Clinical trial NCT02027844: Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia
Official title: Cartoon Distraction and Parental Presence During Induction of Anesthesia on Preoperative Anxiety and Postoperative Behavior Change in Children Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety, Separation
Psychomotor Agitation
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 117
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1 and 2
2. 1-7 years old.
3. elective, single minor surgery under general anesthesia

Exclusion Criteria:

1.Chronic illness, psychological or emotional disorder, abnormal cognitive development 2.Previous anesthetic experience 3.Closure both eyes after surgery 4.Sedative medication or psychoactive drugs medication, 5.History of allergy to the drugs used in our study 6.Expected difficult intubation or respiration such as abnormal airway, reactive airway disease, upper respiratory infection in recent 3 weeks

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Primary outcomes:
measure: Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction
timeFrame: 1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane
Secondary outcomes:
measure: Change From Baseline Parental Anxiety at Postinduction of Anesthesia
timeFrame: 1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia
Other outcomes:
measure: Postoperative Emergence Delirium
timeFrame: at 20 minute in postanesthetic care unit
measure: Postoperative Behavioral Changes
timeFrame: 1. postoperative 2 days, 2 postoperative 14 days
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
Study officials:
affiliation: Yeungnam University College of Medicine
name: Sung Mee Jung, MD
role: PRINCIPAL_INVESTIGATOR
References: