Clinical trial NCT06735456: The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer
Official title: The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Nursing
Mandala
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with a mandala group and control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physiological parameter 1
timeFrame: 2 hours (pre-test and post-test)
measure: Physiological parameter 2
timeFrame: 2 hours (pre-test and post-test)
measure: Physiological parameter 3
timeFrame: 2 hours (pre-test and post-test)
measure: Physiological parameter 4
timeFrame: 2 hours (pre-test and post-test)
measure: Physiological parameter 5
timeFrame: 2 hours (pre-test and post-test)
Secondary outcomes:
measure: Beck Anxiety Scale
timeFrame: 2 hours (pre-test and post-test)
Other outcomes:
Locations:
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Filiz Ünal Toprak
role: PRINCIPAL_INVESTIGATOR
References: