Comparison of Different Pain Rating Scales in Patients With Symptomatic Teeth (CoPRS)

January 20, 2020 updated by: Tan Firat Eyuboglu, Istanbul Medipol University Hospital

Comparison of Different Pain Rating Scales in Patients With Symptomatif Teeth

Patients with symptomatic teeth who applied endodontic clinic between April 2019 and December 2019 for root canal treatment were enrolled in this study. All patients were asked to fill four different rating scales: numerical rating scale, visual analogue scale, color analogue scale and faces rating scale for their relevant tooth which is symptomatic and need of root canal treatment. The four scales were then compared statistically.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

50 patients who applied endodontic clinic between April 2019 and December 2019 and had symptomatic teeth which were in need of root canal treatment were enrolled for this study. Study detail were explained to all patients and they were then kindly asked to signed a consent form. All patients diagnose, age, gender, tooth number were recorded. Patients were then asked to fill four different pain rating scale in an electronic pain rating scale program. Numerical rating scale (NRS) was a scale between "0" and "10", with "0" indicating no pain while "10" indicating worst pain possible. Visual analogue scale (VAS) was a straight line of 10 cm with one end of the line indicated no pain whilst the other end indicated worst pain possible. Color analogue scale (CAS) was the same length of straight line as in VAS with a color change towards to worst pain possible end. Faces rating scale (FRS) consisted of six different faces indicating the level of pain with the first face indicated no pain while the last face indicated worst pain possible. After the patients marked their pain intensity levels in all four scales the results were statistically analyzed to compared the accuracy of four scales with VAS being the golden standard.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34083
        • Istanbul Medipol University School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • symptomatic teeth which is in need of root canal treatment

Exclusion Criteria:

  • systemic diseases
  • age <18 and >80
  • being able to understand and accept the study protocol with a written consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pain rating scales
patients were asked to marked their pain intensity level on numerical rating scale between 0 and 10, on visual analogue scale, a straight line with one end indicating "no pain" and the other end indicating "worst pain possible". on color analogue scale, a straight line with one end indicating "no pain" and the other end indicating "worst pain possible"and color change towards to "worst pain possible" end and on a faces rating scale which consisted of six different faces representing different levels of pain intensity with the first face indicating "no pain" whilst last face indicating "worst pain possible". The result was recorded as pain intensity level.
Diagnostic test: numerical rating scale
patients were asked to marked their pain intensity level on numerical rating scale between 0 and 10 and the result was recorded as pain intensity level.
Other Names:
  • NRS
Other: visual analogue scale
Patients were asked to marked their pain intensity level on visual analogue scale, a straight line with one end indicating "no pain" and the other end indicating "worst pain possible". Then the distance between no pain end and patients' mark was measured and recorded as pain intensity level.
Other Names:
  • VAS
Other: color analogue scale
Patients were asked to marked their pain intensity level on color analogue scale, a straight line with one end indicating "no pain" and the other end indicating "worst pain possible"and color change towards to "worst pain possible" end. Then the distance between no pain end and patients' mark was measured and recorded as pain intensity level.
Other Names:
  • CAS
Other: faces rating scale
Patients were asked marked their pain on a faces rating scale which consisted of six different faces representing different levels of pain intensity with the first face indicating "no pain" whilst last face indicating "worst pain possible". The result was recorded as pain intensity level.
Other Names:
  • FRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numerical rating scale
Time Frame: through study completion, an average of 1 year
pain intesity level of patients were recorded on a scale from 0 (no pain) to 10 (worst pain posbile)
through study completion, an average of 1 year
visual analogue scale
Time Frame: through study completion, an average of 1 year
Patients were asked to mark their pain intesity level on a 10 cm line with one end indicating "no pain" and the other end "worst pain possible". The distance between "no pain" and the mark indicates the pain intesity level.
through study completion, an average of 1 year
color analogue scale
Time Frame: through study completion, an average of 1 year
Patients were asked to mark their pain intesity level on a 10 cm color changing line with one end indicating "no pain" and the other end "worst pain possible". The distance between "no pain" and the mark indicates the pain intesity level.
through study completion, an average of 1 year
faces rating scale
Time Frame: through study completion, an average of 1 year
faces rating scale consists of 6 faces with the first face indicating "no pain" and the last face indicating "worst pain possbile"
through study completion, an average of 1 year
comparison of four rating scales
Time Frame: through study completion, an average of 1 year
all four pain rating scales (numerical rating scale, visual analogue scale, color analogue scale, faces rating scale) were compared to analyze correlation.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Study Chair: Tan F EYUBOGLU, PhD, DDS, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

December 9, 2019

Study Completion (Actual)

December 9, 2019

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 20, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 338 (EDGE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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