Validation of Pain Assessment Scale Faces Thermometer Scale (FTS)
1 other identifier
interventional
600
1 country
2
Brief Summary
The aim of the study was to psychometrically evaluate the electronic self assessment Faces Pain Scale (FPS). Validation is performed in relation to golden standard of pain scale assessments Faces Pain Scale Reversed (FPS-R) and Coloured analogue Scale (CAS). 600 children with a range of illnesses on various paediatric healthcare settings in Sweden, Island, Denmark and USA will be included. Pain assessment will take place postoperatively, in relation to procedures or in a setting where acute pain is identified.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Sep 2021
Typical duration for not_applicable pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2021
CompletedFirst Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 15, 2022
April 1, 2022
9 months
November 10, 2021
April 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Faces Thermometer Scale validity
The Faces Thermometer Scale is a digital pain measure tool, which allows individuals to rate pain experience on a scale from 0 to 10. A higher reading indicates higher pain intensity.
Change in pain assessment at up to 4 hours
Secondary Outcomes (3)
Faces Thermometer Scale content validity validity
Change in pain assessment at up to 4 hours
Color Analog Scale validity
Change in pain assessment at 4 hours
Faces Pain Scale-Revised validity
Up to 15 min
Study Arms (1)
Validation
OTHERInterventions
Participants are introduced to all three painscales and are asked to rate their pain with each and one of them according to instructions for each scale
Eligibility Criteria
You may qualify if:
- Children aged 8-17
- Typically developed child
- Child and caregiver with the ability to understand spoken Swedish
You may not qualify if:
- Children with unstable disease or in need of ICU
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
- Jonkoping Universitycollaborator
- Göteborg Universitycollaborator
Study Sites (2)
Universitetssjukhuset i Linköping
Linköping, Sweden
Skåne University Hospital
Lund, 22100, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
charlotte castor, phd
Lund University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2021
First Posted
April 15, 2022
Study Start
September 17, 2021
Primary Completion
June 1, 2022
Study Completion
December 1, 2022
Last Updated
April 15, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share