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

Not Applicable

Completed

• Conditions: Nurse's Role
• Interventions: Behavioral: Music intervention

• Registration Number: NCT06424587
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-30
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music intervention group	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.

Primary Outcome Measures

Name	Time	Method
anxiety	30 minutes before intrathecal chemotherapy treatment and just after music intervention	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.
fear	30 minutes before intrathecal chemotherapy treatment and just after music intervention	Children's Fear Scale (CFS): The scale can be scored between 0 and 4. An increase in the score means an increase in fear
pain scale	60 minutes after intrathecal chemotherapy treatment	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,

Trial Locations

Locations (1)

Ondokuz Mayis University; 🇹🇷 Samsun, Black Sea, Turkey