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

NCT06424587 | Completed

• 1 other identifier: IT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Nurse's Role

Keywords

anxiety; hematology-oncology nursing; pain intervention; randomized controlled trial; fear

Outcome Measures

Primary Outcomes (3)

• anxiety

  Child Anxiety Meter-State (CAM-S):The scale can be scored between 1 and 10. An increase in the score means an increase in anxiety.

  30 minutes before intrathecal chemotherapy treatment and just after music intervention

• fear

  Children's Fear Scale (CFS): The scale can be scored between 0 and 4. An increase in the score means an increase in fear

  30 minutes before intrathecal chemotherapy treatment and just after music intervention

• pain scale

  Face, Legs, Activity, Cry, Consolability pain scale (FLACC): total score between 0 and 10 is obtained by assigning 0, 1, or 2 points for each category. As the severity of pain increases, the total score increases, and as the severity of pain decreases,

  60 minutes after intrathecal chemotherapy treatment

Study Arms (2)

Music intervention group

EXPERIMENTAL

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.

Behavioral: Music intervention

Control Group

NO INTERVENTION

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

Interventions

Music intervention BEHAVIORAL

: 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

Music intervention group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Black Sea, 55100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Hatice Uzsen, PhD

  ondokuz mayıs üniversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: a parallel group, randomized, controlled experimental study.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: January 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)