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

Not Applicable

Completed

• Conditions: Anxiety and Fear
• Interventions: Device: iPad®; Drug: Midazolam

• Registration Number: NCT05469412
• Lead Sponsor: Aga Khan University

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.

Study Timeline

• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-21
• Study Start: 2023-03-20
• Primary Completion: 2024-03-25
• Study Completion: 2024-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Children aged between 2 and 12 years old
2. ASA I and II
3. Informed consent signed by parents or legal guardians

Exclusion Criteria

1. Previous exposure to surgery
2. Contraindication to midazolam
3. Patients with developmental delay
4. Patients with significant visual/hearing problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	iPad®	Standard management combined with distraction by using technology (Tablets/iPads).
Control group	Midazolam	Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).

Primary Outcome Measures

Name	Time	Method
modified Yale Preoperative Anxiety Scale	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.

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan