Clinical trial NCT04796077: Preparing Children for Anesthesia With an Educational Pop-Up Book
Official title: Efficacy of an Educational Pop-Up Book in Preparing Children for Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Preoperative Anxiety, Pediatric Coping
Keywords: Preoperative education
Patient education
Preoperative anxiety
Pediatric outpatient surgery
Pediatric anesthesia
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2021-03-12
Enrollment: 148
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Observer-Rated Behavioral Anxiety at Anesthesia Induction as assessed by the modified Yale Preoperative Anxiety Scale-Short Form
timeFrame: 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.
Secondary outcomes:
measure: Fear of Anesthesia Induction as assessed by the Children's Fear Scale
timeFrame: Fear was rated after education and before premedication was administered.
measure: Expected Pain from the Anesthesia Mask and During Surgery as assessed by the Faces Pain Scale-Revised
timeFrame: Expected pain was rated after education and before premedication was administered.
measure: Expectations about the Procedure, Attitudes about Anesthesia, and Views of Preoperative Explanations as assessed by a Likert-Scale Questionnaire
timeFrame: The outcomes were rated after education and before premedication was administered.
measure: Self-Reported Coping Strategies for Managing the Stress of Anesthesia Induction
timeFrame: Patients were interviewed after education and before premedication was administered.
measure: Caregiver Satisfaction with the Surgical Experience as assessed by a Likert-Scale Questionnaire
timeFrame: The questionnaire was administered after the patient underwent anesthesia induction.
Other outcomes:
Locations:
city: Duluth
country: United States
facility: Children's Healthcare of Atlanta Satellite Boulevard Outpatient Surgery Center
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta; Emory University School of Medicine
name: Kara K Prickett, MD
role: PRINCIPAL_INVESTIGATOR
References:
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