Music Therapy's Effect on Cancer Patients Undergoing Radiotherapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKocaeli University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Music Therapy

    Other intervention

    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.

  • Standard Care (in control arm)

    Other intervention

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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Music Therapy Group (Experimental Arm)Experimental treatment 1 intervention
Group B: Control Group (Standard Care Arm)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
mmediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).
2

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.

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

Secondary outcomes

1

Change in Procedural Pain Level (VAS)

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.

Time frame
Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session
2

Patient Satisfaction Level (VAS)

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.

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

Other outcomes

1

Baseline Information Level (EORTC QLQ-INFO25)

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.

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

Sponsors and contacts

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