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Reading Preoperatively to Reduce Anxiety in Day Surgery

Primary Purpose

Pre-operative Pediatric Anxiety

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Reading program
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-operative Pediatric Anxiety focused on measuring Pediatric Anxiety, Pediatric Pain

Eligibility Criteria

2 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment

    Control

    Arm Description

    50% randomized to receive treatment: reading pre-operatively

    50% randomized to receive no intervention pre-operatively: no reading

    Outcomes

    Primary Outcome Measures

    Kuttner's face scale of anxiety for children
    Speilberger's State-Trait Anxiety Inventory (STAI) for the adults.

    Secondary Outcome Measures

    Conners' Parent Rating Scale - Revised - Hyperactive and Anxiety scores
    Data from Semi-Structured Qualitative Parental Interviews

    Full Information

    First Posted
    June 15, 2006
    Last Updated
    June 15, 2015
    Sponsor
    IWK Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00338325
    Brief Title
    Reading Preoperatively to Reduce Anxiety in Day Surgery
    Official Title
    A Randomized Trial Of Reading Preoperatively To Day Surgery Children To Reduce Anxiety and Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    April 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    IWK Health Centre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre-operative Pediatric Anxiety
    Keywords
    Pediatric Anxiety, Pediatric Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    50% randomized to receive treatment: reading pre-operatively
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    50% randomized to receive no intervention pre-operatively: no reading
    Intervention Type
    Behavioral
    Intervention Name(s)
    Reading program
    Intervention Description
    Reading of children's story/picture books preoperatively
    Primary Outcome Measure Information:
    Title
    Kuttner's face scale of anxiety for children
    Time Frame
    pre & post surgery
    Title
    Speilberger's State-Trait Anxiety Inventory (STAI) for the adults.
    Time Frame
    pre & post
    Secondary Outcome Measure Information:
    Title
    Conners' Parent Rating Scale - Revised - Hyperactive and Anxiety scores
    Time Frame
    pre
    Title
    Data from Semi-Structured Qualitative Parental Interviews
    Time Frame
    post surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick J. McGrath, PhD.
    Organizational Affiliation
    IWK Health Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Reading Preoperatively to Reduce Anxiety in Day Surgery

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