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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Mandala

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Sağlık Bilimleri Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No application will be made to this group by the researcher.
Experimental: Mandala Group; The patient will undergo mandala painting during 1 session of chemotherapy.	Other: Mandala; The patient will undergo mandala painting during 1 session of chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological parameter 1	Temperature	2 hours (pre-test and post-test)
Physiological parameter 2	Pulse	2 hours (pre-test and post-test)
Physiological parameter 3	Blood pressure	2 hours (pre-test and post-test)
Physiological parameter 4	spO2	2 hours (pre-test and post-test)
Physiological parameter 5	Respiratory rate	2 hours (pre-test and post-test)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Anxiety Scale	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.	2 hours (pre-test and post-test)

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Filiz Ünal Toprak, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Nursing; Mandala
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SBU-FUT-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No