NCT06993441

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

May 13, 2025

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Level

    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 Outcomes (1)

  • anxiety level

    Baseline (before radiotherapy on Day 1) and immediately after the radiotherapy session on Day 1.

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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.

Behavioral: Experimantal group

control group

EXPERIMENTAL
Behavioral: control group

Interventions

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.

Experimental Arm
control groupBEHAVIORAL

No intervention

control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer to participate in the study,
  • years of age and older,
  • No hearing problems,
  • No communication and speech problems

You may not qualify if:

  • Those diagnosed with psychiatric and neurological diseases,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tinazetepe Bayrakli Hospital

Izmir, İzmir, 35900, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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
Dr.

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 28, 2025

Study Start

April 4, 2024

Primary Completion

January 4, 2025

Study Completion

January 30, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Locations