Music Therapy's Effect on Cancer Patients Undergoing Radiotherapy

NCT ID: NCT07261267

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-01-31

Brief Summary

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.

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.

Conditions

Cancer; Radiotherapy

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard Care (in control arm)

Intervention Type: OTHER

Intervention: These patients do not receive the music therapy intervention during their radiotherapy treatment.

Interventions

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.

Intervention Type: OTHER

Standard Care (in control arm)

Intervention: These patients do not receive the music therapy intervention during their radiotherapy treatment.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Ünal Önsüz

Lecturer, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli University Hospital

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ünal Önsüz

Role: CONTACT

unal.onsuz@kocaeli.edu.tr

+905444416990

References

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Other Identifiers

17.07.2025 - 2025/1

Identifier Type: -

Identifier Source: org_study_id