Anxiety, Separation, Psychomotor Agitation
Conditions
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.
Interventions
BEHAVIORALCartoon
Cartoon watching by children during inhalational induction of sevoflurane
BEHAVIORALparental presence
parental presence during inhalational induction of sevoflurane
Sponsors
Yeungnam University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
South Korea
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cartoon cartoon watching by children during inhalational induction of anesthesia in the operating room
Cartoon: Cartoon watching by children during inhalational induction of sevoflurane | 34 |
| 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 | 33 |
| 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 | 37 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Incomlete data | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 1 |
Baseline characteristics
| Characteristic | Cartoon | Paretnal Presence | Combined | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 34 Participants | 33 Participants | 37 Participants | 104 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.5 years STANDARD_DEVIATION 1 | 5.3 years STANDARD_DEVIATION 1.4 | 5.0 years STANDARD_DEVIATION 1.3 | 5.2 years STANDARD_DEVIATION 1.1 |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 19 Participants | 59 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 18 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 33 | 0 / 37 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 | 0 / 37 |
Outcome results
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 * 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cartoon | Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction | Induction | 28.4 units on a scale |
| Cartoon | Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction | Preoperative holding area | 28.4 units on a scale |
| Cartoon | 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 |
| Paretnal Presence | Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction | Induction | 43.4 units on a scale |
| Paretnal Presence | Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction | Preoperative holding area | 28.4 units on a scale |
| Paretnal Presence | Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction | Entrance to the operating room | 33.4 units on a scale |
| Combined | Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction | Induction | 43.4 units on a scale |
| Combined | Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction | Entrance to the operating room | 28.4 units on a scale |
| Combined | Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction | Preoperative holding area | 23.4 units on a scale |
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.
Time frame: 1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cartoon | Change From Baseline Parental Anxiety at Postinduction of Anesthesia | 0.0 units on a scale |
| Paretnal Presence | Change From Baseline Parental Anxiety at Postinduction of Anesthesia | 0.0 units on a scale |
| Combined | Change From Baseline Parental Anxiety at Postinduction of Anesthesia | 0.0 units on a scale |
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.
Time frame: 1. postoperative 2 days, 2 postoperative 14 days
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cartoon | Postoperative Behavioral Changes | postoperative 2 days | 17 participants |
| Cartoon | Postoperative Behavioral Changes | postoperative 14 days | 7 participants |
| Paretnal Presence | Postoperative Behavioral Changes | postoperative 2 days | 19 participants |
| Paretnal Presence | Postoperative Behavioral Changes | postoperative 14 days | 5 participants |
| Combined | Postoperative Behavioral Changes | postoperative 2 days | 15 participants |
| Combined | Postoperative Behavioral Changes | postoperative 14 days | 3 participants |
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: * 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
Population: When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cartoon | Postoperative Emergence Delirium | 13 participants |
| Paretnal Presence | Postoperative Emergence Delirium | 13 participants |
| Combined | Postoperative Emergence Delirium | 20 participants |