Music Therapy's Effect on Cancer Patients Undergoing Radiotherapy

November 21, 2025 updated by: Ünal Önsüz, Kocaeli University

The Effect of Music Therapy on the Radiotherapy Experience of Cancer Patients Undergoing Radiotherapy: A Randomised Controlled Trial

The goal of this randomized controlled clinical study is to learn about the effects of music therapy on anxiety, stress, pain, and patient satisfaction in cancer patients who are newly starting radiotherapy (radiation treatment).

The main questions it aims to answer are:

Can music therapy lower the levels of anxiety and stress in patients receiving radiotherapy? Can music therapy improve the pain felt during the radiotherapy experience and overall satisfaction? Researchers will compare patients receiving standard radiotherapy (control group) with patients receiving music therapy alongside their radiotherapy (experimental group).

Participants (72 total) will:

Be 18 years and older and newly starting curative radiotherapy. Answer short surveys (STAI-SF, SDT, VAS) to measure their anxiety, stress, and pain levels before and after treatment.

Participants in the experimental group will receive a 15-20 minute music therapy session consisting of meditative and instrumental music during their first radiotherapy session.

This study aims to provide reliable data to guide clinical practice by showing whether music therapy offers a multifaceted approach to managing the psychological and physical challenges associated with cancer treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a single-blind randomized controlled trial 20202020evaluating the effect of music therapy in managing the emotional and physical difficulties experienced by cancer patients who are newly starting curative radiotherapy (RT).Study Site: The study will take place at the Kocaeli University Hospital Radiation Oncology Unit.Objectives: The primary aim is to examine the effect of music therapy on anxiety, stress, pain, and patient satisfaction, and to determine how it can improve the RT experience.Intervention Application:Timing and Duration: Music therapy will be administered during the first RT session in sessions lasting 15-20 minutes. (Literature reports that $<20$ minutes reduces anxiety ).Provider: The intervention will be administered by a certified music therapist. Music Selection: Patients will be asked to choose music that has a meditative effect, is instrumental (without lyrics), and lacks peaks (sudden attacks), based on their preference and inclination. The music options provided will include Far Eastern music, music accompanied by a light-beat rhythm instrument (bendir), Ney-heavy Mesnevi music with meditative effects, and meditative Saba makam music.Listening Method: The patient's selected music will be played via headphones for 15 minutes before the session, and as ambient listening during the session. For patients with head and neck or brain cancer, only ambient listening will be used during the procedure for consistency.Data Collection and Timeline:Measurement Location: Measurements will be taken by researchers at the Kocaeli University Radiation Oncology Unit.Study Duration: The study starts on December 1, 2025, and ends on January31, 2026, with a total duration of 7 months.

Statistical Analysis:The collected data will be analyzed using the following methods: Between-group comparisons: Independent Sample T-test or Mann-Whitney U test37.Pre-post changes: Repeated Measures ANOVA.The significance level is set at $p<0.05.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must be a cancer patient 18 years of age or older.
  • Must be newly starting curative external radiotherapy.
  • Must volunteer to participate in the study and sign the Informed Consent form.

Exclusion Criteria:

  • Having an advanced stage psychiatric disorder (e.g., schizophrenia).
  • Having hearing loss.
  • Having a prior history of an adverse reaction to music therapy.
  • Receiving radiotherapy for palliative (symptom relief) purposes.
  • Having received radiotherapy previously (for reasons such as brachytherapy, a different type of cancer, or recurrence).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Therapy Group (Experimental Arm)
Description: Consists of patients receiving curative radiotherapy (RT) who receive the music therapy intervention in addition to standard care to improve their radiotherapy experience.
Other: Music Therapy

Intervention: A personalized 15-20 minute music listening session is administered by a certified music therapist during the first session of radiotherapy.

Patients select from a list of meditative, instrumental (wordless), and music that lacks peaks (sudden attacks).

Music is presented via headphones before the session and as ambient listening during the session.
Active Comparator: Control Group (Standard Care Arm)
Description: Consists of patients receiving curative radiotherapy (RT) who receive only the standard radiation oncology care as per hospital protocol during their treatment.
Other: Standard Care (in control arm)
Intervention: These patients do not receive the music therapy intervention during their radiotherapy treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Level (STAI-SF)
Time Frame: mmediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).
ssessment of the effect of the music therapy intervention on the anxiety levels of cancer patients receiving curative radiotherapy, using the State-Trait Anxiety Inventory-Short Form (STAI-SF). The measured difference will be compared between the intervention group and the control group.
mmediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).
Change in Stress Level (SDT)
Time Frame: Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).
Assessment of the effect of the music therapy intervention on the general distress/stress levels experienced by cancer patients receiving curative radiotherapy, using the Symptom Distress Thermometer (SDT). The measured difference will be compared between the intervention group and the control group.
Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Procedural Pain Level (VAS)
Time Frame: Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session
Assessment of the effect of the music therapy intervention on the severity of pain felt during or related to the radiotherapy procedure, using the Visual Analog Scale (VAS). The measured difference will be compared between the groups.
Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session
Patient Satisfaction Level (VAS)
Time Frame: Immediately after the end of the radiotherapy session (Post-test).
Assessment of the effect of the music therapy intervention on patients' overall satisfaction levels with their radiotherapy experience, using the Visual Analog Scale (VAS). Satisfaction scores will be compared between the groups.
Immediately after the end of the radiotherapy session (Post-test).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Information Level (EORTC QLQ-INFO25)
Time Frame: At the start of the study (Pre-test).
Determination of the baseline Information Levels of enrolled patients using the EORTC QLQ-INFO25. This is used to assess baseline similarity between groups, and the potential effect of the information level on other parameters will also be analyzed.
At the start of the study (Pre-test).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.07.2025 - 2025/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The specific IPD to be shared includes all individual, anonymized patient data collected in the study. This data comprises:

Demographic Data (such as age and gender).

Disease and Treatment Information (such as cancer type, RT start date).

Data from All Scales Used (STAI-SF, SDT, VAS Pain, VAS Satisfaction, and EORTC QLQ-INFO25 scores).

The data will be coded to exclude any direct identifiers that could reveal the participants' identity.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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