N/A
N=117
Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia
Anxiety, Separation · Psychomotor Agitation
Bottom Line
View on ClinicalTrials.gov: NCT02027844 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction — 28.4; 28.4; 23.4; 23.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cartoon (Behavioral); parental presence (Behavioral)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Yeungnam University College of Medicine
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction |
28.4; 28.4; 23.4; 23.4; 33.4; 28.4 | — |
| SECONDARY Change From Baseline Parental Anxiety at Postinduction of Anesthesia |
0.0; 0.0; 0.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) physical status 1 and 2
- 1-7 years old.
- 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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Data sourced from ClinicalTrials.gov (NCT02027844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.