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Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

Primary Purpose

Anxiety, Separation, Psychomotor Agitation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cartoon
parental presence
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety, Separation

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Yeungnam University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Cartoon

Paretnal presence

Combined

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 30, 2013
Last Updated
October 4, 2015
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02027844
Brief Title
Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia
Official Title
Cartoon Distraction and Parental Presence During Induction of Anesthesia on Preoperative Anxiety and Postoperative Behavior Change in Children Undergoing General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Separation, Psychomotor Agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cartoon
Arm Type
Experimental
Arm Description
cartoon watching by children during inhalational induction of anesthesia in the operating room
Arm Title
Paretnal presence
Arm Type
Active Comparator
Arm Description
parental presence with their children during inhalational induction of anesthesia in the operating room
Arm Title
Combined
Arm Type
Experimental
Arm Description
parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Intervention Type
Behavioral
Intervention Name(s)
Cartoon
Other Intervention Name(s)
Cartoon watching by children
Intervention Description
Cartoon watching by children during inhalational induction of sevoflurane
Intervention Type
Behavioral
Intervention Name(s)
parental presence
Intervention Description
parental presence during inhalational induction of sevoflurane
Primary Outcome Measure Information:
Title
Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction
Description
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.
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
Secondary Outcome Measure Information:
Title
Change From Baseline Parental Anxiety at Postinduction of Anesthesia
Description
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.
Time Frame
1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia
Other Pre-specified Outcome Measures:
Title
Postoperative Emergence Delirium
Description
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.
Time Frame
at 20 minute in postanesthetic care unit
Title
Postoperative Behavioral Changes
Description
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.
Time Frame
1. postoperative 2 days, 2 postoperative 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Mee Jung, MD
Organizational Affiliation
Yeungnam University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23051880
Description
Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia
URL
http://www.ncbi.nlm.nih.gov/pubmed/23011563
Description
Cartoon distraction alleviates anxiety in children during induction of anesthesia

Learn more about this trial

Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

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