Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

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

Study Overview

• Status: Completed
• Conditions: Psychomotor Agitation; Anxiety, Separation
• Intervention / Treatment: Behavioral: Cartoon; Behavioral: parental presence

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 Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 705-717
    • Yeungnam University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cartoon; cartoon watching by children during inhalational induction of anesthesia in the operating room	Behavioral: Cartoon; Cartoon watching by children during inhalational induction of sevoflurane; Other Names: Cartoon watching by children
ACTIVE_COMPARATOR: Paretnal presence; parental presence with their children during inhalational induction of anesthesia in the operating room	Behavioral: parental presence; parental presence during inhalational induction of sevoflurane
EXPERIMENTAL: Combined; parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room	Behavioral: Cartoon; Cartoon watching by children during inhalational induction of sevoflurane; Other Names: Cartoon watching by children; Behavioral: parental presence; parental presence during inhalational induction of sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Parental Anxiety at Postinduction 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.	1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Emergence Delirium	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.	at 20 minute in postanesthetic care unit
Postoperative Behavioral Changes	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.	1. postoperative 2 days, 2 postoperative 14 days

Collaborators and Investigators

• Sponsor: Yeungnam University College of Medicine

Publications and helpful links

Helpful Links

• Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia
• Cartoon distraction alleviates anxiety in children during induction of anesthesia

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: January 2, 2014
• First Posted (ESTIMATE): January 6, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 4, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Neurodevelopmental Disorders; Psychomotor Agitation; Anxiety Disorders; Anxiety, Separation
• Other Study ID Numbers: JUNG999ANXIETY