## Protocol Section
### Identification Module
**NCT ID:** NCT06404879

**Brief Title:** The Effect of Parental Anxiety Level on the Child's Anxiety Level and Postoperative Pain in Children Undergoing Surgery.

**Official Title:** The Relationship Between Pre-operative Parental Anxiety Level and the Child's Anxiety Level and Its Effect on Postoperative Pain in Children Aged 2-6 Years Who Will Undergo Inguinal Area Surgery.

#### Organization Study ID Info
**ID:** 25.09.2023/07
#### Organization
**Class:** OTHER
**Full Name:** Giresun University
### Status Module
#### Completion Date
**Date:** 2024-07-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-08

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-07

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-08
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Giresun University

#### Responsible Party

**Investigator Affiliation:** Giresun University

**Investigator Full Name:** Dilek Yeniay

**Investigator Title:** Anesthesiology and Reanimation physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The aim of this prospective study is to investigate whether the anxiety levels of parents of children aged 2-6 years who will undergo inguinal area surgery have an effect on the child\&#39;s preoperative anxiety level and postoperative pain level.

**Detailed Description:** Hospitalization of children for any health problem or treatment is a complex and difficult process that negatively affects the child and his family and creates stress. Surgical treatment in children can be planned or unplanned, minor or major, invasive or non-invasive, but every type of surgery is considered a stressful experience. Studies have shown that by controlling the anxiety and fear experienced in the preoperative period, children can achieve faster recovery in the postoperative period, better pain tolerance and earlier discharge. For this reason, we aim to contribute to the literature by investigating whether the anxiety levels of the parents of children aged 2-6 who will undergo inguinal area surgery affect the child\&#39;s preoperative anxiety level and postoperative pain level.

### Conditions Module

**Conditions:**

- Anxiety

- Children

**Keywords:**

- children

- anxiety

- analgesia

- pediatric

- anaesthesia

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Day

### Arms Interventions Module

#### Arm Group 1

**Description:** Are between the ages of 2-6, are planned to undergo surgery under general anesthesia due to inguinal area pathology, No mental or neurological disorders in both mother and child No vision, hearing or speech problems in both mother and child Parents and children who volunteer to participate in the research will be included in the study.

Those who did not volunteer to participate in the study, Undergoing surgery with a pathology other than the inguinal area, Having emergency surgery Children with pathologies (mental retardation, neurological problems, etc.) that may cause difficulty in communicating with both the family and the child will not be included in the study.

**Intervention Names:**

- Other: determining scores with tests

**Label:** children group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- children group

**Description:** Parents of children preparing for the operation will be given a child and family information form and STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms and will be asked to fill them out themselves.

An anesthesia technician blind to the content of the study will calculate and take notes on the children\&#39;s anxiety levels, according to the m-YPAS (modified Yale Preoperative Anxiety) scale, in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4).

FLACC (Face, Legs, Activity, Cry, Consolabilityscale) scores and spO2, pulse values and complications such as nausea, vomiting and desaturation at the 5th, 10th, 20th and 30th minutes of all children taken to the recovery unit in the postoperative period will be recorded by the recovery unit nurse. . Children who are thought to have pain according to the FLACC score will be given 0.5 mg/kg meperidine as rescue analgesia and a note will be taken.

**Name:** determining scores with tests

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** It will be measured with STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms.

**Measure:** Anxiety level of parents

**Time Frame:** preoperative period

**Description:** According to the m-YPAS (modified Yale Preoperative Anxiety) scale, children's anxiety levels will be calculated in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4).

**Measure:** Anxiety level of the child undergoing surgery

**Time Frame:** preoperative and intraoperative period

**Description:** Pain levels of all children taken to the recovery unit will be measured with the FLACC (Face, Legs, Activity, Cry, Consolabilityscale) score at the 5th, 10th, 20th and 30th minutes.

**Measure:** Pain levels of children undergoing surgery

**Time Frame:** postoperative period

#### Secondary Outcomes

**Description:** beats/min

**Measure:** heart rate

**Time Frame:** intraoperative period

**Description:** beats/min

**Measure:** heart rate

**Time Frame:** up to 8 hour postoperative

**Description:** such as nausea, vomiting and desaturation

**Measure:** complication

**Time Frame:** up to 24 hour postoperative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* The child is between the ages of 2-6
* Patients scheduled for surgery under general anesthesia due to inguinal area pathology
* Surgery performed as planned
* There is no mental or neurological disorder in both the mother and the child.
* There are no vision, hearing or speech problems in both the mother and the child.
* Parents and children who volunteer to participate in the research
* Children with ASA I

Exclusion Criteria:

* Not volunteering to participate in the study (those for whom parental consent cannot be obtained)
* Those who underwent surgery with a pathology other than the inguinal area
* Having emergency surgery
* Children at risk with ASA 2 and above
* Having a pathology that may cause difficulty in communicating with both the family and the child (such as mental retardation, neurological problem).

**Healthy Volunteers:** True

**Maximum Age:** 6 Years

**Minimum Age:** 2 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Children who are planned to undergo surgery under general anesthesia due to inguinal area pathology

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dgyeniay@gmail.com

**Name:** DİLEK YENİAY

**Phone:** +905375521553

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Giresun

**Contacts:**

***Contact 1:***

- **Email:** dgyeniay@gmail.com

- **Name:** Dilek Giresun Gynecology and Pediatrics Training Research Hospital

- **Phone:** +90 454 2163600

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dilek Yeniay

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Turkey

**Facility:** Giresun Gynecology and Pediatrics Training Research Hospital

**State:** Centre

**Zip:** 28000

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Postoperative Pain

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

- ID: D000001008

- Term: Anxiety Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M11595

- Name: Meperidine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
