Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial
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Purpose
This study wants to test the hypothesis that trained clowns can reduce anxiety in children undergoing general anesthesia. We will compare the effect of the clowns to the commonly used anti-anxiety medication we commonly use
| Condition | Intervention |
|---|---|
|
Pre Operative Anxiety |
Behavioral: clowns present Drug: midazolam |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Supportive Care |
| Official Title: | Clowns as Treatment for Preoperative Anxietyin Children- a Randomized Controlled Trial |
- anxiety level [ Time Frame: waiting area and enterance to OR -1 hour ] [ Designated as safety issue: No ]
| Enrollment: | 65 |
| Study Start Date: | January 2006 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
no medication or clowns present during the preopertaive phase
|
|
|
Active Comparator: 2
midazolam a anxiolytic drug was given in the preoperative phase
|
Drug: midazolam
midazolam
|
|
Active Comparator: 3
clowns where present during the preoperative phase
|
Behavioral: clowns present
clowns present during the proccess of induction of anesthesia
|
Detailed Description:
The perioperative environment, often anxiety-provoking for adults, may be quite frightening for children. The detrimental effects of preoperative anxiety are not confined to the preoperative period. Anxiety during induction of anesthesia is correlated with increased distress early in the postoperative period, (Holms Knud, Kain) and maladaptive behavior will follow for the first 2 weeks following surgery in up to 54% of children.
Many preoperative systems allow parental, pharmacologic, and anticipatory interventions to facilitate a relaxed perioperative environment for children. Unfortunately, scheduling conflicts, side effects, and limited resources conspire to limit their usefulness. For example, only 10% of respondents in a recent survey used parental presence during induction of anesthesia (PPIA) for a majority of their patients. This may be due to the belief by some that parental anxiety may in fact increase children's anxiety. (Bevans) According to the same survey, only 50% of children undergoing surgery receive sedating premedication. (Kain). Distraction techniques, such as the use of toys or video games, may also decrease perioperative anxiety, however their effectiveness during induction of anesthesia is not well characterized. The efficacy of toys and video games is somewhat dependent upon the child reaching certain developmental milestones. Anesthesiologists continue to search for an easy and comprehensive method for anxiety reduction in the pediatric surgical population. We propose that specially trained professional clowns may allay preoperative anxiety and result in a smooth anesthetic induction.
Eligibility| Ages Eligible for Study: | 2 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA I and II
- Children aged 2-8 years
Exclusion Criteria:
- Previous surgery
- ASA > II
- Parents' refusal
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Ilan Keidan MD, Director pediatric anesthesia, Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00609960 History of Changes |
| Other Study ID Numbers: | SHEBA-05-3739-IK-CTIL |
| Study First Received: | January 24, 2008 |
| Last Updated: | February 6, 2008 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
children anesthesia anxiety clowns |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Midazolam Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013