Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Interventional group Standard management combined with distraction by using technology (Tablets/iPads). |
Device: iPad®
Use of Technology.
|
| Active Comparator: Control group Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg). |
Drug: Midazolam
Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children aged between 2 and 12 years old
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ASA I and II
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Informed consent signed by parents or legal guardians
Exclusion Criteria:
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Previous exposure to surgery
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Contraindication to midazolam
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Patients with developmental delay
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Patients with significant visual/hearing problems
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Aga Khan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
- 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;(7):CD006447. doi: 10.1002/14651858.CD006447.pub3. Review.
- 2022-7684-21894