The Effect of Mandala Technique on Acute Nausea-vomiting and Comfort Level in Cancer Patients

Nursing Caries Clinical Trial

Official title:

The Effect of Mandala Technique on Acute Nausea-vomiting and Comfort Level in Cancer Patients Receiving Outpatient Chemotherapy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05885126
• Other study ID #: 123456123456
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: May 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cancer is an important health problem in the world and in our country, and it ranks second among the causes of death in our country (20.7%). Chemotherapy, one of the most commonly used methods in cancer treatment, causes many physical and emotional symptoms while treating the disease. Nausea-vomiting is a common problem in cancer care, especially in patients receiving chemotherapy.

In the literature, there are studies examining non-pharmacological interventions for the prevention and management of nausea and vomiting in patients receiving chemotherapy, and it is seen that the interventions are mostly within the scope of complementary and alternative approaches. Patients receiving ambulatory chemotherapy may experience anticipatory nausea in particular, and this is likely to affect the individual's comfort level. In studies conducted in the field, the comfort level of cancer patients receiving chemotherapy was determined as moderate.

Today, mandalas are used effectively in the field of art therapy. The possibility of using mandala in all age groups has contributed to the treatment process of different diseases and disorders, and its effectiveness has been presented to the scientific world with many researches around the world. In adults, the mandala has been used both in the treatment of psychiatric disorders and as a tool to observe the effects of treatments. Art therapy including mandala drawing has significantly reduced the severity of trauma symptoms in individuals with anxiety disorders and post-traumatic stress disorder. In the study of Zhao & Tang (2017) it was determined that mandala drawing therapy reduced the anxiety of cancer patients.

If the reduction of nausea-vomiting affects the comfort level and the person is relieved, a more effective treatment environment is created and the quality of life of the person is increased. In the literature, very limited studies have been reached on the use of the mandala drawing technique in cancer patients. National and international research examining the mandala drawing technique, especially in patients receiving ambulatory chemotherapy, could not be reached. The aim of this study is to determine the effect of mandala drawing technique on nausea-vomiting and comfort level in patients receiving ambulatory chemotherapy. It is anticipated that the study to be conducted will contribute to nursing interventions in the cancer care process and lead to the planning of new research on the subject.

Description:

This research was planned in a quasi-experimental design with pretest-posttest control group. It is aimed to determine the effect of mandala technique on nausea-vomiting and comfort level in patients receiving ambulatory chemotherapy.

For this purpose, the research will be carried out with cancer patients receiving chemotherapy treatment on an outpatient basis at Gaziantep University Medical Faculty Training and Research Hospital and Gaziantep University Oncology Hospital between December 2022 and April 2023. The population of my research will consist of patients who receive outpatient chemotherapy treatment at Gaziantep University Faculty of Medicine Oncology Hospital. Individuals who meet the sampling selection criteria from the specified universe will constitute the sample of the research. Experimental research requires at least 20 samples. In order for a test to meet the parametric test conditions, references were made to the sources stating that the groups must have at least 30 individuals. In the research group of our study, it was planned to include 30 application and 30 control group patients. When these numbers are reached, it is planned to determine the sample impact power by performing power analysis, and to terminate the research when at least 80% preferably 100% positive impact power is reached. Randomization of the sample will be achieved by accepting the first patient who applied to the outpatient chemotherapy unit randomly and with an appointment at the beginning of the study to the control group, and the next patient to the experimental group. The patients will be included in the experimental and control groups in this order until the sample size is reached.

The implementation of the study will start after the necessary permissions are obtained, and the application group will be asked to paint the mandalas provided by the researcher for at least 30 minutes while they are in the chemotherapy unit. The patients will be given the necessary materials during their stay at home, they will be asked to paint mandalas at home for 4 days, and the patient will be supported by phone. No treatment other than standard care will be performed for the control group.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 38
• Est. completion date: August 30, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria for the research:

• 18 years of age or older, conscious, literate, not having vision and hearing problems, being able to communicate verbally,

• Receiving outpatient chemotherapy treatment at Gaziantep University Faculty of Medicine Training and Research Hospital and Gaziantep University Oncology Hospital,

• Receiving a medium and high emetogenic effective chemotherapy regimen

• Having sufficient fine motor skills to paint,

• Not having any diagnosed psychiatric disorder,

• Agreeing to participate in the research

Exclusion criteria from the study:

• Having any communication problems,

• Having sufficient fine motor skills to paint,

• Refusal to participate in the research.

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Nursing Caries
• Vomiting

Intervention

Other:
• MANDALA TECHNIQUE
The ambient light and the position of the laptop table were adjusted appropriately during the intervention to help the participants move freely and eliminate the environmental stimulus. In addition, there was no communication between the patient and the practitioner during the application.

Locations

Country	Name	City	State
Turkey	Gaziantep Islamic and Technology University	Gaziantep
Turkey	Gaziantep Islamic and Technology University	Pazarcik	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Nausea-Vomiting	The change in the patient's nausea and vomiting will be observed using The MASCC Antiemesis Tool (MAT)	5 months
Primary	Genel Comfort Level	The change in the patient's comfort level will be observed by using the General Comfort Scale Short Form.	5 months