REducing Anxiety in CHildren Undergoing Procedures
Condition: Ambulatory Surgery
Study type: Interventional

Summary: 
      This is a small pilot, feasibility study designed as a quality improvement project. The
      purpose is to identify anxiety in children aged 4-12 years who will receive a sedated
      procedure and to see if the use of an iPad as a focused activity will decrease the level of
      anxiety through a small randomized control trial in the Children's Perioperative Unit.
    

Detailed description: 
      Description: The study is a quality improvement project and designed as a small pilot
      randomized control trial. Participants will be randomly assigned to either Group 1 (no
      intervention) or Group 2 (iPad intervention) via a number generator.

      Children randomized to Group 1 receive the standard of care with observation and scoring of
      the mYPAS-SF occurring at three time points (T1 pre-operative holding area-patient room which
      is private, T2 induction of anesthesia, T3 awakening from sedation post procedure).

      Children randomized to Group 2 will be observed at the same time points (T1, T2, T3) but will
      additionally interact with an iPad that has a selection of 3 games downloaded (3 games for
      children ages 4-7 and 3 games for children ages 8-12). The iPad is introduced in between T1
      and T2 and then resumed at T3 until discharge from the clinical unit.

      Process: Following IRB approval, the steps of the study are:

        1. . Subjects meeting inclusion criteria (age, first sedated procedure, English speaking)
           will be identified through daily review of scheduled patient lists by study team
           members. (CPU Nurse Champions, PI).

        2. . Potential subjects will be approached in a private area when they arrive for the
           procedure to make sure they meet the eligibility criteria. Information concerning the
           study will be presented by the CPU Nurse Champion, PI or Research Assistant.

        3. . If the family is interested in participating in the study, further explanation and
           consent and assent (as appropriate) will be obtained by the PI or the Research Assistant
           from the parent and the child.

        4. . A demographic questionnaire will be completed following project consenting and
           enrollment for both groups.

        5. . The mYPAS-SF (screening tool that requires a 30 second observation at three distinct
           time points) will be completed for both groups.

        6. . The iPad will be given to participants randomized to Group 2 T1- Child observed in the
           private holding room area (observation occurs after getting settled in the private room
           prior to the procedure)

      T2-Child observed prior to the induction of anesthesia (observation occurs just prior to the
      administration of anesthesia).

      T3-Child observed upon return to private holding area and awakening from anesthesia
      (observation occurs when child awakens from the anesthesia).
    

Intervention name(s): iPad with downloaded games
Intervention type(s): Other
Intervention description(s): iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT with a control arm equivalent to current standard of care and an intervention arm that includes standard of care plus the addition of an iPad with downloaded games.
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: pre-procedural anxiety; children; pediatric sedation