Health TrialsbyHealthPanel

Validation of Faces Thermometer Scale (FTS)

ConditionPain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-17
SponsorMalmö University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
Change in pain at up to 4 hours

Secondary outcomes

1

Faces Pain Scale-Revised

The Faces Pain Scale-Revised is an analog pain measure tool, which allows individuals to rate pain on a scale from 0 to 10 at intervals of 2. A higher reading indicates higher pain intensity.

Time frame
Change in pain at up to 4 hours
2

Color Analog Scale

The Color Analog Scale is an analog pain measure tool, which allows individuals to rate pain on a continuous scale, which for the observer corresponds to a scale from 0 to 10 at intervals of 0.25. A higher reading indicates higher pain intensity.

Time frame
Change in pain at up to 4 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Malmö University

Lead sponsor

Lund University

Collaborator

Source ClinicalTrials.gov
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