- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06993441
- Original Trial
Music and Symptom Relief in Radiotherapy Patient (MUSİC)
Effects of Music on Pain, Anxiety and Stress Levels in Cancer Patients Receiving Radiotherapy
This randomized controlled study aims to evaluate the effects of music therapy administered during radiotherapy sessions on pain, stress, and anxiety levels in cancer patients. The intervention involves playing Musicure, a therapeutic music track, for 30 minutes via speakers during radiotherapy. The study includes two groups: an intervention group receiving music therapy and a control group receiving standard care without music.
Participants' pain levels were assessed using the Visual Analog Scale (VAS), while anxiety and stress levels were measured using the Face Anxıety Subscale ( FAS).
A total of 120 adult cancer patients undergoing outpatient radiotherapy at Tınaztepe Unıversty were included. The study was conducted under the supervision of Dr. Öğr. Üyesi [Duygu AKBAŞ UYSAL (Principal Investigator) and co-researchers Prof.Dr Fsun ŞENUZUN AYKAR, Prof.Dr Zümra ARICAK ALICIKUŞ The research complies with ethical standards and has received approval from [insert name of ethics committee].
This study investigates a low-cost, non-pharmacological intervention that has the potential to improve symptom management and quality of life in cancer patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İ̇zmi̇r
-
Izmir, İ̇zmi̇r, Turkey, 35900
- Tinazetepe Bayrakli Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteer to participate in the study,
- 18 years of age and older,
- No hearing problems,
- No communication and speech problems
Exclusion Criteria:
- Those diagnosed with psychiatric and neurological diseases,
Study Plan
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: control group
|
No intervention
|
|
Experimental: Experimental Arm
Participants in this group will listen to MusICure music through speakers for 30 minutes during each radiotherapy session.
The intervention is designed to provide a calming auditory experience to reduce anxiety and improve comfort during treatment.
|
Participants in the experimental group listened to MusICure music via speakers for 30 minutes during each radiotherapy session.
The intervention was administered concurrently with radiotherapy and aimed to reduce anxiety and emotional distress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Level
Time Frame: Baseline (before radiotherapy on Day 1) and immediately after the radiotherapy session on Day 1.
|
Changes in pain levels were assessed using the Visual Analog Scale (VAS) immediately before and after a single radiotherapy session.
The VAS score ranges from 0 (no pain) to 10 (worst possible pain).
|
Baseline (before radiotherapy on Day 1) and immediately after the radiotherapy session on Day 1.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anxiety level
Time Frame: Baseline (before radiotherapy on Day 1) and immediately after the radiotherapy session on Day 1.
|
Changes in anxiety levels were assessed using the Facial Anxiety Scale (FAS), a visual scale ranging from 0 (no anxiety) to 5 (severe anxiety), immediately before and after a single radiotherapy session.
|
Baseline (before radiotherapy on Day 1) and immediately after the radiotherapy session on Day 1.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1150
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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