Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT07261267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music Therapy's Effect on Cancer Patients Undergoing Radiotherapy
Sponsor:
Kocaeli University
Organization:
Study Overview
Official Title:
The Effect of Music Therapy on the Radiotherapy Experience of Cancer Patients Undergoing Radiotherapy: A Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: