SurgeryNCT02243410
Visual Analogue Scale - a Quality Assurance Study
An observational study of Surgery, run by Herlev Hospital at 1 site in Denmark.
Trial summary
It has come to our attention that there is not a general consensus of how to apply Visual Analogue Scale (VAS) as a tool in measuring pain amongst postoperative patients in Denmark. The assumption is that patients will grade the level of pain differently dependent on how VAS is presented. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Sep 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All participants will be postoperative patients of Department of Surgery, Department of Gynecology and Department of Orthopaedic Surgery, all based at Herlev Hospital.
Who may be able to join
- Patient must have undergone surgery within the last five days
- The patient must be able and willing to participate in the study
- Must be at 18 years of age or older
- A patient can only participate one time.
Who cannot join
- Previously included patients
- Medically treated patients Linguistic difficulties
- Mentally or physically exhausted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Analogue Scale (VAS) - a Quality Assurance Research Study to Assess the Quality of the VAS as a Means for Measuring Postoperative Pain.
It has come to our attention that there is not a general consensus of how to apply Visual Analogue Scale (VAS) as a tool in measuring pain amongst postoperative patients in Denmark.
The assumption is that patients will grade the level of pain differently dependent on how VAS is presented.
Read the detailed description
To ensure the data is valid for the study it has been decided to base the research material on four different VAS usage, as it is most often used in clinical practise in Denmark. Which in this case implies VAS horizontal, with and without endpoint, and VAS vertical, with and without endpoint. Every participant will grade their pain on each of the listed VAS representations. Furthermore, as a guideline, the participant will be asked to grade the pain on a Numerical Ranking Scale (NRS).
The ordering of VAS lines will be subject to randomization, for each participant
- Conditions
- Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
agreement in VAS values with horizontal vs vertical and with and without stop lines
Measured: First five days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Rosenberg, Herlev Hospital
- Investigators
- Jacob Rosenberg, MD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243410
- Sponsor's protocol ID
- HBK01
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Analogue Scale (VAS) - a Quality Assurance Research Study to Assess the Quality of the VAS as a Means for Measuring Postoperative Pain.
- ClinicalTrials.gov ID
- NCT02243410
- Acronym / sponsor ID
- HBK01
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Sep 2014 (estimated)
- 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.
It has come to our attention that there is not a general consensus of how to apply Visual Analogue Scale (VAS) as a tool in measuring pain amongst postoperative patients in Denmark.
The assumption is that patients will grade the level of pain differently dependent on how VAS is presented.
Detailed description
To ensure the data is valid for the study it has been decided to base the research material on four different VAS usage, as it is most often used in clinical practise in Denmark. Which in this case implies VAS horizontal, with and without endpoint, and VAS vertical, with and without endpoint. Every participant will grade their pain on each of the listed VAS representations. Furthermore, as a guideline, the participant will be asked to grade the pain on a Numerical Ranking Scale (NRS).
The ordering of VAS lines will be subject to randomization, for each participant
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be postoperative patients of Department of Surgery, Department of Gynecology and Department of Orthopaedic Surgery, all based at Herlev Hospital.
Key inclusion criteria (4 listed)
- Patient must have undergone surgery within the last five days
- The patient must be able and willing to participate in the study
- Must be at 18 years of age or older
- A patient can only participate one time.
Key exclusion criteria (3 listed)
- Previously included patients
- Medically treated patients Linguistic difficulties
- Mentally or physically exhausted
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
agreement in VAS values with horizontal vs vertical and with and without stop lines
Time frame: First five days after surgery
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 17 Sep 2014.
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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.
Jacob Rosenberg, MD study chair
Professor
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 Surgery, run by Herlev Hospital at 1 site in Denmark.
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 4 inclusion and 3 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 17 Sep 2014. 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 Denmark. 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?
agreement in VAS values with horizontal vs vertical and with and without stop lines (time frame: First five days after surgery). 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 17 Sep 2014.