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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cartoon | Experimental | cartoon watching by children during inhalational induction of anesthesia in the operating room |
|
| Paretnal presence | Active Comparator | parental presence with their children during inhalational induction of anesthesia in the operating room |
|
| Combined | Experimental | parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cartoon | Behavioral | Cartoon watching by children during inhalational induction of sevoflurane |
|
| 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
| 1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane |
| 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. |
| 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:
When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present. |
Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Sung Mee Jung, MD | Yeungnam University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeungnam University Hospital | Daegu | 705-717 | South Korea |
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| Label | URL |
|---|---|
| Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia | View source |
| Cartoon distraction alleviates anxiety in children during induction of anesthesia | View source |
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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.
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. .
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| ID | Title | Description |
|---|---|---|
| FG000 | Cartoon | cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane |
| FG001 | Paretnal Presence | parental presence with their children during inhalational induction of anesthesia in the operating room parental presence: parental presence during inhalational induction of sevoflurane |
| FG002 | Combined | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cartoon | cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane |
| BG001 | Paretnal Presence |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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
| Posted | Median | Inter-Quartile Range | units on a scale | 1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cartoon | cartoon watching by children during inhalational induction of anesthesia in the operating room Cartoon: Cartoon watching by children during inhalational induction of sevoflurane |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sun Mee Jung, M.D. | Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Deagu, Repulic of Korea | +82-53-620-3368 | applejsm@gmail.com |
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| ID | Term |
|---|---|
| D001010 | Anxiety, Separation |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D065886 | Neurodevelopmental Disorders |
| D020820 | Dyskinesias |
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| parental presence | Behavioral | parental presence during inhalational induction of sevoflurane |
|
| 1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia |
| 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 |
| Protocol Violation |
|
| Incomlete data |
|
parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane
| BG002 | Combined | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
| OG001 | Paretnal Presence | parental presence with their children during inhalational induction of anesthesia in the operating room parental presence: parental presence during inhalational induction of sevoflurane |
| OG002 | Combined | 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 |
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia |
|
|
|
| Other Pre-specified | 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:
When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present. | When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present. | Posted | Number | participants | at 20 minute in postanesthetic care unit |
|
|
|
| Other Pre-specified | 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. | If more than one negative behavior change in children developed, the investigators calculated number of the children who developed new-onset negative behavior change. | Posted | Number | participants | 1. postoperative 2 days, 2 postoperative 14 days |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Paretnal Presence | parental presence with their children during inhalational induction of anesthesia in the operating room parental presence: parental presence during inhalational induction of sevoflurane | 0 | 33 | 0 | 33 |
| EG002 | Combined | 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 | 0 | 37 | 0 | 37 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
|