Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery
12. mars 2020 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
98
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Haifa, Israel, 3498838
- University of Haifa, The Clinical Pain Innovation Lab
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
8 år til 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Quality of pain intensity scores based on the concordance between pain reports on different scales.
Tidsramme: 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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The difference between children assessment vs. nurses assessment.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. juni 2019
Primær fullføring (Faktiske)
20. november 2019
Studiet fullført (Faktiske)
21. november 2019
Datoer for studieregistrering
Først innsendt
8. mars 2020
Først innsendt som oppfylte QC-kriteriene
12. mars 2020
Først lagt ut (Faktiske)
13. mars 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 0091-19-RMB
Plan for individuelle deltakerdata (IPD)
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