Distraction and Nitrous Oxide for Venous Puncture (DISPO)
Comparison in Anxiety and Pain Scores Between Distraction and Nitrous Oxide for Procedural Pain in Children Aged 3 to 9 Years : a Randomized Clinical Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The study is aiming at demonstrating the efficacy of active distraction by an iPad on the anxiety consequent to venipuncture and insertion of a peripheral vein catheter. The comparator is nitrous oxide in a 50% mixture with oxygen that is routinely used for sedation during procedural pain. However, nitrous oxide has secondary effects particularly on the inhibition of Vitamin B12.
The primary outcome is anxiety scores. Secondary outcomes are pain scores and satisfaction of parents and health providers.
All children will have EMLA cream (mixture prilocaine and lidocaine) applied one hour prior to venous punction. Anxiety, pain and satisfaction scores will be recorded at baseline and then within an hour following the venipuncture and insertion of the peripheral vein catheter.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Geneva, Sveits, 1206
- Geneva Children's Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Venous track needed
- French mother tongue
- Age between 3 and 9 years old
Exclusion Criteria:
- Children with cognitive disorder (autism, metabolic disorders,
- Children with cerebral-motor disability
- Children who don't speak french
- Children with ADHD treatment
- Children with epilepsy
- Children who present contraindication to the use of Nitrous oxide
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: iPad distraction
Children of this group will receive the iPad when the nurse will prepare the material for the venous track. They will choose a game adapted to their age and will be able to play it during all the procedure time. Intervention : game on iPad |
Many games will be programmed on the iPad and organized by age.
The child will choose one game and play it during all the procedure time.
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Aktiv komparator: Nitrous Oxide
Children of this group will receive the Nitrous Oxide 3 minutes before the intervention (venous track). They will keep the mask during all the procedure time. Intervention : Nitrous Oxide |
Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Anxiety score
Tidsramme: From one hour prior to venous puncture until 1 hour afterwards
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Anxiety level measured by a scale (modified Yale Preoperative Anxiety Scale) measured at baseline, during the venous puncture and one hour afterwards.
The scale scores from a minimum of 5 (no anxiety) to 22 (extremely anxious).
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From one hour prior to venous puncture until 1 hour afterwards
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain score
Tidsramme: From one hour prior to venous puncture until 1 hour afterwards
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Pain intensity level will be measured at baseline, during the venous puncture and one hour afterwards, by a scale (Visual analog scale), which includes a score of 0 (no Pain) to 10 (worse pain).
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From one hour prior to venous puncture until 1 hour afterwards
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Satisfaction score
Tidsramme: From time of venous puncture until 1 hour afterwards
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Satisfaction of parents and care givers about the cares given to the child using a rating scale from 1(not satisfied at all) to 10 (extremely satisfied).
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From time of venous puncture until 1 hour afterwards
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Manon Cadoux, Student, University of Geneva
- Hovedetterforsker: Virginie Luscher, Student, University of Geneva
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- in progress (Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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