AnxietyNCT05221671
Impact of the Information Leaflet on the Anesthesia Knowledge and Anxiety Levels of Children and Parents
A study testing information leaflet in people with Anxiety and Preoperative Anxiety, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Preoperative Anxiety, Pediatric Anesthesia
- What is being tested?
- information leaflet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University School of Medicine
Ankara, Ankara, 06500
About this study
Official title: Impact of the Information Leaflet on the Preoperative Anesthesia Knowledge and Anxiety Levels of Children and Parents Before the Pediatric Endoscopic Procedures
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.
Read the 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
- Being tested
- information leaflet
- Keywords
- Anxiety; Anesthesia; Preoperative care; Child
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
information leafletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: information leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Parents will be asked to fill out the anesthesia knowledge and anxiety level determination questionnaire in the waiting room before the endoscopy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Erel, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221671
- Sponsor's protocol ID
- 184(13.12.2021)
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall results of research will be shared, individual answers of participants wont be shared.
Publications
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.
PubMed 27317708Cumino 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.
PubMed 24565345Landier 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.
PubMed 28456425Erel S, Kilic AG, Eryilmaz NC, Toyran UO, Egritas Gurkan O. Effect of Educational Brochures on Preprocedural Anxiety in Pediatric Endoscopy: A Randomized Controlled Trial. Turk J Gastroenterol. 2025 Sep 10;36(10):680-691. doi: 10.5152/tjg.2025.25144.
PubMed 40955499
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Information Leaflet on the Preoperative Anesthesia Knowledge and Anxiety Levels of Children and Parents Before the Pediatric Endoscopic Procedures
- ClinicalTrials.gov ID
- NCT05221671
- Acronym / sponsor ID
- 184(13.12.2021)
- Conditions
- Anxiety, Preoperative Anxiety, Pediatric Anesthesia
- Keywords
- Anxiety; Anesthesia; Preoperative care; Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: information leafletDuring 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| information leafletLeaflets 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. | Other | received information leaflet |
Primary outcome
Evaluation of preoperative anxiety scores of children with the Modified Yale Preoperative Anxiety Scale
Time frame: Children's anxiety scale (m-YPAS) will be filled by the researcher observationally before the procedure.
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.
1 secondary outcome
Evaluation of parents' knowledge and anxiety levels about anesthesia with the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 27317708Kassai 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.
- Background: PubMed 24565345Cumino 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.
- Background: PubMed 28456425Landier 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.
- Derived from this study: PubMed 40955499Erel S, Kilic AG, Eryilmaz NC, Toyran UO, Egritas Gurkan O. Effect of Educational Brochures on Preprocedural Anxiety in Pediatric Endoscopy: A Randomized Controlled Trial. Turk J Gastroenterol. 2025 Sep 10;36(10):680-691. doi: 10.5152/tjg.2025.25144.
- Individual participant dataSharing planned: No. Overall results of research will be shared, individual answers of participants wont be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing information leaflet in people with Anxiety and Preoperative Anxiety, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of preoperative anxiety scores of children with the Modified Yale Preoperative Anxiety Scale (time frame: Children's anxiety scale (m-YPAS) will be filled by the researcher observationally before the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05221671, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.