Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT06210802
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2023-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of K-DVPRS
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Validation of Korean Version of Defense and Veterans Pain Rating Scale (DVPRS) for Assessment of Postoperative Pain
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to validate Korean version of Defense and Veterans Pain Rating Scale for the assessment of postoperative pain.
Detailed Description:
Defense and Veterans Pain Rating Scale (DVPRS) is translated into the Korean version through forward-back translation. The K-DVPRS is reviewed by the Korean expert and finally verified by the investigator of this study.
On a day before surgery, postoperative pain at rest and during cough is investigated using K-DVPRS, and K-DVPRS supplementary questions and EQ-5D-5L are conducted. At 24 hours after surgery, postoperative pain of surgical site at rest and during cough is investigated using NRS and K-DVPRS, and K-DVPRS supplementary questions and EQ-5D-5L are conducted. At this time, to assess the reliability of K-DVPRS, postoperative pain of surgical site at rest and during cough is re-investigated using K-DVPRS after 30-60 minutes. At 48 hours after surgery, postoperative pain of surgical site at rest and during cough is investigated using NRS and K-DVPRS, and K-DVPRS supplementary questions and EQ-5D-5L are conducted.
In order to verify the reliability of the K-DVPRS, the internal correlation coefficient (ICC) and Cronbach's alpha coefficient are calculated to evaluate the test-retest reliability. Convergent validity and construction validity are calculated to verify the validity of the K-DVPRS. Spearman correlation analysis between pain intensity at rest and during cough using NRS and K-DVPRS is performed to verify convergent validity. In addition, an inter-item correlation analysis is conducted between pain intensity at rest and during cough using K-DVPRS, scores of K-DVPRS supplemental questions, pain intensity at rest and during cough using NRS, and EQ-5D-5L scores. To verify the construct validity, K-DVPRS score is analyzed by age, sex, operation time, and the severity of surgery. Finally, the Mann-Whitney U test is used to compare the difference in postoperative during at rest and during cough evaluated by K-DVPRS before and 24 hours after surgery. The difference in postoperative pain between 24 and 48 hours after surgery is also compared in the same way. The evaluation success rates of NRS and K-DVPRS are also compared at postoperative 24 and 48 hours.
On a day before surgery, postoperative pain at rest and during cough is investigated using K-DVPRS, and K-DVPRS supplementary questions and EQ-5D-5L are conducted. At 24 hours after surgery, postoperative pain of surgical site at rest and during cough is investigated using NRS and K-DVPRS, and K-DVPRS supplementary questions and EQ-5D-5L are conducted. At this time, to assess the reliability of K-DVPRS, postoperative pain of surgical site at rest and during cough is re-investigated using K-DVPRS after 30-60 minutes. At 48 hours after surgery, postoperative pain of surgical site at rest and during cough is investigated using NRS and K-DVPRS, and K-DVPRS supplementary questions and EQ-5D-5L are conducted.
In order to verify the reliability of the K-DVPRS, the internal correlation coefficient (ICC) and Cronbach's alpha coefficient are calculated to evaluate the test-retest reliability. Convergent validity and construction validity are calculated to verify the validity of the K-DVPRS. Spearman correlation analysis between pain intensity at rest and during cough using NRS and K-DVPRS is performed to verify convergent validity. In addition, an inter-item correlation analysis is conducted between pain intensity at rest and during cough using K-DVPRS, scores of K-DVPRS supplemental questions, pain intensity at rest and during cough using NRS, and EQ-5D-5L scores. To verify the construct validity, K-DVPRS score is analyzed by age, sex, operation time, and the severity of surgery. Finally, the Mann-Whitney U test is used to compare the difference in postoperative during at rest and during cough evaluated by K-DVPRS before and 24 hours after surgery. The difference in postoperative pain between 24 and 48 hours after surgery is also compared in the same way. The evaluation success rates of NRS and K-DVPRS are also compared at postoperative 24 and 48 hours.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: