Trial Title:
Effects of Acupressure and Aromatherapy on Nausea and Vomiting Severity, Anxiety and Comfort Level
NCT ID:
NCT06529458
Condition:
Breast Cancer Patients Receiving Chemotherapy
Conditions: Official terms:
Nausea
Vomiting
Conditions: Keywords:
Chemotherapy
Acupressure
Aromatherapy
Nausea Vomiting Severity
Anxiety
Comfort Level
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Intervention 1 Group
Description:
The researcher will apply pressure to the P6 acupressure point on both wrists for
approximately 5 minutes at the same time as chemotherapy. He will also have the patient
or a relative repeat the method and do it at home three times a day before meals for 5
days.
Arm group label:
Intervention 1 Group
Intervention type:
Other
Intervention name:
Intervention 2 Group
Description:
The researcher will apply drops of ginger oil to the P6 acupressure point on both wrists
for approximately 5 minutes at the same time as chemotherapy, using circular motions. At
the same time, the researcher will have the patient or a relative repeat the method and
apply it at home three times a day before meals for 5 days.
Arm group label:
Intervention 2 Group
Intervention type:
Other
Intervention name:
Control Group
Description:
No interference will be made
Arm group label:
Control Group
Summary:
The aim of the researchers is to evaluate the effects of acupressure applied to the p6
region for 5 days and acupressure applied by applying ginger oil on the severity of
nausea and vomiting, anxiety and comfort levels in patients receiving chemotherapy. The
study is a randomized, controlled experimental study.
It will be conducted on patients diagnosed with breast cancer who are receiving treatment
at the Erciyes University Health Application and Research Center Nazende-Nuri Özkaya
Oncology Day Treatment Center. A total of 60 patients, 20 patients in control, 20
patients in Intervention 1 and 20 patients in Intervention 2 who meet the inclusion
criteria, will be included in the sample according to the block randomization list
created in the computer environment. Attention will be paid to ensure that the patients
have similar characteristics such as being diagnosed with breast cancer, receiving
chemotherapy for the first time, using the same chemotherapy drugs and the same
antiemetic drugs (Adriablastin, Cyclophosphamide, Kytril), gender and age. No application
will be made to the control group.
Data; Data will be collected using the Informed Consent Form, Patient Introduction Form,
Visual Analog Scale (VAS), Rhodes Nausea, Vomiting and Retching Index (INVR), General
Comfort Scale-Short Form, State-Trait Anxiety Inventory (STAI), Patient Monitoring
Schedule-Researcher Form, Acupressure Application Protocol, Acupressure and Aromatherapy
Application Protocol.
Detailed description:
Cancer is a major public health problem that threatens life and health. The aim of cancer
treatment is to extend the life span of the individual and improve the quality of life.
The process of cancer treatment is long and difficult. Cancer patients face various
physical (hair loss, nausea, vomiting, pain, fatigue, loss of appetite, malnutrition and
weakness) and psychological complications (depression, stress and anxiety) that reduce
their quality of life during the treatment process. Despite the use of various treatments
such as surgery, chemotherapy, hormone therapy, radiotherapy, immunotherapy and
biological therapy in cancer treatment today, patients still complain of many physical
and psychological complications. Nausea and vomiting, which are among the side effects of
treatment, are the most common and disturbing symptoms. Despite the development of drug
treatments in recent years, nausea and vomiting due to chemotherapy is seen in an average
of 38%-80% of patients. Nausea due to cancer treatments can be acute (occurring within 24
hours of treatment), delayed (occurring after the first 24 hours of treatment and
continuing for 1-4 days), anticipatory (occurring due to conditioning before or during
treatment), breakthrough nausea and/or vomiting (occurring despite prophylactic
medications and requiring additional treatment), refractory (unresponsive/persistent to
treatment), and chronic vomiting. Nausea and vomiting are known to cause serious problems
such as fluid and electrolyte imbalance, weight loss, dehydration, and malnutrition, as
well as negatively impacting patients' daily activities and quality of life. Uncontrolled
nausea and vomiting can also cause patients to delay or refuse treatment. Anxiety, which
occurs during the long and difficult treatment process of cancer, is often difficult to
define and treat. Some events that may cause anxiety in cancer patients include hearing
the diagnosis, receiving chemotherapy, undergoing surgery, receiving radiation therapy,
and discussing family problems. Anxiety symptoms have been reported to be observed in 20%
to 60% of cancer patients. Today, traditional complementary and alternative medicine
treatments are widely used to relieve cancer symptoms due to their organic nature, fewer
complications, and lower costs. Acupressure is a treatment method that has been used in
Traditional Chinese Medicine for 5000 years. In the literature, acupressure applications
have been used to improve sleep quality, relieve pain related to childbirth and cancer,
reduce fatigue, depression, and anxiety, and relieve nausea and vomiting. Acupressure can
be applied to the P6 acupuncture point with pressure methods using a wrist band or
fingers. The wrist band comes in different sizes and has been developed with a round
hemisphere on its inner surface that can apply pressure to the P6 point. Although the
effect of acupressure on nausea and vomiting has not been fully explained, it is thought
that it reduces nausea and vomiting by increasing the release of neurohormones and
neurotransmitters (beta endorphin, serotonin, histamine) and regulating blood circulation
as a result of stimulating acupressure points. Another study has indicated that
acupressure increases the energy flow on the meridians and thus reduces nausea and
vomiting. In the studies conducted by Genç and Tan with breast cancer patients, it was
reported that pressure applied to the P6 point with acupressure technique was effective
in reducing nausea. Another study conducted on breast cancer patients indicated that
acupressure application to the P6 point caused a decrease in nausea, vomiting and anxiety
levels of the patients and emphasized that more studies should be conducted on this
subject. In another study, patients were divided into two groups for acupressure
application: pressure (n = 22) and wrist band (n = 22). Acupressure was applied to both
wrists for two minutes using the finger pressure method and for fifteen minutes using a
wrist band. The number and severity of nausea and vomiting were found to be statistically
significantly lower in the pressure and wrist band groups compared to placebo
applications. It was found that additional antiemetic drug use was statistically
significantly higher in the placebo groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients who are 18 years of age or older,
- Understand and communicate in Turkish,
- Those who are diagnosed with breast cancer and receive their first course of
chemotherapy,
- Those who are receiving platinum group chemotherapeutic agents (Adriablastin,
Cyclophosphamide) that have a high emotogenic effect,
- Those who are not pregnant and not planning to be pregnant,
- Those whose disease stage is at most stage III,
- Those who do not have any psychiatric disorders,
- Those who do not have wounds, lesions, etc. in the areas where acupressure will be
applied
Exclusion Criteria:
- Individuals who have another disease that may affect nausea and vomiting,
- Those who are allergic to ginger or are bothered by its smell,
- Those who receive simultaneous radiotherapy,
- Those who use other complementary and integrated treatment practices during the
treatment process will be excluded from the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Setenay Batır
Address:
City:
Kayseri
Zip:
38280
Country:
Turkey
Contact:
Last name:
Pınar Tekinsoy Kartın
Start date:
August 29, 2024
Completion date:
August 30, 2025
Lead sponsor:
Agency:
Setenay Batır
Agency class:
Other
Source:
Kayseri City Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06529458
