Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children

Study Overview
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Brief Summary
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The purpose of this study is to find out any beneficial effects of electronic devices over preoperative pharmacological intervention in the preoperative period.

Detailed Description
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Preparation for surgery with the induction of general anesthesia can be a stressful experience for a child. Preoperative anxiety can prolong induction of anesthesia and postoperative recovery, as well as increasing the risk of postoperative delirium, pain, and analgesic use. Pharmacological interventions are associated with increased cost to the hospital, potential surgical delay while waiting for the medication to take effect, and delayed discharge from the recovery room. Non-pharmacological modalities comprise education, behavioral techniques, parental presence at induction of anesthesia, and using technology including cellular phones and tablets/iPad, with each category including an array of effective strategies for reducing anxiety.

Official Title
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To Compare Pharmacological and Non-Pharmacological Interventions (Use of Technology) For Alleviating Preoperative Anxiety In Children Undergoing General Anesthesia In A Tertiary Care Hospital Of Pakistan: A Randomized Controlled Trial.

Conditions
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Anxiety and Fear

Intervention / Treatment
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* Device: iPad®
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged between 2 and 12 years old ASA I and II Informed consent signed by parents or legal guardians Exclusion Criteria: Previous exposure to surgery Contraindication to midazolam Patients with developmental delay Patients with significant visual/hearing problems

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>Standard management combined with distraction by using technology (Tablets/iPads). | Device: iPad®<br>* Use of Technology.<br>* Other names: Tablet;|
| Active Comparator: Control group<br>Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg). | Drug: Midazolam<br>* Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Yale Preoperative Anxiety Scale | The instrument contains 27 items in 5 categories that indicate preoperative anxiety in children: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Scores range from 23.33 to 100, with higher values indicating higher anxiety. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative Anxiety