Pain MeasurementNCT03768102
Comparison of Verbal Rating Scale and Numerical Rating Scale in Post Anesthesia Care Unit
An observational study of Pain Measurement and Acute Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In the postanesthetic care unit(PACU), patients who are recovering from anesthesia are not easy to communicate with. Accordingly, accurate evaluation of acute surgical pain is difficult for PACU patients in spite of severe postoperative pain. Therefore, pain evaluation is clinically important and challenging in PACU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Measurement, Acute Pain, Postoperative Pain
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2018to 30 Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: An adult patient who has been transferred to the recovery room after receiving general anesthesia
Who may be able to join
- Adult patients who underwent general anesthesia
- The American Society of Anesthesiologists(ASA) physical status classification system : class 1, 2, 3
Who cannot join
- The American Society of Anesthesiologists(ASA) physical status classification system : class 4, 5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Verbal Rating Scale and Numerical Rating Scale in Post Anesthesia Care Unit
In the postanesthetic care unit(PACU), patients who are recovering from anesthesia are not easy to communicate with. Accordingly, accurate evaluation of acute surgical pain is difficult for PACU patients in spite of severe postoperative pain. Therefore, pain evaluation is clinically important and challenging in PACU. The pain evaluation tool should be simple and easy to understand for accurate assessment. Among the most commonly used pain assessment methods are numerical rating scale(NRS), visual analogue scale(VAS) and verbal rating scale(VRS). These three methods have proved valid for clinical situations in many studies. VRS appears to be easier to understand than the other two methods for patients in PACU. The purpose of this study is to compare NRS and VRS in PACU patients.
- Conditions
- Pain Measurement, Acute Pain, Postoperative Pain
- Medical subject headings
- Acute Pain, Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement by the numerical rating scale
Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)".
0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Measured: 5 minutes after transferred into the postanesthesia care unit
Pain measurement by the numerical rating scale
Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)" 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Measured: 20 minutes after transferred into the postanesthesia care unit
Pain measurement by the numerical rating scale
Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)" 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Measured: 40 minutes after transferred into the postanesthesia care unit
Pain measurement by the verbal rating scale
Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain
Measured: 5 minutes after transferred into the postanesthesia care unit
Pain measurement by the verbal rating scale
Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain
Measured: 20 minutes after transferred into the postanesthesia care unit
Pain measurement by the verbal rating scale
Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain
Measured: 40 minutes after transferred into the postanesthesia care unit
nonresponse rate of the numerical rating scale
the rate of assessment failures among the total number of assessment
Measured: 1 year
nonresponse rate of the verbal rating scale
the rate of assessment failures among the total number of assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start12 Dec 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain MeasurementStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768102
- Sponsor's protocol ID
- SNUMR2-3
- Status last verified
- Oct 2020
- First submitted
- 30 Nov 2018
- Last updated
- 22 Oct 2020
- Results posted
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Verbal Rating Scale and Numerical Rating Scale in Post Anesthesia Care Unit
- ClinicalTrials.gov ID
- NCT03768102
- Acronym / sponsor ID
- SNUMR2-3
- Conditions
- Pain Measurement, Acute Pain, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 7 Dec 2018 (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.
In the postanesthetic care unit(PACU), patients who are recovering from anesthesia are not easy to communicate with. Accordingly, accurate evaluation of acute surgical pain is difficult for PACU patients in spite of severe postoperative pain. Therefore, pain evaluation is clinically important and challenging in PACU. The pain evaluation tool should be simple and easy to understand for accurate assessment. Among the most commonly used pain assessment methods are numerical rating scale(NRS), visual analogue scale(VAS) and verbal rating scale(VRS). These three methods have proved valid for clinical situations in many studies. VRS appears to be easier to understand than the other two methods for patients in PACU. The purpose of this study is to compare NRS and VRS in PACU patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An adult patient who has been transferred to the recovery room after receiving general anesthesia
Key inclusion criteria (2 listed)
- Adult patients who underwent general anesthesia
- The American Society of Anesthesiologists(ASA) physical status classification system : class 1, 2, 3
Key exclusion criteria (1 listed)
- The American Society of Anesthesiologists(ASA) physical status classification system : class 4, 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain measurement by the numerical rating scale
Time frame: 5 minutes after transferred into the postanesthesia care unit
Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Pain measurement by the numerical rating scale
Time frame: 20 minutes after transferred into the postanesthesia care unit
Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)" 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Pain measurement by the numerical rating scale
Time frame: 40 minutes after transferred into the postanesthesia care unit
Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)" 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Pain measurement by the verbal rating scale
Time frame: 5 minutes after transferred into the postanesthesia care unit
Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain
Pain measurement by the verbal rating scale
Time frame: 20 minutes after transferred into the postanesthesia care unit
Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain
Pain measurement by the verbal rating scale
Time frame: 40 minutes after transferred into the postanesthesia care unit
Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain
nonresponse rate of the numerical rating scale
Time frame: 1 year
the rate of assessment failures among the total number of assessment
nonresponse rate of the verbal rating scale
Time frame: 1 year
the rate of assessment failures among the total number of assessment
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 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Pain Measurement
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Recruiting
Perfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy
Postoperative Pain, Adenotonsillectomy
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
Not yet recruitingObservational study
Pain Prediction Via Machine Learning: Electrical Thresholds and Interoception
University Students
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
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.
Jin-Tae Kim, Ph.D. principal investigator
Seoul National University Hospital
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 Measurement and Acute Pain, 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 2 inclusion and 1 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 22 Oct 2020. 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?
Pain measurement by the numerical rating scale (time frame: 5 minutes after transferred into the postanesthesia care unit). The study lists 8 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 22 Oct 2020.