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Preoperative FastingNCT07876583

Preoperative Fasting and Perioperative Outcomes in Children Undergoing Elective Circumcision

An observational study of Preoperative Fasting and Perioperative Anxiety, run by Burcu Ayvazoğlu.

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Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 1 year to 10 years, men onlyHealthy volunteers can take part
How many people
60 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 15 Jan 2027
Phase
Observational

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 1 year to 10 years
  • Men only
  • Healthy volunteers accepted
  • Child

Study population: 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.

Who may be able to join

  • Scheduled for elective circumcision under general anesthesia at Yahyali State Hospital.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Written informed consent 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.
  • -

Who cannot join

  • Emergency circumcision procedures.
  • 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 corticosteroids, 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.
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  • 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.

About this study

Official title: Association of Adherence to Preoperative Fasting Guidelines With Anxiety, Blood Glucose Levels, and Perioperative Outcomes in Children Undergoing Elective Circumcision: A Prospective Observational Study

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:

Read more

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.

Read the detailed description

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.

Keywords
Pediatric Anesthesia, Preoperative Fasting, Fasting Guideline Adherence, Blood Glucose, Perioperative Anxiety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07876583
Study groupRoleWhat they receive
pediatric circumcision cohortChildren 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: On the day of surgery, immediately before surgery and prior to sedative administration.

Secondary outcomes (6)
  1. 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.

    Measured: On the day of surgery, during the preoperative period before anesthesia induction.

  2. 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.

    Measured: On the day of surgery, immediately before anesthesia induction.

  3. 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.

    Measured: On the day of surgery, before anesthesia induction.

  4. 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.

    Measured: On the day of surgery, before anesthesia induction.

  5. 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.

    Measured: On the day of surgery, before anesthesia induction.

  6. 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.

    Measured: On the day of surgery, during the preoperative assessment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07876583
Sponsor's protocol ID
YahyaliStateH
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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