Effect on Anxiety in Pediatric Patients; Successful Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: Explains the perioperative process with pictures; Behavioral: The perioperative process is only explained

• Registration Number: NCT06427928
• Lead Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Brief Summary

Preoperative anxiety is characterized by subjective emotions such as irritability, irritability, sadness, and unhappiness. Studies have shown that preoperative anxiety negatively affects children both psychologically and physiologically. Preoperative anxiety occurs in 60-80% of children undergoing anesthesia and surgery and is associated with undesirable consequences such as nightmares, separation anxiety, eating disorders, negative behavioral changes such as increased fear of doctors, increased need for analgesics. The aim of this study is to evaluate the preoperative and pre-sedation anxiety levels in pediatric patients by explaining the peroperative process to the patients with drawings.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-24
• Study Start: 2024-07-01
• Primary Completion: 2024-08-30
• Status Verified: 2025-01
• Study Completion: 2025-01-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• ASA I patients without any comorbidities who were operated on by the ENT,
• Patients between the ages of 5-12,
• And patients who could be contacted and did not have any anxiety problems were included.

Exclusion Criteria

• Patients with liver and/or kidney failure, trauma patients, ASAII-III-IV patients, patients with bleeding disorders,
• those using medications that would affect the coagulation system, patients with local anesthetic allergy, patients with immobility and malnutrition, .And patients who did not want to participate in the study were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Explains the perioperative process with pictures	The perioperative process is only explained	-
Explains the perioperative process with pictures	Explains the perioperative process with pictures	-
The perioperative process is only explained	Explains the perioperative process with pictures	-
The perioperative process is only explained	The perioperative process is only explained	-

Primary Outcome Measures

Name	Time	Method
Modified Yale Preoperative Anxiety Scale	surgical ward (T0), in the preoperative waiting area (T1), at the time of separation from the parent to the operating room (T2), upon entry to the operating room (T3), and at the time of starting intravenous induction (T4).	Activity Interested in his/her surroundings, curious, playing with toys, reading (or other age-appropriate activities); may wander around the waiting room or operating room or go to the parent to retrieve a toy; Can gravitate towards operating room equipment 1; He is indifferent to his surroundings, does not play, looks at the ground, plays with his hands and fingers, sucks his thumb; may sit very close to the parent while waiting. 2; Aimless movements directed from the toy towards the parent in an unfocused manner; crazy/exaggerated movements or tricks; writhing, moving on the couch; may push the mask or hug the parent during induction. 3; The person who actively tries to move away, pushing with his feet and arms, can use his whole body to move away; may not be able to separate from the parent who is running around in the waiting room without focusing, not paying attention to toys, or clinging desperately.4; Speech Reading (may not speak in relation to the activity), asking

Secondary Outcome Measures

Name	Time	Method
heart rate	when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation	beats\\minute
Riker agitation scala	after extubation	7 -Dangerous Agitation, 6 - Very Agitated, 5 - Agitated, 4 - Calm and Cooperative, 3 - sedated, 2- Very Sedated, 1 -Unarousable
Visual analog scala	surgical ward (T0), in the preoperative waiting area (T1), at the time of separation from their child	The scale ranged from 0 to 10, where 0 represents not anxious and 10 represents extreme anxiety.
mean arterial pressure	when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after	mmHg

Trial Locations

Locations (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital; 🇹🇷 Diyarbakır, Kayapınar, Turkey