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Completed

NCT Number: NCT02027844

Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

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.

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Key information

Conditions

Anxiety, Separation Aberrant Motor Behavior in Dementia Anxiety Disorders Behavior Behavioral Symptoms Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeungnam University Hospital

Daegu, 705-717, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Cartoon

Behavioral

Cartoon watching by children during inhalational induction of sevoflurane

Other names: Cartoon watching by children

parental presence

Behavioral

parental presence during inhalational induction of sevoflurane

Primary outcomes

  1. 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

  1. 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.

Other outcomes

  1. Postoperative Emergence Delirium

    Time frame: at 20 minute in postanesthetic care unit

    The investigators measure postoperative emergence delirium of children after recovery of anesthesia using Children's Hospital of Eastern Ontario Pain(CHEOP) Scale at 20 minute in postanesthetic care unit

    The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort.

    CHEOPS pain score = SUM(points for all 6 parameters) : Cry, facila, Child verbal, Torso, Touch, legs

    Interpretation:

    • minimum score: 4 = no pain
    • maximum score: 13 = the worst pain

    When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present.

  2. Postoperative Behavioral Changes

    Time frame: 1. postoperative 2 days, 2 postoperative 14 days

    The investigators measure negative postoperative behavioral change of children after discharge of postanesthetic care unit using posthospital behavioral questionnaires( PHBQ ) at postoperative day (POD) 1 by visiting and followed at POD 14 by phone interview.

    The PHBQ consists of 27 items concerning sleep, eating, anxiety, aggressive behaviour, etc.

    The subscales were: general anxiety and regression, separation anxiety, anxiety about sleep, eating disturbance, aggression towards authority, and withdrawal.

    Negative behavior change was evaluated in 6 subscales categories. If more than one negative behavior change developed, the investigators calculated number of children who developed new-onset negative behavior change.

Sponsors and collaborators

Lead sponsor

Yeungnam University College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2014
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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