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Completed

NCT Number: NCT07752667

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cemil Ta

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

mandala

Behavioral

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.

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.

    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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Collaborators

  • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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