Clinical trial NCT06210802: Validation of K-DVPRS
Official title: Validation of Korean Version of Defense and Veterans Pain Rating Scale (DVPRS) for Assessment of Postoperative Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective laparoscopic surgery or robot abdomen surgery (duration ≥ 1 hour) under general anesthesia in Seoul National University Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validity of K-DVPRS
timeFrame: at postoperative 24 and 48 hours
measure: Reliability of K-DVPRS
timeFrame: at postoperative 24 hours
Secondary outcomes:
measure: Evaluation success rate of K-DVPRS
timeFrame: at postoperative 24 and 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: