Music Therapy's Effect on Cancer Patients Undergoing Radiotherapy

NCT07261267 | Not Yet Recruiting

• 1 other identifier: 17.07.2025 - 2025/1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Radiotherapy

Keywords

Music Therapy; Radiotherapy; Anxiety; Pain; Stress

Outcome Measures

Primary Outcomes (2)

• Change in Anxiety Level (STAI-SF)

  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)

  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 Outcomes (2)

• Change in Procedural Pain Level (VAS)

  Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session

• Patient Satisfaction Level (VAS)

  Immediately after the end of the radiotherapy session (Post-test).

Other Outcomes (1)

• Baseline Information Level (EORTC QLQ-INFO25)

  At the start of the study (Pre-test).

Study Arms (2)

Music Therapy Group (Experimental Arm)

EXPERIMENTAL

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

Control Group (Standard Care Arm)

ACTIVE COMPARATOR

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)

Interventions

Music Therapy 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.

Music Therapy Group (Experimental Arm)

Standard Care (in control arm) OTHER

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

Control Group (Standard Care Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Location

Related Publications (11)

• Yang HF, Chang WW, Chou YH, Huang JY, Liao YS, Liao TE, Tseng HC, Chang ST, Chen HL, Ke YF, Tsai PF, Chan HM, Chang BJ, Hwang YT, Tsai HY, Lee YC. Impact of background music listening on anxiety in cancer patients undergoing initial radiation therapy: a randomized clinical trial. Radiat Oncol. 2024 Jun 11;19(1):73. doi: 10.1186/s13014-024-02460-3.

  PMID: 38862982 BACKGROUND

• Wilson JM, Franqueiro AR, Edwards RR, Chai PR, Schreiber KL. Individuals with fibromyalgia report greater pain sensitivity than healthy adults while listening to their favorite music: the contribution of negative affect. Pain Med. 2024 May 2;25(5):352-361. doi: 10.1093/pm/pnae005.

  PMID: 38291916 BACKGROUND

• Terzi, E. (2022). The effect of listening to music with or without patient selection on pain during cesarean section and its contribution to anesthesia technicians. Journal of Experimental and Clinical Medicine, 39(3), 786-792.

  BACKGROUND

• Tao WW, Jiang H, Tao XM, Jiang P, Sha LY, Sun XC. Effects of Acupuncture, Tuina, Tai Chi, Qigong, and Traditional Chinese Medicine Five-Element Music Therapy on Symptom Management and Quality of Life for Cancer Patients: A Meta-Analysis. J Pain Symptom Manage. 2016 Apr;51(4):728-747. doi: 10.1016/j.jpainsymman.2015.11.027. Epub 2016 Feb 12.

  PMID: 26880252 BACKGROUND

• Gulbahar Ates S, Demirel BB, Kekilli E, Ozturk E, Ucmak G. Primary tumor heterogeneity on pre-treatment [68Ga]Ga-PSMA PET/CT for the prediction of biochemical recurrence in prostate cancer. Rev Esp Med Nucl Imagen Mol (Engl Ed). 2024 Nov-Dec;43(6):500032. doi: 10.1016/j.remnie.2024.500032. Epub 2024 Aug 2.

  PMID: 39097169 BACKGROUND

• Hewis J. Music and Music Therapy in the Medical Radiation Sciences. J Med Imaging Radiat Sci. 2018 Dec;49(4):360-364. doi: 10.1016/j.jmir.2018.09.009. Epub 2018 Oct 23. No abstract available.

  PMID: 30514551 BACKGROUND

• Jiang X, Gao J, Zheng Y. Effectiveness of traditional Chinese medicine music therapy on anxiety and depression emotions of lung cancer patients: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021 Mar 26;100(12):e25040. doi: 10.1097/MD.0000000000025040.

  PMID: 33761662 BACKGROUND

• Imani M, Jalali A, Salari N, Abbasi P. Effect of instrumental music on anxiety and depression among hemodialysis patients: A randomized controlled trial. J Educ Health Promot. 2021 Aug 31;10:305. doi: 10.4103/jehp.jehp_1472_20. eCollection 2021.

  PMID: 34667805 BACKGROUND

• Forbes E, Baker AL, Britton B, Clover K, Skelton E, Moore L, Handley T, Oultram S, Oldmeadow C, Gibberd A, McCarter K. A systematic review of nonpharmacological interventions to reduce procedural anxiety among patients undergoing radiation therapy for cancer. Cancer Med. 2023 Oct;12(20):20396-20422. doi: 10.1002/cam4.6573. Epub 2023 Oct 6.

  PMID: 37803922 BACKGROUND

• Fernando GVMC, Wanigabadu LU, Vidanagama B, Samaranayaka TSP, Jeewandara JMKC. "Adjunctive Effects of a Short Session of Music on Pain, Low-mood and Anxiety Modulation among Cancer Patients" - A Randomized Crossover Clinical Trial. Indian J Palliat Care. 2019 Jul-Sep;25(3):367-373. doi: 10.4103/IJPC.IJPC_22_19.

  PMID: 31413450 BACKGROUND

• Chen HH, Lai CH, Hou YJ, Kuo LT. The Efficacy of Music Intervention in Patients with Cancer Receiving Radiation Therapy: A Systematic Review and Meta-Analysis. Cancers (Basel). 2025 Feb 18;17(4):691. doi: 10.3390/cancers17040691.

  PMID: 40002284 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Pain

Interventions

Music Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Ünal Önsüz

CONTACT

+905444416990; unal.onsuz@kocaeli.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PhD

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)