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

NCT ID: NCT05221671

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-01-01

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.

Conditions

Anxiety; Preoperative Anxiety; Pediatric Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

not received information leaflet

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

received information leaflet

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.

Group Type: ACTIVE_COMPARATOR

information leaflet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Selin Erel

attending doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gazi University School of Medicine

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 27317708 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24565345 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28456425 (View on PubMed)

Other Identifiers

184(13.12.2021)

Identifier Type: -

Identifier Source: org_study_id