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The Effect of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels

Primary Purpose

Anxiety, Chemotherapy Effect, Satisfaction, Patient

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music
Sponsored by
Uludag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Music, Chemotherapy, Nursing, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bursa Uludag University Faculty of Medicine Hospital, The Outpatient Chemotherapy UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Relaxing Music Group

Turkish Makam Music Group

Control Group

Arm Description

The 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.

The 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.

The patients in this group will not receive any musical interventions and will receive standard treatment and care during chemotherapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Satisfaction level
Post-intervention satisfaction level assessed by trained research nurse using VAS (0 to 10; 0 means not satisfied, 10 means very satisfied).

Full Information

First Posted
December 29, 2022
Last Updated
March 2, 2023
Sponsor
Uludag University
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1. Study Identification

Unique Protocol Identification Number
NCT05687838
Brief Title
The Effect of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels
Official Title
The Effect of Two Different Types of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Chemotherapy Effect, Satisfaction, Patient, Cancer, Nursing Caries
Keywords
Music, Chemotherapy, Nursing, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relaxing Music Group
Arm Type
Experimental
Arm Description
The 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.
Arm Title
Turkish Makam Music Group
Arm Type
Active Comparator
Arm Description
The 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The patients in this group will not receive any musical interventions and will receive standard treatment and care during chemotherapy.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Music medicine
Primary Outcome Measure Information:
Title
Change from baseline Anxiety level
Description
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.
Time Frame
baseline, 60-120 minute
Secondary Outcome Measure Information:
Title
Nausea level
Description
Baseline and post-intervention nausea level assessed by trained research nurse using VAS (0 to 10; 0 means no nausea,10 means severe nausea).
Time Frame
baseline, 60-120 minute
Title
Satisfaction level
Description
Post-intervention satisfaction level assessed by trained research nurse using VAS (0 to 10; 0 means not satisfied, 10 means very satisfied).
Time Frame
60-120 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Öznur ERBAY DALLI, PhD
Phone
902242940664
Email
oznurerbay@uludag.edu.tr
Facility Information:
Facility Name
Bursa Uludag University Faculty of Medicine Hospital, The Outpatient Chemotherapy Unit
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Öznur ERBAY DALLI, PhD
Phone
902242940664
Email
oznurerbay@uludag.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels

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