Traditional Chinese medicine auricular point acupressure for the relief of pain, fatigue, and gastrointestinal adverse reactions after the injection of novel coronavirus-19 vaccines: a structured summary of a study protocol for a multicentre, three-arm, single-blind, prospective randomized controlled trial.
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ABSTRACT:
SUBMITTER: Fu Q
PROVIDER: S-EPMC7905419 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
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Traditional Chinese medicine auricular point acupressure for the relief of pain, fatigue, and gastrointestinal adverse reactions after the injection of novel coronavirus-19 vaccines: a structured summary of a study protocol for a multicentre, three-arm, single-blind, prospective randomized controlled trial.
Fu Qinwei Q Xie Hui H Zhou Li L Li Xinrong X Liu Yang Y Liu Min M Wang Chaoyu C Wang Xiaocen X Wang Zhiqiao Z Tang Jinfan J Xiao Huan H Xiao Zhiyong Z Zhou Jing J Feng Chengzhi C Wang Li L Ao Zhimin Z Chen Xi X Su Chang C Wu Xuanyu X Zhao Maolan M Hu Sihan S Lin Hanwen H Huang Jiali J Xu Guo G Zhang Qinxiu Q Jiang Luyun L
Trials 20210225 1
<h4>Objectives</h4>To investigate if traditional Chinese medicine (TCM) auricular point acupressure (APA) 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), after the injection of novel coronavirus-19 vaccines (NCVs).<h4>Trial design</h4>The study is designed as a multicentre, parallel-group, three-arm, single-blind, prospective, randomized (1:1:1 ra ...[more]
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Project description:BackgroundSome adverse events following immunization (AEFI) were observed in potential corelation with COVID-19 vaccination but without prevention or ongoing trial for it. We aimed to investigate efficacy of auricular acupressure (AuriAc) therapy in preventing AEFI after first dosage of the vaccine.MethodsWe performed a multicentre randomized controlled trial with three arms, including AuriAc, SAuriAc (sham auricular acupressure), and TrAsU (treatment as usual) group, carried out in four medical institutions in Chengdu, China, from March 17th to April 23rd, 2021. We enrolled participants based on eligibility criteria and randomized them into three groups: AuriAc (AEFI-specific auricular points applied, n = 52), SAuriAc (n = 51) or TrAsU (n = 44) group. Primary outcomes were percentages of any AEFI and local pain, and secondary outcomes were percentages who reported other AEFI. They were followed at 1, 3, 5, 7, and 14 days, by phone or online, with severity evaluated.Results147 participants (73.47% females) were included with median age as 31 years (25-45, IQR). One day after the injection, participants in AuriAc group reported significant reduction on percentages of any AEFI [intention-to-treat, difference of percentage (DP) = -20.13, 95%CI: - 0.39, - 0.02, p = 0.01; per-protocol, DP = -22.21, 95%CI: - 0.40, - 0.03, P = 0.02] and local pain (per-protocol, DP = -18.40, 95%CI: -0.36, -0.01, P = 0.04), compared with TrAsU group. The effects were slight at other follow-up days and for other outcomes, and with a low percentage of mild local allergic reactions.ConclusionsWe firstly explored potential of AuriAc for preventing AEFI related to COVID-19 vaccine injection, which is beneficial for the vaccine recipients, but evidence is limited.Trial registrationchictr.org.cn no. ChiCTR2100043210 (http://www.chictr.org.cn/showproj.aspx?proj=121519).
| S-EPMC9650252 | biostudies-literature
Project description:PurposeThe study aimed to (1) examine the feasibility of providing a training course on auricular point acupressure (APA) for clinical oncology nurses to integrate APA into real-world nursing care settings, and (2) examine the effectiveness of APA on cancer-related pain (CRP) under usual inpatient oncology ward conditions.MethodsThis was a 2-phase feasibility study. Phase 1, an in-person, 8 hour training program was provided to oncology nurses. Phase 2, a prospective and feasibility study was conducted to evaluate the integration of APA into nursing care activities to manage CRP. Oncology patients were included if their pain was rated at ≥4 on a 0 to 10 numeric rating scale in the past 24 hours. Patients received 1 APA treatment administered by the nurses and were instructed to stimulate the points for 3 days. Study outcomes (pain intensity, fatigue, and sleep disturbance), pain medication use, and APA practice were measured by a phone survey daily.ResultsTen oncology nurses received APA training in phase 1. APA had been added to the hospital's electronic health records (EHRs) as a pain treatment. In phase 2, 33 oncology patients received APA treatment with a 100% adherence rate (pressing the seeds 3 times per day, 3 minutes per time based on the suggestion). The side effects of APA were minimal (~8%-12% felt tenderness on the ear). After 3 days of APA, patients reported 38% pain relief, 39% less fatigue, and 45% improvement in sleep disturbance; 24% reduced any type of pain medication use and 19% reduced opioid use (10 mg opioids using milligram morphine equivalent). The major barrier to integrating APA into routine nursing practice was time management (how to include APA in a daily workflow).ConclusionIt is feasible to provide 8-hour training to oncology nurses for mastering APA skill and then integrating APA into their daily nursing care for patients with CRP. Based on the promising findings (decreased pain, improved fatigue and sleep disturbance, and less opioid use), the next step is to conduct a randomized clinical trial with a larger sample to confirm the efficacy of APA for oncology nurses to treat CRP in real-world practice.ClinicalTrial.gov identifier number: NCT04040140.
| S-EPMC10503282 | biostudies-literature
Project description: Not available
| S-EPMC10613998 | biostudies-literature
Project description:BackgroundPostpartum subinvolution of the uterus is a more common condition after cesarean section. Auricular acupressure (AA) is widely used for the treatment of postpartum diseases. However, few studies have explored the effects of AA as a treatment of uterine involution following cesarean section to date. This study aimed to assess the efficacy and safety of AA for uterine involution after cesarean section.MethodsA total of 109 women who underwent cesarean section participated in this study. They were randomly allocated to either real AA or sham AA in a 1:1 ratio by a computer program. For 3 days, the real AA and sham AA groups received treatment 3 times daily. A series of assessments at 42 days after cesarean section, namely on the uterine size, the incidence of hydrometra, the first anal exsufflation time, bleeding volume at 6 hours, bleeding volume at 6-24 hours along with other general assessments were carried out.ResultsA total of 89 women completed the study. The uterine size at 42 days after a cesarean section was 6.3 cm smaller in the real AA group than in the sham AA group (P < 0.01). The incidence of hydrometra on day 42 postpartum was lower in the real AA group than in the sham AA group (P < 0.01). The lochia duration and the first anal exsufflation time after cesarean section were shorter in the real AA group than in the sham AA group (P < 0.05).ConclusionAA improves uterine involution after cesarean section.Trial registrationChiCTR1800015569.
| S-EPMC8144667 | biostudies-literature
Project description:Tobacco smoking is still a worldwide health risk. Current pharmacotherapies have at best, a success rate of no more than 50%. Auricular (ear) acupressure has been purported to be beneficial in achieving smoking cessation in some studies, while in others has been deemed insignificant. We hereby describe the protocol for a three-arm randomised controlled trial to examine the possible benefits of self-administered acupressure for smoking cessation.Sixty consenting participants with confirmed habit of tobacco smoking will be recruited and randomized into three arms to receive either auricular acupressure at five true acupoints (NADA protocol), auricular acupressure at five sham points, or no auricular acupressure at all. Participants having auricular acupressure will exert firm pressure to each acupoint bilaterally via the bead in the attached plasters whenever they feel the urge to smoke. The treatment phase will last for six weeks during which all participants will be assessed weekly to review their smoking log, state of abstinence, end-exhalation carbon monoxide levels and possible adverse effects including withdrawal reactions and stress levels. At any time, a successful quit date will be defined with continuous abstinence for the following consecutive 7 days. From then on, participants will be evaluated individually for continuous abstinence rate (CAR), end-exhalation carbon monoxide levels and adverse effects of stress and withdrawal at specified intervals up to 26 weeks. Expectancy of treatment will be assessed with a four-item Borkovec and Nau self-assessment credibility scale during and after intervention.We incorporate validated outcome measures of smoking cessation into our randomised controlled trial design with the objectives to evaluate the feasibility and possible benefits of self-administered auricular acupressure as a non-invasive alternative to pharmacotherapy for smoking cessation.ClinicalTrials.gov: NCT01389622 (registered Jul 7 2011).
| S-EPMC3328240 | biostudies-literature
Project description:BackgroundDrug-dependent insomnia refers to insomnia patients taking sedatives and sleeping pills regularly for a long period. Auricular acupressure (AA) has attracted growing attention as a complementary treatment for insomnia. Nevertheless, there is a lack of rigorous studies evaluating AA specifically for estazolam-dependent insomnia. Our proposed trial aims to assess the therapeutic effect of AA on estazolam-dependent insomnia.MethodsThis study is a randomized, single-blinded, three-arm controlled trial. No less than 108 participants will be randomized into one of three groups: AA group, sham auricular acupressure (SAA) group, and conventional dosage reduction group. All treatments will be administered for 4 weeks, with a follow-up period of 1 month. The primary clinical outcomes will be estazolam dosing and reduction rates, serum gamma-aminobutyric acid (GABA) and cortisol (CORT) levels. Secondary outcomes will concern the Pittsburgh sleep quality index (PSQI) and Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ). Both intention-to-treat and per-protocol analyses will be performed, with the significance level determined as 5%.DiscussionThe study results will provide evidence on the efficacy and safety of AA in managing estazolam-dependent insomnia by analyzing its immediate effect, time-effect relationship, and reduction of estazolam use.Trial registrationClinicaltrials.gov (identification number: NCT06258226; Registered 5 February 2024, https://clinicaltrials.gov/ct2/show/NCT06258226 ).
| S-EPMC11471019 | biostudies-literature
Project description:BackgroundAuricular acupressure has been used for treating obesity, but inconsistent outcomes have been reported. Moreover, systematic reviews and meta-analyses have seldom addressed the effects of auricular acupressure and duration of treatment in overweight/obese individuals. This study reviewed research articles on auricular acupressure for weight reduction, analyzed the related effects on obesity, and explored the relationships between weight reduction and treatment duration, as well as outcome variables.MethodsWe searched PubMed, Cochrane Library, CINAHL, MEDLINE with Full Text, National Digital Library of Theses and Dissertation in Taiwan, and Airiti Library for articles up to July 4, 2018. Eight eligible trials were identified for qualitative synthesis, and one of them was excluded from quantitative synthesis. Inclusion criteria were as follows: intervention contained auricular acupressure, study subjects were overweight and/or obese, as defined by published authors, and the study design had 2 or more arms for comparison.ResultsPooled analysis of the 7 remaining studies revealed that auricular acupressure alone, or with diet and/or exercise, was effective for weight reduction, particularly for decreasing body weight (BW), body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), body fat mass (BFM), and body fat percentage (BFP), compared with no treatment, sham treatment, or use of surgical tape with diet and/or exercise. However, there was no effect on hip circumference. A 12-week acupressure intervention was associated with a larger effect on lowering BW and BMI compared with 4-, 6-, and 8-week interventions. The methodologic quality of trials included in the quantitative synthesis ranged from scores 2 to 6 based on the modified Jadad scale. Additionally, this meta-analysis combined studies that used different acupoints and outcomes evaluated at different timepoints, which may have been potential sources of bias.ConclusionThe study results indicate that auricular acupressure is effective for weight reduction. However, further vigorous studies that use double-blind randomized controlled design are needed to verify these findings. WC, WHR, BFP, or BFM should be used as obesity-related parameters in weight reduction studies to detect changes in fat, muscle, and skeletal weight.
| S-EPMC6617497 | biostudies-literature
Project description:ObjectiveA systematic review of evaluating the clinical effects of auricular acupressure on patients with depression.MethodsA comprehensive literature search was conducted in various electronic databases including PubMed, Web of Science, Cochrane Library, Google Scholar, CNKI, Wanfang, Embase, and VIP. The search time limit was from the establishment of the database to December, 2023. The included results were integrated and analyzed, and ReviewManager 5.4 was used for meta-analysis.ResultsA total of 13 studies with a total of 504 depression patients were included. Compared with the control group, auricular acupressure showed a significant reduction in depression scores, as reflected in the Hamilton Depression Scale (standardized mean difference [SMD] = -1.50, 95% confidence interval [CI]: -2.25~-0.75); risk rate [RR] = 1.96, 95% CI: 0.66~5.82), Self-Rating Depression Scale (SMD = -0.91, 95% CI: -1.15~-0.67), and Patient Health Questionnaire scores (SMD = -0.94, 95% CI: -1.46~-0.41; all p < 0.01).ConclusionsThe meta-analysis suggested that auricular acupoint therapy is safe and effective in treating depression, and can reduce Hamilton Depression Scale (HAMD) and Pittsburgh Sleep Quality Index (PSQI) scores. There were no obvious adverse reactions. This therapy could therefore be used as a complementary therapeutic approach for patients with depression.
| S-EPMC11915715 | biostudies-literature
Project description:BackgroundPatients on maintenance hemodialysis (MHD) frequently complain of insomnia. Poor sleep quality impairs their quality of life and adversely affects long-term outcome. Previously we applied auricular acupressure therapy (AAT) for MHD patients with insomnia and yielded favorable results. AAT probably improves sleep quality by stimulating the vagus nerve and inhibiting sympathetic overactivity. However, the efficacy of AAT for insomnia in this population is still lacking. The proposed randomized controlled trial (RCT) will evaluate the efficacy and safety of AAT for improvement of sleep quality in MHD patients with insomnia.Methods/designThe proposed study is a multi-center, double-blind (participants and assessors), parallel-group RCT. A total of 112 participants with insomnia will be recruited from six hemodialysis centers in Guangzhou, China, and randomly allocated in a 1:1 ratio to receive auricular acupressure on either active points (AA group) or control points (points irrelevant to insomnia management, SAA group). The treatment will last for 8 weeks prior to a follow-up period of 12 weeks. Evaluation by blinded assessors at baseline, at 8 weeks (end of treatment) as well as at 4-week, 8-week and 12-week follow-ups (after intervention) will include Pittsburgh Sleep Quality Index (PSQI) scores and average weekly dose of hypnotics. The primary endpoint is clinical response rate (percentage of participants who reach a reduction of PSQI global score ≥ 3 in each group) at 8 weeks from baseline. Secondary endpoints include the changes in PSQI scores over time from baseline, as well as the changes in weekly dose of hypnotics.DiscussionThis paper describes the rationale and design of a double-blind RCT that aims to determine the efficacy and safety of AAT for insomnia of hemodialysis patients. If successful, this project will provide evidence of the efficacy and safety of AAT for insomnia of hemodialysis patients.Trial registrationClinicalTrials.gov , Identifier: NCT03015766 . Registered on 22 December 2016.
| S-EPMC5842538 | biostudies-literature
Project description:ContextComplementary therapies are frequently used by breast cancer patients for symptom management; however, documentation of the components of intervention fidelity for studies is not widely available.ObjectiveThis report examines the components of intervention fidelity, as put forth by the Treatment Fidelity Workgroup of the Behavior Change Consortium at the National Institutes for Health (NIH-BCC Workgroup), within an ongoing acupressure study of breast cancer survivors with persistent cancer-related fatigue (PCRF).DesignFor the acupressure study, the research team designed a randomized, controlled trial (RCT) with 3 parallel groups: (1) stimulating acupressure (intervention group); (2) relaxing acupressure (intervention group); and (3) standard care (control group).SettingAt baseline and at wk 3 and wk 6 of the study, women in the acupressure study attended sessions for training and data collection at clinics in the counties of Michigan where they lived. The self-administration of acupressure occurred in participants' homes.ParticipantsTargeted enrollment for the acupressure study is 300 breast cancer survivors who had experienced moderate-to-severe PCRF lasting longer than 1 y beyond treatment. The women are being recruited from 5 counties in Michigan, using the Michigan Tumor Registry to identify potential participants. The subsample report includes 183 participants who have completed all 10 wk of the acupressure study. Most participants in the acupressure study are Caucasian, are married, and have some college education.InterventionThe acupressure study's educators teach participants in the intervention groups to self-administer either relaxing or stimulating acupressure for a 30-min period on a daily basis for 6 wk. All 3 groups receive the usual care for breast cancer survivors.Outcome measuresFor the acupressure study, the participants log the frequency of the self-administered acupressure sessions and their fatigue levels. Symptom assessments are made for all groups by telephone in the acupressure study at wk 2 through wk 5 to assess fatigue. A competency checklist is used at each session of training and retraining of both acupressure educators and participants. For this report, the 5 recommended fidelity components for interventions are (1) dose, (2) training, (3) intervention delivery, (4) intervention receipt, and (5) enactment of the intervention.ResultsThe ongoing RCT incorporated all 5 components of fidelity and can serve as a model for future work in this area.ConclusionsResearch protocols that address intervention fidelity can provide results that support internal and external validity. Clinicians should consider recommending complementary interventions that have incorporated fidelity components into their efficacy testing.
| S-EPMC7841851 | biostudies-literature