An interventional study of Cartoon and parental presence in Anxiety, Separation and Psychomotor Agitation, sponsored by Yeungnam University College of Medicine. Completed at 1 site in South Korea. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2015-11-02.
Sponsored by Yeungnam University College of Medicine · Not applicable, Interventional, and Prevention
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.
59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.
This study's enrollment of 117 is above the median of 68 across 53 interventional studies indexed under Anxiety, Separation.
Browse Anxiety, Separation studies →Yeungnam University College of Medicine is the lead sponsor of 32 studies on the registry; 2 are open to participants now.
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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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cartoon watching by children during inhalational induction of anesthesia in the operating room
Behavioral: Cartoon
parental presence with their children during inhalational induction of anesthesia in the operating room
Behavioral: parental presence
parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room
Behavioral: Cartoon · Behavioral: parental presence
Cartoon watching by children during inhalational induction of sevoflurane
Also known as: Cartoon watching by children
parental presence during inhalational induction of sevoflurane
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
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
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
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
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. .
| Milestone | Cartoon | Paretnal Presence | Combined |
|---|---|---|---|
| Started | 39 | 39 | 39 |
| Completed | 34 | 33 | 37 |
| Not completed | 5 | 6 | 2 |
| Withdrew: Withdrawal by subject | 3 | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 | 1 |
| Withdrew: Protocol violation | 0 | 2 | 0 |
| Withdrew: Incomlete data | 2 | 0 | 0 |
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.
| units on a scale | Cartoon | Paretnal Presence | Combined |
|---|---|---|---|
| Preoperative holding area | 28.4 (23.4 to 36.6) | 28.4 (23.4 to 46.6) | 23.4 (23.4 to 65.3) |
| Entrance to the operating room | 23.4 (23.4 to 31.6) | 33.4 (23.4 to 50.0) | 28.4 (23.4 to 46.6) |
| Induction | 28.4 (23.4 to 46.6) | 43.4 (23.4 to 65.0) | 43.4 (23.4 to 70.0) |
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.
| units on a scale | Cartoon | Paretnal Presence | Combined |
|---|---|---|---|
| Change From Baseline Parental Anxiety at Postinduction of Anesthesia | 0.0 (-6.0 to 3.0) | 0.0 (-3.0 to 3.0) | 0.0 (0.0 to 3.0) |
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.
| participants | Cartoon | Paretnal Presence | Combined |
|---|---|---|---|
| Postoperative Emergence Delirium | 13 | 13 | 20 |
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.
| participants | Cartoon | Paretnal Presence | Combined |
|---|---|---|---|
| postoperative 2 days | 17 | 19 | 15 |
| postoperative 14 days | 7 | 5 | 3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cartoon | — | 0/34 (0%) | 0/34 (0%) |
| Paretnal Presence | — | 0/33 (0%) | 0/33 (0%) |
| Combined | — | 0/37 (0%) | 0/37 (0%) |
| Age, Categorical(Participants) | Cartoon | Paretnal Presence | Combined | Total |
|---|---|---|---|---|
| <=18 years | 34 | 33 | 37 | 104 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Cartoon | Paretnal Presence | Combined | Total |
|---|---|---|---|---|
| Mean | 5.5 ± 1.0 | 5.3 ± 1.4 | 5.0 ± 1.3 | 5.2 ± 1.1 |
| Sex: Female, Male(Participants) | Cartoon | Paretnal Presence | Combined | Total |
|---|---|---|---|---|
| Female | 19 | 21 | 19 | 59 |
| Male | 15 | 12 | 18 | 45 |
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Yeungnam University College of Medicine