Clinical trial NCT05221671: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Preoperative Anxiety
Pediatric Anesthesia
Keywords: Anxiety; Anesthesia; Preoperative care; Child
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 142
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Evaluation of preoperative anxiety scores of children with the Modified Yale Preoperative Anxiety Scale
timeFrame: Children's anxiety scale (m-YPAS) will be filled by the researcher observationally before the procedure.
Secondary outcomes:
measure: Evaluation of parents' knowledge and anxiety levels about anesthesia with the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: Parents will be asked to fill out the anesthesia knowledge and anxiety level determination questionnaire in the waiting room before the endoscopy procedure.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University School of Medicine
Study officials:
References:
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.
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.
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.