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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05687838
Other study ID # 2022-13/18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date August 1, 2023

Study information

Verified date November 2023
Source Uludag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - > 18 years old, - Receiving chemotherapy for the first time. Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Music
Music medicine

Locations

Country Name City State
Turkey Bursa Uludag University Faculty of Medicine Hospital, The Outpatient Chemotherapy Unit Bursa

Sponsors (1)

Lead Sponsor Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Nausea level Baseline and post-intervention nausea level assessed by trained research nurse using VAS (0 to 10; 0 means no nausea,10 means severe nausea). baseline, 60-120 minute
Secondary Satisfaction level Post-intervention satisfaction level assessed by trained research nurse using VAS (0 to 10; 0 means not satisfied, 10 means very satisfied). 60-120 minute
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