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Completed

NCT Number: NCT06427928

Effect on Anxiety in Pediatric Patients; Successful Randomized Controlled Trial

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Modified Yale Preoperative Anxiety Scale

    Time frame: 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 outcomes

  1. Riker agitation scala

    Time frame: after extubation

    7 -Dangerous Agitation, 6 - Very Agitated, 5 - Agitated, 4 - Calm and Cooperative, 3 - sedated, 2- Very Sedated, 1 -Unarousable

  2. Visual analog scala

    Time frame: 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.

  3. mean arterial pressure

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

    mmHg

  4. heart rate

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

    beats\\minute

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

The Effect of Explaining the Perioperative Process with Our Drawings on Anxiety in Pediatric Patients; Prosperative Randomized Controlled Study

Acronym: anxiety

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 24, 2024
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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