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Reading Preoperatively to Reduce Anxiety in Day Surgery

15 juni 2015 bijgewerkt door: IWK Health Centre

A Randomized Trial Of Reading Preoperatively To Day Surgery Children To Reduce Anxiety and Pain

This study is designed to implement the reading of age appropriate books by a trained reader into the waiting area of a pediatric day surgery unit to determine if it is effective at reducing the anxiety and pain levels of parents and children by providing a safe and calming activity for the child. This is a single-centre trial based at the IWK Health Centre. The primary outcome will be based on the anxiety and pain scores of the research participants.

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Gedetailleerde beschrijving

The purpose of this study is 1. to investigate the child and parental anxiolytic effects of reading age-appropriate books by Read To Me readers to the children in the waiting room of day surgery units 2. to investigate if parents use reading to assist their children during their recovery period at home and the impact of this effort. Participants will be asked to report their feelings of anxiety before and after being read to using Kuttner's face scale of anxiety and Speilberger's State-Trait Anxiety Inventory (STAI) for the adults. If the child is less than 5 years of age, a proxy measure of child anxiety will be taken. The anxiety measures will be taken immediately after consent is obtained and then will be taken again 20-60 minutes later. The exact time the second measure is taken after initial anxiety measurements will be recorded. This procedure will be used for both experimental and control groups. Parents will also be asked to fill out Conners' Parent Rating Scale - Revised to assess the usual temperament of their child. Parents and children will be approached to participate in the present study. Consent to be read to and consent to participate in the study will be separated. Families may consent to be read to without consenting to the research. As is the routine in other areas of the hospital, parents will be verbally asked for consent to read to their children by the Read To Me staff. Two trained readers from the Read To Me program at the IWK Health Centre will provide the reading of age-appropriate books to participants in the experimental group.

Research personnel will obtain written consent for participation in the research. The Read To Me activities will include being read to and receiving an activity bag with an age-appropriate paper back book chosen by experienced literacy practitioners, a related craft and literacy activity the child can complete at home after reading the story and a brochure for parents which lists age-specific literacy skills, recommended book lists and reading tips which explain how to share books with children.

Parents will then be asked a few questions in a semi structured qualitative interview regarding their experience in the waiting room. Two days after surgery a follow up interview will take place on the telephone that will include information the parents recorded in the diary they were given at the time of participation in the study. Parents will be given the diary at the time of consent where the child's pain with activity (2-3 times daily), the child's anxiety (2-3 times daily) and the use of distracters during recovery can all be recorded.

Two hundred and fifty two day surgery patients and their parents were assessed for eligibility. 52 refused to participate and 2 parents withdrew from the study because they were not interested in continuing with the research. Two hundred children and their parents were recruited for participation and were randomly assigned by cluster determined by the day they came to surgery to either the control or the experimental group. One hundred and eighteen participants were allocated to the experimental group while eighty-two participants were allocated to the control group.

Both groups will be evaluated for outcome results and will be compared to determine if there is a difference in the anxiety and pain scores collected for each group. It is expected that the children who were in the reading group will report less anxiety and pain during day surgery and during recovery than the children who received usual care.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

200

Fase

  • Fase 2

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 jaar tot 8 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 2-8 years old and their parents
  • who are undergoing Day Surgery at the IWK Health Centre will be eligible to participate in this study.

Exclusion Criteria:

  • children of parents who have not consented to participation in the study will be ineligible to participate.
  • Any parent or child not having a signed authorization form will be ineligible to participate.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment
50% randomized to receive treatment: reading pre-operatively
Reading of children's story/picture books preoperatively
Geen tussenkomst: Control
50% randomized to receive no intervention pre-operatively: no reading

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Kuttner's face scale of anxiety for children
Tijdsspanne: pre & post surgery
pre & post surgery
Speilberger's State-Trait Anxiety Inventory (STAI) for the adults.
Tijdsspanne: pre & post
pre & post

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Conners' Parent Rating Scale - Revised - Hyperactive and Anxiety scores
Tijdsspanne: pre
pre
Data from Semi-Structured Qualitative Parental Interviews
Tijdsspanne: post surgery
post surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Patrick J. McGrath, PhD., IWK Health Centre

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2005

Primaire voltooiing (Werkelijk)

1 juni 2005

Studie voltooiing (Werkelijk)

1 april 2006

Studieregistratiedata

Eerst ingediend

15 juni 2006

Eerst ingediend dat voldeed aan de QC-criteria

15 juni 2006

Eerst geplaatst (Schatting)

20 juni 2006

Updates van studierecords

Laatste update geplaatst (Schatting)

16 juni 2015

Laatste update ingediend die voldeed aan QC-criteria

15 juni 2015

Laatst geverifieerd

1 juni 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 3317
  • IWK studentship award

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Reading program

3
Abonneren