Comparison of Different Pain Rating Scales in Patients With Symptomatic Teeth

Pain Clinical Trial

— CoPRS  

Official title:

Comparison of Different Pain Rating Scales in Patients With Symptomatif Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231955
• Other study ID #: 338
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 9, 2019

Study information

• Verified date: January 2020
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pain
• Pain
• Toothache

Intervention

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:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University School of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1:S17-24. Epub 2005 Dec 1. Review. — View Citation

Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-26. — View Citation

Kremer E, Atkinson JH, Ignelzi RJ. Measurement of pain: patient preference does not confound pain measurement. Pain. 1981 Apr;10(2):241-8. — View 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):217-26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numerical rating scale	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
Primary	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.	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Primary	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"	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year