Effect of Mandala Coloring on Anxiety, Distress, and Comfort in Breast Cancer Patients Receiving Outpatient Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mandala Coloring.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Mandala Coloring on Psychological Distress, Anxiety, and Comfort in Breast Cancer Patients Receiving Outpatient Chemotherapy
Overview
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.
Detailed description
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.
Interventions
- Behavioral Mandala Coloring
Mandala coloring activity performed for 30 minutes during outpatient chemotherapy using mandala coloring books and colored pencils.
Primary outcome measures
- Psychological Distress [Time frame: Before chemotherapy session and immediately after the chemotherapy session (single session).]
Secondary outcome measures (2)
- Anxiety [Time frame: Before chemotherapy session and immediately after the chemotherapy session (single session).]
- Comfort [Time frame: Before chemotherapy session and immediately after the chemotherapy session (single session).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Artvin State Hospital — Artvin
Publications
- [1] Winters S, Martin C, Murphy D, Shokar NK. Breast Cancer Epidemiology, Prevention, and Screening. Prog Mol Biol Transl Sci 2017;151: 1-32. [2] El Masri J, Phadke S. Breast Cancer Epidemiology and Contemporary Breast Cancer Care: A Review of the Literature and Clinical Applications. Clin Obstet Gynecol 2022;65: 461-481. [3] Xiong X, Zheng LW, Ding Y, Chen YF, Cai YW, Wang LP, Huang L, Liu CC, Sh
Identifiers
NCT: NCT07367269 · MANDALA-BC-CHEMO-01