Preparing Children for Anesthesia With an Educational Pop-Up Book

NCT ID: NCT04796077

Last Updated: 2021-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2020-12-18

Brief Summary

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The study evaluated an educational pop-up book about general anesthesia induction as an interactive, child-focused preoperative education resource for pediatric patients undergoing outpatient surgery. The study's objectives were to evaluate the book as an educational tool and to understand the book's effects on patient and caregiver perceptions of the surgical experience. The study's hypotheses were that preoperative education from the pop-up book, compared to standard care, would more effectively reduce children's fear and expected pain, facilitate more positive views of the procedure and preoperative explanations, encourage adaptive coping strategies, reduce behavioral anxiety at anesthesia induction, and increase caregiver satisfaction with the surgical experience.

Detailed Description

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Conditions

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Pediatric Preoperative Anxiety, Pediatric Coping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were allocated via a block-randomized list to either the intervention arm (the educational pop-up book) or the control arm (standard care).
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
An observer-rated behavioral anxiety outcome was masked (raters were blinded to patient group assignments). Other measures were patient self-report (unmasked).

Study Groups

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Pop-Up Book

Patients read an interactive pop-up book about general anesthesia induction in addition to standard consultation with an anesthesia provider.

Group Type EXPERIMENTAL

Pop-Up Book

Intervention Type OTHER

Patients spent 5-10 minutes reading an illustrated pop-up book that promoted active learning about the process of general anesthesia induction.

Standard Care

Patients received standard consultation with an anesthesia provider (standard care).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pop-Up Book

Patients spent 5-10 minutes reading an illustrated pop-up book that promoted active learning about the process of general anesthesia induction.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ages 5-12 (inclusive)
* Undergoing outpatient medical procedures under general anesthesia with inhalation induction
* English-speaking
* Able to provide electronic consent/assent (legal guardian)

Exclusion Criteria

* Patients with severe developmental disabilities
* Unable to obtain electronic consent/assent from a legal guardian
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role collaborator

Children's Healthcare of Atlanta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kara K Prickett, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Healthcare of Atlanta; Emory University School of Medicine

Locations

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Children's Healthcare of Atlanta Satellite Boulevard Outpatient Surgery Center

Duluth, Georgia, United States

Site Status

Countries

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United States

References

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Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.

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Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.

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Cordray H, Patel C, Prickett KK. Reducing Children's Preoperative Fear with an Educational Pop-up Book: A Randomized Controlled Trial. Otolaryngol Head Neck Surg. 2022 Aug;167(2):366-374. doi: 10.1177/01945998211053197. Epub 2021 Oct 26.

Reference Type DERIVED
PMID: 34699270 (View on PubMed)

Other Identifiers

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STUDY00000660

Identifier Type: -

Identifier Source: org_study_id

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