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| Name | Class |
|---|---|
| Dr. Behcet Uz Children's Hospital | OTHER |
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The goal of this observational study is to learn if preoperative anxiety levels can predict the quality of early postoperative recovery, pain intensity, and the occurrence of emergence delirium in pediatric patients aged 2 to 7 years undergoing elective urogenital surgery, specifically hypospadias repair, orchidopexy, and hydrocele surgery.
The main questions it aims to answer are:
Does a higher level of preoperative anxiety lead to increased postoperative pain and a higher incidence of emergence delirium?
Is there a significant relationship between preoperative anxiety and the speed of physical recovery (discharge readiness) as measured by Aldrete scores?
Researchers will compare outcomes of patients with different levels of preoperative anxiety to see if higher anxiety results in poorer recovery profiles in the immediate postoperative period.
Participants will:
Be assessed for anxiety levels using the Modified Yale Preoperative Anxiety Scale (mYPAS) immediately before anesthesia induction.
Undergo a standardized anesthesia protocol for their elective urogenital procedure (hypospadias repair, orchidopexy, or hydrocele surgery).
Be monitored in the Post-Anesthesia Care Unit (PACU) at 0, 15, 30, 45, and 60 minutes after surgery to evaluate physical recovery (Modified Aldrete Score), delirium (PAED scale), and pain intensity (FLACC scale).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Urogenital Surgery Group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Perioperative Management and Observational Assessment | Other | All participants will undergo a standardized general anesthesia protocol for elective urogenital surgery (hypospadias repair, orchidopexy, or hydrocele surgery). The intervention includes: Preoperative Phase: Assessment of anxiety using the mYPAS scale before induction. Intraoperative Phase: Standardized induction and maintenance of anesthesia (e.g., inhalational anesthesia with sevoflurane). Postoperative Phase: Systematic observation in the Post-Anesthesia Care Unit (PACU) using Modified Aldrete, PAED, and FLACC scales at 0, 15, 30, 45, and 60 minutes. No experimental drugs or techniques will be administered; the study focuses on the observational correlation between preoperative anxiety and recovery outcomes." |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity | Measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. This behavioral scale assesses pain in children who cannot communicate verbally. Each of the five categories is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate increased pain intensity (0: Relaxed/Comfortable, 1-3: Mild discomfort, 4-6: Moderate pain, 7-10: Severe pain/discomfort). | Postoperatively at 0, 15, 30, 45, and 60 minutes. |
| Incidence and Severity of Emergence Delirium | Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale consists of five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and inconsolability. The total score ranges from 0 to 20, where higher scores indicate greater severity of delirium. A score of 10 or higher is considered clinically significant for the presence of emergence delirium. | Postoperatively at 0, 15, 30, 45, and 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Physical Recovery and Discharge Readiness | Measured using the Modified Aldrete Score, which evaluates five criteria: activity, respiration, circulation, consciousness, and oxygen saturation. Each criterion is scored 0, 1, or 2. The total score ranges from 0 to 10. Higher scores indicate better physical recovery and greater readiness for discharge from the Post-Anesthesia Care Unit (PACU). A score of 9 or 10 is typically required for safe discharge. |
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Inclusion Criteria:
Male patients aged 2 to 7 years.
ASA (American Society of Anesthesiologists) physical status I or II.
Scheduled for elective urogenital surgery, specifically hypospadias repair, orchidopexy, or hydrocele surgery.
Scheduled to undergo general anesthesia for the procedure.
Patients with no history of neurological or psychiatric disorders.
Provision of written informed consent by the parents or legal guardians.
Exclusion Criteria:
Female patients.
Patients undergoing emergency surgeries or non-urogenital/non-inguinal procedures.
Presence of a diagnosed cognitive impairment or developmental delay.
Parental or legal guardian refusal to provide informed consent.
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The study population consists of pediatric patients aged 2 to 7 years who are scheduled for elective urogenital surgical procedures at a tertiary pediatric training and research hospital. The cohort specifically focuses on patients undergoing common inguinoscrotal surgeries, including hypospadias repair, orchidopexy, and hydrocele surgery, under standardized general anesthesia. Participants are selected from patients who meet the ASA I-II physical status criteria and have no underlying neurological or psychiatric conditions that could interfere with anxiety and delirium assessments.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Behcet Uz Children's Hospital | Izmir | Konak | 35210 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33313588 | Background | Topalel S, Orekici Temel G, Azizoglu M. Evaluation of Preoperative Anxiety in Turkish Paediatric Patients and Validity and Reliability of the Turkish Modified Yale Preoperative Anxiety Scale. Turk J Anaesthesiol Reanim. 2020 Dec;48(6):484-490. doi: 10.5152/TJAR.2020.116. Epub 2020 May 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Anxiety Group (mYPAS ≥ 30) | Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of 30 or higher |
| FG001 | Low Anxiety Group (mYPAS < 30) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2025 |
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| Postoperatively at 0, 15, 30, 45, and 60 minutes. |
Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of less than 30.
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| ID | Title | Description |
|---|---|---|
| BG000 | High Anxiety Group (mYPAS ≥ 30) | Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of 30 or higher |
| BG001 | Low Anxiety Group (mYPAS < 30) | Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of less than 30. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Pain Intensity | Measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. This behavioral scale assesses pain in children who cannot communicate verbally. Each of the five categories is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate increased pain intensity (0: Relaxed/Comfortable, 1-3: Mild discomfort, 4-6: Moderate pain, 7-10: Severe pain/discomfort). | Posted | Median | Inter-Quartile Range | score | Postoperatively at 0, 15, 30, 45, and 60 minutes. |
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| Primary | Incidence and Severity of Emergence Delirium | Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale consists of five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and inconsolability. The total score ranges from 0 to 20, where higher scores indicate greater severity of delirium. A score of 10 or higher is considered clinically significant for the presence of emergence delirium. | Posted | Median | Inter-Quartile Range | score | Postoperatively at 0, 15, 30, 45, and 60 minutes. |
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| Secondary | Postoperative Physical Recovery and Discharge Readiness | Measured using the Modified Aldrete Score, which evaluates five criteria: activity, respiration, circulation, consciousness, and oxygen saturation. Each criterion is scored 0, 1, or 2. The total score ranges from 0 to 10. Higher scores indicate better physical recovery and greater readiness for discharge from the Post-Anesthesia Care Unit (PACU). A score of 9 or 10 is typically required for safe discharge. | Posted | Median | Inter-Quartile Range | score | Postoperatively at 0, 15, 30, 45, and 60 minutes. |
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From the preoperative assessment (immediately before anesthesia induction) until the completion of the 60-minute postoperative follow-up in the Post-Anesthesia Care Unit (PACU), up to 4 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Anxiety Group (mYPAS ≥ 30) | Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of 30 or higher | 0 | 50 | 0 | 50 | 0 | 50 |
| EG001 | Low Anxiety Group (mYPAS < 30) | Pediatric patients aged 2-7 years undergoing elective urogenital surgery with a baseline Modified Yale Preoperative Anxiety Scale (mYPAS) score of less than 30. | 0 | 64 | 0 | 64 | 0 | 64 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gonul Sari | University of Health Sciences, Dr. Behcet Uz Children's Hospital | 5426463501 | +90 | drgonulsari@gmail.com |
| Mar 18, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000091642 | Urogenital Diseases |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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