Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 4:54 PM
Study NCT ID:
NCT06735456
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2024-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Since the application will be performed by the researcher, patients will be blinded in this study. The statistician will be blinded in the evaluation of the data.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups with a mandala group and control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiological parameter 1', 'timeFrame': '2 hours (pre-test and post-test)', 'description': 'Temperature'}, {'measure': 'Physiological parameter 2', 'timeFrame': '2 hours (pre-test and post-test)', 'description': 'Pulse'}, {'measure': 'Physiological parameter 3', 'timeFrame': '2 hours (pre-test and post-test)', 'description': 'Blood pressure'}, {'measure': 'Physiological parameter 4', 'timeFrame': '2 hours (pre-test and post-test)', 'description': 'spO2'}, {'measure': 'Physiological parameter 5', 'timeFrame': '2 hours (pre-test and post-test)', 'description': 'Respiratory rate'}], 'secondaryOutcomes': [{'measure': 'Beck Anxiety Scale', 'timeFrame': '2 hours (pre-test and post-test)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Nursing', 'Mandala'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Since it is a study conducted on breast cancer women, it concerns the female gender.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with breast cancer,\n* Being receiving adjuvant or neoadjuvant chemotherapy,\n* Being over 18 years of age,\n* Ability to communicate in Turkish,\n* Not having a physical disability related to the upper extremities,\n* Agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Advanced stage cancer patients,\n* Having visual, hearing and speech disabilities,\n* Individuals with mental and neuropsychiatric diseases will not be included in the sample.'}, 'identificationModule': {'nctId': 'NCT06735456', 'briefTitle': 'The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer Receiving Chemotherapy', 'orgStudyIdInfo': {'id': 'SBU-FUT-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mandala Group', 'description': 'The patient will undergo mandala painting during 1 session of chemotherapy.', 'interventionNames': ['Other: Mandala']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No application will be made to this group by the researcher.'}], 'interventions': [{'name': 'Mandala', 'type': 'OTHER', 'description': 'The patient will undergo mandala painting during 1 session of chemotherapy.', 'armGroupLabels': ['Mandala Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Sağlık Bilimleri Üniversitesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Filiz Ünal Toprak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saglik Bilimleri Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Filiz Ünal Toprak', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}