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

Primary Purpose

Chemotherapy-induced Nausea and Vomiting, Nursing Caries

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MANDALA TECHNIQUE
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Gaziantep Islamic and Technology University
  • Gaziantep İslamic and Technology University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Acute Nausea-Vomiting
The change in the patient's nausea and vomiting will be observed using The MASCC Antiemesis Tool (MAT)
Genel Comfort Level
The change in the patient's comfort level will be observed by using the General Comfort Scale Short Form.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2023
Last Updated
May 31, 2023
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05885126
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting, Nursing Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in the control group did not receive any intervention during or after treatment.
Intervention Type
Other
Intervention Name(s)
MANDALA TECHNIQUE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute Nausea-Vomiting
Description
The change in the patient's nausea and vomiting will be observed using The MASCC Antiemesis Tool (MAT)
Time Frame
5 months
Title
Genel Comfort Level
Description
The change in the patient's comfort level will be observed by using the General Comfort Scale Short Form.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özlem KARDAŞ KİN
Organizational Affiliation
Gaziantep Islamic and Technology University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziantep Islamic and Technology University
City
Pazarcık
State/Province
Kahramanmaraş
ZIP/Postal Code
(054) 231-0182
Country
Turkey
Facility Name
Gaziantep İslamic and Technology University
City
Gaziantep
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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