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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04258384
Other study ID # 37068608-6100-15-1685
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date December 31, 2019

Study information

Verified date February 2020
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 352
Est. completion date December 31, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

-

Exclusion Criteria:

- Individuals who do not meet the inclusion criteria are excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
survey application
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.

Locations

Country Name City State
Turkey Istanbul Gelisim University Istanbul Istanbul/ Avcilar

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 15 minutes
Secondary 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. 5 minutes
Secondary 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. 10 minutes
Secondary 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. 5 minutes
Secondary 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. 5 minutes
Secondary 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. 5 minutes
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