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

NCT05885126 | Completed

• 1 other identifier: 123456123456
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Chemotherapy-induced Nausea and Vomiting; Nursing Caries

Outcome Measures

Primary Outcomes (2)

• Acute Nausea-Vomiting

  The change in the patient's nausea and vomiting will be observed using The MASCC Antiemesis Tool (MAT)

  5 months

• Genel Comfort Level

  The change in the patient's comfort level will be observed by using the General Comfort Scale Short Form.

  5 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients in the intervention group were allowed to paint mandala templates for 30 minutes during chemotherapy treatment after premedication. Before the application, the patients were informed by the practitioner and given a laptop table, mandala coloring books and crayons, they were asked to paint a mandala template of their choice. 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. The patients in the intervention group were given the materials necessary for painting medallions after the treatment, and they were asked to apply at home for at least 30 minutes the day after the treatment. The patients were supported by telephone to paint while they were at home.

Other: MANDALA TECHNIQUE

Control Group

NO INTERVENTION

Participants in the control group did not receive any intervention during or after treatment.

Interventions

MANDALA TECHNIQUE OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Having any communication problems,
• Having sufficient fine motor skills to paint,
• Refusal to participate in the research.

Sponsors & Collaborators

• Ege University: lead

Study Sites (2)

Gaziantep Islamic and Technology University

Pazarcık, Kahramanmaraş, (054) 231-0182, Turkey (Türkiye)

Location

Gaziantep İslamic and Technology University

Gaziantep, Turkey (Türkiye)

Location

Related Publications (1)

• Celik A, Kin OK. Clinical Trial of Mandala Coloring for Management of Chemotherapy-Induced Nausea and Vomiting. Altern Ther Health Med. 2024 Dec;30(12):13-17.

  PMID: 39565703 DERIVED

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Özlem KARDAŞ KİN

  Gaziantep Islamic and Technology University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: June 1, 2023
• Study Start: December 1, 2022
• Primary Completion: March 15, 2023
• Study Completion: January 30, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)