NCT07464964

Brief Summary

This interventional study aimed to evaluate the effects of music therapy on anxiety and distress levels in patients with prostate cancer undergoing radionuclide therapy. A total of 60 patients who met the eligibility criteria were included in the study. Participants were assigned to either an intervention group or a control group. Patients in the intervention group listened to music through headphones during the radionuclide treatment session, while patients in the control group received standard care without a music intervention. Music selections included various types of non-verbal music such as classical music, Turkish classical music, and other instrumental genres. Participants were allowed to select their preferred music from a predefined list. Psychological distress and anxiety levels were assessed using the Distress Thermometer and the Hospital Anxiety and Depression Scale. Measurements were obtained before the treatment session and again after completion of the radionuclide therapy. The study evaluated whether listening to music during treatment could reduce anxiety and distress levels in patients receiving radionuclide therapy for prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable anxiety

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
Last Updated

March 11, 2026

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

November 20, 2025

Last Update Submit

March 7, 2026

Conditions

Keywords

Music TherapyRadionuclide TherapyProstate CancerAnxietyDistress

Outcome Measures

Primary Outcomes (1)

  • Change in Anxiety Level

    Anxiety levels were assessed using the Hospital Anxiety and Depression Scale (HADS). The scale was administered before radionuclide therapy and again after completion of the treatment session to evaluate changes in anxiety levels between the intervention and control groups.

    Baseline (before radionuclide therapy) and immediately after completion of each radionuclide therapy session, assessed over three treatment cycles

Secondary Outcomes (1)

  • Change in Psychological Distress Level

    Baseline (before radionuclide therapy) and immediately after completion of each radionuclide therapy session, assessed over three treatment cycles

Study Arms (2)

Music Therapy Group

EXPERIMENTAL

Patients in this group listened to self-selected instrumental music through headphones during radionuclide therapy. The music was chosen according to the patient's preference from a categorized list of non-verbal music types. Music was played for approximately 20-40 minutes during the treatment session.

Behavioral: Music Therapy

control group

NO INTERVENTION

Patients in this group received standard care during radionuclide therapy without any music intervention. Anxiety and distress levels were assessed using the same measurement tools as in the intervention group.

Interventions

Music TherapyBEHAVIORAL

Listening to instrumental music through headphones during radionuclide therapy for approximately 20-40 minutes based on patient preference.

Music Therapy Group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Hospital

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related Publications (4)

  • Rennie C, Irvine DS, Huang E, Huang J. Music Therapy as a Form of Nonpharmacologic Pain Modulation in Patients with Cancer: A Systematic Review of the Current Literature. Cancers (Basel). 2022 Sep 11;14(18):4416. doi: 10.3390/cancers14184416.

    PMID: 36139576BACKGROUND
  • Valero-Cantero I, Casals C, Espinar-Toledo M, Baron-Lopez FJ, Martinez-Valero FJ, Garcia-Agua Soler N, Vazquez-Sanchez MA. Effect of Self-Chosen Music in Alleviating the Burden on Family Caregivers of Patients with Advanced Cancer: A Randomised Controlled Trial. Int J Environ Res Public Health. 2023 Mar 6;20(5):4662. doi: 10.3390/ijerph20054662.

    PMID: 36901671BACKGROUND
  • Begovac J, Kuzmanovic N, Bejuk D. Comparison of clinical characteristics of group A streptococcal bacteremia in children and adults. Clin Infect Dis. 1996 Jul;23(1):97-100. doi: 10.1093/clinids/23.1.97.

    PMID: 8816136BACKGROUND
  • He H, Li Z, Zhao X, Chen X. The effect of music therapy on anxiety and pain in patients undergoing prostate biopsy: A systematic review and meta-analysis. Complement Ther Med. 2023 Mar;72:102913. doi: 10.1016/j.ctim.2022.102913. Epub 2022 Dec 26.

    PMID: 36581055BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersProstatic NeoplasmsDisease

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental DisordersGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ezgi Karadağ, Prof

    Dokuz Eylul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were assigned to either an intervention group or a control group using a sequential allocation method. Patients in the intervention group listened to music during radionuclide therapy, while patients in the control group received standard care without music intervention. Anxiety and distress levels were measured before and after the treatment session.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2025

First Posted

March 11, 2026

Study Start

September 1, 2023

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

March 11, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant confidentiality.

Locations