Reading Preoperatively to Reduce Anxiety in Day Surgery
Condition: Pre-operative Pediatric Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Reading program
Intervention type(s): Behavioral
Intervention description(s): Reading of children's story/picture books preoperatively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Anxiety; Pediatric Pain