The Effect of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels
The Effect of Two Different Types of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels
1 other identifier
interventional
75
1 country
1
Brief Summary
Chemotherapy is a treatment that uses natural or synthetic chemicals and biological agents to kill rapidly proliferating cells. As chemotherapeutic drugs prevent the growth and proliferation of cancer cells, they also inhibit the growth of normal cells such as intestinal and oral mucosal epithelium, bone marrow cells, and hair follicle cells. During chemotherapy treatment, which is widely used in the treatment of cancer cases and considered one of the most effective methods of cancer treatment, individuals; may experience side effects such as nausea-vomiting, loss of appetite, mouth ulcers, pain, fatigue, anxiety, depression, sleep problems, and changes in their skin and nails. There are several factors that can trigger anxiety in cancer patients: fear of cancer and its treatment-related side effects, fear of relapse after treatment, uncertainty, concerns about changing roles and relationships, and fear of death. Treatment methods are available for a variety of side effects and negative effects experienced by cancer patients. These methods include pharmacological and nonpharmacological approaches. For example, benzodiazepines are frequently used to treat anxiety in cancer patients. If benzodiazepines are not adequate, low-dose antipsychotics can be used. However, benzodiazepines and their derivatives may reduce respiratory function, induce sedation, and cause confusion. Music is an example of non-pharmacological cognitive-behavioral treatment that is used to control negative symptoms in many fields. The use of music for healing is easy, has no side effects, and is beneficial for physical, psychological, emotional, and spiritual well-being. Anxiety and fear can be reduced by therapeutic music, which increases endorphin secretion and positive emotions. Treatment of serious illnesses such as cancer requires a holistic approach that includes psychological, social, and spiritual support in addition to pharmacological treatment. Therefore, the purpose of this study is to examine how different types of music affect cancer patients' anxiety and satisfaction during chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Aug 2022
1 active site
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
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 29, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedNovember 8, 2023
November 1, 2023
1 year
December 29, 2022
November 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline Anxiety level
Baseline and post-intervention anxiety level assessed by trained research nurse using Spielberg's State-Trait Anxiety Inventory (STAI). The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety.
baseline, 60-120 minute
Secondary Outcomes (2)
Nausea level
baseline, 60-120 minute
Satisfaction level
60-120 minute
Study Arms (3)
Relaxing Music Group
EXPERIMENTALThe patients in this group will listen to specially composed "MusiCure®" compositions, which contain melodies with soft rhythm (60-80 bpm), including harp, cello, strings, and nature sounds (such as rain, bird, forest sound). The patients scheduled to receive chemotherapy for the first time, will be allowed to listen to music for at least one hour during chemotherapy with over-ear headphones (Sennheiser HD280) and an MP3 player. Anxiety and satisfaction levels of the patients will be recorded before and after the music application.
Turkish Makam Music Group
ACTIVE COMPARATORThe patients in this group will listen to the "Rast Makam", which was created as a result of research conducted by the Turkish Music Research and Promotion Group (TÜMATA) and provides individuals with comfort and inner peace. The patients scheduled to receive chemotherapy for the first time, will be allowed to listen to music for at least one hour during chemotherapy with over-ear headphones (Sennheiser HD280) and an MP3 player. Anxiety and satisfaction levels of the patients will be recorded before and after the music application.
Control Group
NO INTERVENTIONThe patients in this group will not receive any musical interventions and will receive standard treatment and care during chemotherapy.
Interventions
Eligibility Criteria
You may qualify if:
- \> 18 years old,
- Receiving chemotherapy for the first time.
You may not qualify if:
- Hearing or vision problems,
- Have a lower education level than secondary school (The STAI is appropriate for those who have at least a sixth-grade reading level),
- Diagnosed with psychiatric and neurological diseases,
- Diagnosed with dementia,
- Received chemotherapy treatment more than once,
- Planned to receive radiotherapy treatment together with chemotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Uludag University Faculty of Medicine Hospital, The Outpatient Chemotherapy Unit
Bursa, 16059, Turkey (Türkiye)
Related Publications (1)
Dalli OE, Dogan DA, Pehlivan S, Yildirim Y, Evrensel T. The effect of two different types of music played to cancer patients during chemotherapy on anxiety, nausea, and satisfaction levels. Support Care Cancer. 2023 Nov 20;31(12):710. doi: 10.1007/s00520-023-08165-9.
PMID: 37982892DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- Asst. Prof.
Study Record Dates
First Submitted
December 29, 2022
First Posted
January 18, 2023
Study Start
August 1, 2022
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
November 8, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share