Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

Not Applicable

Completed

• Conditions: Anxiety, Separation; Psychomotor Agitation
• Interventions: Behavioral: parental presence; Behavioral: Cartoon

• Registration Number: NCT02027844
• Lead Sponsor: Yeungnam University College of Medicine

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-30
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2015-06-23
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-04
• Last Update Submitted: 2015-10-04
• Results First Posted: 2015-11-01
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paretnal presence	parental presence	parental presence with their children during inhalational induction of anesthesia in the operating room
Combined	Cartoon	parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Combined	parental presence	parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon	Cartoon	cartoon watching by children during inhalational induction of anesthesia in the operating room

Primary Outcome Measures

Name	Time	Method
Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Yeungnam University Hospital; 🇰🇷 Daegu, Korea, Republic of