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Impact of the Information Leaflet on the Anesthesia Knowledge and Anxiety Levels of Children and Parents

Primary Purpose

Anxiety, Preoperative Anxiety, Pediatric Anesthesia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
information leaflet
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Anxiety; Anesthesia; Preoperative care; Child

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All children under the age of 18 and their parents who applied to the anesthesia outpatient clinic before the gastroenterological endoscopic procedure
  • Knowing Turkish language
  • Agreeing to participate in the research voluntarily
  • Parent and child not having a diagnosed neuropsychiatric disease
  • Literacy of the child and parent
  • Not having verbal communication barrier

Exclusion Criteria:

  • Refusing to participate in the research
  • Not knowing Turkish language
  • Having a verbal communication barrier
  • Parent and child have a diagnosed neuropsychiatric disease
  • Illiteracy of the child or parent

Sites / Locations

  • Gazi University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

not received information leaflet

received information leaflet

Arm Description

During the preoperative anesthesia clinic examination, demographic data will be recorded and routine information about anesthesia will be provided. However, the information leaflet will not be handed to the patient and parents. The m-YPAS scale for pediatric patients will be evaluated and filled by the investigators before the anesthesia induction. Parents will be asked to fill out questionnaires for anxiety assessment and anesthesia knowledge level in the waiting room before the procedure.

During the preoperative anesthesia evaluation, the children and their parents, who are included in the group who will receive information leaflets according to randomization, will be given information leaflets and both the child and their parents will be asked to read them before the procedure day. Age-appropriate brochures will be provided for children, and parent information leaflets will be provided for parents. The m-YPAS scale for pediatric patients will be evaluated and filled by the investigators before the anesthesia induction. Parents will be asked to fill out questionnaires for anxiety assessment and anesthesia knowledge level in the waiting room before the procedure.

Outcomes

Primary Outcome Measures

Evaluation of preoperative anxiety scores of children with the Modified Yale Preoperative Anxiety Scale
Leaflets have an effect on the anxiety score of children. Children who read information leaflet have lower anxiety scores than children who do not. Children's anxiety levels will be evaluated with the Modified Yale Preoperative Anxiety Scale (m-YPAS). This scale evaluates 22 items in 5 groups. The lowest score is 5, indicating the lowest level of anxiety. The highest score is 22, which indicates the most severe anxiety state.

Secondary Outcome Measures

Evaluation of parents' knowledge and anxiety levels about anesthesia with the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Anxiety levels are lower in children of parents who have higher level of knowledge and lower level of anxiety about anesthesia. The APAIS is a six-item questionnaire used to for the rapid assessment of preoperative anxiety. The APAIS consists of two scales that include a four-item anxiety scale and a two-item information requirement scale. The items are rated on a Likert scale from 1 ("not at all worrying") to 5 ("extremely worrying"). The score ranges of the anxiety subscale and information requirement subscale are 4-20 and 2-10, respectively. High scores are associated with high anxiety levels and information requirement.

Full Information

First Posted
December 23, 2021
Last Updated
January 23, 2022
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05221671
Brief Title
Impact of the Information Leaflet on the Anesthesia Knowledge and Anxiety Levels of Children and Parents
Official Title
Impact of the Information Leaflet on the Preoperative Anesthesia Knowledge and Anxiety Levels of Children and Parents Before the Pediatric Endoscopic Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study includes applying a questionnaire to each child and their parents who applied to the anesthesia outpatient clinic for the gastroenterological endoscopic procedure. Children and parents will be divided into two groups, those who received and those who did not receive information leaflet. With the questionnaire both groups will be compared in terms of knowledge level and anxiety level.
Detailed Description
All children under the age of 18, who meet the inclusion criteria, applied to the outpatient clinic for the preoperative anesthesia evaluation will be included in the study. During the preoperative anesthesia examination, pediatric patients and their parents will be informed about the study, their consent will be obtained, and their demographic data will be recorded. Information leaflets will be given to the one group in that both the child and their parents will read it before the endoscopic procedure. Children will handed leaflet appropriate for their age. The other group will not receive information leaflets. Routine information about anesthesia will be given to both groups. Demographic data, m-YPAS(The modified Yale Preoperative Anxiety Scale), APAIS(Amsterdam Preoperative Anxiety and Information Scale) will be evaluated for both groups before anesthesia induction. The anesthesiologist evaluate anxiety of children, will not know whether the patients received an information leaflets. Parents will be asked to fill out the questionnaire in the waiting room. Anxiety scores will be evaluated by APAIS. The source of their knowledge about anesthesia, how anesthesia applications are made during endoscopy procedures and what their fears about anesthesia are will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Preoperative Anxiety, Pediatric Anesthesia
Keywords
Anxiety; Anesthesia; Preoperative care; Child

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients and parents participating in the study will be divided into two groups by randomization. An information leaflets will be given to one group, but not to other group. Anesthesia knowledge level and anxiety level assessment questionnaires will be administered to both groups. These survey results will be compared between the two groups.
Masking
Investigator
Masking Description
The demographic data of the children and parents who agreed to participate in the study will be recorded by the anesthetist in the polyclinic, and an information leaflet will be given to those who will be included in the group that receives the information leaflet. Anesthesia knowledge level and anxiety level determination questionnaire and m-YPAS will be done by the researchers. Researchers applying these scales will not know which patients are included in the group receiving the information leaflet and which patients are in the control group. Conversion and evaluation of the survey results into study data will be done by other researchers. The principal researcher will supply the communication between these researchers.
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
not received information leaflet
Arm Type
No Intervention
Arm Description
During the preoperative anesthesia clinic examination, demographic data will be recorded and routine information about anesthesia will be provided. However, the information leaflet will not be handed to the patient and parents. The m-YPAS scale for pediatric patients will be evaluated and filled by the investigators before the anesthesia induction. Parents will be asked to fill out questionnaires for anxiety assessment and anesthesia knowledge level in the waiting room before the procedure.
Arm Title
received information leaflet
Arm Type
Active Comparator
Arm Description
During the preoperative anesthesia evaluation, the children and their parents, who are included in the group who will receive information leaflets according to randomization, will be given information leaflets and both the child and their parents will be asked to read them before the procedure day. Age-appropriate brochures will be provided for children, and parent information leaflets will be provided for parents. The m-YPAS scale for pediatric patients will be evaluated and filled by the investigators before the anesthesia induction. Parents will be asked to fill out questionnaires for anxiety assessment and anesthesia knowledge level in the waiting room before the procedure.
Intervention Type
Other
Intervention Name(s)
information leaflet
Intervention Description
Leaflets prepared to inform about anesthesia and endoscopic procedure will be given to both parents and pediatric patients. A standard leaflet has been prepared for parents. Two leaflets have been prepared for children under the age of 12 and for adolescent patients over the age of 12. Unlike routine hospital information forms, all leaflets designed and prepared as a cartoon book. It is narrated using photographs of the materials and toys in the endoscopy room. It was predicted that there would be a difference between the groups who read and did not read this information leaflet in terms of anxiety levels and anesthesia knowledge levels.
Primary Outcome Measure Information:
Title
Evaluation of preoperative anxiety scores of children with the Modified Yale Preoperative Anxiety Scale
Description
Leaflets have an effect on the anxiety score of children. Children who read information leaflet have lower anxiety scores than children who do not. Children's anxiety levels will be evaluated with the Modified Yale Preoperative Anxiety Scale (m-YPAS). This scale evaluates 22 items in 5 groups. The lowest score is 5, indicating the lowest level of anxiety. The highest score is 22, which indicates the most severe anxiety state.
Time Frame
Children's anxiety scale (m-YPAS) will be filled by the researcher observationally before the procedure.
Secondary Outcome Measure Information:
Title
Evaluation of parents' knowledge and anxiety levels about anesthesia with the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Description
Anxiety levels are lower in children of parents who have higher level of knowledge and lower level of anxiety about anesthesia. The APAIS is a six-item questionnaire used to for the rapid assessment of preoperative anxiety. The APAIS consists of two scales that include a four-item anxiety scale and a two-item information requirement scale. The items are rated on a Likert scale from 1 ("not at all worrying") to 5 ("extremely worrying"). The score ranges of the anxiety subscale and information requirement subscale are 4-20 and 2-10, respectively. High scores are associated with high anxiety levels and information requirement.
Time Frame
Parents will be asked to fill out the anesthesia knowledge and anxiety level determination questionnaire in the waiting room before the endoscopy procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All children under the age of 18 and their parents who applied to the anesthesia outpatient clinic before the gastroenterological endoscopic procedure Knowing Turkish language Agreeing to participate in the research voluntarily Parent and child not having a diagnosed neuropsychiatric disease Literacy of the child and parent Not having verbal communication barrier Exclusion Criteria: Refusing to participate in the research Not knowing Turkish language Having a verbal communication barrier Parent and child have a diagnosed neuropsychiatric disease Illiteracy of the child or parent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Selin Eren
Phone
+905052947275
Email
selinerel@yahoo.com
Facility Information:
Facility Name
Gazi University School of Medicine
City
Ankara
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Overall results of research will be shared, individual answers of participants wont be shared.
Citations:
PubMed Identifier
27317708
Citation
Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.
Results Reference
background
PubMed Identifier
24565345
Citation
Cumino Dde O, Cagno G, Goncalves VF, Wajman DS, Mathias LA. Impact of preanesthetic information on anxiety of parents and children. Braz J Anesthesiol. 2013 Nov-Dec;63(6):473-82. doi: 10.1016/j.bjane.2013.04.003. Epub 2013 Dec 5.
Results Reference
background
PubMed Identifier
28456425
Citation
Landier M, Villemagne T, Le Touze A, Braik K, Meignan P, Cook AR, Morel B, Lardy H, Binet A. The position of a written document in preoperative information for pediatric surgery: A randomized controlled trial on parental anxiety, knowledge, and satisfaction. J Pediatr Surg. 2018 Mar;53(3):375-380. doi: 10.1016/j.jpedsurg.2017.04.009. Epub 2017 Apr 21.
Results Reference
background

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Impact of the Information Leaflet on the Anesthesia Knowledge and Anxiety Levels of Children and Parents

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