Effectiveness of Aromatherapy for Relief of Pain, Nausea, and Vomiting after Percutaneous Nephrolithotomy: A Randomized Controlled Trial

2020 ◽  
Vol 27 (6) ◽  
pp. 440-448
Author(s):  
Mojdeh Amirhosseini ◽  
Mahlagha Dehghan ◽  
Parvin Mangolian Shahrbabaki ◽  
Hamid Pakmanesh
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Percutaneous Nephrolithotomy ◽  
Complementary Therapies ◽  
Controlled Trial ◽  
The Other ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Analog Scale ◽  
Randomized Controlled

<b><i>Background:</i></b> Postoperative pain, nausea, and vomiting are common side effects of percutaneous nephrolithotomy. Nowadays, non-pharmacological and complementary therapies have been noticed. Therefore, a study was conducted to determine the effectiveness of lavender and clary sage on the pain, nausea, and vomiting after percutaneous nephrolithotomy. <b><i>Methods:</i></b> This is a randomized clinical trial study on 79 patients undergoing percutaneous nephrolithotomy. Patients were randomly divided into three groups of lavender aromatherapy (<i>n</i> = 27), clary sage aromatherapy (<i>n</i> = 26), and a control group (<i>n</i> = 26). Each of the intervention groups received the inhalation aromatherapy immediately and 3 and 6 h after the operation. Pain, nausea, and emetic episodes in patients of the three groups were measured before the intervention and 30 min after each intervention using a visual analog scale and checklist. <b><i>Results:</i></b> Pain decreased significantly in the clary sage aromatherapy group. Nausea had a downward trend in the two groups of aromatherapy. The lavender aromatherapy group had the lowest incidence of emetic episodes compared to the other groups. <b><i>Conclusion:</i></b> Regarding the annoying pain, nausea, and vomiting after percutaneous nephrolithotomy for patients, and taking into account the complications of drug therapy, the use of complementary non-pharmacological methods can help increase the comfort of patients.

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

2019 ◽  
Vol 17 (1) ◽  
pp. 46-53
Author(s):  
Kaori Ichihara ◽  
Sayako Ouchi ◽  
Sachiko Okayama ◽  
Fukiko Kinoshita ◽  
Mitsunori Miyashita ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Pain Assessment ◽  
Spiritual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

scholarly journals The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Huiqing Xu ◽  
Xu Wei ◽  
Ranxing Zhang ◽  
Ling Li ◽  
Zhijun Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
General Anesthesia ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Randomized Controlled ◽  
Link Type ◽  
Prevention And Treatment

Abstract Background Postoperative nausea and vomiting (PONV) are common in posterior lumbar intervertebral fusion (PLIF) patients undergoing general anesthesia. The previous clinical observation has shown that a traditional acupoint herbal plaster (AHP) is beneficial to patients with PONV. This trial aims to assess the effect of the AHP for the prevention and treatment of PONV after PLIF in patients with general anesthesia. Methods A multicenter, parallel, randomized controlled trial (RCT) will be conducted. A total of 166 participants will be randomized to either a treatment group receiving an AHP or a control groups receiving an acupoint placebo plaster (APP) in a 1:1 ratio. The primary outcomes are the first occurrence and frequency of nausea and vomiting. The secondary outcomes include the severity grading of nausea and vomiting using a visual analog scale (VAS) measurement system, quality of life, and serological indicators. The safety evaluation is mainly about adverse events and skin reactions’ observation. Assessments will be carried out at the baseline, day 1, and day 2 (the end of the intervention). The central randomization system in the clinical trial (http://124.205.181.142:8082/xwtf/) will be used to conduct random allocation. Discussion This scientific methodology design of the trial is expected to provide clinical evidence to support the AHP for the prevention and treatment of PONV. Trial registration This study is retrospectively registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn) on 19 April 2018. ID: ChiCTR1800015768.

scholarly journals Yiqi Fumai Injection for patients with Septic Shock: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Bo-jun Chen ◽  
Zeng Jing ◽  
Cai Xingui ◽  
Cai Hairong ◽  
Luo Sicong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Randomized Controlled Trial ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Small Sample ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background: Septic shock is an important problem in critical care medicine and one of the leading causes of death in intensive care units (ICU). In China, Traditional Chinese medicine (TCM) has been widely used as the adjuvant treatment to improve the symptoms and prognosis in patients with septic shock. Yiqi Fumai Injection (YFI) is one of the most important proprietary TCM for septic shock, previous studies have demonstrated its efficacy and safety. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we designed this study to evaluate the efficacy and safety of using YFI as an adjunct treatment for septic shock.Methods/design: This is a double-blind, randomized, parallel, placebo-controlled clinical trial. A total of 800 participants will be randomly assigned to receive either treatment or placebo in a 1:1 ratio. The treatment group will receive YFI combined with conventional treatment, and the control group will receive 0.9% sodium chloride injection combined with conventional treatment for 2 weeks. The primary outcome is the 28-days mortality. Secondary outcomes are blood lactate levels, hemodynamics, blood gas analysis, immune function indicators, inflammatory indicators, acute physiology improvement and chronic health assessment (APACHE) II scores, and sepsis-related organ failure score (SOFA). Adverse events will be observed and recorded at the same time for safety assessment.Discussion: This randomized controlled trial will help evaluate the efficacy and safety of YFI for the treatment of septic shock. The results of this trial will provide recommendations for the management of septic shock.Trial registration {2a and 2b}：China Clinical Trial Registry, ChiCTR-1900026424.Registered on 15 June 2019.

scholarly journals Effectiveness of CRSCE-Based De-escalation Training on Reducing Physical Restraint in Psychiatric Hospitals: A Cluster Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Junrong Ye ◽  
Zhichun Xia ◽  
Chen Wang ◽  
Yao Liao ◽  
Yu Xu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Physical Restraint ◽  
Psychiatric Hospitals ◽  
Control Group ◽  
Unexpected Events ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Experimental Group

Background: The use of physical restraint (PR) causes clinical and ethical issues; great efforts are being made to reduce the use of PR in psychiatric hospitals globally.Aim: This study aimed to examine the effectiveness of CRSCE-based de-escalation training on reducing PR in psychiatric hospitals.Method: The proposed study adopted cluster randomized controlled trial design. Twelve wards of a psychiatric hospital were randomly allocated to experimental group (n = 6) and control group (n = 6). Wards of control group were assigned to routine training regarding PR; wards of experimental group underwent the same routine training while additionally received CRSCE-based de-escalation training. Before and after CRSCE-based de-escalation training, the frequency of and the duration of PR, and the numbers and level of unexpected events caused by PR, were recorded.Results: After CRSCE-based de-escalation training, the frequency (inpatients and patients admitted within 24 h) of and the duration of PR of experimental group, showed a descending trend and were significantly lower than those of control group (P &lt; 0.01); compared to control group, the numbers of unexpected events (level II and level III) and injury caused by PR of experimental group had been markedly reduced (P &lt; 0.05).Conclusions: CRSCE-based de-escalation training would be useful to reduce the use of PR and the unexpected event caused by PR in psychiatric hospitals. The modules of CRSCE-based de-escalation training can be adopted for future intervention minimizing clinical use of PR.Clinical Trial Registration: This study was registered at Chinese Clinical Trial Registry (Registration Number: ChiCTR1900022211).

scholarly journals Preemptive Treatment of Nausea and Vomiting of Pregnancy: Results of a Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Caroline Maltepe ◽  
Gideon Koren
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Controlled Trial ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Preemptive Therapy ◽  
Previous Pregnancy ◽  
Preemptive Treatment ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

Objectives. To determine whether the initiation of treatment (preemptive treatment) before the symptoms of nausea and vomiting of pregnancy (NVP) versus when the symptoms begin can improve the outcome in patients at a high risk for recurrence of severe NVP.Study Design. Prospective, randomized controlled trial.Results. Preemptive therapy conferred a significant reduction in HG as compared to the previous pregnancy (P=0.047). In the preemptive arm, there were 2.5-fold fewer cases of moderate-severe cases of NVP than those in the control group (15.4% versus 39.13%) in the first 3 weeks of NVP (P=0.05). In the preemptive group, significantly more women had their NVP resolved before giving birth (78.2% versus 50%) (P<0.002).Conclusions. Preemptive treatment with antiemetics is superior to the treatment that starts only when the symptoms have already occurred in decreasing the risk of severe forms of NVP.

Efficacy of Gastroplegia Patch on treating postoperative gastroplegia: A multicenter, double-blind, randomized controlled trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10110-10110
Author(s):  
Tian Zhou ◽  
Qin Zhou ◽  
Yanbin Wang ◽  
Yingjiang Ye ◽  
Yantao Tian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Tube Feeding ◽  
Control Group ◽  
Double Blind ◽  
Randomized Controlled ◽  
Patch Group ◽  
Gastroenterological Cancer

10110 Background: Postoperative gastroplegia is common in digestive cancer patients and there were no effective treatments. Gastroplegia Patch is an external-used Chinese Herbal Medicine recipe. It has been applied clinically for more than ten years, which showed good effect. We conducted this study to verify its safety and efficacy on the symptoms of postoperative gastroplegia. Methods: This clinical trial was designed as a multi-center, double-blind, superior effect, randomized controlled trial. It has been registered in ISRCTN (No.18291857) before initiation and was monitored by the third party. Patient inclusion criteria: 1. Gastroenterological cancer patient who was diagnosed as post-surgery gastroplegia, could not eat and need tube feeding (parenteral nutrition or with Jejunum nutrient canal); 2. The local identification of abdomen is cold pattern, which means this kind of patient prefers heat to cold, likes hot food and hates cold ones. Eligible participants were randomized into two arms, placebo arm and Patch arm, respectively. Beside the basic treatments (nutrition support, gastrointestinal decompression, promoting gastric dynamics medicine), placebo or Gastroplegia Patch was applied in control group or Patch group, respectively. Placebos or the patches were allocated at two acupuncture points ( Zhongwan and Shenque). The intervention course was 14 days or reached primary endpoint. The primary endpoint was able to eat without tube feeding. Results: All the 120 eligible participants (60 per arm) were recruited from four AAA hospitals in Beijing, China. Analysis was conducted based on intent-to-treat strategy. After the intervention, 68.33% of the participants in the Patch group were able to eat without tube feeding, which significantly higher than that of 41.67% in the control group (p = 0.003). It took 8 days on average in the Patch group to show effect, which significantly faster than that of 10 days in the control group (p = 0.017). The incidences of adverse events were compatible between the two arms (p = 0.244). Conclusions: Gastroplegia Patch is safe and effective in treating postoperative gastroplegia in gastroenterological cancer patients with cold syndrome. Clinical trial information: 18291857.

Russian and Low-Frequency Currents Induced Similar Neuromuscular Adaptations in Soccer Players: A Randomized Controlled Trial

2020 ◽  
Vol 29 (5) ◽  
pp. 594-601
Author(s):  
Karenina Arrais Guida Modesto ◽  
Pedro Ferreira Alves de Oliveira ◽  
Hellora Gonçalves Fonseca ◽  
Klaus Porto Azevedo ◽  
Vinicius Guzzoni ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Electrical Stimulation ◽  
Controlled Trial ◽  
Neuromuscular Electrical Stimulation ◽  
Soccer Players ◽  
Control Group ◽  
Analog Scale ◽  
Maximal Voluntary Isometric Contraction ◽  
Randomized Controlled ◽  
Neuromuscular Adaptations

Context: Neuromuscular electrical stimulation is widely used to induce muscular strength increase; however, no study has compared Russian current (RC) with pulsed current (PC) effects after a training program. Objectives: We studied the effects of different neuromuscular electrical stimulation currents, RC, and PC on the neuromuscular system after a 6-week training period. Design: Blinded randomized controlled trial. Setting: Laboratory. Patients: A total of 27 male soccer players (age 22.2 [2.2] y, body mass 74.2 [10.0] kg, height 177 [0] cm, and body mass index 23.7 [2.9] kg/cm2 for the control group; 22.1 [3.1] y, 69.7 [5.7] kg, 174 [0] cm, and 23.0 [2.5] kg/cm for the PC group; and 23.0 [3.4] y, 72.1 [10.7] kg, 175 [0] cm, and 23.5 [3.4] kg/cm for the RC group) were randomized into 3 groups: (1) control group; (2) RC (2500 Hz, burst 100 Hz, and phase duration 200 μs); and (3) PC (100 Hz and 200 μs). Intervention: The experimental groups trained for 6 weeks, with 3 sessions per week with neuromuscular electrical stimulation. Main Outcome Measures: Maximal voluntary isometric contraction and evoked torque, muscle architecture, sensory discomfort (visual analog scale), and electromyographic activity were evaluated before and after the 6-week period. Results: Evoked torque increased in the RC (169.5% [78.2%], P < .01) and PC (248.7% [81.1%], P < .01) groups. Muscle thickness and pennation angle increased in the RC (8.7% [3.8%] and 16.7% [9.0%], P < .01) and PC (16.1% [8.0%] and 27.4% [11.0%], P < .01) groups. The PC demonstrated lower values for visual analog scale (38.8% [17.1%], P < .01). There was no significant time difference for maximal voluntary isometric contraction and root mean square values (P > .05). For all these variables, there was no difference between the RC and PC (P > .05). Conclusion: Despite the widespread use of RC in clinical practice, RC and PC training programs produced similar neuromuscular adaptations in soccer players. Nonetheless, as PC generated less perceived discomfort, it could be preferred after several training sessions.

scholarly journals Efficacy and safety of Acupuncture for Gastrointestinal Dysfunction after Laparoscopy: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
LISHA LIU ◽  
XIULI YUAN ◽  
QUANMIN JIANG ◽  
LEI YANG ◽  
GUANGQIANG HUANG ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Laparoscopic Surgery ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Gastrointestinal Dysfunction ◽  
Blank Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Postoperative gastrointestinal dysfunction is one of the common complications after surgery. At present, there has no internationally recognized acupuncture program although it has a positive effect on the recovery of postoperative gastrointestinal function. In this report, we have designed a scientific trial protocol to analyze the feasibility of applying acupuncture to gastrointestinal dysfunction after laparoscopic surgery. We intend to conduct a randomized controlled trial based on this protocol to evaluate the efficacy and safety of the acupuncture for postoperative gastrointestinal dysfunction. Method / design: This study is a randomized, evaluator blinded, controlled, multi-center clinical trial, which has been designed according to the Consolidated Standards of Reporting Trials (CONSORT 2010) and the standard for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). The subjects will be chosen from the inpatients who have undergone laparoscopic surgery of Mianyang Hospital Affiliated to Chengdu University of traditional Chinese medicine, Mianyang Third People's Hospital and Mianyang Anzhou District People's Hospital. According to the random number generated by SPSS 25.0 software, the qualified subjects will be randomly assigned to the experimental group, the control group, and the blank group. Therapies will be performed 30 minutes after operation, the experimental group will be treated with acupuncture, the control group will be treated with intravenous injection of granisetron, and the blank group will be treated with intravenous injection of physiological saline. The main outcome is the first time of flatus after operation, and the secondary outcomes are abdominal pain, abdominal distention, nausea, vomiting times, gastrointestinal hormone level, and mental state. We will also evaluate the efficacy and safety of acupuncture on the basis of the principle of good clinical practice (GCP). Discuss: This is a standardized and scientific clinical trial to evaluate the efficacy and safety of acupuncture for gastrointestinal dysfunction after laparoscopic surgery. Our goal is to provide objective evidence and improve the acupoint prescription in clinical practice, so as to promote the clinical application of this technology. Trial registration China clinical trial registration ID: CHICTR -1800016991. Registered on 6 July 2018.Discussion

scholarly journals Octreotide Safety and Efficacy in Pediatric Non-variceal Upper Gastrointestinal Bleeding, A Randomized Controlled Trial

2020 ◽  
Author(s):  
Bahador Mirrahimi ◽  
Pejman Rohani ◽  
Omid Moradi ◽  
Azin Hemmati
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Pediatric Population ◽  
Controlled Trial ◽  
Control Group ◽  
Somatostatin Analogue ◽  
Gi Bleeding ◽  
Upper Gi Bleeding ◽  
Upper Gi ◽  
Randomized Controlled

Abstract Background: Octreotide as somatostatin analogue decrease the production of gastrointestinal (GI) peptides. Its consumption in pediatric population has been limited to control of bleeding episodes with variceal origin. In this randomized controlled trial, we aim to assess octreotide as an add-on therapy to conventional regimen of proton pump inhibitors in controlling upper GI bleeding in pediatric population.Methods: In a prospective randomized controlled clinical trial, in Mofid Children's Hospital, Tehran, Iran, pediatric patients with age of 0 to 15 years diagnosed with acute non-variceal upper GI bleeding allocated to receive Octreotide or placebo and pantoprazole concomitantly. Medication administration initiated after patient’s stabilization. Patients with hepatic failure, liver stigma, coagulopathy thrombocytopenia etc. were excluded. Demographic, clinical and preclinical data were recorded in prepared sheets. All patients were followed until therapy discontinuation.Results: Forty-three patients with the mean age of 4.98 ± 3.79 years with confirmed non-variceal upper GI bleeding included to the study. Most patients had no specific etiology for their bleeding episode. Patients in intervention and control group received pantoprazole in comparable doses. No differences in baseline hemoglobin values was observed but final hemoglobin values were higher in intervention group. No differences in bleeding duration observed. In regard of adverse drug reaction due to octreotide infusion, none was observed in any patient. Conclusions: Our study demonstrated that octreotide does not alter bleeding duration but need for transfusion in non-variceal upper GI bleeding but it may have effect on amount of blood loss.Trial registration: The study was registered in Iranian Registry of Clinical Trial by the code of IRCT20120415009475N6.

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