Auricular Acupressure for Adverse Events Following Immunization Related To COVID-19 Vaccine Injection: Study Protocol for a Multicenter, Three-Arm, Blinded Randomized Controlled Trial

Abstract Background Some pain, fatigue, and gastrointestinal adverse reactions were observed in potential association with injection of COVID-19 vaccines. However, there were no preventive intervention for it. We aim to investigate efficacy of auricular acupressure (AA) therapy in preventing and (or) relieving AEFI after injection of COVID-19 vaccine. Methods/design: The study design is a randomized controlled, multicentre, three-arm, single-blind trial. Participants meeting the inclusion criteria will be advertised and enrolled, and assigned randomly in the medical institutions for post-injection observation. No less than 360 participants will be randomized into one of three groups: auricular acupressure group, sham auricular acupressure group and wait-list group. Interventions will be performed immediately, and will happen 4 to 5 times per day for 5 days. The primary clinical outcomes will be quality and quantity evaluation among participants who reported any AEFI and who reported local pain at injection site. Secondary outcomes will concern headache, muscle and (or) joint pain, fatigue, nausea, vomiting, diarrhoea, and other potential events. All the outcomes will be assessed at baseline, 1, 3, 5, 7, and 14 days after the injection. Both intention-to-treat and per-protocol analyses will be performed, with significance level determined at the 5 % level. Discussion Results of this trial will help clarify the value of auricular acupressure therapy in preventing and (or) relieving overall and certain adverse events following immunization after injection of COVID-19 vaccine. Trial registration: This trial was registered in the China Clinical Trial Registry (ChiCTR) (ChiCTR2100043210) on 8th February, 2021.

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Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial

Trials ◽

10.1186/s13063-021-05837-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Qinwei Fu ◽

Hui Xie ◽

Li Zhou ◽

Xinrong Li ◽

Yang Liu ◽

...

Keyword(s):

Adverse Events ◽

Preventive Intervention ◽

Controlled Trial ◽

Clinical Trial Registry ◽

Significance Level ◽

Intention To Treat ◽

Medical Institutions ◽

Auricular Acupressure ◽

Potential Association ◽

Gastrointestinal Adverse Events

Abstract Background Some pain, fatigue, and gastrointestinal adverse events were observed in potential association with injection of COVID-19 vaccines, while there was no preventive intervention for it. We aim to investigate the efficacy of auricular acupressure (AA) therapy in preventing and relieving AEFI after injection of COVID-19 vaccine. Methods The study design is a randomized, multicentre, three-arm controlled, single-blind trial. Participants meeting the inclusion criteria will be advertised and enrolled and assigned in the medical institutions randomly for post-injection observation. No less than 360 participants will be randomized into one of three groups: auricular acupressure group, sham auricular acupressure group, and wait-list group. Interventions will be performed immediately and will happen 4 to 5 times per day for 5 days. The primary clinical outcomes will be quality and quantity evaluation among participants who reported any AEFI and who reported local pain at injection site. Secondary outcomes will concern headache, muscle and (or) joint pain, fatigue, nausea, vomiting, diarrhoea, and other potential events. All the outcomes will be assessed at baseline and 1, 3, 5, 7, and 14 days after the injection. Both intention-to-treat and per-protocol analyses will be performed, with significance level determined as 5%. Discussion Results of this trial will help to clarify the value of auricular acupressure therapy in preventing and relieving overall and certain adverse events following immunization after injection of COVID-19 vaccine. Trial registration China Clinical Trial Registry (ChiCTR) (ChiCTR2100043210). Registered on 8 February, 2021.

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Vonoprazan-Based Regimen Is More Useful than PPI-Based One as a First-LineHelicobacter pyloriEradication: A Randomized Controlled Trial

Canadian Journal of Gastroenterology and Hepatology ◽

10.1155/2017/4385161 ◽

2017 ◽

Vol 2017 ◽

pp. 1-7 ◽

Cited By ~ 17

Author(s):

Masafumi Maruyama ◽

Naoki Tanaka ◽

Daisuke Kubota ◽

Masayuki Miyajima ◽

Takefumi Kimura ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Eradication Rate ◽

Controlled Trial ◽

Eradication Therapy ◽

Group Versus ◽

Intention To Treat ◽

Randomized Controlled ◽

Primary Endpoints ◽

H Pylori

Background. A new agent, potassium-competitive acid blocker vonoprazan (VPZ) has potent acid-inhibitory effects and may offer advantages over conventionalH. pylorieradication therapies. We aimed to compare the eradication rate between VPZ-based treatment and PPI-based one.Methods. This randomized controlled trial was designed to assign 141 patients withH. pylori-positive gastritis to VPZ group (VPZ 20 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days) or PPI group (rabeprazole 20 mg or lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days). Primary endpoints were eradication rates and adverse events.Results. Seventy of 72 patients in VPZ group and 63 of 69 patients in PPI group completed the treatment after 7 days. The eradication rate was significantly higher in VPZ group than PPI group by intention-to-treat analysis (95.8% versus 69.6%,P=0.00003, 95% confidence interval [CI] 88.3-99.1% versus 57.3-80.1%) and per-protocol analysis (95.7% versus 71.4%,P=0.0002, 95% CI 88.0-99.1% versus 58.7-82.1%). The incidence of adverse events was not different between the groups (26.3% in VPZ group versus 37.7% in PPI group,P=0.15).Conclusion. VPZ-based regimen is more useful than that PPI-based regimen as a first-lineH. pylorieradication therapy.

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Comparing Effect of Auricular Acupressure and Body Acupressure on Pain and Duration of First Stage of Labor: Study Protocol for a Randomized Controlled Trial

10.21203/rs.1.20/v3 ◽

2019 ◽

Author(s):

Zainab Alimoradi ◽

farideh kazemi ◽

Mahboubeh Valiani ◽

Maryam Gorji

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Active Phase ◽

Routine Care ◽

Labor Pain ◽

Significance Level ◽

Randomized Controlled ◽

Auricular Acupressure ◽

Chi Squared ◽

First Stage Of Labor

Abstract Background labor pain is one of the leading causes for fear of childbirth. Acupressure is a non-pharmacological pain relief method which showed promising results. Comparing the effect of body acupressure at multiple points and auricular acupressure on the pain and duration of labor, the present study is designed. Methods/Design In a randomized controlled trial, 90 primigravida women who attend for childbirth would be randomly assigned to three groups (interventions: body acupressure and auricular acupressure, control: routine care). In order to determine the allocation sequence with 1:1:1 ratio, the computer-generated 6-block randomization techniques would be used. To hide the allocation, the type of intervention will be written based on the generated sequence and put in opaque enveloped pockets; then, the pockets as well as questionnaires are encoded respectively. The pain score of all the participants would be measured at the peak uterine contraction at the 4cm cervical dilation and at 10 cm dilation based on visual analog scale (VAS). Duration of the active phase of labor in these groups are recorded too. Data are imported into SPSS-16 software. First, normality of the data distribution will be investigated. To compare the labor duration among the research groups, ANOVA would be used, which will be followed, in case of significance, by the Scheffe post-hoc test. Furthermore, Chi-squared test would be used to compare the categorized demographic variables and ANOVA or Kruskal-Wallis tests will be used to compare the quantitative variables in the studied groups. significance level of 0.05 is considered significant. Discussion In this study the effect of auricular acupressure and body acupressure on pain and duration of first stage of labor will be compared. Trial registration number IRCT20180218038789N1 in 2018-03-04; pre result.

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Comparing Effect of Auricular Acupressure and Body Acupressure on Pain and Duration of First Stage of Labor: Study Protocol for a Randomized Controlled Trial

10.21203/rs.1.20/v4 ◽

2019 ◽

Author(s):

Zainab Alimoradi ◽

Farideh Kazemi ◽

Mahboubeh Valiani ◽

Maryam Gorji

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Active Phase ◽

Routine Care ◽

Labor Pain ◽

Significance Level ◽

Randomized Controlled ◽

Auricular Acupressure ◽

Chi Squared ◽

First Stage Of Labor

Abstract Background Labor pain is one of the leading causes for fear of childbirth. Acupressure is a non-pharmacological pain relief method which showed promising results. Comparing the effect of body acupressure at multiple points and auricular acupressure on the pain and duration of labor, the present study is designed. Methods/Design In a randomized controlled trial, 90 primigravida women who attend for childbirth would be randomly assigned to three groups (interventions: body acupressure and auricular acupressure, control: routine care). In order to determine the allocation sequence with 1:1:1 ratio, the computer-generated 6-block randomization techniques would be used. To hide the allocation, the type of intervention will be written based on the generated sequence and put in opaque enveloped pockets; then, the pockets as well as questionnaires are encoded respectively. The pain score of all the participants would be measured at the peak uterine contraction at the 4cm cervical dilation and at 10 cm dilation based on visual analog scale (VAS). Duration of the active phase of labor in these groups are recorded too. Data are imported into SPSS-16 software. First, normality of the data distribution will be investigated. To compare the labor duration among the research groups, ANOVA would be used, which will be followed, in case of significance, by the Scheffe post-hoc test. Furthermore, Chi-squared test would be used to compare the categorized demographic variables and ANOVA or Kruskal-Wallis tests will be used to compare the quantitative variables in the studied groups. significance level of 0.05 is considered significant. Discussion In this study the effect of auricular acupressure and body acupressure on pain and duration of first stage of labor will be compared.

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Comparing Effect of Auricular Acupressure and Body Acupressure on Pain and Duration of First Stage of Labor: Study Protocol for a Randomized Controlled Trial

10.21203/rs.1.20/v2 ◽

2019 ◽

Author(s):

Zainab Alimoradi ◽

farideh kazemi ◽

Mahboubeh Valiani ◽

Maryam Gorji

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Active Phase ◽

Routine Care ◽

Labor Pain ◽

Significance Level ◽

Randomized Controlled ◽

Auricular Acupressure ◽

Chi Squared ◽

First Stage Of Labor

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Comparing the effect of auricular acupressure and body acupressure on pain and duration of the first stage of labor: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3896-0 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Zainab Alimoradi ◽

Farideh Kazemi ◽

Mahboubeh Valiani ◽

Maryam Gorji

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Active Phase ◽

Routine Care ◽

Labor Pain ◽

Significance Level ◽

Randomized Controlled ◽

Auricular Acupressure ◽

Chi Squared ◽

First Stage Of Labor

Abstract Background Labor pain is one of the leading causes of fear of childbirth. Acupressure is a non-pharmacological pain relief method that has shown promising results in relieving this pain. The present study is designed to compare the effects of body acupressure at multiple points and auricular acupressure on the pain and duration of labor. Methods/design In a randomized controlled trial, 90 primigravida women who attend for childbirth will be randomly assigned to one of three groups (intervention groups of either body acupressure or auricular acupressure; control, consisting of routine care). Computer-generated six-block randomization techniques will be used to determine the allocation sequence with a 1:1:1 ratio. To hide the allocation, the type of intervention will be written according to the generated sequence and put in opaque envelopes; these as well as questionnaires will be encoded. The pain score for all participants will be measured at the peak uterine contraction at 4-cm cervical dilation and at 10-cm dilation based on a visual analog scale (VAS). The duration of the active phase of labor in these groups will be recorded too. Data will be imported into SPSS-16 software. First, normality of the data distribution will be investigated. To compare labor duration among the research groups, ANOVA will be used, which will be followed, in case of significance, by the Scheffe post hoc test. Furthermore, Chi-squared test will be used to compare the categorized demographic variables and ANOVA or Kruskal–Wallis tests will be used to compare the quantitative variables in the studied groups. A significance level of 0.05 is considered significant. Discussion In this study the effect of auricular acupressure and body acupressure on pain and duration of first stage of labor will be compared. Trial registration Iranian Registry of Clinical Trials, IRCT20180218038789N1. Registered 2018-03-04; pre result.

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Comparing Effect of Auricular Acupressure and Body Acupressure on Pain and Duration of First Stage of Labor: Study Protocol for a Randomized Controlled Trial

10.21203/rs.1.20/v1 ◽

2018 ◽

Author(s):

Zainab Alimoradi ◽

Farideh Kazemi ◽

Mahboubeh Valiani ◽

MSc Maryam Gorji

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Active Phase ◽

Routine Care ◽

Labor Pain ◽

Significance Level ◽

Randomized Controlled ◽

Auricular Acupressure ◽

Chi Squared ◽

First Stage Of Labor

Abstract Background: labor pain is one of the leading causes for fear of childbirth. Acupressure is a non-pharmacological pain relief method which showed promising results. Comparing the effect of body acupressure at multiple points and auricular acupressure on the pain and duration of labor, the present study is designed. Methods/Design: In a randomized controlled trial, 90 primigravida women who attend for childbirth, would be randomly assigned to three groups (interventions: body acupressure and auricular acupressure, control: routine care). In order to determine the allocation sequence with 1:1:1 ratio, the computer-generated 6-block randomization techniques would be used. To hide the allocation, the type of intervention will be written based on the generated sequence and put in opaque enveloped pockets; then, the pockets as well as questionnaires are encoded respectively. The pain score of all the participants would be measured at the peak uterine contraction at the 4cm cervical dilation and at 10 cm dilation based on visual analog scale (VAS). Duration of the active phase of labor in these groups are recorded too. Data are imported into SPSS-16 software. First, normality of the data distribution will be investigated. To compare the labor duration among the research groups, ANOVA would be used, which will be followed, in case of significance, by the Scheffe post-hoc test. Furthermore, Chi-squared test would be used to compare the categorized demographic variables and ANOVA or Kruskal-Wallis tests will be used to compare the quantitative variables in the studied groups. significance level of 0.05 is considered significant. Discussion: In this study the effect of auricular acupressure and body acupressure on pain and duration of first stage of labor will be compared.

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Faculty Opinions recommendation of Inhalational versus Intravenous Induction of Anesthesia in Children with a High Risk of Perioperative Respiratory Adverse Events: A Randomized Controlled Trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.732786749.793554105 ◽

2018 ◽

Author(s):

Yoshinori Nakata

Keyword(s):

Randomized Controlled Trial ◽

High Risk ◽

Adverse Events ◽

Controlled Trial ◽

Randomized Controlled

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The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

Journal of Reconstructive Microsurgery ◽

10.1055/s-0041-1724465 ◽

2021 ◽

Author(s):

Ronnie L. Shammas ◽

Caitlin E. Marks ◽

Gloria Broadwater ◽

Elliot Le ◽

Adam D. Glener ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Breast Reconstruction ◽

Controlled Trial ◽

Depression Scale ◽

Control Group ◽

Lavender Oil ◽

Entire Cohort ◽

Randomized Controlled ◽

Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

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Water exchange-assisted vs. carbon dioxide-insufflated single-balloon enteroscopy: randomized controlled trial

Endoscopy ◽

10.1055/a-1459-4571 ◽

2021 ◽

Author(s):

Shaopeng Liu ◽

Tao Dong ◽

Yupeng Shi ◽

Hui Luo ◽

Xianmin Xue ◽

...

Keyword(s):

Carbon Dioxide ◽

Randomized Controlled Trial ◽

Adverse Events ◽

Water Exchange ◽

Controlled Trial ◽

Control Group ◽

Balloon Enteroscopy ◽

Randomized Controlled ◽

Single Balloon ◽

Single Balloon Enteroscopy

Background and study aims Single-balloon enteroscopy (SBE) is a valuable but difficult modality for the diagnosis and treatment of small-bowel diseases. The water exchange (WE) method has the advantage of facilitating intubation during colonoscopy. Here, we evaluated the effects of WE on procedure-related variables related to SBE. Patients and methods This randomized controlled trial was conducted in a tertiary-care referral center in China. Patients with attempt at total enteroscopy (ATE) were randomly allocated to undergo WE-assisted (WE group) or carbon dioxide-insufflated enteroscopy (CO2 group). All patients were planned to undergo both antegrade and retrograde procedures. The primary outcome was the total enteroscopy rate (TER). Secondary outcomes included maximal insertion depth, positive findings, procedural time and adverse events. Results In total, 110 patients were enrolled, with 55 in each group. Baseline characteristics between the two groups were comparable. TER was achieved in 58.2% (32/55) of the WE group and 36.4% (20/55) of the control group (p=0.022). The estimated intubation depth was 521.2±101.4 cm in the WE group and 481.6±95.2 cm in the CO2 group (p=0.037). The insertion time was prolonged in the WE group compared with CO2 group (178.9±45.1 min vs. 154.2±27.6 min, p<0.001). Endoscopic findings and adverse events were comparable between the two groups. Conclusions The WE method improved TER and increased intubation depth during SBE. The use of WE did not increase complications of enteroscopy. Clinical trial registation: https://clinicaltrials.gov/， NCT01942863.

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