Back to resultsThe Effect of Music on Pain and Anxiety in Patients Receiving Chemotherapy During COVID-19
Primary Purpose
Cancer, Chemotherapy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Listening Music
Not Listening Music
Sponsored by
About this trial
This is an interventional health services research trial for Cancer focused on measuring Anxiety, COVID-19, Music, Pain, Patients receiving chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Over the age 18,
- Being able to communicate,
- Being literate,
- Having no diagnosis of psychiatric,
- Have the necessary technological equipment (phone, internet, etc.)
Exclusion Criteria:
- Existing infection
- Receiving palliative chemotherapy
Sites / Locations
- Vocational School of Health Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala)
The data have been collected by the researcher with Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala).The posttest was administered 1 hour after the pretest.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05334641
Brief Title
The Effect of Music on Pain and Anxiety in Patients Receiving Chemotherapy During COVID-19
Official Title
The Effect of Music on Pain and Anxiety in Patients Receiving Chemotherapy During COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu 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
Introduction: This study has been conducted to determine the effect of music on pain and anxiety levels in patients receiving chemotherapy during COVID-19.
Methods: The research has been carried out in a real trial model with adult patients receiving chemotherapy. The sample of the study is consisted of 92 patients (45 in the experimental group and 47 for the control group). The data have been collected by the researcher with Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala) between March 2020 and July 2020, through the links sent to the phones of participants on the day they received chemotherapy.
Results: The mean scores obtained from the post-test STAI (53.11±4.77) and VAS (3.44±2.53) scales in the experimental group have been determined to statistically significantly decrease when compared to the pre-test measurement data (STAI:54.26±4.26; VAS:4.22±2.41) (p<0.05). No statistically significant difference has been determined between pre-test and post-test mean scores of the patients in the control group.
Conclusion: It has been observed that music applications reduce the pain and anxiety levels of patients receiving chemotherapy during the COVID-19 process. It can be recommended to use music applications in the management of pain and anxiety symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Chemotherapy
Keywords
Anxiety, COVID-19, Music, Pain, Patients receiving chemotherapy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Listening Music
Intervention Description
The patients in the experimental group were listened to music.
Intervention Type
Other
Intervention Name(s)
Not Listening Music
Intervention Description
The control group was not listened to music.
Primary Outcome Measure Information:
Title
Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala)
Description
The data have been collected by the researcher with Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala).The posttest was administered 1 hour after the pretest.
Time Frame
The posttest was administered 1 hour after the pretest.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over the age 18,
Being able to communicate,
Being literate,
Having no diagnosis of psychiatric,
Have the necessary technological equipment (phone, internet, etc.)
Exclusion Criteria:
Existing infection
Receiving palliative chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rukuye AYLAZ
Organizational Affiliation
Inonu University
Official's Role
Study Director
Facility Information:
Facility Name
Vocational School of Health Services
City
Malatya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Music on Pain and Anxiety in Patients Receiving Chemotherapy During COVID-19
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