NCT05322018

Brief Summary

The aim of this study is to evaluate validity and reliability of a novel digital pain measure tool, the Faces Thermometer Scale (FTS). Pain is commonly reported by children and adolescents undergoing dental treatment. Pain is also a strongly contributing factor in the development of Dental Fear and Anxiety (DFA). Professionals often underestimate the pain perceived by their patients. Self-report tools are seldom used to measure pain in a clinical setting, denying child patients the possibility to communicate their pain experiences. The aim of this study is to evaluate validity and reliability of a digital self-report pain measure tool, the Faces Thermometer Scale (FTS). Children and adolescents (N=150) aged 8 to 17 years visiting a dental clinic will be asked to score their pain using three different self-report pain tools; FTS, Faces Pain Scale-Revised (FPS-R) and Color Analog Scale (CAS). The validity and reliability of FPS-R and CAS is long established and will therefore be used to evaluate the psychometric properties of FTS.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

3.6 years

First QC Date

February 9, 2022

Last Update Submit

May 14, 2025

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Faces Thermometer Scale

    The Faces Thermometer Scale is a digital pain measure tool, which allows individuals to rate pain on a scale from 0 to 10 at intervals of 1. A higher reading indicates higher pain intensity.

    Change in pain at up to 4 hours

Secondary Outcomes (2)

  • Faces Pain Scale-Revised

    Change in pain at up to 4 hours

  • Color Analog Scale

    Change in pain at up to 4 hours

Interventions

Faces Thermometer Scale (FTS)DIAGNOSTIC_TEST

The Faces Thermometer Scale (FTS) is a one-item measure with 11 numeric rating scale steps (0, no pain to 10, much pain). Each step is associated with different faces and colors. The app presents all information in text, sound, and picture. FTS is part of PicPecc, an application for mobile devices. The child/adolescent assesses their pain on a tablet by moving the finger on the scale and points to the color and face that represent their appraised level of pain.

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents, 8 to 17 years of age, undergoing dental procedures and/or examinations

You may qualify if:

  • to 17 years of age, undergoing dental procedures and/or examinations

You may not qualify if:

  • cannot understand Swedish nor instructions on how to use the pain measure tools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malmö University

Malmo, Skåne County, 205 06, Sweden

RECRUITING

Related Publications (11)

  • Ghanei M, Arnrup K, Robertson A. Procedural pain in routine dental care for children: a part of the Swedish BITA study. Eur Arch Paediatr Dent. 2018 Oct;19(5):365-372. doi: 10.1007/s40368-018-0368-2. Epub 2018 Sep 7.

    PMID: 30194611BACKGROUND

  • Smeland AH, Twycross A, Lundeberg S, Rustoen T. Nurses' Knowledge, Attitudes and Clinical Practice in Pediatric Postoperative Pain Management. Pain Manag Nurs. 2018 Dec;19(6):585-598. doi: 10.1016/j.pmn.2018.04.006. Epub 2018 May 16.

    PMID: 29778756BACKGROUND

  • Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

    PMID: 11427329BACKGROUND

  • Klingberg G, Vannas Lofqvist L, Bjarnason S, Noren JG. Dental behavior management problems in Swedish children. Community Dent Oral Epidemiol. 1994 Jun;22(3):201-5. doi: 10.1111/j.1600-0528.1994.tb01841.x.

    PMID: 8070250BACKGROUND

  • McGrath PA, Seifert CE, Speechley KN, Booth JC, Stitt L, Gibson MC. A new analogue scale for assessing children's pain: an initial validation study. Pain. 1996 Mar;64(3):435-443. doi: 10.1016/0304-3959(95)00171-9.

    PMID: 8783307BACKGROUND

  • Raadal M, Strand GV, Amarante EC, Kvale G. Relationship between caries prevalence at 5 years of age and dental anxiety at 10. Eur J Paediatr Dent. 2002 Mar;3(1):22-6.

    PMID: 12871013BACKGROUND

  • Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.

    PMID: 32694387BACKGROUND

  • Tsze DS, von Baeyer CL, Bulloch B, Dayan PS. Validation of self-report pain scales in children. Pediatrics. 2013 Oct;132(4):e971-9. doi: 10.1542/peds.2013-1509. Epub 2013 Sep 2.

    PMID: 23999954BACKGROUND

  • Versloot J, Veerkamp JS, Hoogstraten J. Assessment of pain by the child, dentist, and independent observers. Pediatr Dent. 2004 Sep-Oct;26(5):445-9.

    PMID: 15460301BACKGROUND

  • Wood C, von Baeyer CL, Falinower S, Moyse D, Annequin D, Legout V. Electronic and paper versions of a faces pain intensity scale: concordance and preference in hospitalized children. BMC Pediatr. 2011 Oct 12;11:87. doi: 10.1186/1471-2431-11-87.

    PMID: 21989306BACKGROUND

  • Beyer JE, McGrath PJ, Berde CB. Discordance between self-report and behavioral pain measures in children aged 3-7 years after surgery. J Pain Symptom Manage. 1990 Dec;5(6):350-6. doi: 10.1016/0885-3924(90)90029-j.

    PMID: 2269802BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gunilla Klingberg, Professor

    Malmö University

    STUDY CHAIR

Central Study Contacts

Rikard Roxner, PhDstudent

CONTACT

+46406658480rikard.roxner@mau.se

Henrik Berlin, PhD

CONTACT

+46406658488henrik.berlin@mau.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2022

First Posted

April 11, 2022

Study Start

May 1, 2022

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)