## Protocol Section
### Identification Module
**NCT ID:** NCT06427928

**Acronym:** anxiety in ped

**Brief Title:** Effect on Anxiety in Pediatric Patients; Successful Randomized Controlled Trial

**Official Title:** The Effect of Explaining the Perioperative Process With Our Drawings on Anxiety in Pediatric Patients; Prosperative Randomized Controlled Study

#### Organization Study ID Info
**ID:** HTSoner
#### Organization
**Class:** OTHER
**Full Name:** Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

**Investigator Full Name:** Hülya Tosun Söner

**Investigator Title:** Anesthesiology and Reanimation Spesialist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Anxiety

**Keywords:**

- perioperative anxiety

- pediatric

- general anhesthesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 74

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Explains the perioperative process with pictures

- Behavioral: The perioperative process is only explained

**Label:** Explains the perioperative process with pictures

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Behavioral: Explains the perioperative process with pictures

- Behavioral: The perioperative process is only explained

**Label:** The perioperative process is only explained

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Explains the perioperative process with pictures

- The perioperative process is only explained

**Description:** 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.

**Name:** Explains the perioperative process with pictures

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Explains the perioperative process with pictures

- The perioperative process is only explained

**Description:** 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.

**Name:** The perioperative process is only explained

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Modified Yale Preoperative Anxiety Scale

**Time Frame:** While being taken from the preoperative room to the operating room and just before anesthetizing in the operating room

#### Secondary Outcomes

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

**Measure:** Riker agitation scala

**Time Frame:** after extubation

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 12 Years

**Minimum Age:** 5 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hulyatosunsoner@hotmail.com

**Name:** Hülya Tosun Söner

**Phone:** +905352792102

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Misc Info Module

- Version Holder: 2024-05-31
