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The effect of mandala staining on nausea, vomiting and dry heaves in women with breast cancer undergoing chemotherapy

Protocol summary

Study aim
The effect of mandala staining on nausea, vomiting and dry heaves in women with breast cancer undergoing chemotherapy
Design
Sampling is done by random method and allocation in two test and control groups by random block method, phase 2 study, including attrition, is done on 29 patients.
Settings and conduct
Sampling in Yas Hospital will be done by random method and block classification into intervention and control groups. Mandala design for coloring and Rhodes index for data collection before, 1 and 12 hours after chemotherapy is provided to the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: under treatment with adriamycin and cyclophosphamide regimen, presence of nausea, vomiting, Exclusion criteria: stopping chemotherapy, undergoing radiotherapy during the study, using over-the-counter medications to control nausea. Suffering from other diseases with the complication of nausea and vomiting, taking narcotics or sedatives or other complementary methods, having a defect or disability in the dominant hand that prevents coloring.
Intervention groups
In second session of chemotherapy, the Rhodes Nausea, Vomiting and Burping Index is provided to both groups to be completed immediately, 1 and 12 hours after the end of chemotherapy by the patient or his caregiver. In the third session, simultaneously with the administration of pre-chemotherapy drugs (Cetril and Dexamethasone), the questionnaire of the second session are taken, one of the mandala designs along with colored pencils are provided to the patients of the intervention group. Immediately, 1 and 12 hours after the end of chemotherapy, the Rhodes index is completed and delivered to the researcher in the fourth session. These steps will be repeated for the fourth session of chemotherapy.
Main outcome variables
nausea, vomiting and dry heaves

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220611055138N1
Registration date: 2023-09-02, 1402/06/11
Registration timing: retrospective

Last update: 2023-09-02, 1402/06/11
Update count: 0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Faezeh Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5522 5151
Email address
f.ghorbani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mandala staining on nausea, vomiting and dry heaves in women with breast cancer undergoing chemotherapy
Public title
The effect of mandala staining on nausea, vomiting and dry heaves in women with breast cancer undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and older Literacy for the patient or caregiver Interest and satisfaction to participate in the research Treated with adriamycin and cyclophosphamide Perform at least one chemotherapy session Nausea, vomiting and dry heaves in the first session of chemotherapy (self-report) Do not have another illness with nausea, vomiting and wheezing according to the file and self-report Do not take any other medication with nausea, vomiting and nausea as reported and self-report Do not use narcotics or sedatives according to the file and self-report Absence of cognitive and psychiatric disorders (according to the file) No impairment in vision and hearing No defects or disabilities in the dominant hand so as to prevent staining. Do not use self-medication or other complementary medicine to reduce nausea, vomiting and nausea
Exclusion criteria:
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples will be selected from the patients referred to Yas Hospital based on the inclusion criteria, and then they will be placed in 4-block tables according to the order of referral and divided into intervention and control groups. In order to prevent information leakage, the implementation method and study objectives will be introduced to the people of the intervention group along with the necessary explanations, in a separate room.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Telar 10, 17 shahrivar st, zirab, savadkooh, mazandaran
City
Babol
Province
Mazandaran
Postal code
4781955855
Approval date
2022-05-29, 1401/03/08
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.060

Health conditions studied

1

Description of health condition studied
Nausea
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

2

Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Rhodes nausea, vomiting and dry heaves questionnaire score
Timepoint
In sessions two, three and four immediately, one hour and 12 hours after chemotherapy
Method of measurement
Nausea and vomitting Rohds Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Before the intervention: In the second session of chemotherapy, Rhodes nausea, vomiting and gag index are provided to the samples of both groups by providing complete explanations until immediately, one hour later and 12 hours after the end of chemotherapy by the patient Or their caregiver is completed and delivered to the researcher at the next chemotherapy session. Intervention: 1- Before the start of the third session, the researcher makes the necessary arrangements with the samples of the experimental group to attend half an hour before the start of chemotherapy. 2- In the third session, at the same time as prescribing the drugs before chemotherapy (ketril and dexamethasone), the researcher receives the questionnaire of the second session and gives one of the mandala designs along with the colored pencil to the patient in 20 minutes. May paint accurately. Immediately, one hour later and 12 hours after the end of chemotherapy, the Rhodes index is completed again by the patient or his caregiver and delivered to the researcher in the fourth session of chemotherapy. Steps one and two will be repeated for the fourth session of chemotherapy.
Category
Treatment - Other

2

Description
Control group: People assigned to the control group will not receive any intervention other than chemotherapy. In order to compare the data, the Rhodes index will be completed before, one and 12 hours after chemotherapy by the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Yas Hospital
Full name of responsible person
Hengameh karimi
Street address
Yas Hospital, Nejat-Ollahi Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
4781955855
Phone
+98 21 4216 0000
Email
faezeghorbani97@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Ganj-Afrooz street, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4781955855
Phone
+98 11 3220 8143
Email
Faezehghorbani97@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hengameh karimi
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ramsar Fatemeh Zahra School Of Nursing
City
Ramsar
Province
Mazandaran
Postal code
4781955855
Phone
+98 11 5522 5151
Email
Hengamehkarimister@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
hengameh karimi
Position
teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
nursing faculty of ramsar
City
Ramsar
Province
Mazandaran
Postal code
4781955855
Phone
+98 11 5522 5151
Email
faezehghorbani97@ gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
faezehghorbani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
telar 10, 17 shahrivar st, zirab, savadkooh, mazandaran
City
zirab
Province
Mazandaran
Postal code
4781955855
Phone
+98 11 4245 1738
Email
faezehghorbani97@ gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
.
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
.
What processes are involved for a request to access data/document
.
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