- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04258384
The Turkish Cross-Cultural Adaptation, Validity and Reliability of VMPCI
February 5, 2020 updated by: Yeditepe University
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
352
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Istanbul/ Avcılar
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Istanbul, Istanbul/ Avcılar, Turkey, 34320
- İstanbul Gelişim University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria: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.
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Exclusion Criteria:
- Individuals who do not meet the inclusion criteria are excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic Data Form
Time Frame: 5 minutes
|
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.
|
5 minutes
|
SF36
Time Frame: 10 minutes
|
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.
|
10 minutes
|
McGill Melzack Pain Questionnaire
Time Frame: 5 minutes
|
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.
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5 minutes
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Pain Coping Scale
Time Frame: 5 minutes
|
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.
|
5 minutes
|
Pain Coping Inventory
Time Frame: 5 minutes
|
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.
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5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Actual)
December 30, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
February 4, 2020
First Submitted That Met QC Criteria
February 5, 2020
First Posted (Actual)
February 6, 2020
Study Record Updates
Last Update Posted (Actual)
February 6, 2020
Last Update Submitted That Met QC Criteria
February 5, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 37068608-6100-15-1685
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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