- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00535457
The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
It is not uncommon for children to undergo surgery. Surgery is a threatening event that is composed of various stress-provoking stimuli. Pre-operative anxiety is a common emotional response among operated children and their parents. In the current study we are going to examine if tricks done by the anesthesiologist before anesthetic induction are equally as effective as oral midazolam premedication in the reduction of pre-operative anxiety in children before and after surgery. A successful anxiety reduction may be advantageous over pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay and by reducing postoperative maladaptive behavior rate.
Study hypothesis: 1. similar anxiety scores will be observed in children that will watch their anesthesiologist performing tricks and in those who will receive oral midazolam premedication but no tricks.
2. Similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.
Studieoversikt
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
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Tel Hashomer, Israel, 52621
- Sheba Medical Center
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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:
- age 3-12 years
- minor surgeries / diagnostic procedures such as endoscopy, biopsy
Exclusion Criteria:
- children that do not speak Hebrew
- American Society of Anesthesiologists (ASA) status above II
- a need for regional anesthesia only
- a need for an intravenous (IV) cannulation at the induction room or operating room before the induction of anesthesia.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
Children will watch tricks ("magic") before anesthesia induction
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Watching "magic"; Study patients will watch the anesthesiologist performing tricks ("magic") before anesthesia induction.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
anxiety scores
Tidsramme: Technical problems with video-taping of the patients still avoid us from recruiting patients. Therefore, the time frame of the study is still unclear tome.
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Technical problems with video-taping of the patients still avoid us from recruiting patients. Therefore, the time frame of the study is still unclear tome.
|
postoperative maladaptive behavior rate
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Sekundære resultatmål
Resultatmål |
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preoperative anxiety scores and rate of postoperative maladaptive behavior
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ze'ev Shenkman, MD, Sheba Medical Center
Studierekorddatoer
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
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
- SHEBA-07-4786-ZS-CTIL
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