Clinical Trial: Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Cartoon Distraction and Parental Presence During Induction of Anesthesia on Preoperative Anxiety and Postoperative Behavior Change in Children Undergoing General Anesthesia
Brief Summary: Nearly 50% of young children undergoing surgery exhibit high level of anxiety during induction of anesthesia because of exposure to unfamiliar environment and people and separation from parents. Increased preoperative anxiety may impact postoperative behavior changes such as emergence agitation, separation anxiety and sleep disturbance. Although some pediatric anesthesiologists routinely permit parental presence to reduce the anxiety during induction of anesthesia, previous studies have reported conflicting results. Recently the distraction using video game or animated cartoon has been reported to reduce anxiety of young children during induction of anesthesia. However, it was still undetermined whether distraction has its own ability to reduce children's anxiety separated from parental presence because they evaluated the effect of video method in the parental presence. The investigators design to investigated the efficacy of distraction with watching cartoon, parental presence and combined with watching cartoon and parental presence on reduction of anxiety during inhalational induction of anesthesia using sevoflurane. In addition this study includes long-term effect of each intervention such as postoperative emergence agitation and postoperative behavior change in children.
Detailed Summary: This study is different from previous reports as follow. First, investigators separate the effect of cartoon distraction and parental presence on minimizing preoperative anxiety and determine whether an interaction between two different interventions is existent. Second, investigators evaluate the effect of preoperative anxiety on the long-term behavioral change of children. It was not clarified yet in clinical practice. Third, investigators evaluate the effect of each intervention on parental anxiety before and after induction of anesthesia.
Sponsor: Yeungnam University College of Medicine
Current Primary Outcome: Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction [ Time Frame: 1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane ]
The investigators measure change in anxiety of children using Modified Yale Preoperative Anxiety scale (m-YPAS): Scale changes from Activities, Vocalization, Expressing emotions, State of arousal, Interaction with family members.
Each domain received a partial score based on the punctuation observed divided by the number of categories of that domain. The score of each domain is added to the others
Total scores ranged from 23.4 to 100 The scores considered "cut points" to determine whether a patient had/had not anxiety were 23
- Without anxiety: 23.4 e 30
- With anxiety: greater than 30.
Original Primary Outcome: Change from baseline anxiety at induction of anesthesia [ Time Frame: 1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane ]
Current Secondary Outcome: Change From Baseline Parental Anxiety at Postinduction of Anesthesia [ Time Frame: 1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia ]
The investigators measure change of parental anxiety using State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a psychological inventory and consists of 40 questions on a self-report basis.
The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.
Higher scores are positively correlated with higher levels of anxiety.
Each type of anxiety has its own scale of 20 different questions that are scored.
Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Original Secondary Outcome: Change From Baseline Parental Anxiety at Postinduction of Anesthesia [ Time Frame: 1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia ]
Information By: Yeungnam University College of Medicine
Dates:
Date Received: December 30, 2013
Date Started: December 2013
Date Completion:
Last Updated: October 4, 2015
Last Verified: October 2015
