Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery
12 mars 2020 uppdaterad av: University of Haifa
Treating pain, just as treating other medical conditions, depends on accurate assessment of patient's condition. When assessing pain, as other subjective symptoms, the challenge is twofold because the assessment is dependent on patient's understanding and use of the scale, all the more so in children
So far, attempts to improve pain assessments have been focused on the development and refining pain scales. No emphasis has been placed on improving patient's ability to report their pain. Our purpose is to evaluate a training program designed to improve the quality of children's post-surgical pain intensity reports.
After receiving Helsinki approval, eligible children and their parents will signed informed-consent. After surgery, the children, their parents, and the department nurses will assess children's pain intensity. Immediately after the nurse assessment, parents will assess their child's pain (blindly and independently) and the children will report their pain on four different pain scales.
Children aged 8-17, hospitalized in Rambam medical-center for elective surgery will be invited to participate. Children in the experimental group will be exposed to a training program, developed for this study, aimed to teach and train how to report pain. The control group will receive the standard pre-surgical instructions.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
98
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Haifa, Israel, 3498838
- University of Haifa, The Clinical Pain Innovation Lab
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
8 år till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- children at age 8-17 years;
- absence of psychiatry, cognitive, and/or neurological disorders;
- understand the purpose and the instructions of the study, agree to participate and parent signed inform consent.
Exclusion Criteria:
1. children suffering from Post traumatic stress disorder.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Interventional arm
The intervention, which was aimed to educate children on how to use pain scales and provide reliable pain assessments was based on a two short animation clips, lasting approximately 5 min each, and a short (5 min) guided interaction between the study nurse and the participants, in between the two clips.
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The first animation clip focuses on the importance of pain assessment introduce three pain scales (categorical, NPS and faces) followed by explanations on their properties and on the appropriate way to use them.The second movie was aimed to provide an opportunity to implement the new knowledge in case studies
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Övrig: Control
Children underwent the routine pre-operative preparations, which included a section on pain assessment.
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Routine preoperative preparations, which included a section on pain assessment instructions.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Quality of pain intensity scores based on the concordance between pain reports on different scales.
Tidsram: Pain intensity rating before analgesic consumption.
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The average difference between scores reported on the different scales was calculated as follows: The difference between to pain scores reported on each possible pairs of two scales was calculated in absolute values.
The average difference of the 6 pairs was calculated.
The 5-point CAT was transformed into a 0-10 scale by multiplying its values by 2.5.
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Pain intensity rating before analgesic consumption.
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Quality of pain intensity scores based on the concordance between pain reports on different scales.
Tidsram: Pain intensity rating one hour after analgesic consumption.
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The average difference between scores reported on the different scales was calculated as follows: The difference between to pain scores reported on each possible pairs of two scales was calculated in absolute values.
The average difference of the 6 pairs was calculated.
The 5-point CAT was transformed into a 0-10 scale by multiplying its values by 2.5.
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Pain intensity rating one hour after analgesic consumption.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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The difference between children assessment vs. nurses assessment.
Tidsram: NPS ratings before and one hour after analgesic consumption
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The difference between children pain assessment vs. nurses assessment on a 0-10 numerical pain scale (NPS), in which 0 indicates "no pain" and 10 "the worst pain imaginable."
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NPS ratings before and one hour after analgesic consumption
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The average difference between children assessment vs. parents.
Tidsram: NPS ratings before and one hour after analgesic consumption
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The difference between children pain assessment vs. parents assessment on a 0-10 numerical pain scale (NPS), in which 0 indicates "no pain" and 10 "the worst pain imaginable."
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NPS ratings before and one hour after analgesic consumption
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The average decrease in pain following analgesia: NPS
Tidsram: NPS ratings before and one hour after analgesic consumption
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The average decrease in pain following analgesic consumption (Delta NPS) based on a 0-10 numerical pain scale (NPS), in which 0 indicates "no pain" and 10 "the worst pain imaginable."
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NPS ratings before and one hour after analgesic consumption
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Quality of pain intensity scores based on the concordance between pain reports on different scales.
Tidsram: Pain intensity ratings before analgesic consumption.
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The within-subjects standard deviation (SD) between the 4 pain scores (provided at the same time of assessment).
To assure that variability will be appropriately reflected by this measure, subjects who reported only "0" or only "10" in all 4 scales were excluded from this analysis due to potential bias of the within-subjects SD due to floor or ceiling effects.
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Pain intensity ratings before analgesic consumption.
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Quality of pain intensity scores based on the concordance between pain reports on different scales.
Tidsram: Pain intensity ratings one hour after analgesic consumption.
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The within-subjects standard deviation (SD) between the 4 pain scores (provided at the same time of assessment).
To assure that variability will be appropriately reflected by this measure, subjects who reported only "0" or only "10" in all 4 scales were excluded from this analysis due to potential bias of the within-subjects SD due to floor or ceiling effects.
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Pain intensity ratings one hour after analgesic consumption.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 juni 2019
Primärt slutförande (Faktisk)
20 november 2019
Avslutad studie (Faktisk)
21 november 2019
Studieregistreringsdatum
Först inskickad
8 mars 2020
Först inskickad som uppfyllde QC-kriterierna
12 mars 2020
Första postat (Faktisk)
13 mars 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 mars 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 mars 2020
Senast verifierad
1 mars 2020
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 0091-19-RMB
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