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

Primary Purpose

Anxiety and Fear

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
iPad®
Midazolam
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety and Fear focused on measuring Preoperative Anxiety

Eligibility Criteria

2 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aga Khan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional group

Control group

Arm Description

Standard management combined with distraction by using technology (Tablets/iPads).

Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 13, 2022
Last Updated
August 1, 2023
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT05469412
Brief Title
Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety and Fear
Keywords
Preoperative Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Standard management combined with distraction by using technology (Tablets/iPads).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).
Intervention Type
Device
Intervention Name(s)
iPad®
Other Intervention Name(s)
Tablet
Intervention Description
Use of Technology.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).
Primary Outcome Measure Information:
Title
modified Yale Preoperative Anxiety Scale
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Asghar Ali, FCPS
Phone
+9234862897
Ext
2897
Email
asghar.ashraf@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bushra Salim, FCPS
Phone
+9234862897
Ext
2897
Email
bushra.salim@aku.edu
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Asghar, FCPS
Phone
+92 21 3486
Ext
4636
Email
asghar.ashraf@aku.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26171895
Citation
Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
Results Reference
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PubMed Identifier
33456927
Citation
Agbayani CG, Fortier MA, Kain ZN. Non-pharmacological methods of reducing perioperative anxiety in children. BJA Educ. 2020 Dec;20(12):424-430. doi: 10.1016/j.bjae.2020.08.003. Epub 2020 Oct 21. No abstract available.
Results Reference
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PubMed Identifier
32256348
Citation
Cheng X, Chen Z, Zhang L, Xu P, Qin F, Jiao X, Wang Y, Lin M, Zeng L, Huang L, Yu D. Efficacy and Safety of Midazolam Oral Solution for Sedative Hypnosis and Anti-anxiety in Children: A Systematic Review and Meta-Analysis. Front Pharmacol. 2020 Mar 18;11:225. doi: 10.3389/fphar.2020.00225. eCollection 2020.
Results Reference
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Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children

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