NCT05322018 Validation of Faces Thermometer Scale (FTS)
| NCT ID | NCT05322018 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Malmö University |
| Condition | Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-05-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 8 to 17 years of age, undergoing dental procedures and/or examinations Exclusion Criteria: * cannot understand Swedish nor instructions on how to use the pain measure tools
Contact & Investigator
Gunilla Klingberg, Professor
STUDY CHAIR
Malmö University
Frequently Asked Questions
Who can join the NCT05322018 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05322018 currently recruiting?
Yes, NCT05322018 is actively recruiting participants. Contact the research team at rikard.roxner@mau.se for enrollment information.
Where is the NCT05322018 trial being conducted?
This trial is being conducted at Malmö, Sweden.
Who is sponsoring the NCT05322018 clinical trial?
NCT05322018 is sponsored by Malmö University. The principal investigator is Gunilla Klingberg, Professor at Malmö University. The trial plans to enroll 150 participants.