## Protocol Section
### Identification Module
**NCT ID:** NCT06424587

**Brief Title:** The Effect of Music Intervention on Anxiety, Fear, and Pain in Pediatric Patients Receiving Intrathecal Chemotherapy

**Official Title:** The Effect of Music Intervention on Anxiety, Fear, and Pain in Pediatric Patients Receiving Intrathecal Chemotherapy

#### Organization Study ID Info
**ID:** IT
#### Organization
**Class:** OTHER
**Full Name:** Ondokuz Mayıs University
### Status Module
#### Completion Date
**Date:** 2023-12-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

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

#### Lead Sponsor

**Class:** OTHER

**Name:** Ondokuz Mayıs University

#### Responsible Party

**Investigator Affiliation:** Ondokuz Mayıs University

**Investigator Full Name:** Hatice Uzşen

**Investigator Title:** Research assistant

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Intrathecal chemotherapy is often used to prevent the spread of cancer to the central nervous system in pediatric patients and is one of the most invasive procedures. It is believed that the way it is administered and the complications experienced after treatment negatively affect the comfort of the pediatric patient, leading them to refuse the treatment.

**Detailed Description:** Receiving sedation is one of the pharmacological procedures for intrathecal chemotherapy which creates a particularly difficult situation for the child. However, since pharmacological methods increase the cost and cause toxicity in children, in recent years, the symptoms that occur in cancer treatment have been tried to be controlled with non-pharmacological methods. Music intervention facilitates a sense of control in patients and provides mental distraction, emotional smoothness, and relaxation, which have been found to have pain relief effects.

### Conditions Module

**Conditions:**

- Nurse's Role

**Keywords:**

- anxiety

- hematology-oncology nursing

- pain intervention

- randomized controlled trial

- fear

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** a parallel group, randomized, controlled experimental study.

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In addition to the routine practice of the clinic, the pediatric patients in this group listened to music through headphones for 20 minutes just before the procedure to reduce the child's anxiety and fear. The therapeutic effect of music was used. Before the study, children between the ages of 6 and 12 who were inpatients at the clinic were asked what music they most liked to listen to, what kind of music they liked, and what their favorite artists and songs were. The music was selected based on the children's answers. In addition, the researcher added children's songs by a musician named Banu Kanıbelli.

**Intervention Names:**

- Behavioral: Music intervention

**Label:** Music intervention group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Children were verbally informed about the treatment process and invasive procedures from the day they were diagnosed with the disease. The children in this group were verbally informed by the nurse in charge of the clinic about the intrathecal chemotherapy treatment and why it was performed

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Music intervention group

**Description:** : In addition to the routine practice of the clinic, the pediatric patients in this group listened to music through headphones for 20 minutes just before the procedure to reduce the child's anxiety and fear. The therapeutic effect of music was used. Before the study, children between the ages of 6 and 12 who were inpatients at the clinic were asked what music they most liked to listen to, what kind of music they liked, and what their favorite artists and songs were. The music was selected based on the children's answers. In addition, the researcher added children's songs by a musician named Banu Kanıbelli

**Name:** Music intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Child Anxiety Meter-State

**Measure:** anxiety

**Time Frame:** 30 minutes before intrathecal chemotherapy treatment and just after music intervention

**Description:** Children's Fear Scale

**Measure:** fear

**Time Frame:** 30 minutes before intrathecal chemotherapy treatment and just after music intervention

**Description:** Face, Legs, Activity, Cry, Consolability (FLACC) pain scale

**Measure:** pain scale

**Time Frame:** 60 minutes after intrathecal chemotherapy treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* To be between 6-12 years old,
* Being treated in the Hematology and Oncology Clinic,
* About to receive intrathecal chemotherapy treatment,
* The child not having pain before intrathecal chemotherapy treatment

Exclusion criteria were,

* Refusing to participate in the study,
* Being under 6 years of age and over 10 years of age,
* The child having pain prior to intrathecal chemotherapy treatment,
* Having any physical or mental disability,
* Not being able to speak Turkish.

**Maximum Age:** 12 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Samsun

**Country:** Turkey

**Facility:** Ondokuz Mayis University

**State:** Black Sea

**Zip:** 55100

#### Overall Officials

**Official 1:**

**Affiliation:** ondokuz mayıs üniversity

**Name:** Hatice Uzsen, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
