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

Primary Purpose

Pain, Dental Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
numerical rating scale
visual analogue scale
color analogue scale
faces rating scale
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pain focused on measuring numerical rating scale, visual analogue scale, color analogue scale, faces rating scale, pain intensity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Istanbul Medipol University School of Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pain rating scales

Arm Description

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.

Outcomes

Primary Outcome Measures

numerical rating scale
pain intesity level of patients were recorded on a scale from 0 (no pain) to 10 (worst pain posbile)
visual analogue scale
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.
color analogue scale
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.
faces rating scale
faces rating scale consists of 6 faces with the first face indicating "no pain" and the last face indicating "worst pain possbile"
comparison of four rating scales
all four pain rating scales (numerical rating scale, visual analogue scale, color analogue scale, faces rating scale) were compared to analyze correlation.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2019
Last Updated
January 20, 2020
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04231955
Brief Title
Comparison of Different Pain Rating Scales in Patients With Symptomatic Teeth
Acronym
CoPRS
Official Title
Comparison of Different Pain Rating Scales in Patients With Symptomatif Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Dental Pain
Keywords
numerical rating scale, visual analogue scale, color analogue scale, faces rating scale, pain intensity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all 50 patients marked their pain intensity levels of their relevant tooth in four different rating scales.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pain rating scales
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
numerical rating scale
Other Intervention Name(s)
NRS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
visual analogue scale
Other Intervention Name(s)
VAS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
color analogue scale
Other Intervention Name(s)
CAS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
faces rating scale
Other Intervention Name(s)
FRS
Intervention Description
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.
Primary Outcome Measure Information:
Title
numerical rating scale
Description
pain intesity level of patients were recorded on a scale from 0 (no pain) to 10 (worst pain posbile)
Time Frame
through study completion, an average of 1 year
Title
visual analogue scale
Description
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.
Time Frame
through study completion, an average of 1 year
Title
color analogue scale
Description
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.
Time Frame
through study completion, an average of 1 year
Title
faces rating scale
Description
faces rating scale consists of 6 faces with the first face indicating "no pain" and the last face indicating "worst pain possbile"
Time Frame
through study completion, an average of 1 year
Title
comparison of four rating scales
Description
all four pain rating scales (numerical rating scale, visual analogue scale, color analogue scale, faces rating scale) were compared to analyze correlation.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tan F EYUBOGLU, PhD, DDS
Organizational Affiliation
Assistant Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Medipol University School of Dentistry
City
Istanbul
ZIP/Postal Code
34083
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared.
Citations:
PubMed Identifier
16320034
Citation
Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
Results Reference
result
PubMed Identifier
8008411
Citation
Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217-226. doi: 10.1016/0304-3959(94)90097-3.
Results Reference
result
PubMed Identifier
3785962
Citation
Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
Results Reference
result
PubMed Identifier
7267140
Citation
Kremer E, Atkinson HJ, Ignelzi RJ. Measurement of pain: patient preference does not confound pain measurement. Pain. 1981 Apr;10(2):241-248. doi: 10.1016/0304-3959(81)90199-8.
Results Reference
result

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Comparison of Different Pain Rating Scales in Patients With Symptomatic Teeth

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