Trial Outcomes & Findings for Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia (NCT NCT02027844)
NCT ID: NCT02027844
Last Updated: 2015-11-02
Results Overview
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.
COMPLETED
NA
117 participants
1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane
2015-11-02
Participant Flow
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. .
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.
Participant milestones
| Measure |
Cartoon
cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
39
|
|
Overall Study
COMPLETED
|
34
|
33
|
37
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
2
|
Reasons for withdrawal
| Measure |
Cartoon
cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
|
Overall Study
Incomlete data
|
2
|
0
|
0
|
Baseline Characteristics
Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia
Baseline characteristics by cohort
| Measure |
Cartoon
n=34 Participants
cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
|
Paretnal Presence
n=33 Participants
parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane
|
Combined
n=37 Participants
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
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
5.5 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
5.3 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
5.0 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.2 years
STANDARD_DEVIATION 1.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevofluraneThe 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.
Outcome measures
| Measure |
Cartoon
n=34 Participants
cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
|
Paretnal Presence
n=33 Participants
parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane
|
Combined
n=37 Participants
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
|
|---|---|---|---|
|
Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction
Preoperative holding area
|
28.4 units on a scale
Interval 23.4 to 36.6
|
28.4 units on a scale
Interval 23.4 to 46.6
|
23.4 units on a scale
Interval 23.4 to 65.3
|
|
Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction
Entrance to the operating room
|
23.4 units on a scale
Interval 23.4 to 31.6
|
33.4 units on a scale
Interval 23.4 to 50.0
|
28.4 units on a scale
Interval 23.4 to 46.6
|
|
Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction
Induction
|
28.4 units on a scale
Interval 23.4 to 46.6
|
43.4 units on a scale
Interval 23.4 to 65.0
|
43.4 units on a scale
Interval 23.4 to 70.0
|
SECONDARY outcome
Timeframe: 1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesiaThe 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.
Outcome measures
| Measure |
Cartoon
n=34 Participants
cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
|
Paretnal Presence
n=33 Participants
parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane
|
Combined
n=37 Participants
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
|
|---|---|---|---|
|
Change From Baseline Parental Anxiety at Postinduction of Anesthesia
|
0.0 units on a scale
Interval -6.0 to 3.0
|
0.0 units on a scale
Interval -3.0 to 3.0
|
0.0 units on a scale
Interval 0.0 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 20 minute in postanesthetic care unitPopulation: When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present.
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.
Outcome measures
| Measure |
Cartoon
n=34 Participants
cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
|
Paretnal Presence
n=33 Participants
parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane
|
Combined
n=37 Participants
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
|
|---|---|---|---|
|
Postoperative Emergence Delirium
|
13 participants
|
13 participants
|
20 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1. postoperative 2 days, 2 postoperative 14 daysPopulation: If more than one negative behavior change in children developed, the investigators calculated number of the children who developed new-onset negative behavior change.
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.
Outcome measures
| Measure |
Cartoon
n=34 Participants
cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane
|
Paretnal Presence
n=33 Participants
parental presence with their children during inhalational induction of anesthesia in the operating room
parental presence: parental presence during inhalational induction of sevoflurane
|
Combined
n=37 Participants
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
|
|---|---|---|---|
|
Postoperative Behavioral Changes
postoperative 2 days
|
17 participants
|
19 participants
|
15 participants
|
|
Postoperative Behavioral Changes
postoperative 14 days
|
7 participants
|
5 participants
|
3 participants
|
Adverse Events
Cartoon
Paretnal Presence
Combined
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sun Mee Jung, M.D.
Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Deagu, Repulic of Korea
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place