An observational study in Preoperative Fasting, Perioperative Anxiety and Perioperative Hypoglycemia, sponsored by Burcu Ayvazoğlu. Not yet recruiting. Open to male participants aged 1 Year to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Burcu Ayvazoğlu · Observational
This prospective observational study aims to evaluate adherence to preoperative fasting guidelines and investigate the relationship between actual fasting durations, anxiety levels, and blood glucose levels in children aged 1-10 years undergoing elective circumcision under general anesthesia.
The main questions this study aims to answer are:
Are the actual preoperative fasting durations in children longer than the recommended fasting durations?
Are prolonged fasting durations associated with increased preoperative anxiety levels in children?
Is there a relationship between fasting durations and parental anxiety levels?
Are prolonged fasting durations associated with preoperative blood glucose levels in children?
Do parental educational levels influence adherence to preoperative fasting recommendations?
The study will include children aged 1-10 years who are scheduled to undergo elective circumcision under general anesthesia at Yahyali State Hospital, Kayseri, Türkiye.
Parents will be asked to report the last time their children consumed solid foods and clear liquids, and actual fasting durations will be calculated. Before surgery, children's anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS), while parental anxiety levels will be evaluated using the State-Trait Anxiety Inventory-State (STAI-State). Preoperative blood glucose levels will also be measured.
No experimental treatments or interventions will be performed, and participation in the study will not result in any changes to routine anesthesia, surgical procedures, or perioperative care.
This single-center, prospective observational study will be conducted at Yahyali State Hospital, Kayseri, Türkiye, and will include children aged 1-10 years scheduled for elective circumcision under general anesthesia. Children with American Society of Anesthesiologists (ASA) physical status I-II will be eligible for inclusion. Written informed consent will be obtained from parents or legal guardians before enrollment.
During the preoperative anesthesia assessment, families will receive verbal instructions regarding fasting requirements in accordance with routine institutional practice. On the day of surgery, parents will be asked to report the time of their child's last solid food and clear liquid intake. Actual fasting durations will be calculated in hours and recorded separately.
Demographic and clinical characteristics, including age, height, weight, body mass index, ASA physical status, comorbidities, and previous anesthesia or surgical experience, will be documented. Maternal and paternal educational levels will also be recorded.
Before surgery and prior to the administration of any sedative medication, children's anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS). Parental situational anxiety will be evaluated using the State-Trait Anxiety Inventory-State (STAI-State).
Preoperative blood glucose levels will be measured immediately after routine peripheral intravenous cannulation and before the administration of intravenous fluids or medications. No additional venipuncture will be performed for research purposes.
Actual solid food and clear liquid fasting durations will be analyzed as continuous variables to investigate their associations with children's preoperative anxiety scores, parental anxiety scores, and blood glucose levels. Participants will also be classified according to whether their fasting durations are consistent with current pediatric fasting recommendations or exceed the recommended durations.
The relationship between parental educational levels and adherence to fasting recommendations will be evaluated. Associations between children's and parents' anxiety scores will also be examined.
Statistical analyses will include appropriate correlation analyses, group comparisons, and multivariable linear regression to assess the association between fasting duration and children's anxiety while considering potential confounding factors, such as age, previous anesthesia or surgical experience, parental anxiety, and parental educational levels. Statistical significance will be set at p \< 0.05.
All surgical procedures, anesthesia management, and postoperative care will follow routine clinical practice. No experimental medications, additional invasive procedures, or modifications to standard treatment will be introduced as part of the study.
706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.
This study's planned enrollment of 60 is below the median of 86 across 131 observational studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →Burcu Ayvazoğlu is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of children aged 1-10 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled to undergo elective circumcision under general anesthesia at Yahyali State Hospital, Kayseri, Türkiye. Children who meet the eligibility criteria and whose parents or legal guardians provide written informed consent will be included in this single-center, prospective observational study.
Inclusion Criteria:Children aged 1-10 years.
Scheduled for elective circumcision under general anesthesia at Yahyali State Hospital.
(ASA) physical status I or II.
Written obtained from a parent or legal guardian.
Verbal assent from the child when appropriate for age and developmental level.
Parents or legal guardians able to reliably report the time of the child's last solid food and clear liquid intake.
Ability to complete preoperative anxiety assessments (m-YPAS and STAI-State) and blood glucose measurement according to the study protocol.
Parent or legal guardian willing to participate in the study's data collection procedures.
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Exclusion Criteria:
Circumcision performed under anesthesia techniques other than general anesthesia.
ASA physical status III or higher.
Diabetes mellitus, congenital metabolic disorders, endocrine diseases, or chronic conditions affecting glucose metabolism.
Regular use of medications that may affect blood glucose or anxiety levels, including , insulin, oral antidiabetic agents, or psychiatric medications.
Developmental delay, autism spectrum disorder, neurodevelopmental disorders, or neurological or psychiatric conditions that prevent reliable m-YPAS assessment.
Parents or legal guardians with cognitive impairment, communication difficulties, or inability to read and understand Turkish, preventing completion of the STAI-State questionnaire.
Inability to reliably determine or report the time of the child's last solid food or clear liquid intake.
Refusal to participate or absence of written informed consent from a parent or legal guardian.
Incomplete study data or inability to complete the study protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children undergoing elective circumcision under anesthesia will be prospectively observed. Preoperative fasting durations for solids and liquids will bw recorded and perioperative blood glucose levels will be assessed. The association between fasting duration and blood glucose levels will be evaluated. No additional fasting intervention will be assigned by the investigators.
Preoperative Anxiety Level in Children
Children's preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS). The association between preoperative solid food and clear liquid fasting durations, measured in minutes, and m-YPAS scores will be evaluated. Higher m-YPAS scores indicate greater anxiety
Time frame: On the day of surgery, immediately before surgery and prior to sedative administration.
Parental Preoperative Anxiety Level
Parental preoperative anxiety will be assessed using the State-Trait Anxiety Inventory-State (STAI-State). Total scores range from 20 to 80, with higher scores indicating greater anxiety. The association between actual preoperative fasting durations, measured in minutes, and parental anxiety scores will be evaluated.
Time frame: On the day of surgery, during the preoperative period before anesthesia induction.
Preoperative Blood Glucose Level
Preoperative blood glucose levels will be measured in mg/dL immediately after routine intravenous cannulation and before the administration of intravenous fluids or medications. The association between fasting durations, measured in minutes, and blood glucose levels will be evaluated.
Time frame: On the day of surgery, immediately before anesthesia induction.
Actual Solid Food Fasting Duration
The duration of preoperative fasting for solid foods will be calculated in minutes based on the time of the last solid food intake reported by parents and the time of anesthesia induction.
Time frame: On the day of surgery, before anesthesia induction.
Actual Clear Liquid Fasting Duration
The duration of preoperative fasting for clear liquids will be calculated in minutes based on the time of the last clear liquid intake reported by parents and the time of anesthesia induction.
Time frame: On the day of surgery, before anesthesia induction.
Adherence to Preoperative Fasting Guidelines
Adherence to current pediatric preoperative fasting recommendations will be assessed using actual solid food and clear liquid fasting durations. The proportion of children whose fasting durations are consistent with guideline recommendations will be calculated.
Time frame: On the day of surgery, before anesthesia induction.
Association Between Parental Education and Fasting Duration
Maternal and paternal educational levels will be recorded and their associations with actual preoperative solid food and clear liquid fasting durations, measured in minutes, will be evaluated.
Time frame: On the day of surgery, during the preoperative assessment.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jan 2027, 2 months later.
Of 52 non-industry observational studies under Hypoglycemia, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's planned 2 months is below that.
Counting every sponsor, half of 53 studies reached it within 22 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Burcu Ayvazoğlu