Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

• Sponsor: Yeungnam University College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02027844
• Collaborator: (none)
• Enrollment: 117
• Location: 1
• Arms: 3
• Duration (Months): 18
• Patients Per Site Per Month: 6.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety, Separation; Psychomotor Agitation	Behavioral: Cartoon; Behavioral: parental presence	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 117 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Cartoon Distraction and Parental Presence During Induction of Anesthesia on Preoperative Anxiety and Postoperative Behavior Change in Children Undergoing General Anesthesia
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

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]

   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 Outcome Measures

1. Postoperative Emergence Delirium [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yeungnam University Hospital	Daegu		Korea, Republic of	705-717

Sponsors and Collaborators

• Yeungnam University College of Medicine

Investigators

• Principal Investigator: Sung Mee Jung, MD, Yeungnam University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Sung Mee Jung, Associate professor, Yeungnam University College of Medicine
• ClinicalTrials.gov Identifier: NCT02027844
• Other Study ID Numbers: JUNG999ANXIETY
• First Posted: Jan 6, 2014
• Last Update Posted: Nov 1, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Psychomotor Agitation; Anxiety Disorders; Anxiety, Separation

Study Results

Participant Flow

Recruitment Details	This study was conducted Yeungnam University Hospital in South korea from Dec. 30. 2013 to October. 31. 2014. One hundred and seventeen children aged between 2 and 7 years, ASA physical status I or II scheduled for elective minor surgery under general anesthesia were enrolled. .
Pre-assignment Detail	Children with a chronic illness, developmental delay, a neuropsychiatric disease, cancer, experience of a recent stressful life event, previous anesthetic experience, sedative medication, or emergency surgery were excluded.

Arm/Group Title	Cartoon	Paretnal Presence	Combined
Arm/Group Description	cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane	parental presence with their children during inhalational induction of anesthesia in the operating room parental presence: parental presence during inhalational induction of sevoflurane	parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane parental presence: parental presence during inhalational induction of sevoflurane
Period Title: Overall Study
STARTED	39	39	39
COMPLETED	34	33	37
NOT COMPLETED	5	6	2

Baseline Characteristics

Arm/Group Title	Cartoon	Paretnal Presence	Combined	Total
Arm/Group Description	cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane	parental presence with their children during inhalational induction of anesthesia in the operating room parental presence: parental presence during inhalational induction of sevoflurane	parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane parental presence: parental presence during inhalational induction of sevoflurane	Total of all reporting groups
Overall Participants	34	33	37	104
Age (Count of Participants)
<=18 years	34 100%	33 100%	37 100%	104 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.5 (1.0)	5.3 (1.4)	5.0 (1.3)	5.2 (1.1)
Sex: Female, Male (Count of Participants)
Female	19 55.9%	21 63.6%	19 51.4%	59 56.7%
Male	15 44.1%	12 36.4%	18 48.6%	45 43.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cartoon	Paretnal Presence	Combined
Arm/Group Description	cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane	parental presence with their children during inhalational induction of anesthesia in the operating room parental presence: parental presence during inhalational induction of sevoflurane	parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane parental presence: parental presence during inhalational induction of sevoflurane
Measure Participants	34	33	37
Preoperative holding area	28.4	28.4	23.4
Entrance to the operating room	23.4	33.4	28.4
Induction	28.4	43.4	43.4

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cartoon	Paretnal Presence	Combined
Arm/Group Description	cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane	parental presence with their children during inhalational induction of anesthesia in the operating room parental presence: parental presence during inhalational induction of sevoflurane	parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane parental presence: parental presence during inhalational induction of sevoflurane
Measure Participants	34	33	37
Median (Inter-Quartile Range) [units on a scale]	0.0	0.0	0.0

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cartoon	Paretnal Presence	Combined
Arm/Group Description	cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane	parental presence with their children during inhalational induction of anesthesia in the operating room parental presence: parental presence during inhalational induction of sevoflurane	parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane parental presence: parental presence during inhalational induction of sevoflurane
Measure Participants	34	33	37
Number [participants]	13 38.2%	13 39.4%	20 54.1%

4. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

If more than one negative behavior change in children developed, the investigators calculated number of the children who developed new-onset negative behavior change.

Arm/Group Title	Cartoon	Paretnal Presence	Combined
Arm/Group Description	cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane	parental presence with their children during inhalational induction of anesthesia in the operating room parental presence: parental presence during inhalational induction of sevoflurane	parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane parental presence: parental presence during inhalational induction of sevoflurane
Measure Participants	34	33	37
postoperative 2 days	17 50%	19 57.6%	15 40.5%
postoperative 14 days	7 20.6%	5 15.2%	3 8.1%

Adverse Events

Arm/Group Title	Cartoon		Paretnal Presence		Combined
Arm/Group Description	cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane		parental presence with their children during inhalational induction of anesthesia in the operating room parental presence: parental presence during inhalational induction of sevoflurane		parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane parental presence: parental presence during inhalational induction of sevoflurane
All Cause Mortality
	Cartoon		Paretnal Presence		Combined
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cartoon		Paretnal Presence		Combined
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)		0/37 (0%)
Other (Not Including Serious) Adverse Events
	Cartoon		Paretnal Presence		Combined
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)		0/37 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.