1. To determine the effect of massage on reducing nausea and vomiting of patients with chemotherapy in adults' patients.
2: To determine the effect of aromatherapy on reducing nausea and vomiting of patients with chemotherapy in adults' patients.
3: To determine the effect of massage and aromatherapy on reducing nausea and vomiting of patients with chemotherapy in adults' patients.
Design
Comparative, randomized, controlled clinical trial with a parallel group design of 90 patients.
Settings and conduct
This study was conducted in the oncology centers of Wasit hospitals, where the study included 90 patients who entered the hospital to receive chemotherapy. They were divided into three groups, and a study was conducted on them.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Adult patients aged (18 and above) years old diagnosed with cancer undergoing chemotherapy; voluntary participated in the study; read and write; Patients experiencing nausea and vomiting; have no problems communicating and are fully conscious.
Exclusion Criteria: Patients who refused to participate in the study; patients with a history of allergy to massage oil or aromatherapy; had any record of respiratory diseases like asthma; patients with a history of psychiatric disorders; impaired vision and skin ulcers.
Intervention groups
Two groups/ massage groups apply foot massage for 15 minute with the use of Peppermint oil and aromatherapy groups inhale aroma for 10 minute
Main outcome variables
Reduced nausea and vomiting intensity caused by chemotherapy for patient with cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231027059871N1
Registration date:2024-01-23, 1402/11/03
Registration timing:retrospective
Last update:2024-01-23, 1402/11/03
Update count:0
Registration date
2024-01-23, 1402/11/03
Registrant information
Name
Karrar Al zubaidy
Name of organization / entity
University of Baghdad/ college of nursing
Country
Iraq
Phone
+964 772 372 7372
Email address
karrar.abd2202m@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-20, 1402/09/29
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"Effect of Massage and Aromatherapy on Nausea and Vomiting of Patient with Chemotherapy: A Randomized Control Trial"
Public title
Reducing Nausea and Vomiting in Patient-Related Chemotherapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients aged 18 and above diagnosed with cancer and undergoing chemotherapy
Read and write
Patients experiencing nausea and vomiting
Have no problems communicating
Fully conscious.
Exclusion criteria:
Skin ulcer
Patients with a history of psychiatric disorders
Respiratory diseases like asthma
Patients with a history of allergy to massage oil or aromatherapy
Patients who have problems communicating and are unconscious
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In order to maintain a transparent and scientific-based randomization process, simple randomization will use three cards of different colors in a box for the sample to select one card that represents the group of the study. The yellow card represents the aromatherapy group, the blue card represents the massage group, and the black card represents the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
Street address
5, Al-Jamiya District., Gold Street
City
Al-zubaidiya
Postal code
70001
Approval date
2023-11-22, 1402/09/01
Ethics committee reference number
4356/8/1/3/1
Health conditions studied
1
Description of health condition studied
Chemotherapy Induced Nausea and Vomiting
ICD-10 code
C80.1
ICD-10 code description
Malignant (primary) neoplasm, unspecified
Primary outcomes
1
Description
Nausea and Vomiting-related Chemotherapy
Timepoint
After 24 hours from intervention
Method of measurement
Rhodes Index Scale Rhodes index of nausea, vomiting and retching (24 hours after chemotherapy)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Massage therapy group: Patients receive regular massage sessions during chemotherapy in the foot area for 15 minutes using peppermint oil.
Category
N/A
2
Description
Intervention group: Aromatherapy group: All patients were male and female lying in the supine position in the chemotherapy administration unit. Three drops of peppermint oil were placed with a dropper on a sterile gauze that was tied around the participants' collar for inhalation for 10 minutes while taking chemotherapy. After that, the Rhodes Index Scale was measured to evaluate the severity of nausea and vomiting 24 hours after taking the therapeutic dose.
Category
N/A
3
Description
Control group: Patients receive standard chemotherapy care without additional interventions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology Center
Full name of responsible person
Karrar Hassan Abd al Sada
Street address
5, Al-Dhahab Street., Al-Jamiya neighborhood., Al-Zubaidiyah city,
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The researcher acknowledges that the scientific community has verifiable findings from the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed, reputable journals
When the data will become available and for how long
Once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution
From where data/document is obtainable
The author's professional email that will be available with the published manuscript can be used to contact the author. e-Mail: karrarhassan220@gmail.com
What processes are involved for a request to access data/document