3. 0-21 points indicate low anxiety, 22-35 points indicate moderate anxiety, and 36 points and above indicate high anxiety.
Measured: 4 weeks
Nottingham Health Profile
The Nottingham Health Profile was developed in England in 1985 to evaluate the health-related quality of life in individuals and has been translated into many languages. The Nottingham Health Profile is a general quality of life survey that evaluates individuals' health problems and the extent to which the problems affect their daily living activities. In 2000, its Turkish validity and reliability were tested in patients with osteoarthritis by Küçükdeveci et al. Nottingham Health Profile Survey consists of a total of 38 questions and 6 subheadings. Subheadings were classified as energy (3 items), social isolation (5 items), pain (8 items), sleep (5 items), physical activity (8 items) and emotional reactions (9 items). The answers to the questions are defined as Yes/No. Each subheading is scored between 0-100. A high total score indicates poor health status.
Measured: 4 weeks
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index is a scale that provides information about sleep quality and the type and severity of sleep disturbance in the last month. In this scale, the person's sleep quality; Sleep latency is evaluated by sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. The Turkish validity and reliability study of the scale was conducted by Ağargün et al. Each survey question is given a score of 0-3, with higher scores reflecting poor sleep quality. If the total score obtained from the scale is less than 5, it is defined as 'Good sleep quality', and if it is 5 or above, it is defined as 'Bad sleep quality'.
Measured: 4 weeks
Tampa Kinesiophobia Scale
Tampa Kinesiophobia Scale is a 17-question scale developed to measure the fear of movement/re-injury. The scale includes injury/re-injury and fear-avoidance parameters in work-related activities. A Turkish validity and reliability study was conducted by Yılmaz et al. in 2011.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start20 Nov 2023
- Primary completion1 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Koce, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052228
- Sponsor's protocol ID
- 21-39
- Status last verified
- Feb 2024
- First submitted
- 18 Sep 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation and Turkish Version of the Worry About Pain Questionnaire in Individuals With Musculoskeletal Pain: Reliability and Validity Study
- ClinicalTrials.gov ID
- NCT06052228
- Acronym / sponsor ID
- 21-39
- Conditions
- Pain, Chronic, Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 25 Sep 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.
Pain is one of the main complaints that causes people to apply to health institutions. Pain is seen as a passive warning signal of an underlying disease process; When it becomes chronic, it is considered a disease on its own. Pain that persists longer than the expected recovery time is defined as chronic pain.
Pain is associated with a number of psychological, physical, and social factors. Clinical observations report that various psychological problems, especially anxiety, and depression, accompany chronic pain, and the long-term persistence of pain significantly impacts a patient's quality of life. Chronic musculoskeletal pain causes fatigue, sleep disruption, and activity and participation restrictions. Therefore, evaluation of pain originating from the musculoskeletal system and factors that cause and increase pain need to be addressed from a biopsychosocial perspective. Chronic pain is an ideal environment for anxiety to develop. If the person's chronic pain cannot be resolved, anxiety increases and the anxiety becomes excessive, the person may lose the ability to distinguish what is dangerous from what is not, as he cannot evaluate pain-related cues properly. Anxiety and depression scales are often used to assess the long-term psychosocial consequences of chronic musculoskeletal pain. However, these scales are inadequate to explain the relationship between pain and anxiety. The Worry About Pain Questionnaire is a self-report scale of 15 items specifically developed to assess pain-related pressure.
To our knowledge, there is no standard, valid, and reliable Turkish questionnaire in the literature that evaluates the pain-related concerns of individuals with musculoskeletal pain and takes into account the cultural differences of Turkish patients. For this reason, our study aims to translate and culturally adapt the Worry About Pain Questionnaire into Turkish in individuals with chronic musculoskeletal pain and to examine the psychometric properties of the Turkish Worry About Pain Questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment Group | – | Other: Assessment GroupEvaluation forms will be applied to the participant who meets the inclusion criteria by face-to-face interview method. The sociodemographic information of the participants and the time taken to answer the questions in the questionnaires will vary according to each participants but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1-week intervals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals with Musculoskeletal Pain
Key inclusion criteria (5 listed)
- Being able to read and write in Turkish
- Not having any cognitive impairment
- Having chronic musculoskeletal pain
- Being over 18 years of age
- Being willing and volunteer to work
Key exclusion criteria (4 listed)
- Having a complaint of pain in the musculoskeletal system due to cancer, fracture or surgery within the last 6 months.
- Having severe cognitive impairment
- Having a systemic disease such as rheumatoid arthritis, diabetes mellitus
- Having any neuromuscular disease (such as MS, myopathy)
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 |
|---|---|---|
| Assessment GroupEvaluation forms will be applied to the participant who meets the inclusion criteria by face-to-face interview method. The sociodemographic information of the participants and the time taken to answer the questions in the questionnaires will vary according to each participants but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1-week intervals. | Other | Assessment Group |
Primary outcome
The Worry About Pain Questionnaire
Time frame: 4 weeks
The Worry About Pain Questionnaire will be used to evaluate participants' pain-related anxiety levels. Worry About Pain Questionnaire is a Likert-type survey consisting of a total of 15 items. Each question in the survey is scored from 0 (never) to 10 (always). Questions 1, 2, 4, 5, 6, 7, 8, 10, 11, 12 assess the impact of worrying about pain. Questions 3, 9, 13, 14, 15 assess concern about the ability to manage pain.
Fear of Pain Scale III
Time frame: 4 weeks
Fear of Pain Scale III, which is used to evaluate the participants' fear of pain, consists of a total of 30 items. A Turkish validity and reliability study was conducted by Ünver et al. in 2018.
Short Form McGill Pain Scale
Time frame: 4 weeks
The McGill Pain Scale Short Form combines the features of the standard McGill Pain Questionnaire and is used to evaluate pain caused by chronic cancer pain, chronic back pain, fibromyalgia syndrome, osteoarthritis pain, neuropathic pain, mastalgia and rheumatoid arthritis. Turkish validity and reliability study was conducted by Yakut et al. in 2007.
Pain Pressure Threshold
Time frame: 4 weeks
Pressure algometer (dolorimeter) will be used to evaluate sensitivity to pain and determine pressure perception. Pressure algometers have proven useful in assessing fibrositis and hypersensitive points, trigger points, arthritis activation, and visceral pain-pressure sensitivity. For this reason, in our study, the pain pressure threshold will be determined from the trigger points in the upper, middle and lower fibers of the trapezius muscle.
5 secondary outcomes
Beck Depression Inventory,
Time frame: 4 weeks
Beck Anxiety Inventory
Time frame: 4 weeks
Nottingham Health Profile
Time frame: 4 weeks
Pittsburgh Sleep Quality Index
Time frame: 4 weeks
Tampa Kinesiophobia Scale
Time frame: 4 weeks
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 21 Feb 2024.
- Individual participant dataSharing planned: No
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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 Pain, Chronic and Musculoskeletal Pain, run by Istinye 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 5 inclusion and 4 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 21 Feb 2024. 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?
The Worry About Pain Questionnaire (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 21 Feb 2024.