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Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

12. februar 2013 opdateret af: Geir Hoff, Sykehuset Telemark
The purpose of this study is to establish reliability and validity of the Norwegian version of the Comfort behavioral scale.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Structured pain assessment is the foundation for the management of pain. Several different pain measurement tools exists, among them the Comfort behavioral scale (van Dijk, 2005), developed from the original Comfort scale (Ambuel, 1992). The psychometric properties of the Comfort scale have been tested in several studies, but so far no Norwegian version of the scale has been developed and tested. Neither has the scale been tested in spontaneously breathing children undergoing minor surgery. The aim of this study is to establish incipient psychometric properties of the Norwegian version of the scale among children aged 0-3 years admitted for elective minor surgery.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Norge
    • Telemark
      • Skien, Telemark, Norge, N-3710
        • Telemark Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 måneder til 3 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Children admitted to Telemark Hospital (level II hospital) and meeting the inclusion and exclusion criteria specified

Beskrivelse

Inclusion Criteria:

  • Younger than 3 years old at the time of surgery
  • Day care patients admitted for minor elective surgery

Exclusion Criteria:

  • Pre-entry use of sedation and/or analgesics
  • Neurological or other diseases or drugs (neuromuscular blockers) thet significantly influence motor activity, facial expression, cognition, or emotional state, ex. cerebral palsy, myopathy, severe mental retardation, severe hypotonia, neuromuscular disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Increase in Comfort behavioral scale score
Tidsramme: Within 24 hours after admission to the hospital for surgery
Testing the hypothesis that there will be a clincal significant increase in Comfort-score when the scores from admission and after surgery are compared. The highest registered score obtained during the first 24 hours after surgery will be used for this analysis. We assume that the score at admission reflects no pain/sedation, while the scores after surgery reflect varying degree of pain
Within 24 hours after admission to the hospital for surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Convergent validity of the Comfort behavioral scale
Tidsramme: Within 24 hours after admission to the hospital for surgery
The correlations between each of the items of the scale and between each item and the overall Comfort behavioral scale-score will be calculated
Within 24 hours after admission to the hospital for surgery
Inter-rater reliability of the Comfort behavioral scale
Tidsramme: Within 24 hours after admission to the hospital for surgery
Calculate the inter-rater reliability among nurses for the Norwegian version of the Comfort behavioral scale
Within 24 hours after admission to the hospital for surgery
Reduction in Comfort behavioral scale score (2)
Tidsramme: Within 24 hours after admission to the hospital for surgery
Testing the hypothesis that there will be a clinically significant reduction in Comfort-score when the scores from after the administration of pre-medication and after surgery when the child still has a laryngeal mask in place is compared. We assume that the score after premedication is given reflects a light sedation while the scores after surgery when the child still has a laryngela mask in place reflects deep sedation.
Within 24 hours after admission to the hospital for surgery
Reduction in Comfort behavioral scale score (1)
Tidsramme: Within 24 hours after admission to the hospital for surgery
Testing the hypothesis that there will be a clincal significant reduction in Comfort-score when the scores from admission and after the administration of pre-medication are compared. We assume that the score at admission reflect no pain/sedation, while the scores after pre-medication is given reflect sedation
Within 24 hours after admission to the hospital for surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sykehuset Telemark

Samarbejdspartnere

Karolinska Institutet

Efterforskere

  • Studiestol: Leena Jylli, PhD, Karolinska Institutet

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Faktiske)

1. september 2011

Studieafslutning (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

3. august 2010

Først indsendt, der opfyldte QC-kriterier

12. august 2010

Først opslået (Skøn)

13. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. februar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2013

Sidst verificeret

1. februar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2010/1268 (REK)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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