Validation of K-DVPRS

Pain, Postoperative Clinical Trial

Official title:

Validation of Korean Version of Defense and Veterans Pain Rating Scale (DVPRS) for Assessment of Postoperative Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210802
• Other study ID #: 2311-172-1489
• Status: Not yet recruiting
• Start date: January 22, 2024
• Est. completion date: December 25, 2025

Study information

• Verified date: December 2023
• Source: Seoul National University Hospital
• Contact: Ho Jin Lee, MD,PhD
• Phone: 82-02-2072-0039
• Email: zenerdiode03[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to validate Korean version of Defense and Veterans Pain Rating Scale for the assessment of postoperative pain.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 25, 2025
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients undergoing elective laparoscopic surgery (duration = 1 hour) under general anesthesia

Exclusion Criteria:

• Patients with ASA PS = III

• Patients with a difficulty to answer postoperative pain-related questions or K-DVPRS

• Patients with red-green color blindness or difficulty distinguishing colors

• Patients who are inappropriate for this clinical trial based on the investigator's opinionr

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• Korean version of Defense and Veterans Pain Rating Scale
Defense and Veterans Pain Rating Scale translated into Korean

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of K-DVPRS	convergent validity and construct validity	at postoperative 24 and 48 hours
Primary	Reliability of K-DVPRS	test-retest reliability	at postoperative 24 hours
Secondary	Evaluation success rate of K-DVPRS		at postoperative 24 and 48 hours