Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

NCT02027844 | Completed Results

• 1 other identifier: JUNG999ANXIETY
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety, Separation; Psychomotor Agitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (2)

• Postoperative Emergence Delirium

  at 20 minute in postanesthetic care unit

• Postoperative Behavioral Changes

  1. postoperative 2 days, 2 postoperative 14 days

Study Arms (3)

Cartoon

EXPERIMENTAL

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

Behavioral: Cartoon

Paretnal presence

ACTIVE COMPARATOR

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

Behavioral: parental presence

Combined

EXPERIMENTAL

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

Behavioral: Cartoon; Behavioral: parental presence

Interventions

Cartoon BEHAVIORAL

Cartoon watching by children during inhalational induction of sevoflurane

Also known as: Cartoon watching by children

Cartoon; Combined

parental presence BEHAVIORAL

parental presence during inhalational induction of sevoflurane

Combined; Paretnal presence

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam University Hospital

Daegu, 705-717, South Korea

Location

Related Links

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

MeSH Terms

Conditions

Anxiety, Separation; Psychomotor Agitation

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Parental anxiety was assessed using a self-reporting rating scale. we did't measure the baseline temperament of children using a validated behavioral assessment tool and were unable to calculate the 'use of parents' item of the mYPAS.

Results Point of Contact

• Title: Sun Mee Jung, M.D.
• Organization: Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Deagu, Repulic of Korea

applejsm@gmail.com

+82-53-620-3368

Study Officials

• Sung Mee Jung, MD

  Yeungnam University College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 6, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 2, 2015
• Results First Posted: November 2, 2015

Record last verified: 2015-10

Locations

KR (1)