Skip to main content
Clinical Trials/NCT02027844
NCT02027844
Completed
Not Applicable

Cartoon Distraction and Parental Presence During Induction of Anesthesia on Preoperative Anxiety and Postoperative Behavior Change in Children Undergoing General Anesthesia

Yeungnam University College of Medicine1 site in 1 country117 target enrollmentStarted: December 2013Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
117
Locations
1
Primary Endpoint
Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
1 Year to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) physical status 1 and 2
  • 1-7 years old.
  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change From Baseline Parental Anxiety at Postinduction of Anesthesia(1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sung Mee Jung

Associate professor

Yeungnam University College of Medicine

Study Sites (1)

Loading locations...

Similar Trials