Effects of Acupressure and Aromatherapy on Nausea and Vomiting Severity, Anxiety and Comfort Level
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2024
CompletedFirst Posted
Study publicly available on registry
July 31, 2024
CompletedStudy Start
First participant enrolled
August 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2025
CompletedAugust 22, 2024
August 1, 2024
6 months
July 26, 2024
August 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Visual Analog Scale (VAS)
The scale consists of a horizontal line 100 mm/10 cm long. At the left end of the line is 0 "No nausea", while at the right end is 10 "Severe nausea". The patient will be asked to mark the point on the line that will accurately reflect their nausea. In patient selection, 5 mm and below on the scale will be evaluated as "no nausea" and all values above will be evaluated as "experiencing nausea".
Day 1
Rhodes Index of Nausea, Vomiting ve Retching- INVR
This index measures the number of nausea, vomiting and retching episodes and the distress experienced by individuals in the last 12 hours using a Likert-type assessment. The index consists of 8 questions. Each answer is scored as "0" for the least distress; "4" for the most distress.
Day 1
General Comfort Scale-Short Form
The scale consists of three sub-dimensions: relief (1-9 items), relaxation (10-18 items) and superiority (19-28 items). The lowest score that can be obtained from the scale is 28 and the highest score is 168. As the score obtained from the scale decreases, it indicates that the individual's comfort level is low. The lowest value "1" indicates low comfort and "6" indicates high comfort level.
Day 1
State-Trait Anxiety Inventory
While the state anxiety scale only provides information about what is felt at that moment, the trait anxiety scale was developed to measure what has been felt over the last 7 days. In interpreting the scores, the total score obtained from both scales varies between 20 and 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.
Day 1
Secondary Outcomes (1)
Visual Analog Scale (VAS)
Immediately after chemotherapy treatment
Other Outcomes (6)
Visual Analog Scale (VAS)
One day after chemotherapy treatment
Rhodes Index of Nausea, Vomiting ve Retching- INVR
One day after chemotherapy treatment
Visual Analog Scale (VAS)
2nd, 3rd, 4th day after chemotherapy treatment
- +3 more other outcomes
Study Arms (3)
Intervention 1 Group
EXPERIMENTALThe 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.
Intervention 2 Group
EXPERIMENTALThe 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.
Control Group
OTHERNo interference will be made
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Setenay Batırlead
Study Sites (1)
Setenay Batır
Kayseri, 38280, Turkey (Türkiye)
Related Publications (1)
Genc F, Tan M. The effect of acupressure application on chemotherapy-induced nausea, vomiting, and anxiety in patients with breast cancer. Palliat Support Care. 2015 Apr;13(2):275-84. doi: 10.1017/S1478951514000248. Epub 2014 Apr 30.
PMID: 24787745BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Pınar Tekinsoy Kartın
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
July 26, 2024
First Posted
July 31, 2024
Study Start
August 29, 2024
Primary Completion
March 1, 2025
Study Completion
August 30, 2025
Last Updated
August 22, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share