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

A

Aydin Adnan Menderes University

Status

Enrolling

Conditions

Postoperative Pain
Urogenital Diseases
Emergence Delirium in Pediatric Anesthesia
Preoperative Anxiety

Treatments

Other: Standardized Perioperative Management and Observational Assessment

Study type

Observational

Funder types

Other

Identifiers

NCT07343388
GOA-155

Details and patient eligibility

About

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).

Enrollment

60 estimated patients

Sex

Male

Ages

2 to 7 years old

Volunteers

No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

Pediatric Urogenital Surgery Group
Treatment:
Other: Standardized Perioperative Management and Observational Assessment

Trial contacts and locations

1

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Central trial contact

Gonul Sari, M.D.

Data sourced from clinicaltrials.gov

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