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Completed

NCT Number: NCT06210802

Validation of K-DVPRS

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

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, KS013, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing elective laparoscopic surgery or robot abdomen 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

Treatment and study plan

Korean version of Defense and Veterans Pain Rating Scale

Other

Defense and Veterans Pain Rating Scale translated into Korean

Primary outcomes

  1. Validity of K-DVPRS

    Time frame: at postoperative 24 and 48 hours

    convergent validity and construct validity

  2. Reliability of K-DVPRS

    Time frame: at postoperative 24 hours

    test-retest reliability

Secondary outcomes

  1. Evaluation success rate of K-DVPRS

    Time frame: at postoperative 24 and 48 hours

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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