An interventional study of auricular point sticking in Dysgeusia, Acupressure and Chemotherapy Effect, sponsored by Affiliated Hospital of Jiangnan University. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Affiliated Hospital of Jiangnan University · Not applicable, Interventional, and Treatment
To explore the intervention effect of auricular point sticking on chemotherapy-induced taste alterations in cancer patients, and analyze its relationship with quality of life, nutritional status and psychology of patients.
Taste alteration is a common adverse reaction in patients with chemotherapy. The incidence of taste alteration varies with chemotherapy drugs, ranging from 36% to 84%, among which platinum chemotherapeutic drugs are most likely to cause severe taste alteration. The taste alteration does not pose a serious threat to the life of patients, so it is often ignored by patients and medical staff. Dysgeusia is positively correlated with the loss of appetite, which can directly lead to the loss of appetite and insufficient intake of nutrients in patients, and even stimulate patients' anxiety, psychological pain and other negative emotions. In severe cases, it can cause malnutrition, reduce the chemotherapy compliance of cancer patients, and ultimately reduce the quality of life of patients. Therefore, for patients with platinum chemotherapy, it is necessary to pay close attention to the change of taste during chemotherapy, and apply effective nursing interventions to pay attention as soon as possible, so as to improve the quality of life of patients.
52 studies on the registry are indexed under Dysgeusia; 12 are open to participants now.
This study's enrollment of 120 is above the median of 49 across 28 interventional studies indexed under Dysgeusia.
Browse Dysgeusia studies →Affiliated Hospital of Jiangnan University is the lead sponsor of 28 studies on the registry; 11 are open to participants now.
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The control group receives routine nursing, including admission education, routine nursing of adverse reactions to chemotherapy, diet guidance for chemotherapy patients, precautions for various examinations, discharge guidance and follow-up.
Auricular point sticking therapy is performed on the basis of control group. The acupoint intervention group is established, and the research team consists of 2 graduate students, 1 graduate supervisor, 1 head nurse, 1 chief physician of traditional Chinese medicine, and 1 nursing expert. The nursing expert is responsible for the overall design of the project, and the director of traditional Chinese medicine is responsible for the selection of acupoints and the training of nurses for massage. The supervisor of graduate students and the head nurse are responsible for the overall quality control of the intervention process, while the graduate students are responsible for the preliminary and final screening of research objects, the implementation of intervention programs, the organization, coordination and recording of the entire intervention process and the collection of data.
Behavioral: auricular point sticking
1. Acupoint selection: Select Shenmen, spleen, stomach, liver, sympathetic, tongue, digestive system under the cortex, three focal, ear-back spleen. 2. Operation: Use 75% ethanol to disinfect auricular broad skin; To be dry, use tweezers to pick up the middle of the small square tape stuck with Wang do not line seeds, align the indentation and stick well, press gently with the finger abdomen, the strength to the patient feel acid swelling, pain and heat sense and can tolerate it. 3. Press frequency and course of treatment: it is asked to press 4 times a day, once in the morning, middle and evening before going to bed, 3-5 minutes each time, the duration of hospitalization for patients with chemotherapy is generally 3-5 days, intervention begins on the first day of chemotherapy medication, the day of discharge for patients to replace the other side of the ear acupoint, removed after 4 days of discharge. A total of 2 chemotherapy courses were treated.
Taste alterations
The Chinese version of the Chemotherapy-induced Taste Alteration Scale (CiTAS), was used to assess the patients' taste alterations. The scale has 18 items in three dimensions, namely taste alteration, unpleasant taste alteration, unpleasant symptoms and problems. The scale is a Like-5 scale with a minimum score of 18 and a maximum score of 90, with higher scores indicating more severe symptoms of taste alterations. The scale has been verified by research and has good reliability and validity.
Time frame: T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks.
Quality of life for cancer patients
With the use of the European Organization for Research on Treatment of Cancer, the most widely used guideline in clinical practice, The EORTC Quality of Life Core Questionnaire (QLQ-C30) was used to evaluate the quality of life of patients.A total of 30 items and 15 domains were included, including 5 functional domains, 9 symptom domains and 1 general health/quality of life domain. Among them, the general health status/quality of life domain was divided into 7 grades, which were calculated from 1 to 7 points according to the answer options. Other items were on a 4-point scale, and "never", "a little", "a lot" and "a lot" were scored from 1 to 4 respectively. The domain score was obtained by summing the item scores included in each domain and dividing by the number of items included, ranging from 0 to 100. A lower score indicates a better quality of life.
Time frame: T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks. T5:8 weeks.
Anxiety and depression
The Chinese version of Hospital Anxiety and Depression Scale (HADS) was used to assess the anxiety and depression level of patients. There were 14 items in total, including 7 items for anxiety and 7 items for depression. Each item was scored from 0 to 3, with a minimum score of 0 and a maximum score of 42, and the higher the score, the more serious the level of anxiety and depression.
Time frame: T1: Baseline. T2:2 weeks. T3:4 weeks. T4:5 weeks. T5:8 weeks.
Nutritional status 1
The nutritional status of patients was evaluated according to their weight.
Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Nutritional status 2
The nutritional status of patients was evaluated according to their BMI.BMI= weight (in kilograms) divided by the square of height (in meters). The standard of BMI for Chinese adult residents is about 18.4, less than or equal to 18.4 is thin, 18.5 to 23.9 is normal, 24 to 27.9 is overweight, and more than or equal to 28 is obese.
Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Nutritional status 3
The nutritional status of patients was evaluated according weight loss rate.
Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Nutritional status 4
The nutritional status of patients was evaluated according to their serum total protein and albumin index.
Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks.
Ran from Jun 2023 to primary completion in Sep 2023, 3 months.
Of 18 interventional studies with no phase under Dysgeusia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 16. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Affiliated Hospital of Jiangnan University