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Completed

NCT Number: NCT04796077

Preparing Children for Anesthesia With an Educational Pop-Up Book

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.

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Key information

Conditions

Pediatric Preoperative Anxiety, Pediatric Coping

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta Satellite Boulevard Outpatient Surgery Center

Duluth, Georgia, 30096-5803, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pop-Up Book

Other

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

Primary outcomes

  1. Observer-Rated Behavioral Anxiety at Anesthesia Induction as assessed by the modified Yale Preoperative Anxiety Scale-Short Form

    Time frame: 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 outcomes

  1. Fear of Anesthesia Induction as assessed by the Children's Fear Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Children's Healthcare of Atlanta

Other

Collaborators

  • Emory University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2021
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.