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

NCT ID: NCT06424587

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-30

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

Nurse's Role

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Music intervention group

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.

Group Type: EXPERIMENTAL

Music intervention

Intervention Type: 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

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music intervention

: 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 Type: BEHAVIORAL

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

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Uzşen

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice Uzsen, PhD

Role: PRINCIPAL_INVESTIGATOR

ondokuz mayıs üniversity

Locations

Ondokuz Mayis University

Samsun, Black Sea, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IT

Identifier Type: -

Identifier Source: org_study_id