Pain, ChronicNCT04258384
The Turkish Cross-Cultural Adaptation, Validity and Reliability of VMPCI
An observational study of Pain, Chronic, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to adapt the Vanderbilt Multidimensional Pain Coping Inventory into Turkish, to investigate its cultural adaptation, validity and reliability. The study was completed with 352 volunteers who fulfilled the criteria to be included in the Rheumatology Clinic of Istanbul Haydarpaşa Numune Training… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- survey application
- How many people
- 352 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included individuals whose native language is Turkish, who are literate, over the age of 18, diagnosed with rheumatoid arthritis, without cognitive impairment and communication problems, and who want to participate in the study.
Who may be able to join
None listed.
Who cannot join
- Individuals who do not meet the inclusion criteria are excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Gelisim University
Istanbul, Istanbul/ Avcılar, 34320
About this study
Official title: The Turkish Cross-Cultural Adaptation, Validity and Reliability of Vanderbilt Multidimensional Pain Coping Inventory
This study was planned to adapt the Vanderbilt Multidimensional Pain Coping Inventory into Turkish, to investigate its cultural adaptation, validity and reliability. The study was completed with 352 volunteers who fulfilled the criteria to be included in the Rheumatology Clinic of Istanbul Haydarpaşa Numune Training and Research Hospital. Data collection tools used in the study; Demographic Data Form, Mcgill and Melzack Pain Questionnaire, Short Form-36 (SF-36), Vanderbilt Multidimensional Pain Coping Inventory (VMPCI), Pain Coping Inventory (PCI), Pain Coping Scale were used.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic, progressive, inflammatory, autoimmune disease of unknown etiology, mainly affecting synovial joints, causing loss of function. The main reason that directs RA patients to medical treatment is pain. Chronic pain causes limitation of movement, sleep problems, fatigue, stress and depression, as well as physiological and psychological problems that cause negative effects on the quality of life of the individual. The patient's thoughts, expectations, and methods of coping with pain are effective in pain control. In order to identify and treat the painful condition, individual coping methods of the patient and the effectiveness of these methods should be evaluated. This study was planned to adapt the Vanderbilt Multidimensional Pain Coping Inventory into Turkish, to investigate its cultural adaptation, validity and reliability. The study was completed with 352 volunteers who fulfilled the criteria to be included in the Rheumatology Clinic of Istanbul Haydarpasa Numune Training and Research Hospital. Data collection tools used in the study; Demographic Data Form, Mcgill and Melzack Pain Questionnaire, Short Form-36 (SF-36), Vanderbilt Multidimensional Pain Coping Inventory (VMPCI), Pain Coping Inventory (PCI), Pain Coping Scale were used. The language validity of the Turkish form of the scale was provided by the translation-back translation method. Expert opinion was obtained for scale of validity. In order to evaluate the reliability of the Turkish version of the scale; internal consistency coefficient, test retest and parallel form methods were used. After all these analyzes, the reliability and validity of the Turkish version of the VMPCI scale was obtained. In addition to this study, the descriptive characteristics of the sample, SF-36 scale, Mcgill and Melzack Pain Questionnaire results were examined alone and together with the sub-dimensions of the scale.
- Conditions
- Pain, Chronic
- Being tested
- survey application
- Keywords
- Rheumatoid Arthritis, pain, coping, validity, reliability
- Medical subject headings
- Chronic Pain, Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey applicationOther
Data collection tools used in the study; Demographic Data Form, Mcgill and Melzack Pain Questionnaire, Short Form-36 (SF-36), Vanderbilt Multidimensional Pain Coping Inventory (VMPCI), Pain Coping Inventory (PCI), Pain Coping Scale were used.
| Study group | Role | What they receive |
|---|---|---|
| Patient | The study included individuals whose native language is Turkish, who are literate, over the age of 18, diagnosed with rheumatoid arthritis, without cognitive impairment and communication problems, and who want to participate in the study. Receives: Other: survey application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vanderbilt Multidimensiyonel Pain Coping Inventory
Patients are asked to mark their preferred behaviors and the thoughts of the hospital when their pain is moderate or high intensity.
Measured: 15 minutes
Secondary outcomes (5)
Demographic Data Form
This form prepared by the researcher includes the socio-demographic characteristics of the patients who will participate in the study, the history of the disease, findings related to the characteristics related to pain and exacerbations.
Measured: 5 minutes
SF36
The scale includes 36 questions that evaluate 8 sub-scales of health as physical function, physical role difficulty, pain, general health, vitality, social function, emotional role function, mental health topics.
Measured: 10 minutes
McGill Melzack Pain Questionnaire
It consists of four parts. In the first part, it is desired to mark the shape of the pain on the figure and use the letters "D" if deep pain is heard, "Y" if the pain is superficial, and "D - Y" if the two conditions are experienced at the same time. In the second part, there are twenty word groups that define pain in terms of sensory, perceptual and evaluation. Each of the word groups consists of two-six words that describe pain in different ways. In the third part, there is a time relationship of pain. It includes phrases to understand the continuity and frequency of pain and to identify situations that increase or decrease pain. The last section contains words that indicate the severity of pain. With this questionnaire used in the study, it was aimed to determine the location of the pain, the feeling of the patient, the relationship of pain time, the severity of the pain and the level of livable pain for the patient.
Measured: 5 minutes
Pain Coping Scale
The scale determines how chronic pain patients cope with organic or psychogenic pain. It consists of self-coping, helplessness, conscious cognitive interventions, and medical remedy sub-scales.
Measured: 5 minutes
Pain Coping Inventory
It evaluates how often patients with chronic pain use behavioral and cognitive methods to deal with pain. Active as transforming pain, moving away and reducing demand; There are six passive sub-dimensions as retreat, anxiety and rest.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jun 2019
- Primary completion30 Dec 2019
- Study completion31 Dec 2019
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.
- 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
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258384
- Sponsor's protocol ID
- 37068608-6100-15-1685
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Turkish Cross-Cultural Adaptation, Validity and Reliability of Vanderbilt Multidimensional Pain Coping Inventory
- ClinicalTrials.gov ID
- NCT04258384
- Acronym / sponsor ID
- 37068608-6100-15-1685
- Conditions
- Pain, Chronic
- Keywords
- Rheumatoid Arthritis, pain, coping, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Feb 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.
This study was planned to adapt the Vanderbilt Multidimensional Pain Coping Inventory into Turkish, to investigate its cultural adaptation, validity and reliability. The study was completed with 352 volunteers who fulfilled the criteria to be included in the Rheumatology Clinic of Istanbul Haydarpaşa Numune Training and Research Hospital. Data collection tools used in the study; Demographic Data Form, Mcgill and Melzack Pain Questionnaire, Short Form-36 (SF-36), Vanderbilt Multidimensional Pain Coping Inventory (VMPCI), Pain Coping Inventory (PCI), Pain Coping Scale were used.
Detailed description
Rheumatoid arthritis (RA) is a chronic, progressive, inflammatory, autoimmune disease of unknown etiology, mainly affecting synovial joints, causing loss of function. The main reason that directs RA patients to medical treatment is pain. Chronic pain causes limitation of movement, sleep problems, fatigue, stress and depression, as well as physiological and psychological problems that cause negative effects on the quality of life of the individual. The patient's thoughts, expectations, and methods of coping with pain are effective in pain control. In order to identify and treat the painful condition, individual coping methods of the patient and the effectiveness of these methods should be evaluated. This study was planned to adapt the Vanderbilt Multidimensional Pain Coping Inventory into Turkish, to investigate its cultural adaptation, validity and reliability. The study was completed with 352 volunteers who fulfilled the criteria to be included in the Rheumatology Clinic of Istanbul Haydarpasa Numune Training and Research Hospital. Data collection tools used in the study; Demographic Data Form, Mcgill and Melzack Pain Questionnaire, Short Form-36 (SF-36), Vanderbilt Multidimensional Pain Coping Inventory (VMPCI), Pain Coping Inventory (PCI), Pain Coping Scale were used. The language validity of the Turkish form of the scale was provided by the translation-back translation method. Expert opinion was obtained for scale of validity. In order to evaluate the reliability of the Turkish version of the scale; internal consistency coefficient, test retest and parallel form methods were used. After all these analyzes, the reliability and validity of the Turkish version of the VMPCI scale was obtained. In addition to this study, the descriptive characteristics of the sample, SF-36 scale, Mcgill and Melzack Pain Questionnaire results were examined alone and together with the sub-dimensions of the scale.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: survey applicationThe study included individuals whose native language is Turkish, who are literate, over the age of 18, diagnosed with rheumatoid arthritis, without cognitive impairment and communication problems, and who want to participate in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included individuals whose native language is Turkish, who are literate, over the age of 18, diagnosed with rheumatoid arthritis, without cognitive impairment and communication problems, and who want to participate in the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Individuals who do not meet the inclusion criteria are excluded from the study.
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 |
|---|---|---|
| survey applicationData collection tools used in the study; Demographic Data Form, Mcgill and Melzack Pain Questionnaire, Short Form-36 (SF-36), Vanderbilt Multidimensional Pain Coping Inventory (VMPCI), Pain Coping Inventory (PCI), Pain Coping Scale were used. | Other | Patient |
Primary outcome
Vanderbilt Multidimensiyonel Pain Coping Inventory
Time frame: 15 minutes
Patients are asked to mark their preferred behaviors and the thoughts of the hospital when their pain is moderate or high intensity.
5 secondary outcomes
Demographic Data Form
Time frame: 5 minutes
SF36
Time frame: 10 minutes
McGill Melzack Pain Questionnaire
Time frame: 5 minutes
Pain Coping Scale
Time frame: 5 minutes
Pain Coping Inventory
Time frame: 5 minutes
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 6 Feb 2020.
- 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, run by Yeditepe 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 0 inclusion and 1 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 6 Feb 2020. 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?
Vanderbilt Multidimensiyonel Pain Coping Inventory (time frame: 15 minutes). 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 6 Feb 2020.