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

Nurse's Role Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06424587
• Other study ID #: IT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2024
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nurse's Role

Intervention

Behavioral:
• 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 Kanibelli

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun	Black Sea

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anxiety	Child Anxiety Meter-State	30 minutes before intrathecal chemotherapy treatment and just after music intervention
Primary	fear	Children's Fear Scale	30 minutes before intrathecal chemotherapy treatment and just after music intervention
Primary	pain scale	Face, Legs, Activity, Cry, Consolability (FLACC) pain scale	60 minutes after intrathecal chemotherapy treatment