Relationship Between Preoperative Anxiety, Postoperative Pain, and Emergence Delirium in Pediatric Surgery
NCT ID: NCT07343388
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2026-01-01
2026-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pediatric Urogenital Surgery Group
Standardized Perioperative Management and Observational Assessment
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."
Interventions
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Standardized Perioperative Management and Observational Assessment
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."
Eligibility Criteria
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Inclusion Criteria
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.
2 Years
7 Years
MALE
No
Sponsors
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Dr. Behcet Uz Children's Hospital
OTHER
Aydin Adnan Menderes University
OTHER
Responsible Party
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Gonul Sari
MD
Locations
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Dr. Behcet Uz Children's Hospital
Izmir, Konak, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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GOA-155
Identifier Type: -
Identifier Source: org_study_id
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