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

Anxiety Clinical Trial

Official title:

Impact of the Information Leaflet on the Preoperative Anesthesia Knowledge and Anxiety Levels of Children and Parents Before the Pediatric Endoscopic Procedures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05221671
• Other study ID #: 184(13.12.2021)
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2022
• Source: Gazi University
• Contact: Selin Eren
• Phone: +905052947275
• Email: selinerel[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: January 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pediatric Anesthesia
• Preoperative Anxiety

Intervention

Other:
• information leaflet
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.

Locations

Country	Name	City	State
Turkey	Gazi University School of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Cumino Dde O, Cagno G, Gonçalves 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. — View 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. — View Citation

Landier M, Villemagne T, Le Touze A, Braïk 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Children's anxiety scale (m-YPAS) will be filled by the researcher observationally before the procedure.
Secondary	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.	Parents will be asked to fill out the anesthesia knowledge and anxiety level determination questionnaire in the waiting room before the endoscopy procedure.