Effects of Acupressure and Aromatherapy on Nausea and Vomiting Severity, Anxiety and Comfort Level
NCT Number: NCT06529458
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Patients Receiving Chemotherapy
Interventions: OTHER: Intervention 1 Group|OTHER: Intervention 2 Group|OTHER: Control Group
Sponsor: Setenay Batır
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-29
Completion Date: 2025-08-30
Locations: Setenay Batır, Kayseri, 38280, Turkey

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.

Primary Outcome Measures: 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 Outcome Measures: 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"., Immediately after chemotherapy treatment
Other Outcome Measures: 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"., One day after chemotherapy treatment|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., One day after chemotherapy treatment|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"., 2nd, 3rd, 4th day after chemotherapy treatment|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"., 5th day after chemotherapy treatment|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., 5th day after chemotherapy treatment|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., 5th day after chemotherapy treatment