Pediatric Preoperative Anxiety, Pediatric Coping Clinical Trial
Official title:
Efficacy of an Educational Pop-Up Book in Preparing Children for Anesthesia: A Randomized Controlled Trial
| Verified date | March 2021 |
| Source | Children's Healthcare of Atlanta |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 148 |
| Est. completion date | December 18, 2020 |
| Est. primary completion date | December 18, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 5 Years to 12 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Healthcare of Atlanta Satellite Boulevard Outpatient Surgery Center | Duluth | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Healthcare of Atlanta | Emory University |
United States,
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* Note: There are 21 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Observer-Rated Behavioral Anxiety at Anesthesia Induction as assessed by the modified Yale Preoperative Anxiety Scale-Short Form | 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. | 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 | Fear of Anesthesia Induction as assessed by the Children's Fear Scale | 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). | Fear was rated after education and before premedication was administered. | |
| Secondary | Expected Pain from the Anesthesia Mask and During Surgery as assessed by the Faces Pain Scale-Revised | 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). | Expected pain was rated after education and before premedication was administered. | |
| Secondary | Expectations about the Procedure, Attitudes about Anesthesia, and Views of Preoperative Explanations as assessed by a Likert-Scale Questionnaire | 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). | The outcomes were rated after education and before premedication was administered. | |
| Secondary | Self-Reported Coping Strategies for Managing the Stress of Anesthesia Induction | In a prospective interview, patients reported coping strategies for managing the stress of anesthesia induction. Greater frequencies of adaptive coping strategies indicated better outcomes. | Patients were interviewed after education and before premedication was administered. | |
| Secondary | Caregiver Satisfaction with the Surgical Experience as assessed by a Likert-Scale Questionnaire | 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). | The questionnaire was administered after the patient underwent anesthesia induction. |