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NCT Number: NCT07367269

Effect of Mandala Coloring on Anxiety, Distress, and Comfort in Breast Cancer Patients Receiving Outpatient Chemotherapy

Breast cancer patients receiving chemotherapy often experience psychological distress, anxiety, and discomfort during treatment. Non-drug supportive methods may help improve patients' well-being during chemotherapy.

This study aims to evaluate whether mandala coloring during outpatient chemotherapy can reduce psychological distress and anxiety and improve comfort in breast cancer patients. Participants will be randomly assigned to either a mandala coloring group or a routine care group. Patients in the intervention group will color mandala patterns for 30 minutes during their chemotherapy session, while the control group will receive routine care only.

Psychological distress, anxiety, and comfort levels will be measured before and after the chemotherapy session in both groups. The results of this study may provide evidence for a simple and low-cost supportive intervention to improve the psychological well-being of breast cancer patients during 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

Artvin State Hospital

Artvin, Turkey (Türkiye)

Location status: Recruiting

Location contact

Efe Hasdemir, MD

CONTACT

[email protected]

5433750709

About this study

Breast cancer is one of the most common malignancies among women and chemotherapy is a fundamental component of its treatment. However, chemotherapy is frequently associated with psychological distress, anxiety, and decreased comfort, which may negatively affect patients' quality of life and treatment adherence. Supportive non-pharmacological interventions that are easy to apply during chemotherapy are therefore needed.

Mandala coloring is a complementary approach that has been reported to reduce anxiety and psychological distress and improve well-being in patients with cancer. Nevertheless, evidence regarding its effectiveness during outpatient chemotherapy sessions remains limited. This study is designed to evaluate the effect of mandala coloring applied during outpatient chemotherapy on psychological distress, anxiety, and comfort in breast cancer patients.

This study is a randomized controlled experimental trial that will be conducted in the Chemotherapy Unit of Artvin State Hospital. A total of 60 breast cancer patients receiving outpatient chemotherapy will be recruited. Participants will be randomly assigned in a 1:1 ratio to either an intervention group (mandala coloring) or a control group (routine care). Block randomization with allocation concealment using sequentially numbered opaque sealed envelopes will be used.

Patients in the intervention group will perform mandala coloring for 30 minutes starting at the beginning of their chemotherapy session. They will be provided with mandala coloring books and colored pencils and will continue to receive routine medical care during the session. Patients in the control group will receive routine care only, without any coloring activity.

Psychological distress, anxiety, and comfort will be assessed before and after the chemotherapy session in both groups. Distress will be measured using the Distress Thermometer. Anxiety will be evaluated using the State Anxiety subscale of the State-Trait Anxiety Inventory. Comfort will be assessed using the General Comfort Scale. Pre-test and post-test measurements will be compared between groups to determine the effect of the mandala coloring intervention.

The findings of this study may contribute evidence for a simple, low-cost, and easily applicable supportive intervention to improve psychological well-being and comfort in breast cancer patients undergoing outpatient chemotherapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being 18 years of age or older
  • Having a diagnosis of breast cancer and receiving chemotherapy
  • Having no communication problems
  • Having no physical disability that would prevent mandala coloring
  • Being willing to participate in the study

Exclusion criteria

  • not meeting inclusion criteria

Treatment and study plan

Mandala Coloring

Behavioral

Mandala coloring activity performed for 30 minutes during outpatient chemotherapy using mandala coloring books and colored pencils.

Primary outcomes

  1. Psychological Distress

    Time frame: Before chemotherapy session and immediately after the chemotherapy session (single session).

    Psychological distress will be measured using the Distress Thermometer. Participants rate their level of distress on a scale from 0 (no distress) to 10 (extreme distress). Higher scores indicate greater psychological distress.

Secondary outcomes

  1. Anxiety

    Time frame: Before chemotherapy session and immediately after the chemotherapy session (single session).

    Anxiety will be measured using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S). Scores range from 20 to 80, with higher scores indicating higher levels of anxiety.

  2. Comfort

    Time frame: Before chemotherapy session and immediately after the chemotherapy session (single session).

    Comfort will be measured using the General Comfort Scale. Scores range from 1 to 4, with higher scores indicating higher levels of comfort.

Study contacts

Contact information is provided by the study sponsor or research team.

Efe Hasdemir Efe Hasdemir, MD

CONTACT

[email protected]

+90 5433750709

Sponsors and collaborators

Lead sponsor

Artvin Coruh University

Other

Registry information

Official study title

The Effect of Mandala Coloring on Psychological Distress, Anxiety, and Comfort in Breast Cancer Patients Receiving Outpatient Chemotherapy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Feb 3, 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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