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Effect on Anxiety in Pediatric Patients; Successful Randomized Controlled Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06427928
Acronym
anxiety
Enrollment
58
Registered
2024-05-24
Start date
2024-07-01
Completion date
2025-01-01
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

perioperative anxiety, pediatric, general anhesthesia

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.

Interventions

BEHAVIORALExplains the perioperative process with pictures

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.

BEHAVIORALThe perioperative process is only explained

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.

Sponsors

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Modified Yale Preoperative Anxiety Scalesurgical 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

MeasureTime frameDescription
Riker agitation scalaafter extubation7 -Dangerous Agitation, 6 - Very Agitated, 5 - Agitated, 4 - Calm and Cooperative, 3 - sedated, 2- Very Sedated, 1 -Unarousable
Visual analog scalasurgical ward (T0), in the preoperative waiting area (T1), at the time of separation from their childThe scale ranged from 0 to 10, where 0 represents not anxious and 10 represents extreme anxiety.
mean arterial pressurewhen you come to the operating room table after anesthesia induction Intraoperative 30 minutes aftermmHg
heart ratewhen you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubationbeats\\minute

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026