DepressionEMDCNCT06180629
The Effect of Music During Chemotherapy
A study testing Music conset and normal treatment routine in people with Depression and Anxiety, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: Chemotherapy treatment is a very different and difficult process. Considering the many physiological and psychological problems that patients experience during and after the treatment process, chemotherapy symptoms and psychological problems affect the quality of life of patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- Music conset and normal treatment routine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2023to 15 Sep 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Can read and write
- Open to communication and cooperation
- Having a smartphone
- No hearing problems
- Not in the terminal period
Show all 10Show fewer
- No psychiatric treatment
- Receiving chemotherapy 1 time per week
- Patients who have received one course of chemotherapy and come to the first session of the second course
- Being willing and voluntary to participate in the research
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Music During Chemotherapy On Depression, Anxiety, Stress Levels And Chemotherapy Symptoms
Purpose: Chemotherapy treatment is a very different and difficult process. Considering the many physiological and psychological problems that patients experience during and after the treatment process, chemotherapy symptoms and psychological problems affect the quality of life of patients. Along with the burden of the disease, patients who experience physiological problems during chemotherapy may experience depression, stress, and anxiety. Therefore, this study was conducted to determine the effect of music played during chemotherapy on depression, anxiety, stress levels, and chemotherapy symptoms.
Method: This study was conducted in a randomized controlled manner with a pretest-posttest control group random design model. The study population consisted of patients receiving treatment in the outpatient chemotherapy unit of Maltepe University Faculty of Medicine Hospital. The study sample consisted of 49 patients who met the inclusion criteria. The power analysis determined that the sample number was 42 people in total, 21 in the experimental group and 21 in the control group. However, considering the data losses, it was decided that the number would be 25 experimental and 25 control. When one patient from the experimental group did not want to continue, the study was completed with 49 patients, 24 in the experimental group and 25 in the control group. The music recital will be applied 4 times in total, once a week, until the patients complete 1 cycle, i.e. 4 sessions. Patients in the experimental group were administered the Depression, Anxiety, Stress Scale (DASS -42) and Edmonton Symptom Diagnostic Scale (ESDS) before each session until the completion of one cycle, and music was played for 20-25 minutes during chemotherapy. After chemotherapy, the scales were applied again. In the control group, the scales were applied before chemotherapy treatment, no intervention was made during chemotherapy and the scales were applied again after chemotherapy.
Read the detailed description
Population and sample: Patients who met the inclusion criteria (18 years of age or older, literate, open to communication and cooperation, having a smartphone, not having hearing problems, not in the terminal period, not receiving psychiatric treatment, receiving chemotherapy once a week, having received one course of chemotherapy, coming to the first session of the second course, and being willing and volunteering to participate in the study) were included in the study. The minimum sample size required to determine the number of patients to be assigned to the experimental and control groups was calculated using the G*Power 3.1.9.2 package program (Faul, Erdfelder, Lang et al. (2007). Considering that there may be people who may drop out of the study during the study process, it was planned to take an additional 20% sample for the study. In this case, the study sample was planned to be 50 people in total, 25 people for each of the experimental and control groups. One patient from the experimental group was excluded from the study because he did not want to continue the intervention and the study was completed with a total of 49 patients (experimental=24, control=25). Participants were numbered from 1 to 88, and 25 intervention and 25 control groups were created from the www.random.org site, taking into account the possibility of data loss.
Data collection and program application: Before starting the research, the ethics committee decision dated 02/02/2023 and numbered 2022/03-08 was taken from X Ethics Committee.
Data were collected through face-to-face interviews. Patients were asked to fill out an informed consent form before the application and their consent was obtained. Before chemotherapy started, the patients in the experimental group were informed about the music recital. Environmental factors such as light, sound and temperature were controlled and measures were taken to create a safe environment. Patient Information Form, DASS-42 Scale and ESTS were applied to the patients in both groups. After intravenous access was opened and premedication (approximately 15 minutes) was applied, they were helped to take a comfortable position in a way to maintain intravenous safety. In the experimental group, the music to be played on the patients' phones was recorded and the patient was informed. Headphones to be used for the music were provided by the researcher to the patients who did not have them. When chemotherapy started, the researcher left the patients alone during the treatment.
During the chemotherapy session; the patients in the experimental group were provided with the music of their choice during the session and the routine applications in the unit were continued, while the patients in the control group were only provided with the routine applications in the unit.
After the chemotherapy session; DASS-42 and EDSS were applied to the patients in both groups. The application continued in this way 1 time a week for a total of 4 weeks.
- Conditions
- Depression, Anxiety, Stress, Chemotherapy Effect
- Being tested
- Music conset, normal treatment routine
- Keywords
- Depression, Stres, Anxiety, Chemotherapy Effect, Nursing, Music
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music consetBehavioural
The music modes to be used (Rast and Hüseyni), classical music, nature music, and listening time of 20-30 minutes were determined by taking expert opinion from a faculty member from the Conservatory department and by reviewing the literature. The researcher asked the patients to choose the music genres. After each patient decided on the music they wanted to listen to, the researcher recorded the selected music genres on their smartphones. The music playback application was played to the patients in the experimental group for 20-25 minutes in each session for 4 sessions, i.e. 4 times in total, once a week for a month, until the end of one course. During each session, the patients listened to the music genre they had chosen each week.
normal treatment routineOther
normal treatment routine
| Study group | Role | What they receive |
|---|---|---|
| Music Consert | Experimental | During the chemotherapy sessions, the patients in the experimental group listened to music for 20-25 minutes, once a week for a total of 4 weeks, by choosing a music genre decided by the patient himself/herself from 3 music genres selected by the researcher based on scientific content and expert opinion. Receives: Behavioral: Music conset |
| control group | Active comparator | The control group continued their normal treatment routine. No application was performed. Only pre-test and post-tests were applied. Receives: Other: normal treatment routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression-Anxiety-Stress Scale (DASS-42)
The scale consists of a total of 42 items; items with D (14 items) indicate depression, items with A (14 items) indicate anxiety, and items with S (14 items) indicate stress. The scale consists of 14 items, each answered using a 0-3 scale. Where (0) means it has never been applied to me, (3) means it has been applied to me a lot or most of the time. The normal range of scores is 0-9 for depression, 0-7 for anxiety and 0-14 for stress. Scores above these ranges indicate the degree of the problem, from mild to extreme.
Measured: up to 24 weeks
Edmonton Symptom Diagnostic Scale (ESDS)
10 symptoms are questioned: pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, feeling unwell, shortness of breath and other problems. The patient is asked to match his/her symptoms with a number from 0 to 10 that he/she thinks best suits him/her. 0 indicates that he/she has no symptoms, 10 indicates that the symptom is very severe.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start5 Jun 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Sılgan, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180629
- Sponsor's protocol ID
- 2022/03-08
- Acronym
- EMDC
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silgan M, Ozturk S. The Effect of Music During Chemotherapy Treatment on Depression, Anxiety, Stress Levels and Chemotherapy Symptoms: A Randomized Controlled Trial. Int J Nurs Pract. 2026 Aug;32(4):e70169. doi: 10.1111/ijn.70169.
PubMed 42421597
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Music During Chemotherapy On Depression, Anxiety, Stress Levels And Chemotherapy Symptoms
- ClinicalTrials.gov ID
- NCT06180629
- Acronym / sponsor ID
- EMDC / 2022/03-08
- Conditions
- Depression, Anxiety, Stress, Chemotherapy Effect
- Keywords
- Depression, Stres, Anxiety, Chemotherapy Effect, Nursing, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 22 Dec 2023 (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.
Purpose: Chemotherapy treatment is a very different and difficult process. Considering the many physiological and psychological problems that patients experience during and after the treatment process, chemotherapy symptoms and psychological problems affect the quality of life of patients. Along with the burden of the disease, patients who experience physiological problems during chemotherapy may experience depression, stress, and anxiety. Therefore, this study was conducted to determine the effect of music played during chemotherapy on depression, anxiety, stress levels, and chemotherapy symptoms.
Method: This study was conducted in a randomized controlled manner with a pretest-posttest control group random design model. The study population consisted of patients receiving treatment in the outpatient chemotherapy unit of Maltepe University Faculty of Medicine Hospital. The study sample consisted of 49 patients who met the inclusion criteria. The power analysis determined that the sample number was 42 people in total, 21 in the experimental group and 21 in the control group. However, considering the data losses, it was decided that the number would be 25 experimental and 25 control. When one patient from the experimental group did not want to continue, the study was completed with 49 patients, 24 in the experimental group and 25 in the control group. The music recital will be applied 4 times in total, once a week, until the patients complete 1 cycle, i.e. 4 sessions. Patients in the experimental group were administered the Depression, Anxiety, Stress Scale (DASS -42) and Edmonton Symptom Diagnostic Scale (ESDS) before each session until the completion of one cycle, and music was played for 20-25 minutes during chemotherapy. After chemotherapy, the scales were applied again. In the control group, the scales were applied before chemotherapy treatment, no intervention was made during chemotherapy and the scales were applied again after chemotherapy.
Detailed description
Population and sample: Patients who met the inclusion criteria (18 years of age or older, literate, open to communication and cooperation, having a smartphone, not having hearing problems, not in the terminal period, not receiving psychiatric treatment, receiving chemotherapy once a week, having received one course of chemotherapy, coming to the first session of the second course, and being willing and volunteering to participate in the study) were included in the study. The minimum sample size required to determine the number of patients to be assigned to the experimental and control groups was calculated using the G*Power 3.1.9.2 package program (Faul, Erdfelder, Lang et al. (2007). Considering that there may be people who may drop out of the study during the study process, it was planned to take an additional 20% sample for the study. In this case, the study sample was planned to be 50 people in total, 25 people for each of the experimental and control groups. One patient from the experimental group was excluded from the study because he did not want to continue the intervention and the study was completed with a total of 49 patients (experimental=24, control=25). Participants were numbered from 1 to 88, and 25 intervention and 25 control groups were created from the www.random.org site, taking into account the possibility of data loss.
Data collection and program application: Before starting the research, the ethics committee decision dated 02/02/2023 and numbered 2022/03-08 was taken from X Ethics Committee.
Data were collected through face-to-face interviews. Patients were asked to fill out an informed consent form before the application and their consent was obtained. Before chemotherapy started, the patients in the experimental group were informed about the music recital. Environmental factors such as light, sound and temperature were controlled and measures were taken to create a safe environment. Patient Information Form, DASS-42 Scale and ESTS were applied to the patients in both groups. After intravenous access was opened and premedication (approximately 15 minutes) was applied, they were helped to take a comfortable position in a way to maintain intravenous safety. In the experimental group, the music to be played on the patients' phones was recorded and the patient was informed. Headphones to be used for the music were provided by the researcher to the patients who did not have them. When chemotherapy started, the researcher left the patients alone during the treatment.
During the chemotherapy session; the patients in the experimental group were provided with the music of their choice during the session and the routine applications in the unit were continued, while the patients in the control group were only provided with the routine applications in the unit.
After the chemotherapy session; DASS-42 and EDSS were applied to the patients in both groups. The application continued in this way 1 time a week for a total of 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Consert | Experimental | Behavioral: Music consetDuring the chemotherapy sessions, the patients in the experimental group listened to music for 20-25 minutes, once a week for a total of 4 weeks, by choosing a music genre decided by the patient himself/herself from 3 music genres selected by the researcher based on scientific content and expert opinion. |
| control group | Active comparator | Other: normal treatment routineThe control group continued their normal treatment routine. No application was performed. Only pre-test and post-tests were applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years and older
- Can read and write
- Open to communication and cooperation
- Having a smartphone
- No hearing problems
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Music consetThe music modes to be used (Rast and Hüseyni), classical music, nature music, and listening time of 20-30 minutes were determined by taking expert opinion from a faculty member from the Conservatory department and by reviewing the literature. The researcher asked the patients to choose the music genres. After each patient decided on the music they wanted to listen to, the researcher recorded the selected music genres on their smartphones. The music playback application was played to the patients in the experimental group for 20-25 minutes in each session for 4 sessions, i.e. 4 times in total, once a week for a month, until the end of one course. During each session, the patients listened to the music genre they had chosen each week. | Behavioural | Music Consert |
| normal treatment routinenormal treatment routine | Other | control group |
Primary outcome
Depression-Anxiety-Stress Scale (DASS-42)
Time frame: up to 24 weeks
The scale consists of a total of 42 items; items with D (14 items) indicate depression, items with A (14 items) indicate anxiety, and items with S (14 items) indicate stress. The scale consists of 14 items, each answered using a 0-3 scale. Where (0) means it has never been applied to me, (3) means it has been applied to me a lot or most of the time. The normal range of scores is 0-9 for depression, 0-7 for anxiety and 0-14 for stress. Scores above these ranges indicate the degree of the problem, from mild to extreme.
Edmonton Symptom Diagnostic Scale (ESDS)
Time frame: up to 24 weeks
10 symptoms are questioned: pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, feeling unwell, shortness of breath and other problems. The patient is asked to match his/her symptoms with a number from 0 to 10 that he/she thinks best suits him/her. 0 indicates that he/she has no symptoms, 10 indicates that the symptom is very severe.
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 22 Dec 2023.
- Derived from this study: PubMed 42421597Silgan M, Ozturk S. The Effect of Music During Chemotherapy Treatment on Depression, Anxiety, Stress Levels and Chemotherapy Symptoms: A Randomized Controlled Trial. Int J Nurs Pract. 2026 Aug;32(4):e70169. doi: 10.1111/ijn.70169.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music conset and normal treatment routine in people with Depression and Anxiety, run by Maltepe 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 10 inclusion and 1 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 22 Dec 2023. 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?
Depression-Anxiety-Stress Scale (DASS-42) (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06180629, which also lists 1 linked publication.
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 22 Dec 2023.