CancerNCT07752667
The Effect of a Music-Assisted Mandala Intervention on Psychological Well-being and Quality of Life in Cancer Patients Undergoing Chemotherapy
A study testing Mandala in people with Cancer and Mandala, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Cancer is one of the most significant global health issues of our time. Chemotherapy, one of the methods used to treat cancer, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Mandala, Psychological Well-being
- What is being tested?
- Mandala
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 30 Aug 2025
- 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
- patients who have been diagnosed with cancer,
- aged 18 or over,
- receiving chemotherapy for the first time,
- able to hold a pen,
- agreed to take part in the study
Who cannot join
- Decline to participate in the study or do not provide written informed consent.
- Have physical conditions that would prevent participation in the mandala intervention (e.g., severe pain, severe nausea, or severe vomiting).
- Have mental health conditions or cognitive impairment that limit their ability to communicate or participate in the intervention.
- Experience fatigue primarily due to causes other than chemotherapy (e.g., severe anemia with hemoglobin < 9 g/dL).
- Are unable to hold or use a pen to complete the mandala activity.
Trial locations and contacts
1 site in 1 country.
About this study
Cancer is one of the most significant global health issues of our time. Chemotherapy, one of the methods used to treat cancer, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. It has been reported that treatment adherence problems are more common in patients with a high symptom burden associated with these side effects. For this reason, it is crucial that patients have achieved psychological adaptation to their condition and treatment in order for the treatment to be effective, to ensure that toxicity is kept under control, and to ensure that the course of the disease progresses favourably. In cases of illness and failure to adhere to treatment, this can lead to unnecessary visits to the doctor, visits to A\&E, hospitalisation, and an increase in the use of healthcare services and associated costs; it may also result in the development of treatment resistance, an increased burden on patients and carers, disease progression, and even death. Various non-pharmacological approaches, such as exercise, expressing emotions and art therapy, can be used to ensure the patient's adherence to treatment. It has been reported that mandala practice, a form of art therapy, reduces anxiety, fatigue, insomnia and stress. In light of this information, the aim of this study is to assess the effect of mandala practice on psychological adjustment to the disease and treatment, and on quality of life, in cancer patients undergoing chemotherapy.
Read the detailed description
Today, cancer is a leading cause of death worldwide. However, thanks to advances in medicine and modern technology, the availability of tests and diagnostic methods used to detect cancer at an early stage, and the use of increasingly effective treatments-including chemotherapeutic agents-the number of cancer survivors is also rising. Chemotherapy, one of these treatment methods, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. It has been reported that treatment adherence problems are more common in patients with a high symptom burden associated with these side effects. For this reason, it is crucial that patients have achieved psychological adaptation to their condition and treatment in order for the treatment to be effective, to ensure that toxicity is managed, and to ensure a positive progression of the disease. In cases of non-adherence to treatment or non-compliance with the condition, this can lead to unnecessary visits to the doctor, visits to A\&E, hospitalisation, and an increase in the use of healthcare services and associated costs; it may also result in the development of treatment resistance, an increased burden on patients and carers, disease progression, and even death. Various non-pharmacological approaches, such as exercise, expressing emotions and art therapy, can be used to ensure the patient's adherence to treatment.Mandala, one of the forms of art therapy, is a Sanskrit term meaning 'circle' or 'centre'. It describes designs created by the repetition of geometric patterns in various forms, centred around a point and arranged in a pattern. Its origins date back to India, and it is a form of art practised in Asian culture as a means of religious contemplation and meditation. The mandala, one of the tools used by art therapists, is employed to promote relaxation and generate positive energy. It is believed that the drawings people make inside the circle represent their thoughts at that moment, help them to forget the turmoil they are experiencing, and assist them in withdrawing into themselves by enabling them to concentrate on the act of drawing itself. A review of the literature indicates that mandala practice has been reported to reduce anxiety, fatigue, insomnia and stress. In light of this information, the aim of this study is to assess the effect of mandala practice on psychological adjustment to the disease and treatment, and on quality of life, in cancer patients undergoing chemotherapy.
- Conditions
- Cancer, Mandala, Psychological Well-being, Quality of Life (QOL), Chemotherapy
- Being tested
- Mandala
- Keywords
- Cancer, Music, Chemotherapy, Psychological Well-being, Quality of life (QOL), Mandala
- Medical subject headings
- Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MandalaBehavioural
Arm Description: After watching an instructional video on how to carry out the mandala activity, the patient will complete their first mandala colouring session during the treatment. The patient and their family will then be sent home with a mandala colouring book and coloured pencils to carry out the mandala activity on a weekly basis. The experimental group will repeat the mandala activity once a week for 8 weeks as part of their chemotherapy treatment, with each session lasting 60-90 minutes (a different mandala will be provided each week). They will be able to choose any design and colour they wish from the mandala book. Patients will be advised to listen to classical music during the activity. Patients will be contacted by telephone on a weekly basis to check whether they have carried out the mandala session.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will complete the Patient Information Form, the EORTC QLQ-C30 and the Psychological Impact of Cancer Scale; no specific intervention will be carried out, and the clinic's standard protocol will be followed. |
| Mandala Group | Experimental | After watching an instructional video on how to carry out the mandala activity, the patient will complete their first mandala colouring session during the treatment. The patient and their family will then be sent home with a mandala colouring book and coloured pencils to carry out the mandala activity on a weekly basis. The experimental group will repeat the mandala activity once a week for 8 weeks as part of their chemotherapy treatment, with each session lasting 60-90 minutes (a different mandala will be provided each week). They will be able to choose any design and colour they wish from the mandala book. Patients will be advised to listen to classical music during the activity. Patients will be contacted by telephone on a weekly basis to check whether they have carried out the mandala session. Receives: Behavioral: Mandala |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Psychological Impact of Cancer Score, as Measured by the Psychological Impact of Cancer Scale, Compared with the Baseline Value.
The psychological impact of cancer will be assessed using the Psychological Impact of Cancer Scale. Higher scores indicate a better psychological impact.
Measured: Baseline, Week 4, and Week 8.
Change in patients' quality of life scores, as measured by the EORTC QLQ-C30, compared with baseline
Patients' quality of life will be assessed using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) scale. Higher scores indicate a higher quality of life.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start30 Dec 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following the explanation of the study, patients who gave their verbal and written consent to participate were divided into two groups-the experimental group and the control group-using a randomisation checklist prepared prior to the study. Whilst the intervention group underwent the mandala therapy, the control group was treated according to the clinic's standard protocol.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Responsible party
- Principal investigator, Emel Emine Kayikci, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752667
- Sponsor's protocol ID
- IstanbulMU14
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2026
- Last updated
- 7 Aug 2026
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Music-Assisted Mandala Intervention on Psychological Well-being and Quality of Life in Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07752667
- Acronym / sponsor ID
- IstanbulMU14
- Conditions
- Cancer, Mandala, Psychological Well-being, Quality of Life (QOL), Chemotherapy
- Keywords
- Cancer, Music, Chemotherapy, Psychological Well-being, Quality of life (QOL), Mandala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 7 Aug 2026 (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.
Cancer is one of the most significant global health issues of our time. Chemotherapy, one of the methods used to treat cancer, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. It has been reported that treatment adherence problems are more common in patients with a high symptom burden associated with these side effects. For this reason, it is crucial that patients have achieved psychological adaptation to their condition and treatment in order for the treatment to be effective, to ensure that toxicity is kept under control, and to ensure that the course of the disease progresses favourably. In cases of illness and failure to adhere to treatment, this can lead to unnecessary visits to the doctor, visits to A\&E, hospitalisation, and an increase in the use of healthcare services and associated costs; it may also result in the development of treatment resistance, an increased burden on patients and carers, disease progression, and even death. Various non-pharmacological approaches, such as exercise, expressing emotions and art therapy, can be used to ensure the patient's adherence to treatment. It has been reported that mandala practice, a form of art therapy, reduces anxiety, fatigue, insomnia and stress. In light of this information, the aim of this study is to assess the effect of mandala practice on psychological adjustment to the disease and treatment, and on quality of life, in cancer patients undergoing chemotherapy.
Detailed description
Today, cancer is a leading cause of death worldwide. However, thanks to advances in medicine and modern technology, the availability of tests and diagnostic methods used to detect cancer at an early stage, and the use of increasingly effective treatments-including chemotherapeutic agents-the number of cancer survivors is also rising. Chemotherapy, one of these treatment methods, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. It has been reported that treatment adherence problems are more common in patients with a high symptom burden associated with these side effects. For this reason, it is crucial that patients have achieved psychological adaptation to their condition and treatment in order for the treatment to be effective, to ensure that toxicity is managed, and to ensure a positive progression of the disease. In cases of non-adherence to treatment or non-compliance with the condition, this can lead to unnecessary visits to the doctor, visits to A\&E, hospitalisation, and an increase in the use of healthcare services and associated costs; it may also result in the development of treatment resistance, an increased burden on patients and carers, disease progression, and even death. Various non-pharmacological approaches, such as exercise, expressing emotions and art therapy, can be used to ensure the patient's adherence to treatment.Mandala, one of the forms of art therapy, is a Sanskrit term meaning 'circle' or 'centre'. It describes designs created by the repetition of geometric patterns in various forms, centred around a point and arranged in a pattern. Its origins date back to India, and it is a form of art practised in Asian culture as a means of religious contemplation and meditation. The mandala, one of the tools used by art therapists, is employed to promote relaxation and generate positive energy. It is believed that the drawings people make inside the circle represent their thoughts at that moment, help them to forget the turmoil they are experiencing, and assist them in withdrawing into themselves by enabling them to concentrate on the act of drawing itself. A review of the literature indicates that mandala practice has been reported to reduce anxiety, fatigue, insomnia and stress. In light of this information, the aim of this study is to assess the effect of mandala practice on psychological adjustment to the disease and treatment, and on quality of life, in cancer patients undergoing chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following the explanation of the study, patients who gave their verbal and written consent to participate were divided into two groups-the experimental group and the control group-using a randomisation checklist prepared prior to the study. Whilst the intervention group underwent the mandala therapy, the control group was treated according to the clinic's standard protocol.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will complete the Patient Information Form, the EORTC QLQ-C30 and the Psychological Impact of Cancer Scale; no specific intervention will be carried out, and the clinic's standard protocol will be followed. |
| Mandala Group | Experimental | Behavioral: MandalaAfter watching an instructional video on how to carry out the mandala activity, the patient will complete their first mandala colouring session during the treatment. The patient and their family will then be sent home with a mandala colouring book and coloured pencils to carry out the mandala activity on a weekly basis. The experimental group will repeat the mandala activity once a week for 8 weeks as part of their chemotherapy treatment, with each session lasting 60-90 minutes (a different mandala will be provided each week). They will be able to choose any design and colour they wish from the mandala book. Patients will be advised to listen to classical music during the activity. Patients will be contacted by telephone on a weekly basis to check whether they have carried out the mandala session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients who have been diagnosed with cancer,
- aged 18 or over,
- receiving chemotherapy for the first time,
- able to hold a pen,
- agreed to take part in the study
Key exclusion criteria (5 listed)
- Decline to participate in the study or do not provide written informed consent.
- Have physical conditions that would prevent participation in the mandala intervention (e.g., severe pain, severe nausea, or severe vomiting).
- Have mental health conditions or cognitive impairment that limit their ability to communicate or participate in the intervention.
- Experience fatigue primarily due to causes other than chemotherapy (e.g., severe anemia with hemoglobin < 9 g/dL).
- Are unable to hold or use a pen to complete the mandala activity.
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 |
|---|---|---|
| MandalaArm Description: After watching an instructional video on how to carry out the mandala activity, the patient will complete their first mandala colouring session during the treatment. The patient and their family will then be sent home with a mandala colouring book and coloured pencils to carry out the mandala activity on a weekly basis. The experimental group will repeat the mandala activity once a week for 8 weeks as part of their chemotherapy treatment, with each session lasting 60-90 minutes (a different mandala will be provided each week). They will be able to choose any design and colour they wish from the mandala book. Patients will be advised to listen to classical music during the activity. Patients will be contacted by telephone on a weekly basis to check whether they have carried out the mandala session. | Behavioural | Mandala Group |
Primary outcome
Change in the Psychological Impact of Cancer Score, as Measured by the Psychological Impact of Cancer Scale, Compared with the Baseline Value.
Time frame: Baseline, Week 4, and Week 8.
The psychological impact of cancer will be assessed using the Psychological Impact of Cancer Scale. Higher scores indicate a better psychological impact.
Change in patients' quality of life scores, as measured by the EORTC QLQ-C30, compared with baseline
Time frame: Baseline, Week 4, and Week 8
Patients' quality of life will be assessed using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) scale. Higher scores indicate a higher quality of life.
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 7 Aug 2026.
- 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 Mandala in people with Cancer and Mandala, run by Istanbul Medeniyet 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 5 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 7 Aug 2026. 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?
Change in the Psychological Impact of Cancer Score, as Measured by the Psychological Impact of Cancer Scale, Compared with the Baseline Value. (time frame: Baseline, Week 4, and Week 8.). 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?
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 7 Aug 2026.