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Completed

NCT Number: NCT06735456

The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer

This study will be conducted to examine the effect of mandala painting on anxiety, physiological parameters and patient satisfaction in women with breast cancer receiving chemotherapy.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sağlık Bilimleri Üniversitesi

Ankara, Turkey (Türkiye)

About this study

Breast cancer is among the most common cancers that cause death in women in the world and in our country (1). One of the most commonly used treatment options for breast cancer is chemotherapy. However, many side effects occur depending on the chemotherapy regimen used. The most common side effects in patients receiving chemotherapy are; nausea, vomiting, anemia, fatigue, insomnia, mucositis, and peripheral neuropathy (2, 3). It is stated that the probability of anxiety in people with cancer is 50% or more, while the rate of chronic anxiety is 30%. It is expected that the quality of life will be positively affected by detecting and reducing the level of anxiety and adapting patients to their own treatment (4). Mandala, a type of art therapy method; Although it has various shapes, the round one is generally preferred and is a meditation tool used to convey feelings and thoughts. Studies have shown that art therapy helps individuals feel more peaceful by helping to alleviate strong negative emotions that cause severe discomfort (7). In a study conducted in Hong Kong, the sample group included women with both breast cancer and gynecological cancer. Art therapy was applied to the participants, and as a result of the research, it was observed that the women's psychological distress decreased and their mental well-being increased (8). It is known that the problems experienced by cancer patients can be reduced by changing cognitive focus, similar to art therapy. In a study, cancer patients receiving chemotherapy watched TV series and movies (51.3%), dreamed (26.6%), listened to music (26.6%), visited friends and relatives (19.6%), looked at flowers (14%), walked or walked. It is observed that their depression and anxiety decrease when they engage in activities such as exercising (14%) (9).In the literature, there are mandala studies applied to different patient groups, but no national or international study has been found regarding the effects of mandala painting during chemotherapy in breast cancer patients. Therefore, this study will be conducted to examine the effect of mandala painting on anxiety, physiological parameters and patient satisfaction in women with breast cancer receiving chemotherapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being diagnosed with breast cancer,
  • Being receiving adjuvant or neoadjuvant chemotherapy,
  • Being over 18 years of age,
  • Ability to communicate in Turkish,
  • Not having a physical disability related to the upper extremities,
  • Agreeing to participate in the study.

Exclusion criteria

  • Advanced stage cancer patients,
  • Having visual, hearing and speech disabilities,
  • Individuals with mental and neuropsychiatric diseases will not be included in the sample.

Treatment and study plan

Mandala

Other

The patient will undergo mandala painting during 1 session of chemotherapy.

Primary outcomes

  1. Physiological parameter 1

    Time frame: 2 hours (pre-test and post-test)

    Temperature

  2. Physiological parameter 2

    Time frame: 2 hours (pre-test and post-test)

    Pulse

  3. Physiological parameter 3

    Time frame: 2 hours (pre-test and post-test)

    Blood pressure

  4. Physiological parameter 4

    Time frame: 2 hours (pre-test and post-test)

    spO2

  5. Physiological parameter 5

    Time frame: 2 hours (pre-test and post-test)

    Respiratory rate

Secondary outcomes

  1. Beck Anxiety Scale

    Time frame: 2 hours (pre-test and post-test)

    The scale is a Likert-type self-evaluation scale consisting of 21 items and scored between 0-3. A high total score indicates the level of anxiety experienced by the person. The score range varies between 0 and 63. Evaluation of the scale is as follows: 0-7 points with no anxiety symptoms, 8-15 with mild anxiety symptoms, 16-25 with moderate anxiety symptoms, and 26-63 with severe anxiety symptoms. Higher scores from the scale mean worse results.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer Receiving Chemotherapy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Jul 3, 2025

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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