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.
Overview
- Phase
- Not Applicable
- Intervention
- iPad®
- Conditions
- Anxiety and Fear
- Sponsor
- Aga Khan University
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- modified Yale Preoperative Anxiety Scale
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Muhammad Asghar Ali
Associate Professor
Aga Khan University
Eligibility Criteria
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
Arms & Interventions
Interventional group
Standard management combined with distraction by using technology (Tablets/iPads).
Intervention: iPad®
Control group
Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).
Intervention: Midazolam
Outcomes
Primary Outcomes
modified Yale Preoperative Anxiety Scale
Time Frame: Day 1
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.