scholarly journals Immediate effect of an acupressure strap simulating wrist-ankle acupuncture on menstrual pain in young women: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Shu-jie Zhai ◽  
Yi Ruan ◽  
Yue Liu ◽  
Zhen Lin ◽  
Chen Xia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Analgesic Effect ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Pain Intensity Score ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled

Abstract Background: Dysmenorrhea seriously affects the ability to perform normal social activities and decreases quality of life. Primary dysmenorrhea can be effectively treated with acupuncture. Based on the wrist-ankle acupuncture (WAA) theory, we designed a portable WAA point compression treatment strap that treats diseases by automatically applying pressure to acupuncture points. The proposed study aims to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. Methods: The study will be a randomized controlled trial conducted from 1 May 2019 30 May 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria. Participants will be randomly divided into two groups in a 1:1 allocation ratio. The intervention group will use the acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the non-acupressure wrist-ankle strap with the tip compression parts removed. All participants will be treated for 30 min on the first day of menstruation. The main outcome measures are the pain intensity score measured by the visual analogue scale, and the onset time of analgesia. The secondary outcome measures are the pain threshold at Yinlingquan (SP 9) , skin temperature at Guanyuan (CV 4) , and expectations and satisfaction of patients as investigated via the Expectation and Treatment Credibility Scale. Discussion: This trial will be the first study to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. The quality of this study is ensured by the strict randomization, non-acupressure control, and blinded design. The results may provide a potential alternative treatment for primary dysmenorrhea and evidence-based proof of the analgesic effect of WAA. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1900021727. Registered on 7 March 2019. http://www.chictr.org.cn/listbycreater.aspx

scholarly journals Effect of posterior quadratus lumborum blockade on the quality of recovery after major gynaecological laparoscopic surgery: A randomized controlled trial

2019 ◽  
Vol 47 (2) ◽  
pp. 146-151 ◽  
Author(s):  
Hiroko Fujimoto ◽  
Tomoya Irie ◽  
Takahiro Mihara ◽  
Yusuke Mizuno ◽  
Takeshi Nomura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Laparoscopic Surgery ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Quality Of Recovery ◽  
Randomized Controlled ◽  
Quadratus Lumborum

Bilateral quadratus lumborum blockade (QLB) using ultrasound guidance has been introduced as an abdominal truncal block to improve postoperative analgesia and quality of recovery (QoR) after abdominal surgery, but efficacy remains controversial. The primary aim of this study was to evaluate the efficacy of posterior QLB on the postoperative QoR, and secondarily to evaluate postoperative pain after gynaecological laparoscopic surgery (LS). This study was a single-centre randomized controlled trial. QLB group patients underwent bilateral posterior quadratus lumborum injections with 25–30 mL of 0.25% levobupivacaine after induction of general anaesthesia; the control group underwent no block. Both groups were administered fentanyl-based intravenous patient-controlled analgesia postoperatively. The postoperative QoR was measured using the Quality of Recovery 40 (QoR-40) questionnaire score; postoperative pain was evaluated using the visual analogue scale (VAS) and the cumulative postoperative fentanyl dose. Thirty-one and 29 patients were randomised to the QLB and control groups, respectively. The intraoperative remifentanil dosage was significantly less in the QLB group. The median (interquartile range) for the QoR-40 score was not different between the groups: 154 (133–168) in the QLB group and 158 (144–172) in the control group. There were no statistically significant differences in secondary outcome variables. Single-shot QLB did not improve the QoR or postoperative pain in patients managed by multimodal analgesia after gynaecological LS.

scholarly journals Acupuncture for osteoporosis: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
M Huang ◽  
MX Lai ◽  
XY Wang ◽  
YF Wang ◽  
J Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Primary Osteoporosis ◽  
Randomized Controlled ◽  
Acupuncture And Moxibustion ◽  
One Year ◽  
Experimental Group

Abstract Background: The rapid increase in the prevalence of osteoporosis and the rate of fractures after osteoporosis indicates that osteoporosis has become a serious global public health problem. A recent meta-analysis showed that oral alendronate and parenteral injection of zoledronate had no statistical significance in preventing postmenopausal hip fractures. Acupuncture and moxibustion are widely used in the treatment of osteoporosis due to their good analgesic effects. Early observation showed that integral adjustment of acupuncture and moxibustion therapy could improve the quality of life of patients with osteoporosis and prevent the occurrence of osteoporosis fractures. As the observation period of fracture is too long, it is necessary to carry out a large and strictly designed multi-center randomized trial covering the risk factors of fracture and fracture induction, so as to evaluate the effectiveness of acupuncture and moxibustion in the treatment of primary osteoporosis.Methods/Design: A multicenter randomized controlled trial will be performed in three hospitals. 312 participants patients within primary osteoporosis will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture and western medicine while the control group is treated with Western medicine. All the patients will receive a 3-month treatment and 6-month,and one year follow-ups. The primary outcome is the bone mineral density (BMD), the secondary outcome is Bone-derived alkaline phosphatase(BALP), bone glaprotein(BGP), visual pain scale score(VAS),Traditional Chinese Medicine (TCM) syndrome scores, quality of daily life score(QOL) and adverse events. Outcome measures (including primary and secondary outcome measures) are collected at baseline,3 months of the intervention, Causes and number of falls are collected at 6 months and one year after the intervention.Discussion: This study will provide clinical evidence for the treatment of primary osteoporosis with holistic adjustment acupuncture. This study will evaluate the synergistic effect of acupuncture treatment for primary osteoporosis and provide evidence for clinical treatment.Trial registration: This trial was registed at Chinese Clinical Trial Registry, registration date: 5 August 2018.URL:http://www.chictr.org.cn,registration number:ChiCTR1800017581.

scholarly journals Smoking cessation with smartphone applications (SWAPP): study protocol for a randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Janina Lüscher ◽  
Corina Berli ◽  
Philipp Schwaninger ◽  
Urte Scholz
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Smoking Abstinence ◽  
Smartphone Apps ◽  
Randomized Controlled ◽  
Quit Smoking

Abstract Background Tobacco smoking remains one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real-time. The social context of smokers has, however, been neglected in smartphone apps promoting smoking cessation. This randomized controlled trial investigates the effectiveness of a smartphone app in which smokers quit smoking with the help of a social network member. Methods This protocol describes the design of a single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Participants of this study are adult smokers who smoke at least one cigarette per day and intend to quit smoking at a self-set quit date. Blocking as means of group-balanced randomization is used to allocate participants to intervention or control conditions. Both intervention and control group use a smartphone-compatible device for measuring their daily smoking behavior objectively via exhaled carbon monoxide. In addition, the intervention group is instructed to use the SmokeFree Buddy app, a multicomponent app that also facilitates smoking-cessation specific social support from a buddy over a smartphone application. All participants fill out a baseline diary for three consecutive days and are invited to the lab for a background assessment. They subsequently participate in an end-of-day diary phase from 7 days before and until 20 days after a self-set quit date. Six months after the self-set quit date a follow-up diary for three consecutive days takes place. The primary outcome measures are daily self-reported and objectively-assessed smoking abstinence and secondary outcome measures are daily self-reported number of cigarettes smoked. Discussion This is the first study examining the effectiveness of a smoking cessation mobile intervention using the SmokeFree Buddy app compared to a control group in a real-life setting around a self-set quit date using a portable objective measure to assess smoking abstinence. Opportunities and challenges with running studies with smoking participants and certain design-related decisions are discussed. Trial registration This trial was prospectively registered on 04/04/2018 at ISRCTNregistry: ISRCTN11154315.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

scholarly journals Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

2002 ◽  
Vol 9 (4) ◽  
pp. 253-259 ◽  
Author(s):  
Robert L Cowie ◽  
Margot F Underwood ◽  
Cinde B Little ◽  
Ian Mitchell ◽  
Sheldon Spier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Disease Specific

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

scholarly journals Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Endoscopic Surgery ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial

scholarly journals PREWARMING FOR PREVENTION OF PERIOPERATIVE HYPOTHERMIA IN PATIENTS WITH COMBINED EPIDURAL AND GENERAL ANESTHESIA: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
General Anesthesia ◽  
Outcome Measures ◽  
Medical Center ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Perioperative Hypothermia ◽  
Randomized Controlled ◽  
Physical Status Classification ◽  
American Society

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

scholarly journals Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Mastour Saeed Alshahrani ◽  
Jaya Shanker Tedla ◽  
Ravi Shankar Reddy ◽  
Faisal Asiri
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Disability ◽  
Sf 36 ◽  
Neck Disability ◽  
Experimental Group

Background. Neck pain is one of the world’s leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP. Methods. Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment. Results. The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with p < 0.05 in both the groups but the experimental group improvements were more significant than the control group with p < 0.05 . Conclusion. Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.

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