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Completed

NCT Number: NCT06424587

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

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.

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Key information

Conditions

Nurse's Role Anxiety Disorders Mental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, Black Sea, 55100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. anxiety

    Time frame: 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.

  2. fear

    Time frame: 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

  3. pain scale

    Time frame: 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,

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 22, 2024
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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