- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07581119
Effect of Mandala Coloring on Nausea, Fatigue, and Well-Being in Chemotherapy Patients (MANDALACHEMO)
The Effect of Mandala Coloring on Nausea, Vomiting, Fatigue, and Psychological Well-Being in Cancer Patients Receiving Chemotherapy
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
This study is a clinical trial designed to investigate the effects of mandala coloring on nausea, vomiting, fatigue, and psychological well-being in cancer patients receiving chemotherapy. Chemotherapy is commonly associated with both physical and psychological side effects that negatively impact patients' quality of life.
The intervention consists of structured mandala coloring sessions conducted during chemotherapy cycles. Participants will perform the coloring activity in a calm and appropriate clinical environment. No pharmacological or additional psychological interventions will be applied during the study period.
Outcome measures include the severity of nausea, vomiting, and fatigue, as well as psychological well-being levels, assessed using validated scales at baseline and after the intervention. Differences in these outcomes will be analyzed to evaluate the effectiveness of the mandala coloring intervention.
The study is expected to provide evidence regarding low-cost, non-pharmacological supportive care methods that may improve symptom management and psychological health in chemotherapy patients.
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Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Şehitkamil
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Gaziantep, Şehitkamil, Turcja (Türkiye), 27000
- Gaziantep University Vocational School of Health Services
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adult patients diagnosed with cancer Patients receiving chemotherapy treatment Age 18 years and older Patients who are able to communicate verbally Patients who agree to participate in the study and sign informed consent form Patients without cognitive impairment
Exclusion Criteria:
- Patients with severe psychiatric disorders Patients with visual or cognitive impairments preventing participation in mandala coloring Patients in critical clinical condition or intensive care unit Patients who refuse to continue participation Patients receiving additional concurrent psychological interventions
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: The effect of mandala practice on nausea, vomiting, and fatigue
Cancer patients receiving chemotherapy in this group participated in a structured mandala painting intervention in addition to standard care.
The intervention was applied during chemotherapy infusion and continued within the first 24 hours after treatment.
Patients engaged in individual coloring activities using standardized mandala templates in a calm environment aimed at promoting relaxation and reducing symptom burden.
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Participants in the intervention group performed a structured mandala coloring activity designed to promote relaxation and reduce chemotherapy-related symptoms.
Pre-designed mandala patterns and colored pencils were provided.
The session was conducted in a quiet environment and lasted approximately 20-30 minutes.
The intervention was applied once.
Outcomes including nausea, vomiting, fatigue, and psychological well-being were assessed within 24 hours after the intervention.
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Brak interwencji: Control: Standard Care
Patients in this group received standard chemotherapy care only without any additional non-pharmacological intervention.
Outcomes such as nausea, vomiting, fatigue, and psychological well-being were assessed for comparison with the experimental group.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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The Effect of Mandala Coloring on Nausea, Vomiting, Fatigue, and Psychological Well-Being in Cancer Patients Receiving Chemotherapy
Ramy czasowe: Within 24 hours after the intervention
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Nausea and vomiting severity were assessed using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
Fatigue levels were measured using a standardized fatigue scale, and psychological well-being was assessed using a validated psychological well-being scale.
Outcome measures were compared between the mandala painting group and the control group before and within 24 hours after the intervention.
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Within 24 hours after the intervention
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The effects of mandala painting on nausea, vomiting, fatigue, and psychological well-being in cancer patients undergoing chemotherapy.
Ramy czasowe: 24 hours after intervention
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Fatigue Severity Questionnaire: The fatigue severity scale is a unidimensional questionnaire with a total score of 16 on a seven-point Likert scale, and higher total scores indicate greater fatigue. Psychological Well-being Scale: The scale consists of 8 items and is a 7-point Likert type. The scale is single-dimensional, with a minimum score of 8 and a maximum score of 56. Higher scores on the scale indicate higher overall psychological well-being. |
24 hours after intervention
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Adile Neşe, University of Gaziantep
Publikacje i pomocne linki
Publikacje ogólne
- Yuruk E, Todil T, Askan F, Kara M, Hacisalihoglu A. Effects of mandala art therapy (coloring) on nausea, vomiting, pain and anxiety in children and youth receiving outpatient chemotherapy. J Pediatr Nurs. 2026 Jan-Feb;86:366-374. doi: 10.1016/j.pedn.2025.11.029. Epub 2025 Nov 26.
- Dadashi N, Khanali Mojen L, Ilkhani M, Nasirie M, Mirzaee HR, Boozaripour M. Effect of Mandala Art Therapy on Quality of Life in Breast Cancer Patients. Asian Pac J Cancer Prev. 2025 Jul 1;26(7):2533-2540. doi: 10.31557/APJCP.2025.26.7.2533.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Mandala Coloring Chemotherapy
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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