PainCoPRSNCT04231955
Comparison of Different Pain Rating Scales in Patients With Symptomatic Teeth
A study testing numerical rating scale, visual analogue scale and color analogue scale in people with Pain and Dental Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Dental Pain
- What is being tested?
- numerical rating scale, visual analogue scale and color analogue scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 9 Dec 2019
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- symptomatic teeth which is in need of root canal treatment
Who cannot join
- systemic diseases
- age <18 and >80
- being able to understand and accept the study protocol with a written consent form.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University School of Dentistry
Istanbul, 34083
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Dental Pain
- Being tested
- numerical rating scale, visual analogue scale, color analogue scale, faces rating scale
- Keywords
- numerical rating scale, visual analogue scale, color analogue scale, faces rating scale, pain intensity
- Medical subject headings
- Pain, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
numerical rating scaleDiagnostic test
Also called NRS
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.
visual analogue scaleOther
Also called VAS
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 scaleOther
Also called CAS
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 scaleOther
Also called FRS
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.
| Study group | Role | What they receive |
|---|---|---|
| pain rating scales | Experimental | 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. Receives: Diagnostic Test: numerical rating scale; Other: visual analogue scale; Other: color analogue scale; Other: faces rating scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale
pain intesity level of patients were recorded on a scale from 0 (no pain) to 10 (worst pain posbile)
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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"
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 May 2019
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all 50 patients marked their pain intensity levels of their relevant tooth in four different rating scales.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Firat Eyuboglu, Istanbul Medipol University Hospital
- Investigators
- Tan F EYUBOGLU, PhD, DDS, Study chair, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231955
- Sponsor's protocol ID
- 338
- Acronym
- CoPRS
- Status last verified
- Jan 2020
- First submitted
- 9 Dec 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Publications
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.
PubMed 16320034Price 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.
PubMed 8008411Jensen 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.
PubMed 3785962Kremer 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.
PubMed 7267140
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Pain Rating Scales in Patients With Symptomatif Teeth
- ClinicalTrials.gov ID
- NCT04231955
- Acronym / sponsor ID
- CoPRS / 338
- Conditions
- Pain, Dental Pain
- Keywords
- numerical rating scale, visual analogue scale, color analogue scale, faces rating scale, pain intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 18 Jan 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all 50 patients marked their pain intensity levels of their relevant tooth in four different rating scales.
| Arm | Type | Receives |
|---|---|---|
| pain rating scales | Experimental | Diagnostic Test: numerical rating scale, Other: visual analogue scale, Other: color analogue scale, Other: faces rating scalepatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic teeth which is in need of root canal treatment
Key exclusion criteria (3 listed)
- systemic diseases
- age <18 and >80
- being able to understand and accept the study protocol with a written consent form.
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 |
|---|---|---|
| numerical rating scaleAlso: NRSpatients 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. | Diagnostic test | pain rating scales |
| visual analogue scaleAlso: VASPatients 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 | pain rating scales |
| color analogue scaleAlso: CASPatients 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 | pain rating scales |
| faces rating scaleAlso: FRSPatients 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 | pain rating scales |
Primary outcome
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)
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.
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.
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"
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.
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 2020.
- Results publication: PubMed 16320034Haefeli 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 publication: PubMed 8008411Price 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 publication: PubMed 3785962Jensen 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 publication: PubMed 7267140Kremer 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.
- Individual participant dataSharing planned: No. IPD will not be shared.
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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.
Tan F EYUBOGLU, PhD, DDS study chair
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing numerical rating scale, visual analogue scale and color analogue scale in people with Pain and Dental Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 3 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 2020. 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 Turkey (Türkiye). 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?
numerical rating scale (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04231955, which also lists 4 linked publications.
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 2020.