scholarly journals Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Na Nie ◽  
Le Chen ◽  
Tong Li ◽  
Chuanlong Zhou ◽  
Bangwei Li ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Control Group ◽  
Life Questionnaire ◽  
Comparative Effect ◽  
Clinical Trial Registry ◽  
Self Rating ◽  
And Control

Abstract Background: Headache attacks severely impaired life quality and increase economic burden of migraineurs. Electroacupuncture (EA) has been used world-widely to treat several pain-related diseases including migraine. However, whether EA with low- or high-frequency exerts distinct analgesic effect remains unknown and need to further study.Methods/Design: This study is a randomized, prospective randomized trial with three parallel arms. A total of 129 migraine outpatients will be randomly allocated to 2Hz EA group, 100Hz EA group and control group. Twelve treatment sessions will be performed over a four-week period. The primary outcome will be measured by frequency of migraine attacks at baseline, four-week of treatment and consecutive four-week follow-up. Secondary outcome measures will be number of days with migraine, frequency of taking ibuprofen, Visual Analogue Scale (VAS), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Migraine Specific Quality of Life questionnaire (MSQ), safety and compliance evaluation.Discussion: This trial is expected to comparative effect of electroacupuncture with different frequency on headache attacks in migraineur.Trial registration: Chinese Clinical Trial Registry, ChiCTR-1800017259.Registered on 20 July 2018.Registered on 20 July 2018.

Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo- controlled trial

2021 ◽  
Author(s):  
Na Nie ◽  
Le Chen ◽  
Tong Li ◽  
Chuanlong Zhou ◽  
Bangwei Li ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Control Group ◽  
Placebo Control ◽  
Life Questionnaire ◽  
Clinical Trial Registry ◽  
The Past ◽  
Self Rating ◽  
Post Randomisation

Abstract Background: Headache attacks severely impaired life quality and increase economic burden of migraineurs. Electroacupuncture (EA) has been used world-widely to treat several pain-related diseases including migraine. However, whether EA with low- or high-frequency exerts distinct analgesic effect remains unknown and need to further study. Methods/Design: This study is a randomised, single-blinded, placebo-controlled trial with three parallel arms. A total of 144 migraine outpatients will be randomly allocated to 2Hz EA group, 100Hz EA group and placebo control group. The duration of the trial is 20 weeks, including a 4-week long baseline assessment period (week-4-0), 4-week long treatment period (week 1-4), and 12-week long follow-up period (week 5-16). Twelve treatment sessions will be performed over a four-week period (week 1-4). The primary outcome will be measured by frequency of migraine attacks in the past 4 week at the end of week 4 post-randomisation. Secondary outcome will be measured by frequency of migraine attacks in the past 4 week at the end of week 8,12,16 post-randomisation, number of days with migraine, dosage of ibuprofen, the scores of Visual Analogue Scale (VAS), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Migraine Specific Quality of Life questionnaire (MSQ) in the past 4 week at the end of week 4, 8, 12, 16 post-randomisation. Safety assessment, compliance and blinding evaluation will be carried out at the end of week 16 post-randomisation. Discussion: The recruitment will be started at 1 June, 2021 and expected to finish at 31 May, 2023. We aimed to clarify the dominant frequency of EA on headache attacks in migraineur. Trial registration: Chinese Clinical Trial Registry, ChiCTR-1800017259. Registered on 20 July 2018.

scholarly journals Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Na Nie ◽  
Le Chen ◽  
Tong Li ◽  
Chuanlong Zhou ◽  
Bangwei Li ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Control Group ◽  
Placebo Control ◽  
Life Questionnaire ◽  
Clinical Trial Registry ◽  
The Past ◽  
Self Rating ◽  
Post Randomisation

Abstract Background Headache attacks severely impaired life quality and increase the economic burden of migraineurs. Electroacupuncture (EA) has been used worldwidely to treat several pain-related diseases including migraines. However, whether EA with low or high frequency exerts a distinct analgesic effect remains unknown and needs further study. Methods/Design This study is a randomised, single-blinded, placebo-controlled trial with three parallel arms. A total of 144 migraine outpatients will be randomly allocated to the 2 Hz EA group, 100 Hz EA group and placebo control group. The duration of the trial is 20 weeks, including a 4-week-long baseline assessment period (weeks − 4–0), a 4-week-long treatment period (weeks 1–4) and a 12-week-long follow-up period (weeks 5–16). Twelve treatment sessions will be performed over a 4-week period (weeks 1–4). The primary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of week 4 post-randomisation. The secondary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of weeks 8, 12 and16 post-randomisation; number of days with migraine; dosage of ibuprofen; the scores of visual analogue scale (VAS); Self-Rating Anxiety Scale (SAS); Self-Rating Depression Scale (SDS); and Migraine Specific Quality of Life questionnaire (MSQ) in the past 4 weeks at the end of weeks 4, 8, 12 and 16 post-randomisation. Safety assessment, compliance and blinding evaluation will be carried out at the end of week 16 post-randomisation. Discussion The recruitment will be started on 1 June 2021 and expected to finish on 31 May 2023. We aimed to clarify the dominant frequency of EA on headache attacks in a migraineur. Trial registration Chinese Clinical Trial Registry ChiCTR-1800017259. Registered on 20 July 2018. 

scholarly journals Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e032799 ◽  
Author(s):  
Titus Beyuo ◽  
Emma Lawrence ◽  
Elizabeth S Langen ◽  
Samuel A Oppong
Keyword(s):  
Randomised Controlled Trial ◽  
Health Outcomes ◽  
Magnesium Sulfate ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
University Of Michigan ◽  
Clinical Trial Registry ◽  
Randomised Controlled ◽  
Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

scholarly journals Effect of Exercise Program on Fatigue and Depression among Geriatric Patients Undergoing Hemodialysis

2019 ◽  
Vol 8 (2) ◽  
pp. 23
Author(s):  
Soad Hassan Abd Elhameed ◽  
Doaa El Sayed Fadila
Keyword(s):  
Geriatric Patients ◽  
Controlled Trial ◽  
Geriatric Depression Scale ◽  
Depression Scale ◽  
Exercise Program ◽  
Structured Interview ◽  
University Hospital ◽  
Control Group ◽  
Control Groups ◽  
And Control

Background: Fatigue is one of the foremost common complications faced the hemodialysis elderly patients. Fatigue not only impact the daily lives and activities of patients but it conjointly influences their quality of life, which can afterwards result in magnified depression, tiny social interactions and increase dependency on others.Aim: Determine the effect of exercise program on fatigue and depression among geriatric patients undergoing hemodialysis.Design: Randomized controlled trial (pretest post-test) design was used.Setting: The study was carried out in the dialysis units of Mansoura University Hospital and New Mansoura General Hospital.Subjects: A purposive sample of 62 geriatric patients undergoing hemodialysis was selected and randomly allocated into two equal groups, study group (n = 31) and control group (n =31).Tools: Three tools were used; Structured interview questionnaire sheet, Multidimensional Fatigue Inventory Scale and Geriatric Depression Scale Short Form.Results: The mean age of the study and control groups was 63.45±4.49 and 64.7±5.25 respectively. A high statistically significant change in fatigue and depression score (pre and post 2 months) between the study and the control groups was observed (P=0.000). Moreover, a statistically significant relation was observed between fatigue and age of the hemodialysis geriatric patients after implementation of the exercise program (P= 0.002).Conclusion: Implementation of the exercise program proved to be effective in improving the level of fatigue and depression among geriatric patients undergoing hemodialysis in the study group.Recommendation: Encourage geriatric patients undergoing hemodialysis to perform regularly range of motion and relaxation exercises in order to alleviate fatigue and overcome depression.  

Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma – a randomized controlled trial

2012 ◽  
Vol 27 (2) ◽  
pp. 133-141 ◽  
Author(s):  
Venkatesan Prem ◽  
Ramesh Chandra Sahoo ◽  
Prabha Adhikari
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Control Group ◽  
Life Questionnaire ◽  
Control Groups ◽  
Quality Of Life Questionnaire ◽  
Randomized Controlled ◽  
Questionnaire Score ◽  
And Control

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.

scholarly journals The Application and Research of Humanistic Care in Operation Room

2021 ◽  
Vol 2 (2) ◽  
Author(s):  
Yanjie Han
Keyword(s):  
Depression Scale ◽  
Nursing Intervention ◽  
Anxiety Scale ◽  
Control Group ◽  
Good Doctor ◽  
Operation Room ◽  
Self Rating ◽  
And Control ◽  
Experimental Group ◽  
Made In

Objective — To conduct studies on the application effect of humanistic care in the operation room. Methods — A total of 90 patients who received surgical treatment in our hospital from January 2021 to May 2021 were selected and divided into experimental group and control group based on the order of admission, with 45 patients in each group. The patients in the control group were treated with routine surgical nursing, and the patients in the experimental group were treated with humanistic care on the basis of routine surgical nursing. Comparison was made in the application effect of the two groups. Results — The scores of Self-Rating Depression Scale and Self-Rating Anxiety Scale in two groups demonstrated significant decreasing. The scores of the Self-Rating Depression Scale and Self-Rating Anxiety Scale were significantly reduced in the two groups after psychological nursing intervention. Conclusions — Effective humanistic care can not only contributes to the relief of anxiety or depression and other unhealthy emotions of patients, but also serves as an important way to maintain a good doctor-patient relationship. Humanistic care has certain application value in clinical applications.

scholarly journals Breast Microecology Improvement Using Probiotics Following Needle Aspiration in Patients With Lactational Breast Abscess: a Multi-center Randomized Double-blind Controlled Trial

2021 ◽  
Author(s):  
Yi Zhang ◽  
Yajun Gao ◽  
Jing Qin ◽  
Xiaoting Li ◽  
Fei Jiang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Reaction Rates ◽  
Needle Aspiration ◽  
Healing Time ◽  
Control Group ◽  
Cure Rate ◽  
Control Groups ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
And Control

Abstract Background: Studies show that oral probiotics can improve the breast microecology and thus alleviate the inflammatory response; however, there is a lack of experimental data corresponding to cases with existing abscesses. We aimed to investigate the effect of Lactobacillus fermentum CECT5716 during needle aspiration in patients with lactational breast abscesses.Methods: Patients (aged 20–41 years) with lactational single-cavity breast abscesses (diameter 3–6 cm) from 12 hospitals were randomly assigned to the experimental (n=51) and control groups (n=50). Outcome measures included the abscess cure rate on day-5 of treatment, delactation rate, relieving pain rate, and the number of needle aspirations until day-28.Results: The experimental group’s 5-day cure rate (43.1%, 22/51) was significantly higher (p<0.05). The breastfeeding continuation on day-5 did not differ significantly (experimental group: 88.2%, 45/51; control group: 96.0%, 48/50; p=0.269). In the experimental and control groups, 19.6% and 14.0% of patients experienced moderate to severe pain on day-5, respectively, with no statistically significant differences (p=0.451). The median number of needle aspirations up to day-28 was two in the experimental (1–3 times) and control (1–4 times) groups, with no statistically significant differences (Mann–Whitney U test, p=0.322). Four patients in each group developed diarrhea, with adverse reaction rates of 7.84% (4/51) and 8.0% (4/50), respectively. No adverse reactions were reported in the infants.Conclusion: L. fermentum can shorten the healing time in patients with lactational breast abscesses.Trial registration: This study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn), registration number: ChiCTR2000032682, registration date: May 6, 2020.

scholarly journals Efficacy of acetaminophen with and without oxycodone for analgesia in nonoperative treatment of extremity fractures in adults: Protocol for a double-blind randomized clinical trial

2019 ◽  
Author(s):  
Tao Gao ◽  
Hongyi Zhu ◽  
Changqing Zhang ◽  
Yimin Chai ◽  
Cheng Guo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Nonoperative Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Double Blind ◽  
Randomized Controlled ◽  
Limb Fracture ◽  
Self Rating ◽  
Limb Fractures

Abstract Background: Opioids and acetaminophen are both widely used to relieve pain after nonoperative treatment of limb fractures, but evidence for superiority of opioids versus acetaminophen is lacking. In this study we aim to determine whether acetaminophen is noninferior to the acetaminophen/oxycodone combination for pain relief after nonoperative fixation of an extremity limb fracture. We hypothesize that acetaminophen is noninferior to the acetaminophen/oxycodone combination. Methods: A double-blind, randomized controlled trial will be conducted. Power analysis determined that 1,226 participants will be needed (p<0.05, power 90%). Patients with acute limb fracture who receive nonoperative treatment will be recruited and randomly allocated into two groups: the intervention group will receive oral oxycodone (5 mg)/acetaminophen (325 mg), and the control group will receive acetaminophen (650 mg) only. The primary outcome measure will be scores on the 11-point Numeric Rating Scale (NRS-11) over 14 days. Secondary outcome measures are scores on the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), EuroQol five dimensions’ questionnaire (EQ-5d), self-rated satisfaction with the analgesia produced, self-reported nighttime sleep duration, number of intervention or control pills used, total duration for taking intervention or control medication. Change of pain scores and the number of times that analgesic drugs were taken in the two groups will be statistically evaluated with t-student tests according to their fracture site. Discussion: This study will be a randomized controlled trial that is adequately powered to test the hypothesis that acetaminophen is noninferior to the combination of acetaminophen and oxycodone in relieving objectively measured pain after nonoperative treatment of limb fractures in adults. It is hopeful to provide a safe and effective analgesic plan for such patients. Trial Registration: ChiCTR registry: ChiCTR1800017015 ( http://www.chictr.org.cn/showproj.aspx?proj=28612). Registered on 8 July 2018. Keywords: Opioids, acetaminophen, fracture, nonoperative treatment.

scholarly journals Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial

2021 ◽  
Vol 20 ◽  
pp. 153473542110586
Author(s):  
Jialing Zhang ◽  
Mingxiao Yang ◽  
Tsz Him So ◽  
Tien Yee Chang ◽  
Zongshi Qin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Short Form ◽  
Controlled Trial ◽  
Depression Scale ◽  
Acupuncture Group ◽  
Sleep Diary ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Auricular Acupressure

Objective Insomnia is a highly prevalent and disturbing symptom in breast cancer patients under or post chemotherapy. If not appropriately treated, it can persist for years after the completion of cancer treatments. Acupuncture has been widely used for alleviating insomnia. The aim of this study is to examine the feasibility, efficacy and safety of acupuncture for chemotherapy-related insomnia among patients with breast cancer. Materials and Methods This is a trial protocol for a randomized, sham-controlled, subject- and assessor-blinded clinical trial. A total of 138 eligible participants will be assigned randomly to acupuncture or sham control group at a ratio of 1:1. Participants in acupuncture group will receive electroacupuncture (EA) plus auricular acupressure (AA) treatment, while subjects in sham acupuncture group will receive sham EA plus sham AA. Both acupuncture and sham treatments will be given twice weekly for 6 weeks, followed by maintenance treatments once every 4 weeks for 12 weeks (15 sessions totally). The primary outcome is the change of Insomnia Severity Index score between baseline and the end of 6-week treatment. Secondary outcome measurements include Actiwatch, sleep diary, Pittsburgh Sleep Quality Index, Functional Assessment of Cancer Therapy-Breast Cancer, Hospital Anxiety and Depression Scale, Brief Pain Inventory-Short Form, Brief Fatigue Inventory, Acupuncture Expectancy Scale, credibility, and adverse events. Participants will be followed up to 42 weeks. Conclusions This trial will expand our understanding of the feasibility, efficacy, and safety of acupuncture as a treatment for alleviating chemotherapy-related insomnia in patients with breast cancer. EA plus AA, if proven to be effective, can be implemented into routine settings to play a role in insomnia management for patients with breast cancer.

scholarly journals Effect of acupuncture on insomnia in menopausal women: A Study protocol for a Randomized Controlled Trial

2018 ◽  
Author(s):  
Shanshan Li ◽  
Ping Yin ◽  
Xuan Yin ◽  
Anna Bogachko ◽  
Tingting Liang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Depression Scale ◽  
Menopausal Transition ◽  
Syndrome Differentiation ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Rating ◽  
Menopausal Women

Abstract Background: China today has high occurrences of insomnia in perimenopausal women. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials to provide evidence regarding their effectiveness. We design a randomized controlled trial of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method/Design: In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in a 1:1 ratio. Participants will receive a total of 18 sessions of treatment for eight consecutive weeks. Treatments will be given three times per week in the first four weeks, twice a week for the next two weeks and finally treatment once weekly for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22), and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, week four, week eight, and first and the third month following the end of treatment. Discussion: If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, this positive outcome could provide evidence for clinical application.

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