CancerNCT05334641
The Effect of Music on Pain and Anxiety in Patients Receiving Chemotherapy During COVID-19
A study testing Listening Music and Not Listening Music in people with Cancer and Chemotherapy, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapy
- What is being tested?
- Listening Music and Not Listening Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age 18,
- Being able to communicate,
- Being literate,
- Having no diagnosis of psychiatric,
- Have the necessary technological equipment (phone, internet, etc.)
Who cannot join
- Existing infection
- Receiving palliative chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Cancer, Chemotherapy
- Being tested
- Listening Music, Not Listening Music
- Keywords
- Anxiety, COVID-19, Music, Pain, Patients receiving chemotherapy
- Medical subject headings
- Neoplasms, Anxiety Disorders, COVID-19, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening MusicOther
The patients in the experimental group were listened to music.
Not Listening MusicOther
The control group was not listened to music.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Other: Listening Music |
| Control Group | Active comparator | Not described Receives: Other: Not Listening Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The posttest was administered 1 hour after the pretest.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start3 Mar 2020
- Primary completion29 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsum Yetis Koca, Inonu University
- Investigators
- Rukuye AYLAZ, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334641
- Sponsor's protocol ID
- InonuGYKoca001
- Status last verified
- Apr 2022
- First submitted
- 17 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Pain and Anxiety in Patients Receiving Chemotherapy During COVID-19
- ClinicalTrials.gov ID
- NCT05334641
- Acronym / sponsor ID
- InonuGYKoca001
- Conditions
- Cancer, Chemotherapy
- Keywords
- Anxiety, COVID-19, Music, Pain, Patients receiving chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Listening Music |
| Control Group | Active comparator | Other: Not Listening Music |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over the age 18,
- Being able to communicate,
- Being literate,
- Having no diagnosis of psychiatric,
- Have the necessary technological equipment (phone, internet, etc.)
Key exclusion criteria (2 listed)
- Existing infection
- Receiving palliative chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listening MusicThe patients in the experimental group were listened to music. | Other | Experimental Group |
| Not Listening MusicThe control group was not listened to music. | Other | Control Group |
Primary outcome
Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala)
Time frame: The posttest was administered 1 hour after the pretest.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rukuye AYLAZ study director
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening Music and Not Listening Music in people with Cancer and Chemotherapy, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala) (time frame: The posttest was administered 1 hour after the pretest.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.