Clinical trial NCT05885126: The Effect of Mandala Technique on Acute Nausea-vomiting and Comfort Level in Cancer Patients
Official title: The Effect of Mandala Technique on Acute Nausea-vomiting and Comfort Level in Cancer Patients Receiving Outpatient Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Nursing Caries
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample recruited for the research consisted of 38 individuals (19 individuals in the control group, 19 in intervention group) who were 18 years and older, were receiving a high emetogenic chemotherapy regimen for the first time, had sufficient fine motor skills to paint and were volunteering to participate in research. Exclusion criteria were any physical or mental disability that limited communication or coloring the mandala template. Homogeneity was ensured by including patients who received chemotherapy regimen with high emetogenicity. Patient lists numbered according to even and odd numbers were given in a sealed envelope to a practitioner independent from the researchers.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute Nausea-Vomiting
timeFrame: 5 months
measure: Genel Comfort Level
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pazarcık
country: Turkey
facility: Gaziantep Islamic and Technology University
state: Kahramanmaraş
city: Gaziantep
country: Turkey
facility: Gaziantep İslamic and Technology University
Study officials:
affiliation: Gaziantep Islamic and Technology University
name: Özlem KARDAŞ KİN
role: PRINCIPAL_INVESTIGATOR
References: