Objectives of Study:
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To investigate whether traditional Chinese medicine auricular point acupressure can alleviate and (or) reduce the pain (including injection site pain, headache, other muscle and joint pain), fatigue, and gastrointestinal adverse reactions (including nausea, vomiting, diarrhea), and the degree of the alleviation, after the injection of novel coronavirus-19 vaccines.
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Description for medicine or protocol of treatment in detail:
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1.Traditional Chinese medicine auricular point plasters
The "Ziyu" brand auricular point sticking plasters will be used in both auricular point acupressure group and sham auricular point acupressure group with a small spherical vaccaria seeds in center of plasters. The seeds are black, circular shape, minimal, and did not leave any smell. It is produced by Hebei Heshi medical device Co., Ltd., batch number: Q / HHS 01-2016, validity: 3 years.
2.Traditional Chinese medicine auricular points selection
(1)Auricular point acupressure group: Before the beginning of the clinical trial, the auricular points were selected according to the international standard auricular point guidelines, expert consensus and possible adverse reactions after the injection of coronavirus-19 vaccines, which have been found in previous clinical studies. The selected auricular acupoints were marked on the diagram of auricular acupoints, including (bilateral):
Shenmen (TF4), Spleen (CO13), Heart (CO15), Subcortex (AT4), Sympathesis (AH6a)
(2)Sham auricular point acupressure group: Before the beginning of the clinical trial, the auricular points were selected according to the international standard auricular point guidelines, expert consensus, which are not related to the possible adverse reactions after the injection of coronavirus-19 vaccines according to previous clinical studies. The selected auricular acupoints were marked on the diagram of auricular acupoints, including (bilateral):
Anus (HX5), Urethra (HX3), Helix 1 (HX9), Helix 2 (HX10), Helix 3 (Hx11)
(3)Blank control group: No intervention after the injection of coronavirus-19 vaccines, and the participants will be followed up at the same time as the two groups.
3.Operation method of traditional Chinese medicine auricular point plasters sticking and acupressure
Researchers will apply auricular point plaster sticking according to the marked the diagram of auricular acupoints. First of all, 75% medical disinfectant alcohol was dipped with a sterile cotton swab to wipe the place where plasters were to be pasted on the auricular points of participants, and dry the points with a dry sterile cotton swab. Then use medical tweezers to clip the auricular point plasters, stick it on the auricular point gently, and press it with a little force.
auricular point acupressure group and sham auricular point acupressure group will be sticked twice. The first time will be after the injection of coronavirus-19 vaccines immediately, and the second time will be after the second injection of coronavirus-19 vaccines again immediately.
After pasting, the subjects will be asked to press their auricular point plasters 3-4 times a day, about 1 minute each time. The retention time of each auricular point plaster sticking is 5 days. No intervention after the injection of coronavirus-19 vaccines, and the participants will be followed up at the same time as the two groups.
4.Other precautions
(1)After receiving the auricular points plasters sticking, the subjects will be instructed to press the place of plasters sticking symmetrically and gently, but not to rub or use too much force. They will be told to pay attention to prevent the plasters from being wet or contaminated, so as not to cause skin inflammation.
(2)In case of severe pain or local adhesive allergy, subjects will be told to tear off the auricular points plasters immediately and gently, report in time, pay attention to it and handle as appropriate.
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Exclusion criteria:
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1. Those who are not suitable to be vaccinated because they belong to the contraindication or cautious population;
2. Those who have participated in other clinical trials within 4 weeks before the start of this study;
3. Headache occurred more than 3 times in the past week, and the degree of pain affected daily life; Or the subjects reported the following headache diseases: such as primary headache (migraine, tension headache, cervicogenic headache), and other diseases leading to secondary headache; Or the subjects had a long-term history of chronic headache (> 3 months), but the diagnosis was not clear or the cause was unknown;
4. Muscle or joint pain in other parts of the body occurred more than 3 times in the past week, and the degree of pain had an impact on daily life; Or the subjects reported the existing muscle or joint pain diseases, such as periarthritis of shoulder, tendinitis, rotator cuff injury, tenosynovitis, tenosynovitis, muscle or joint injury, rheumatoid arthritis or rheumatoid arthritis pain, and muscle with pain; Or the patients had a long history of chronic muscle or joint pain (> 3 months), but the diagnosis was not clear or the cause was unknown;
5. There were more than 3 times of unexplained obvious fatigue in the past week, and the degree of fatigue had an impact on daily life; Or the subjects reported the following fatigue related diseases: malignant tumor (cancer), hypotension, chronic fatigue syndrome, anemia, pulmonary heart disease, chronic obstructive pulmonary disease, cold, hypothyroidism, hypoglycemia, heart failure, diabetes, etc.; Or subjects with a long-term history of fatigue (> 3 months), but no clear diagnosis or unknown cause;
6. There were more than 3 times of unexplained diarrhea in the past week, which affected daily life; Or the subjects reported the following diarrhea related diseases: enteritis, hyperthyroidism, diabetes, gastrointestinal cancer, Crohn's disease, intestinal tuberculosis, intestinal fungal infection, chronic bacillary dysentery, etc.; Or the subjects had a long history of diarrhea (> 3 weeks), but the diagnosis was not clear or the cause was unknown;
7. Nausea, retching or vomiting of unknown cause occurred for more than 4 times in the past week, which affected daily life; Or the subjects reported the following nausea, retching or vomiting related diseases: such as Meniere's syndrome, vestibular neuritis, gastritis, enteritis, gastroesophageal reflux disease, intestinal obstruction, intussusception, motion sickness, hyperthyroidism, gastrointestinal cancer, etc.; Or the subjects had Long term history of nausea, retching or vomiting (> 1 month), but no definite diagnosis or unknown cause;
8. Those who are in use or have received traditional Chinese medicine auricular point plasters sticking and acupressure within 2 weeks before the trial;
9. Pregnant or lactating women;
10. Patients with other serious primary diseases and psychosis.
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