Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

NCT ID: NCT02027844

Last Updated: 2015-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Anxiety, Separation Psychomotor Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cartoon

cartoon watching by children during inhalational induction of anesthesia in the operating room

Group Type EXPERIMENTAL

Cartoon

Intervention Type BEHAVIORAL

Cartoon watching by children during inhalational induction of sevoflurane

Paretnal presence

parental presence with their children during inhalational induction of anesthesia in the operating room

Group Type ACTIVE_COMPARATOR

parental presence

Intervention Type BEHAVIORAL

parental presence during inhalational induction of sevoflurane

Combined

parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room

Group Type EXPERIMENTAL

Cartoon

Intervention Type BEHAVIORAL

Cartoon watching by children during inhalational induction of sevoflurane

parental presence

Intervention Type BEHAVIORAL

parental presence during inhalational induction of sevoflurane

Interventions

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Cartoon

Cartoon watching by children during inhalational induction of sevoflurane

Intervention Type BEHAVIORAL

parental presence

parental presence during inhalational induction of sevoflurane

Intervention Type BEHAVIORAL

Other Intervention Names

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Cartoon watching by children

Eligibility Criteria

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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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Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sung Mee Jung

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung Mee Jung, MD

Role: PRINCIPAL_INVESTIGATOR

Yeungnam University College of Medicine

Locations

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Yeungnam University Hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/23051880

Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia

http://www.ncbi.nlm.nih.gov/pubmed/23011563

Cartoon distraction alleviates anxiety in children during induction of anesthesia

Other Identifiers

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JUNG999ANXIETY

Identifier Type: -

Identifier Source: org_study_id

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