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Preparing Children for Anesthesia With an Educational Pop-Up Book

Efficacy of an Educational Pop-Up Book in Preparing Children for Anesthesia: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04796077
Enrollment
148
Registered
2021-03-12
Start date
2020-08-26
Completion date
2020-12-18
Last updated
2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Preoperative Anxiety, Pediatric Coping

Keywords

Preoperative education, Patient education, Preoperative anxiety, Pediatric outpatient surgery, Pediatric anesthesia

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.

Interventions

OTHERPop-Up Book

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

Sponsors

Emory University
CollaboratorOTHER
Children's Healthcare of Atlanta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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).

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).

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Observer-Rated Behavioral Anxiety at Anesthesia Induction as assessed by the modified Yale Preoperative Anxiety Scale-Short FormBaseline 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

MeasureTime frameDescription
Fear of Anesthesia Induction as assessed by the Children's Fear ScaleFear 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).
Expected Pain from the Anesthesia Mask and During Surgery as assessed by the Faces Pain Scale-RevisedExpected 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).
Expectations about the Procedure, Attitudes about Anesthesia, and Views of Preoperative Explanations as assessed by a Likert-Scale QuestionnaireThe 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).
Self-Reported Coping Strategies for Managing the Stress of Anesthesia InductionPatients 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.
Caregiver Satisfaction with the Surgical Experience as assessed by a Likert-Scale QuestionnaireThe 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026