Pain Clinical Trial
Official title:
Validation of Pain Assessment Tool FTS
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility | Inclusion Criteria: - Children aged 8-17 - Typically developed child - Child and caregiver with the ability to understand spoken Swedish Exclusion Criteria: • Children with unstable disease or in need of ICU |
Country | Name | City | State |
---|---|---|---|
Sweden | Universitetssjukhuset i Linköping | Linköping | |
Sweden | Skåne University Hospital | Lund |
Lead Sponsor | Collaborator |
---|---|
Lund University | Göteborg University, Jonkoping University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Faces Thermometer Scale content validity 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 | Color Analog Scale validity | The Color Analog Scale is an analog pain measure tool, which allows individuals to rate pain experience on a scale 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. | Change in pain assessment at 4 hours | |
Secondary | Faces Pain Scale-Revised validity | The Faces Pain Scale-Revised is an analog pain measure tool, which allows individuals to rate pain experience on a scale from 0 to 10 at intervals of 2. A higher reading indicates higher pain intensity. | Up to 15 min |
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