Relationship Between Preoperative Anxiety, Postoperative Pain, and Emergence Delirium in Pediatric Surgery

NCT ID: NCT07343388

Last Updated: 2026-01-15

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Postoperative Pain Preoperative Anxiety Emergence Delirium in Pediatric Anesthesia Urogenital Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric Urogenital Surgery Group

Standardized Perioperative Management and Observational Assessment

Intervention Type 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."

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."

Intervention Type OTHER

Eligibility Criteria

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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

* Patients outside the specified age range (younger than 2 or older than 7 years).

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Behcet Uz Children's Hospital

OTHER

Sponsor Role collaborator

Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Gonul Sari

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Behcet Uz Children's Hospital

Izmir, Konak, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gonul Sari, M.D.

Role: CONTACT

+905426463501

Facility Contacts

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Kubra Evren Sahin, Assoc. Prof.

Role: primary

+905057123379

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.

Reference Type BACKGROUND
PMID: 33313588 (View on PubMed)

Other Identifiers

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GOA-155

Identifier Type: -

Identifier Source: org_study_id

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