Pain, PostoperativeNCT06210802
Validation of K-DVPRS
An observational study of Pain, Postoperative, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aimed to validate Korean version of Defense and Veterans Pain Rating Scale for the assessment of postoperative pain. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Korean version of Defense and Veterans Pain Rating Scale
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jan 2024to 22 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective laparoscopic surgery or robot abdomen surgery (duration ≥ 1 hour) under general anesthesia in Seoul National University Hospital
Who may be able to join
- Patients undergoing elective laparoscopic surgery or robot abdomen surgery (duration ≥ 1 hour) under general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Korean Version of Defense and Veterans Pain Rating Scale (DVPRS) for Assessment of Postoperative Pain
This study aimed to validate Korean version of Defense and Veterans Pain Rating Scale for the assessment of postoperative pain.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Korean version of Defense and Veterans Pain Rating Scale
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean version of Defense and Veterans Pain Rating ScaleOther
Defense and Veterans Pain Rating Scale translated into Korean
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of K-DVPRS
convergent validity and construct validity
Measured: at postoperative 24 and 48 hours
Reliability of K-DVPRS
test-retest reliability
Measured: at postoperative 24 hours
Secondary outcomes (1)
Evaluation success rate of K-DVPRS
Measured: at postoperative 24 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start22 Jan 2024
- Primary completion20 Jul 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210802
- Sponsor's protocol ID
- 2311-172-1489
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2023
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Korean Version of Defense and Veterans Pain Rating Scale (DVPRS) for Assessment of Postoperative Pain
- ClinicalTrials.gov ID
- NCT06210802
- Acronym / sponsor ID
- 2311-172-1489
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective laparoscopic surgery or robot abdomen surgery (duration ≥ 1 hour) under general anesthesia in Seoul National University Hospital
Key inclusion criteria (1 listed)
- Patients undergoing elective laparoscopic surgery or robot abdomen surgery (duration ≥ 1 hour) under general anesthesia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean version of Defense and Veterans Pain Rating ScaleDefense and Veterans Pain Rating Scale translated into Korean | Other | – |
Primary outcome
Validity of K-DVPRS
Time frame: at postoperative 24 and 48 hours
convergent validity and construct validity
Reliability of K-DVPRS
Time frame: at postoperative 24 hours
test-retest reliability
1 secondary outcome
Evaluation success rate of K-DVPRS
Time frame: at postoperative 24 and 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of K-DVPRS (time frame: at postoperative 24 and 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.