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CompletedNCT07752667Updated Aug 7, 2026

The Effect of a Music-Assisted Mandala Intervention on Psychological Well-being and Quality of Life in Cancer Patients Undergoing Chemotherapy

An interventional study of Mandala in Cancer, Mandala and Psychological Well-being, sponsored by Istanbul Medeniyet University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Istanbul Medeniyet University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Dec 2024, registered Jul 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cancer
  • Mandala
  • Psychological Well-being
  • Quality of Life (QOL)
  • Chemotherapy

Keywords

  • Cancer
  • Music
  • Chemotherapy
  • Psychological Well-being
  • Quality of life (QOL)
  • Mandala
03

In context

Neoplasms

10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 7,704 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Istanbul Medeniyet University is the lead sponsor of 192 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Decline to participate in the study or do not provide written .
  • 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 \< 9 g/dL).
  • Are unable to hold or use a pen to complete the mandala activity.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • No intervention
    Control

    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.

  • Experimental
    Mandala Group

    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.

    Behavioral: Mandala

Interventions

  • BehavioralMandala

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 4, and Week 8.

  2. 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.

    Time frame: Baseline, Week 4, and Week 8

07

Study locations

1 site
  • Cemil Ta
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2024 to primary completion in Aug 2025, 8 months.

Of 1,983 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 8 months is below that.

Counting every sponsor, half of 2,058 studies reached it within 29 months; a quarter within 13 and three quarters within 52.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2026
First posted
Aug 7, 2026
StartActual
Dec 30, 2024
Primary completionActual
Aug 30, 2025
CompletionActual
Aug 30, 2025
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07752667
Collaborators
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Responsible party
Emel Emine Kayikci (Assisstant Professor, Istanbul Medeniyet University) — Principal investigator
First posted
Aug 7, 2026
Start date
Dec 30, 2024
Primary completion
Aug 30, 2025
Completion
Aug 30, 2025
Last update
Aug 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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