A GameBoy as a Distraction Before Surgery in Children
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Preoperative anxiety is characterized by subjective feelings of tension, apprehension,
      nervousness and worry. In children, preoperative anxiety is reported to result in
      postoperative negative psychological effects, including nightmares, separation anxiety,
      eating problems and increased fear of doctors. Anxiety in children can be expressed in many
      forms. Many children look scared, become agitated, breathe deeply, tremble, and stop talking
      or playing and start to cry. They may unexpectedly urinate or may actively attempt to escape
      from the medical personnel. These reactions reflect the child's fear of separation from the
      parents, as well as loss of control, unfamiliar routines, instruments and hospital procedures
      [1].

      Previous studies have assessed anxiety in children during the preoperative period and the
      effects of premedication and parental presence during induction of anesthesia (PPIA) [2].
      Midazolam has been proven to reduce preoperative anxiety in children [3]. Side effects
      related to oral midazolam administered to healthy children are minimal and the drug can be
      reversed with flumazenil but post operative recovery may be delayed in those children
      undergoing a short surgical procedure. It is the experience of the investigator that there
      are some children who have such low levels of anxiety they do not require any intervention

      Distraction may be particularly helpful in children ages 6-12 as these children may not
      receive preoperative medication due to their curiosity about the environment. Previous
      studies regarding distraction therapy have focused on the parent either blowing bubbles or
      reading to a child [4]. Studies where the child is actively engaged in a distraction activity
      have not been documented.

      The purpose of this investigation is to determine whether in the presence of a parent an
      interactive distraction intervention, i.e. Game Boy which is a hand held video game, is as
      effective as preoperative Midazolam in reducing preoperative anxiety. This study may help in
      the search for a low cost and easy to implement method of reducing anxiety for children
      undergoing surgery.
    

Detailed description: 
      Preoperative anxiety is characterized by subjective feelings of tension, apprehension,
      nervousness and worry. In children, preoperative anxiety is reported to result in
      postoperative negative psychological effects, including nightmares, separation anxiety,
      eating problems and increased fear of doctors. Anxiety in children can be expressed in many
      forms. Many children look scared, become agitated, breathe deeply, tremble, and stop talking
      or playing and start to cry. They may unexpectedly urinate or may actively attempt to escape
      from the medical personnel. These reactions reflect the child's fear of separation from the
      parents, as well as loss of control, unfamiliar routines, instruments and hospital procedures
      [1].

      Previous studies have assessed anxiety in children during the preoperative period and the
      effects of premedication and parental presence during induction of anesthesia (PPIA) [2].
      Midazolam has been proven to reduce preoperative anxiety in children [3]. Side effects
      related to oral midazolam administered to healthy children are minimal and the drug can be
      reversed with flumazenil but post operative recovery may be delayed in those children
      undergoing a short surgical procedure. It is the experience of the investigator that there
      are some children who have such low levels of anxiety they do not require any intervention

      Distraction may be particularly helpful in children ages 6-12 as these children may not
      receive preoperative medication due to their curiosity about the environment. Previous
      studies regarding distraction therapy have focused on the parent either blowing bubbles or
      reading to a child [4]. Studies where the child is actively engaged in a distraction activity
      have not been documented.

      The purpose of this investigation is to determine whether in the presence of a parent an
      interactive distraction intervention, i.e. Game Boy which is a hand held video game, is as
      effective as preoperative Midazolam in reducing preoperative anxiety. This study may help in
      the search for a low cost and easy to implement method of reducing anxiety for children
      undergoing surgery.
    

Intervention name(s): midazolam or GameBoy or parental presence
Intervention type(s): Drug
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: presurgical anxiety, children,