Breast CancerNCT06735456
The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer
A study testing Mandala in people with Breast Cancer, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mandala
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Advanced stage cancer patients,
- Having visual, hearing and speech disabilities,
- Individuals with mental and neuropsychiatric diseases will not be included in the sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Mandala
- Keywords
- Breast cancer, Nursing, Mandala
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MandalaOther
The patient will undergo mandala painting during 1 session of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Mandala Group | Experimental | The patient will undergo mandala painting during 1 session of chemotherapy. Receives: Other: Mandala |
| Control Group | No intervention | No application will be made to this group by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological parameter 1
Temperature
Measured: 2 hours (pre-test and post-test)
Physiological parameter 2
Pulse
Measured: 2 hours (pre-test and post-test)
Physiological parameter 3
Blood pressure
Measured: 2 hours (pre-test and post-test)
Physiological parameter 4
spO2
Measured: 2 hours (pre-test and post-test)
Physiological parameter 5
Respiratory rate
Measured: 2 hours (pre-test and post-test)
Secondary outcomes (1)
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.
Measured: 2 hours (pre-test and post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start24 Feb 2024
- Primary completion30 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with a mandala group and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Ünal Toprak, Saglik Bilimleri Universitesi
- Investigators
- Filiz Ünal Toprak, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735456
- Sponsor's protocol ID
- SBU-FUT-03
- Status last verified
- Jun 2025
- First submitted
- 6 Dec 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT06735456
- Acronym / sponsor ID
- SBU-FUT-03
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Nursing, Mandala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with a mandala group and control group
| Arm | Type | Receives |
|---|---|---|
| Mandala Group | Experimental | Other: MandalaThe patient will undergo mandala painting during 1 session of chemotherapy. |
| Control Group | No intervention | –No application will be made to this group by the researcher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- Advanced stage cancer patients,
- Having visual, hearing and speech disabilities,
- Individuals with mental and neuropsychiatric diseases will not be included in the sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MandalaThe patient will undergo mandala painting during 1 session of chemotherapy. | Other | Mandala Group |
Primary outcome
Physiological parameter 1
Time frame: 2 hours (pre-test and post-test)
Temperature
Physiological parameter 2
Time frame: 2 hours (pre-test and post-test)
Pulse
Physiological parameter 3
Time frame: 2 hours (pre-test and post-test)
Blood pressure
Physiological parameter 4
Time frame: 2 hours (pre-test and post-test)
spO2
Physiological parameter 5
Time frame: 2 hours (pre-test and post-test)
Respiratory rate
1 secondary outcome
Beck Anxiety Scale
Time frame: 2 hours (pre-test and post-test)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filiz Ünal Toprak principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala in people with Breast Cancer, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological parameter 1 (time frame: 2 hours (pre-test and post-test)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.