Pediatric Preoperative Anxiety, Pediatric CopingNCT04796077
Preparing Children for Anesthesia With an Educational Pop-Up Book
A study testing Pop-Up Book in people with Pediatric Preoperative Anxiety, Pediatric Coping, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Preoperative Anxiety, Pediatric Coping
- What is being tested?
- Pop-Up Book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 5-12 (inclusive)
- Undergoing outpatient medical procedures under general anesthesia with inhalation induction
- English-speaking
- Able to provide electronic consent/assent (legal guardian)
Who cannot join
- Patients with severe developmental disabilities
- Unable to obtain electronic consent/assent from a legal guardian
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta Satellite Boulevard Outpatient Surgery Center
Duluth, Georgia, 30096-5803
About this study
Official title: Efficacy of an Educational Pop-Up Book in Preparing Children for Anesthesia: A Randomized Controlled Trial
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.
- Being tested
- Pop-Up Book
- Keywords
- Preoperative education, Patient education, Preoperative anxiety, Pediatric outpatient surgery, Pediatric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pop-Up BookOther
Patients spent 5-10 minutes reading an illustrated pop-up book that promoted active learning about the process of general anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Pop-Up Book | Experimental | Patients read an interactive pop-up book about general anesthesia induction in addition to standard consultation with an anesthesia provider. Receives: Other: Pop-Up Book |
| Standard Care | No intervention | Patients received standard consultation with an anesthesia provider (standard care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (5)
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).
Measured: Fear was rated after education and before premedication was administered.
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).
Measured: Expected pain was rated after education and before premedication was administered.
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).
Measured: The outcomes were rated after education and before premedication was administered.
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.
Measured: Patients were interviewed after education and before premedication was administered.
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).
Measured: The questionnaire was administered after the patient underwent anesthesia induction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start26 Aug 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Pediatric Preoperative Anxiety, Pediatric CopingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Kara K Prickett, MD, Principal investigator, Children's Healthcare of Atlanta; Emory University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796077
- Sponsor's protocol ID
- STUDY00000660
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (including data dictionaries) will be made available to interested researchers, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to Dr Kara Prickett \[kara.prickett@emory.edu\].
Publications
Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
PubMed 16882820Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
PubMed 15562048Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.
PubMed 23865442Claar RL, Walker LS, Smith CA. The influence of appraisals in understanding children's experiences with medical procedures. J Pediatr Psychol. 2002 Oct-Nov;27(7):553-63. doi: 10.1093/jpepsy/27.7.553.
PubMed 12228327Fortier MA, Chorney JM, Rony RY, Perret-Karimi D, Rinehart JB, Camilon FS, Kain ZN. Children's desire for perioperative information. Anesth Analg. 2009 Oct;109(4):1085-90. doi: 10.1213/ane.0b013e3181b1dd48.
PubMed 19762736Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013.
PubMed 17197846West N, Christopher N, Stratton K, Gorges M, Brown Z. Reducing preoperative anxiety with Child Life preparation prior to intravenous induction of anesthesia: A randomized controlled trial. Paediatr Anaesth. 2020 Feb;30(2):168-180. doi: 10.1111/pan.13802. Epub 2020 Jan 8.
PubMed 31869478Dalley JS, McMurtry CM. Teddy and I Get a Check-Up: A Pilot Educational Intervention Teaching Children Coping Strategies for Managing Procedure-Related Pain and Fear. Pain Res Manag. 2016;2016:4383967. doi: 10.1155/2016/4383967. Epub 2016 Apr 7.
PubMed 27445612Hatava P, Olsson GL, Lagerkranser M. Preoperative psychological preparation for children undergoing ENT operations: a comparison of two methods. Paediatr Anaesth. 2000;10(5):477-86. doi: 10.1046/j.1460-9592.2000.00537.x.
PubMed 11012950Mahajan L, Wyllie R, Steffen R, Kay M, Kitaoka G, Dettorre J, Sarigol S, McCue K. The effects of a psychological preparation program on anxiety in children and adolescents undergoing gastrointestinal endoscopy. J Pediatr Gastroenterol Nutr. 1998 Aug;27(2):161-5. doi: 10.1097/00005176-199808000-00006.
PubMed 9702646Kain ZN, MacLaren JE, Hammell C, Novoa C, Fortier MA, Huszti H, Mayes L. Healthcare provider-child-parent communication in the preoperative surgical setting. Paediatr Anaesth. 2009 Apr;19(4):376-84. doi: 10.1111/j.1460-9592.2008.02921.x. Epub 2009 Jan 27.
PubMed 19187045Heckmann M, Beauchesne MA. Pediatric perioperative education current practices: a national survey of children's hospitals in the United States. J Perioper Pract. 2013 May;23(5):100-6. doi: 10.1177/175045891302300501.
PubMed 23767262Fortier MA, Del Rosario AM, Martin SR, Kain ZN. Perioperative anxiety in children. Paediatr Anaesth. 2010 Apr;20(4):318-22. doi: 10.1111/j.1460-9592.2010.03263.x. Epub 2010 Feb 23.
PubMed 20199609Chorney JM, Kain ZN. Behavioral analysis of children's response to induction of anesthesia. Anesth Analg. 2009 Nov;109(5):1434-40. doi: 10.1213/ane.0b013e3181b412cf. Epub 2009 Aug 27.
PubMed 19713262Fortier MA, Bunzli E, Walthall J, Olshansky E, Saadat H, Santistevan R, Mayes L, Kain ZN. Web-based tailored intervention for preparation of parents and children for outpatient surgery (WebTIPS): formative evaluation and randomized controlled trial. Anesth Analg. 2015 Apr;120(4):915-22. doi: 10.1213/ANE.0000000000000632.
PubMed 25790213
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Educational Pop-Up Book in Preparing Children for Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04796077
- Acronym / sponsor ID
- STUDY00000660
- Keywords
- Preoperative education, Patient education, Preoperative anxiety, Pediatric outpatient surgery, Pediatric anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Pop-Up Book | Experimental | Other: Pop-Up BookPatients read an interactive pop-up book about general anesthesia induction in addition to standard consultation with an anesthesia provider. |
| Standard Care | No intervention | –Patients received standard consultation with an anesthesia provider (standard care). |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 5-12 (inclusive)
- Undergoing outpatient medical procedures under general anesthesia with inhalation induction
- English-speaking
- Able to provide electronic consent/assent (legal guardian)
Key exclusion criteria (2 listed)
- Patients with severe developmental disabilities
- Unable to obtain electronic consent/assent from a legal guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pop-Up BookPatients spent 5-10 minutes reading an illustrated pop-up book that promoted active learning about the process of general anesthesia induction. | Other | Pop-Up Book |
Primary outcome
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.
5 secondary outcomes
Fear of Anesthesia Induction as assessed by the Children's Fear Scale
Time frame: Fear was rated after education and before premedication was administered.
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.
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.
Self-Reported Coping Strategies for Managing the Stress of Anesthesia Induction
Time frame: Patients were interviewed after education and before premedication was administered.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Background: PubMed 16882820Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
- Background: PubMed 15562048Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
- Background: PubMed 23865442Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.
- Background: PubMed 12228327Claar RL, Walker LS, Smith CA. The influence of appraisals in understanding children's experiences with medical procedures. J Pediatr Psychol. 2002 Oct-Nov;27(7):553-63. doi: 10.1093/jpepsy/27.7.553.
- Background: PubMed 19762736Fortier MA, Chorney JM, Rony RY, Perret-Karimi D, Rinehart JB, Camilon FS, Kain ZN. Children's desire for perioperative information. Anesth Analg. 2009 Oct;109(4):1085-90. doi: 10.1213/ane.0b013e3181b1dd48.
- Background: PubMed 17197846Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013.
- Background: PubMed 31869478West N, Christopher N, Stratton K, Gorges M, Brown Z. Reducing preoperative anxiety with Child Life preparation prior to intravenous induction of anesthesia: A randomized controlled trial. Paediatr Anaesth. 2020 Feb;30(2):168-180. doi: 10.1111/pan.13802. Epub 2020 Jan 8.
- Background: PubMed 27445612Dalley JS, McMurtry CM. Teddy and I Get a Check-Up: A Pilot Educational Intervention Teaching Children Coping Strategies for Managing Procedure-Related Pain and Fear. Pain Res Manag. 2016;2016:4383967. doi: 10.1155/2016/4383967. Epub 2016 Apr 7.
- Background: PubMed 11012950Hatava P, Olsson GL, Lagerkranser M. Preoperative psychological preparation for children undergoing ENT operations: a comparison of two methods. Paediatr Anaesth. 2000;10(5):477-86. doi: 10.1046/j.1460-9592.2000.00537.x.
- Background: PubMed 9702646Mahajan L, Wyllie R, Steffen R, Kay M, Kitaoka G, Dettorre J, Sarigol S, McCue K. The effects of a psychological preparation program on anxiety in children and adolescents undergoing gastrointestinal endoscopy. J Pediatr Gastroenterol Nutr. 1998 Aug;27(2):161-5. doi: 10.1097/00005176-199808000-00006.
- Background: PubMed 19187045Kain ZN, MacLaren JE, Hammell C, Novoa C, Fortier MA, Huszti H, Mayes L. Healthcare provider-child-parent communication in the preoperative surgical setting. Paediatr Anaesth. 2009 Apr;19(4):376-84. doi: 10.1111/j.1460-9592.2008.02921.x. Epub 2009 Jan 27.
- Background: PubMed 23767262Heckmann M, Beauchesne MA. Pediatric perioperative education current practices: a national survey of children's hospitals in the United States. J Perioper Pract. 2013 May;23(5):100-6. doi: 10.1177/175045891302300501.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (including data dictionaries) will be made available to interested researchers, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to Dr Kara Prickett [kara.prickett@emory.edu].
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara K Prickett, MD principal investigator
Children's Healthcare of Atlanta; Emory University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pop-Up Book in people with Pediatric Preoperative Anxiety, Pediatric Coping, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04796077, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.