Effect on Anxiety in Pediatric Patients; Successful Randomized Controlled Trial

NCT06427928 | Completed

• 1 other identifier: HTSoner
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

perioperative anxiety; pediatric; general anhesthesia

Outcome Measures

Primary Outcomes (1)

• Modified Yale Preoperative Anxiety Scale

  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

  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).

Secondary Outcomes (4)

• Riker agitation scala

  after extubation

• Visual analog scala

  surgical ward (T0), in the preoperative waiting area (T1), at the time of separation from their child

• mean arterial pressure

  when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after

• heart rate

  when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation

Study Arms (2)

Explains the perioperative process with pictures

ACTIVE COMPARATOR

Behavioral: Explains the perioperative process with pictures; Behavioral: The perioperative process is only explained

The perioperative process is only explained

OTHER

Behavioral: Explains the perioperative process with pictures; Behavioral: The perioperative process is only explained

Interventions

Explains the perioperative process with pictures BEHAVIORAL

We will draw pictures of the preoperative area, operating room and postoperative areas of our operating room and explain the process to 34 of the children who will undergo surgery with these pictures. We will explain the process to the other 34 people without the pictures we have. We planned to measure the anxiety levels between the two groups with the modified Yale scale.

Explains the perioperative process with pictures; The perioperative process is only explained

The perioperative process is only explained BEHAVIORAL

We will draw pictures of the preoperative area, operating room and postoperative areas of our operating room and explain the process to 34 of the children who will undergo surgery with these pictures. We will explain the process to the other 34 people without the pictures we have. We planned to measure the anxiety levels between the two groups with the modified Yale scale.

Explains the perioperative process with pictures; The perioperative process is only explained

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Spesialist

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 24, 2024
• Study Start: July 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: January 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)