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

NCT05221671 | Completed

• 1 other identifier: 184(13.12.2021)
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Preoperative Anxiety; Pediatric Anesthesia

Keywords

Anxiety; Anesthesia; Preoperative care; Child

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of parents' knowledge and anxiety levels about anesthesia with the Amsterdam Preoperative Anxiety and Information Scale (APAIS)

  Parents will be asked to fill out the anesthesia knowledge and anxiety level determination questionnaire in the waiting room before the endoscopy procedure.

Study Arms (2)

not received information leaflet

NO INTERVENTION

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.

received information leaflet

ACTIVE COMPARATOR

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.

Other: information leaflet

Interventions

information leaflet 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.

received information leaflet

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University School of Medicine

Ankara, Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 27317708 BACKGROUND

• 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.

  PMID: 24565345 BACKGROUND

• 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.

  PMID: 28456425 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending doctor

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 3, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 12, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)