Post-operative PainNCT01878903
Electronic Visual Analogue Scale in Acute Postoperative Pain
An observational study of Post-operative Pain, run by Cheung Chi Wai at 1 site in China.
Trial summary
When assessing acute post-operative pain, the validity, reproducibility and reliability of Visual Analogue Scale (VAS) and verbal Numerical Rating Scale (NRS) have been investigated extensively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Electronic VAS
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Sep 2013
- 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: This study will be conducted at the population of Hong Kong.
Who may be able to join
- All Chinese or English speaking patients 18 years or above, who are taken care by the acute pain service in Queen Mary Hospital, Hong Kong are eligible for inclusion.
Who cannot join
- Patients suffer from dementia, visual or hearing impairment will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Deaprtment of Anaesthesiology, The University of Hong Kong
Hong Kong
About this study
Official title: Prospective Comparative Study of Electronic Visual Analogue Scale and Verbal Numerical Rating Scale in Acute Post-operative Pain.
When assessing acute post-operative pain, the validity, reproducibility and reliability of Visual Analogue Scale (VAS) and verbal Numerical Rating Scale (NRS) have been investigated extensively. The use of electronic version of VAS has been published in the recent 10 years yet publication related to its use in pain medicine were few. Jamison et al have shown good correlation between electronic VAS vs paper VAS on healthy volunteers using weight as the stimulus. In normal subjects as well as fibromyalgia patients, electronic form of VAS could be used to describe different levels of experimental heat stimulation.
Long term study had been done where electronic pain diary were compared against paper diary in recording pain in 36 patients with chronic low back pain. The 2 scales showed good correlation. This author use a software that is Palm-top computer based. Following these few studies, validation study in chronic pain patient were published. A Palm-top computer based VAS was compared with paper NRS in 200 chronic pain patients. The pain level recorded by the two methods were considered equivalent by the author. However, Palm-top computer has almost disappeared from the market nowadays.
Read more
Recent handheld electronic devices (iPad®) were incorporated with touch screen input interface which allow users to use their finger as the input device. To our knowledge, there is no published data concerning iPad-based VAS, especially in post-operative pain. We would like to compare the data obtained from electronic VAS on iPad with verbal numerical rating scale when acute post-operative pain is assessed.
Hypothesis The null hypothesis is that the two pain measurement method do not correlate. The Spearman correlation coefficient between electronic VAS and verbal NRS will be reported.
Read the detailed description
Objective:
To assess the agreement between the pain level measured by electronic VAS and verbal NRS in acute pain situation. Secondary objective is to determine the test-re-test reliability of electronic VAS.
Method:
All Chinese or English speaking patients 18 years or above, who are taken care by the acute pain service in Queen Mary Hospital are eligible for inclusion. Patients suffer from dementia, visual or hearing impairment will be excluded. Written consent will be obtained.
Pain specialist responsible for the acute pain service will assess patients' condition during daily ward round while patients are using patient controlled analgesia (PCA) device, receiving epidural infusion or peripheral nerve local anaesthetic infusion. For the pain assessment, patient will be asked to rate their current pain level using verbal numerical rating scale (NRS) as a standard or care. (0 being no pain, 10 being worst pain imaginable) Within one minute, the patient will be asked by the investigator, who is blinded to the verbal NRS, to rate the current pain level again on an electronic version of visual analogue scale on iPad® (vasQ Clinical©, Maki NAKATA 2011) The electronic VAS displayed on iPad® is a horizontal scale with "No Pain" on the left, "Worst Pain Imaginable" on the right. Patient can use the finger to mark the level of pain on the iPad® screen by moving a diamond shape marker alone the horizontal line. The length of the scale is divided electronically into 100 equal parts. There will be 101 possible score (0 - 10.0, which indicate the distance of the diamond marker from the left end of the scale. The score will be stored together with the patient's identifier.
Patients' clinical pain management will not be altered by the data obtained from the electronic VAS.
Patients will be asked to rate the current pain level after 1 minute using the electronic VAS again to evaluate the test-retest reliability of the tool.
Sample size Previous studies have shown that when VAS assessment was repeated in a short period of time, the standard deviation of the difference between the two measurements is around 8 mm (on a 100 mm scale). A sample size of 84 patients will be able to limit the 95% confidence interval of the mean difference between the pain assessment to +/- 3 mm. 92 patients will be recruited assuming a drop out rate of 10%.
Analysis The agreement between electronic VAS and verbal NRS will be evaluated using Spearman rank correlation6 and Bland-Altman method. The Spearman coefficient will be presented together with 95% confident interval (CI). The Bland-Altman method involves plotting the mean of the electronic VAS and NRS against the difference between the 2 scores for each pair of data. Mean difference +/- standard deviation of the differences between electronic VAS and verbal NRS will be presented.
The analysis will be repeated for the 2 sets of electronic VAS obtained 1 minute apart to evaluate the test-retest reliability of the electronic VAS.
- Conditions
- Post-operative Pain
- Being tested
- Electronic VAS
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic VASOther
Also called i-pad assessment
Post-opearive pain patients will be assessed using electional VAS and verbal NRS
| Study group | Role | What they receive |
|---|---|---|
| i-pad VAS | All patients will be in one arm and they will be asked for post-operative pain using verbal NRS and visual VAS with i-pad Receives: Other: Electronic VAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores
Measured: The participants will be ask for pain scores (NRS and VRS with i-Pad) at postoperative day 1(the following day after the operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheung Chi Wai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cheung Chi Wai, The University of Hong Kong
- Investigators
- Chun Yin Wat, MBBS, Principal investigator, Department of Anaesthesiology, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878903
- Sponsor's protocol ID
- UW-13-166
- Status last verified
- Jan 2014
- First submitted
- 1 Apr 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of Electronic Visual Analogue Scale and Verbal Numerical Rating Scale in Acute Post-operative Pain.
- ClinicalTrials.gov ID
- NCT01878903
- Acronym / sponsor ID
- UW-13-166
- Conditions
- Post-operative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cheung Chi WaiUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Jun 2013 (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.
When assessing acute post-operative pain, the validity, reproducibility and reliability of Visual Analogue Scale (VAS) and verbal Numerical Rating Scale (NRS) have been investigated extensively. The use of electronic version of VAS has been published in the recent 10 years yet publication related to its use in pain medicine were few. Jamison et al have shown good correlation between electronic VAS vs paper VAS on healthy volunteers using weight as the stimulus. In normal subjects as well as fibromyalgia patients, electronic form of VAS could be used to describe different levels of experimental heat stimulation.
Long term study had been done where electronic pain diary were compared against paper diary in recording pain in 36 patients with chronic low back pain. The 2 scales showed good correlation. This author use a software that is Palm-top computer based. Following these few studies, validation study in chronic pain patient were published. A Palm-top computer based VAS was compared with paper NRS in 200 chronic pain patients. The pain level recorded by the two methods were considered equivalent by the author. However, Palm-top computer has almost disappeared from the market nowadays.
Recent handheld electronic devices (iPad®) were incorporated with touch screen input interface which allow users to use their finger as the input device. To our knowledge, there is no published data concerning iPad-based VAS, especially in post-operative pain. We would like to compare the data obtained from electronic VAS on iPad with verbal numerical rating scale when acute post-operative pain is assessed.
Hypothesis The null hypothesis is that the two pain measurement method do not correlate. The Spearman correlation coefficient between electronic VAS and verbal NRS will be reported.
Detailed description
Objective:
To assess the agreement between the pain level measured by electronic VAS and verbal NRS in acute pain situation. Secondary objective is to determine the test-re-test reliability of electronic VAS.
Method:
All Chinese or English speaking patients 18 years or above, who are taken care by the acute pain service in Queen Mary Hospital are eligible for inclusion. Patients suffer from dementia, visual or hearing impairment will be excluded. Written consent will be obtained.
Pain specialist responsible for the acute pain service will assess patients' condition during daily ward round while patients are using patient controlled analgesia (PCA) device, receiving epidural infusion or peripheral nerve local anaesthetic infusion. For the pain assessment, patient will be asked to rate their current pain level using verbal numerical rating scale (NRS) as a standard or care. (0 being no pain, 10 being worst pain imaginable) Within one minute, the patient will be asked by the investigator, who is blinded to the verbal NRS, to rate the current pain level again on an electronic version of visual analogue scale on iPad® (vasQ Clinical©, Maki NAKATA 2011) The electronic VAS displayed on iPad® is a horizontal scale with "No Pain" on the left, "Worst Pain Imaginable" on the right. Patient can use the finger to mark the level of pain on the iPad® screen by moving a diamond shape marker alone the horizontal line. The length of the scale is divided electronically into 100 equal parts. There will be 101 possible score (0 - 10.0, which indicate the distance of the diamond marker from the left end of the scale. The score will be stored together with the patient's identifier.
Patients' clinical pain management will not be altered by the data obtained from the electronic VAS.
Patients will be asked to rate the current pain level after 1 minute using the electronic VAS again to evaluate the test-retest reliability of the tool.
Sample size Previous studies have shown that when VAS assessment was repeated in a short period of time, the standard deviation of the difference between the two measurements is around 8 mm (on a 100 mm scale). A sample size of 84 patients will be able to limit the 95% confidence interval of the mean difference between the pain assessment to +/- 3 mm. 92 patients will be recruited assuming a drop out rate of 10%.
Analysis The agreement between electronic VAS and verbal NRS will be evaluated using Spearman rank correlation6 and Bland-Altman method. The Spearman coefficient will be presented together with 95% confident interval (CI). The Bland-Altman method involves plotting the mean of the electronic VAS and NRS against the difference between the 2 scores for each pair of data. Mean difference +/- standard deviation of the differences between electronic VAS and verbal NRS will be presented.
The analysis will be repeated for the 2 sets of electronic VAS obtained 1 minute apart to evaluate the test-retest reliability of the electronic VAS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| i-pad VAS | – | Other: Electronic VASAll patients will be in one arm and they will be asked for post-operative pain using verbal NRS and visual VAS with i-pad |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted at the population of Hong Kong.
Key inclusion criteria (1 listed)
- All Chinese or English speaking patients 18 years or above, who are taken care by the acute pain service in Queen Mary Hospital, Hong Kong are eligible for inclusion.
Key exclusion criteria (1 listed)
- Patients suffer from dementia, visual or hearing impairment will be excluded.
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 |
|---|---|---|
| Electronic VASAlso: i-pad assessmentPost-opearive pain patients will be assessed using electional VAS and verbal NRS | Other | i-pad VAS |
Primary outcome
Postoperative Pain Scores
Time frame: The participants will be ask for pain scores (NRS and VRS with i-Pad) at postoperative day 1(the following day after the operation)
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 Jan 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.
Chun Yin Wat, MBBS principal investigator
Department of Anaesthesiology, Queen Mary Hospital, Hong Kong
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 Post-operative Pain, run by Cheung Chi Wai at 1 site in China.
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 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 Jan 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 China. 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?
Postoperative Pain Scores (time frame: The participants will be ask for pain scores (NRS and VRS with i-Pad) at postoperative day 1(the following day after the operation)). 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 Jan 2014.