- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT05329467
Validation of Pain Assessment Scale Faces Thermometer Scale (FTS)
Validation of Pain Assessment Tool FTS
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
The Faces Pain Scale-Revised (FPS-R) and Coloured Analogue Scale (CAS), two commonly used analogue pain scales for self-report with good validity and reliability in psychometric evaluations with children 8-17 years of age were used as golden standard for study 1. A systematic review found strong recommendation for the use of FPS-R and CAS for acute pain and weak endorsement for post-operative pain in children above the age of seven9.
Procedure A convenience sample of total of 600 children 8-17 years of age will be enrolled in four groups with 150 children in each group based on a power calculation Group 1: Children with no pain. Group 2: Children experiencing acute pain requiring pain treatment/pain management. Group 3: Children who will undergo medical procedures that are associated with pain, e.g., intramuscular injections, lumbar punctures, and wound care awakening and without strong sedatives. Group 4: Children who will undergo minor surgery. The data collection follows a predetermined study protocol, estimated time for data collection is six to twelve months at each site to fulfil power calculation requisites. Prior to data collection, a pilot study will be done with children (n=20) at Skåne University Hospital and the study protocol will be evaluated for cultural sensitivity with children (n=5) in each country. All assessments will be performed in the child's primary language. In all encounters the words "hurt" or "pain" will be used interchangeably, depending on what seem to be most understandable for each child. The attending nurse/physician will identify eligible study participants and provides the child and the child's caregivers with oral and written information about the study and seeks formal informed consent. The child will be allocated a personal study code. The code also determines the randomized order of pain assessment, i.e., FTS→FPS-R→CAS; CAS→FTS→FPS-R; FPS-R→CAS→FTS which will be used for all assessments by the child to avoid assessment bias. The nurse will present each of the three scales to the child in the same order as assigned to the particular child for the assessment. Data on pain assessment will be collected at specific time points according to which of the four groups it is (Figure 4).
Data from the digital FTS assessment will be transformed by the nurse and documented together with data from FPS-R and CAS into a coded individual paper study form. At all follow- up assessments the child will be asked if he/she experiences more, less, or about the same level of pain as at the previous assessment.
Psychometric properties in terms of validity and reliability of the FTS in relation to the FPS-R and the CAS in our study population will be determined by the use of comparative statistics. Most adequate tests (e.g., Pearson's or Spearman's correlation, regression analysis) will be chosen s depending on data distribution. For group 1 a cut-off score at 0-3 and for group 2 cut-off at 4-10 will be used.
Convergent validity will be assessed by determining correlations and agreement between the FTS, the FPS-R and the CAS for self-assessing pain in children. Discriminative validity (being part of convergent validity) will be assessed to determine to what extent the FTS actually measure only the construct pain, and not something else (e.g., anxiety) by comparing the initial mean FTS, FPS-R, and CAS scores in children with painful conditions, versus those with non-painful conditions. Construct validity (responsivity) in children with painful conditions will be determined by comparing the initial mean FTS, FPS-R, and CAS pain scores with their respective post-treatment pain score. Children with no pain will be assessed in a similar fashion and expect that there should be no difference between the initial and 30-45-minute scores. Reliability (the degree to which pain scores are consistent from one assessment to the next) will be assessed by test-retest analysis in the subgroup of children with painful conditions reporting that their pain is "about the same" both pre- and post-treatment.
Demographic data, e.g., age, sex, native spoken language and ethnicity will be collected through a questionnaire filled out by the child or caregiver. Data on diagnosis, reason for care and information on pain management between assessment one and two, will be collected through a questionnaire in the study form filled out by the nurse. Study forms will be collected from the site by the research group (local PI at each site) and transformed and stored at a secure digital database at Lund University.
Pain assessment will be performed two - four times each with all three scales. Their ratings are documented digitally via the FTS Webb browser on the tablet that provides the scale and by the analogous on a study protocol by the nurse for the two analogue scales. The children provide background data on a questionnaire at baseline. Consecutive sampling will be performed to include another 100 children in 8-17 for evaluation of anticipated pain by the use of the Charleston Paediatric Pain Pictures (CPPP). The child is asked to grade the anticipated level of pain that they associate the illustration on each picture with. The researcher will encourage the child to describe how they reach their decision using a "think-aloud" method. The child's reasoning will be recorded and transcribed verbatim and analysed using a phenomenographic method.
Tanulmány típusa
Beiratkozás (Várható)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: charlotte castor, phd
- Telefonszám: +46462221878
- E-mail: charlotte.castor@med.lu.se
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: stefan nilsson, ass prof
- E-mail: stefan.nilsson.4@gu.se
Tanulmányi helyek
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Linköping, Svédország
- Toborzás
- Universitetssjukhuset i Linköping
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Kapcsolatba lépni:
- Angelica Höök, RN
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Lund, Svédország, 22100
- Toborzás
- Skåne University Hospital
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Kapcsolatba lépni:
- Pernilla Stenström, dr, ass prof
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Egyéb: Validation
|
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
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Faces Thermometer Scale validity
Időkeret: Change in pain assessment at up to 4 hours
|
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.
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Change in pain assessment at up to 4 hours
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Faces Thermometer Scale content validity validity
Időkeret: Change in pain assessment at up to 4 hours
|
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
|
Color Analog Scale validity
Időkeret: Change in pain assessment at 4 hours
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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.
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Change in pain assessment at 4 hours
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Faces Pain Scale-Revised validity
Időkeret: Up to 15 min
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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.
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Up to 15 min
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: charlotte castor, phd, Lund University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- PR2020-0026
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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