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Preparing Children for Anesthesia With an Educational Pop-Up Book

Sponsor
Children's Healthcare of Atlanta (Other)
Overall Status
Completed
CT.gov ID
NCT04796077
Collaborator
Emory University (Other)
148
Enrollment
1
Location
2
Arms
3.7
Actual Duration (Months)
39.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pop-Up Book
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients were allocated via a block-randomized list to either the intervention arm (the educational pop-up book) or the control arm (standard care).Patients were allocated via a block-randomized list to either the intervention arm (the educational pop-up book) or the control arm (standard care).
Masking:
Single (Outcomes Assessor)
Masking Description:
An observer-rated behavioral anxiety outcome was masked (raters were blinded to patient group assignments). Other measures were patient self-report (unmasked).
Primary Purpose:
Other
Official Title:
Efficacy of an Educational Pop-Up Book in Preparing Children for Anesthesia: A Randomized Controlled Trial
Actual Study Start Date :
Aug 26, 2020
Actual Primary Completion Date :
Dec 18, 2020
Actual Study Completion Date :
Dec 18, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pop-Up Book

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

Other: 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.
No Intervention: Standard Care

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

Outcome Measures

Primary Outcome Measures

  1. Observer-Rated Behavioral Anxiety at Anesthesia Induction as assessed by the modified Yale Preoperative Anxiety Scale-Short Form [Baseline anxiety was rated upon initial entry into the preoperative holding area; anxiety at induction was rated while patients received inhalational induction via an anesthesia mask.]

    Patients' behavioral anxiety at anesthesia induction was assessed relative to baseline using the observer-rated modified Yale Preoperative Anxiety Scale-Short Form. The scale ranges from 22.92-100; higher scores indicate greater anxiety (worse outcomes). Raters were preoperative nurses and circulating nurses blinded to group assignments.

Secondary Outcome Measures

  1. Fear of Anesthesia Induction as assessed by the Children's Fear Scale [Fear was rated after education and before premedication was administered.]

    Patients self-reported their fear of anesthesia induction using the Children's Fear Scale. The scale ranges from 0-4; higher scores indicate greater fear (worse outcomes).

  2. Expected Pain from the Anesthesia Mask and During Surgery as assessed by the Faces Pain Scale-Revised [Expected pain was rated after education and before premedication was administered.]

    Patients self-reported how much pain they expected (1) from the anesthesia mask and (2) while asleep for the surgical procedure using the Faces Pain Scale-Revised. The scale ranges from 0-5; higher scores indicate greater expected pain (worse outcomes).

  3. Expectations about the Procedure, Attitudes about Anesthesia, and Views of Preoperative Explanations as assessed by a Likert-Scale Questionnaire [The outcomes were rated after education and before premedication was administered.]

    Patients self-reported their perceptions of the procedure and preoperative explanations (the pop-up book or provider consultation) using a 9-item Likert-scale questionnaire. The questionnaire was scored from 1-5; higher scores indicated more positive views (better outcomes).

  4. Self-Reported Coping Strategies for Managing the Stress of Anesthesia Induction [Patients were interviewed after education and before premedication was administered.]

    In a prospective interview, patients reported coping strategies for managing the stress of anesthesia induction. Greater frequencies of adaptive coping strategies indicated better outcomes.

  5. Caregiver Satisfaction with the Surgical Experience as assessed by a Likert-Scale Questionnaire [The questionnaire was administered after the patient underwent anesthesia induction.]

    Caregivers reported their satisfaction with the surgical experience using a 10-item Likert-scale questionnaire. The questionnaire was scored from 1-5; higher scores indicated more positive views (better outcomes).

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Healthcare of Atlanta Satellite Boulevard Outpatient Surgery Center Duluth Georgia United States 30096-5803

Sponsors and Collaborators

  • Children's Healthcare of Atlanta
  • Emory University

Investigators

  • Principal Investigator: Kara K Prickett, MD, Children's Healthcare of Atlanta; Emory University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT04796077
Other Study ID Numbers:
  • STUDY00000660
First Posted:
Mar 12, 2021
Last Update Posted:
Mar 12, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Children's Healthcare of Atlanta
Preoperative education
Patient education
Preoperative anxiety
Pediatric outpatient surgery
Pediatric anesthesia

Study Results

No Results Posted as of Mar 12, 2021