- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07464964
Effects of Music Therapy on Anxiety and Distress Levels During Radionuclide Treatment in Prostate Cancer Patients (MUSIC-PRT)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
ntervention and Implementation Eligible patients undergoing radionuclide therapy in the nuclear medicine unit were evaluated for participation in the study. After receiving information about the study and providing written informed consent, participants were allocated to either the intervention group or the control group. The first eligible patient was assigned to the intervention group and the second patient to the control group. This sequence was continued until a total of 60 patients were included in the study.
Patients in the intervention group listened to music during radionuclide therapy, while patients in the control group received standard care without music intervention.
Music Intervention The music intervention consisted of listening to instrumental, non-verbal music through headphones during radionuclide therapy. Participants were allowed to choose their preferred music from a categorized list including classical music, Turkish classical music, Turkish makam music (Uşşak, Rast, Zirgüle, Hüseyni), jazz music, and other instrumental music genres.
Music playlists were prepared according to patient preferences prior to the treatment session. Participants were instructed on how to use the headphones and how to adjust the volume to a comfortable level. The music was played continuously during the treatment session for approximately 20-40 minutes.
Individual music preference was considered an important factor in the intervention. Therefore, patients were allowed to select music genres that they felt most comfortable with. Only instrumental or lyric-free music was used to minimize distraction and promote relaxation.
Intervention Protocol Intervention Group Before radionuclide therapy, participants completed a questionnaire regarding sociodemographic and disease-related characteristics. Baseline levels of anxiety and distress were measured using the Hospital Anxiety and Depression Scale (HADS) and the Distress Thermometer.
During radionuclide therapy, patients listened to their selected music through headphones for approximately 20-40 minutes. At the end of the treatment session, the Distress Thermometer and HADS were administered again to assess post-treatment anxiety and distress levels.
Control Group Patients in the control group received standard care without music intervention. Before radionuclide therapy, participants completed the sociodemographic and disease-related questionnaire as well as baseline assessments using the Hospital Anxiety and Depression Scale and the Distress Thermometer.
At the end of the treatment session, the same assessment tools were administered again to evaluate post-treatment anxiety and distress levels.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Balçova
-
Izmir, Balçova, Turkey (Türkiye), 35330
- Dokuz Eylul University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Therapy Group
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.
|
Listening to instrumental music through headphones during radionuclide therapy for approximately 20-40 minutes based on patient preference.
|
|
No Intervention: control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Anxiety Level
Time Frame: Baseline (before radionuclide therapy) and immediately after completion of each radionuclide therapy session, assessed over three treatment cycles
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Psychological Distress Level
Time Frame: Baseline (before radionuclide therapy) and immediately after completion of each radionuclide therapy session, assessed over three treatment cycles
|
Distress levels will be assessed using the Distress Thermometer, which ranges from 0 (no distress) to 10 (extreme distress).
Higher scores indicate greater psychological distress.
|
Baseline (before radionuclide therapy) and immediately after completion of each radionuclide therapy session, assessed over three treatment cycles
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ezgi Karadağ, Prof, Dokuz Eylül University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Mental Disorders
- Pathologic Processes
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Pathological Conditions, Signs and Symptoms
- Prostatic Neoplasms
- Anxiety Disorders
- Disease
- Therapeutics
- Complementary Therapies
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Music Therapy
Other Study ID Numbers
- DokuzEU-SBE-EUT-02 (Other Identifier: Dokuz Eylul University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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