NCT01878903

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

April 1, 2013

Last Update Submit

January 21, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Scores

    The participants will be ask for pain scores (NRS and VRS with i-Pad) at postoperative day 1(the following day after the operation)

Study Arms (1)

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

Other: Electronic VAS

Interventions

Post-opearive pain patients will be assessed using electional VAS and verbal NRS

Also known as: i-pad assessment
i-pad VAS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted at the population of Hong Kong.

You may not qualify if:

  • Patients suffer from dementia, visual or hearing impairment will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deaprtment of Anaesthesiology, The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Chun Yin Wat, MBBS

    Department of Anaesthesiology, Queen Mary Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

April 1, 2013

First Posted

June 17, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations