Pre-operative Pediatric Anxiety Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment