scholarly journals Effect of Xiangbin Prescription in Gastrointestinal Function After Gynecological Abdominal Surgery: a Randomized Controlled Trial

2021 ◽  
Author(s):  
Yuyan Wu ◽  
Jinxuan Lin ◽  
Haiping Zeng ◽  
Yi Chen ◽  
Zhiqiang Chen ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Abdominal Surgery ◽  
Controlled Trial ◽  
Controlled Study ◽  
Chewing Gum ◽  
Control Group ◽  
Gastrointestinal Function ◽  
Blank Control Group ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background: Recovery of gastrointestinal function after gynecological abdominal surgery is a major clinical problem. An effective intervention to promote the rapid recovery of gastrointestinal function postoperatively is lacking. This randomized trial investigated whether Xiangbin prescription (XBP) was feasible in terms of efficacy and safety on gastrointestinal function recovery in patients after gynecological abdominal surgery. Methods: A randomized controlled study was conducted, in which 190 patients with gynecological abdominal surgery who met the inclusion and exclusion criteria were enrolled. They were assigned randomly to XBP group, chewing gum group or blank control group, and respectively received the following treatments: took the XBP twice a day, chewed a piece of gum for about 15 minutes each 4 hours, or received conventional western basic treatment, starting on postoperative day 1 until defecation. Three groups were compared in terms of primary outcomes including the time of the first defecation and the time of the first flatus and secondary outcomes including the level of Ghrelin (GHRL) and the incidence of postoperative complications. Meanwhile, the safety of this trial was evaluated. Results: There was no statistical difference in baseline characteristics among the three groups. For the time of the first flatus, XBP group (22.33 ± 6.68 h) showed less time compared with the chewing gum group (23.06 ± 7.37 h), while it was shorter than that in the blank control group (25.86 ± 7.93 h) with significant difference (P < 0.05). As for the time of the first defecation, XBP group (38.65 ± 12.96 h) showed shorter time significantly compared with both the chewing gum group (47.29 ± 14.50 h) and the blank control group (54.01 ± 20.32 h) (P < 0.05). For the postoperative GHRL levels, XBP group was higher than that in the chewing gum group with no significant difference and had more significant improvement of the GHRL levels at postoperative day 3 compared with the blank control group (P < 0.05). For postoperative complications, XBP group had lower incidence than the other two groups but with no significant difference. For safety evaluations, no serious adverse events occurred in the three groups. Conclusions: XBP could promote the recovery of gastrointestinal function after gynecological abdominal surgery and it is overall safe. Trial registration: This trial was retrospectively registered by Chinese Clinical Trial Registry with the identifier number, ChiCTR1900026327, at September 30, 2019. http://www.chictr.org.cn/.

scholarly journals Modulation of the human immune status by spinal thermal massage: a non-randomized controlled study

2021 ◽  
Keyword(s):  
Quality Of Life ◽  
Nk Cells ◽  
Nk Cell ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Experimental Group

Thermal and massage therapies have long been used to control pain. Although spinal thermal massage (STM) has been used worldwide, its effectiveness has not been proven in a controlled clinical study. We here conducted a non-randomized controlled trial to assess the pain-relieving and immunomodulatory effects of STM in old-aged patients experiencing pain or disability. The experimental group was treated with STM five times a week for 8 weeks and rehabilitative regular care (RRC). The control group was treated with only RRC. Pain and immunological parameters were tested before treatment and after 4 and 8 weeks of treatment. The scores of three pain parameters were lowered by STM, and the differences between the groups were statistically significant at the two time points (p < 0.01). Quality of life determined using the 3-level EuroQol five-dimensional questionnaire scores was significantly higher in patients in the experimental group than those in the control group. Effect sizes (ES) were in the range of medium to large in the pain-related measures (0.54–1.22). The total leukocyte counts and the proportions of lymphocytes and subsets were not significantly different between the groups, whereas the proportions of monocytes and natural killer (NK) cells were higher in the experimental group than in the control group after 8 weeks (p < 0.05). The production of interleukin (IL)-4 and interferon γ in T cells was not significantly different between the groups, whereas the production of IL-2 was high in the control group. However, there was a significant increase in IFN-γ production by NK cells in the experimental group (at 4 weeks, p < 0.05). ES were medium in the immunological measures (0.53–0.68). No significant difference was observed in the production of proinflammatory cytokines, IL-1β, tumor necrosis factor α, or IL-6 between the groups. In conclusion, STM treatment has a positive effect on subjective pain and quality of life. It also enhanced NK cell proportion and activity, suggesting that STM may be beneficial in the prevention of viral diseases and cancer in old-aged people.

scholarly journals The effect of remote ischemic preconditioning on postoperative cardiac and inflammatory biomarkers in pancreatic surgery: a randomized controlled trial

2020 ◽  
Author(s):  
Laura van Zeggeren ◽  
Remco A. Visser ◽  
Lisette M. Vernooij ◽  
Ineke M. Dijkstra ◽  
Madeleen Bosma ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Abdominal Surgery ◽  
Ischemic Preconditioning ◽  
Myocardial Injury ◽  
Controlled Trial ◽  
Inflammatory Biomarkers ◽  
Remote Ischemic Preconditioning ◽  
Control Group ◽  
Randomized Controlled ◽  
Roche Diagnostics

ABSTRACTBackgroundCardiac and inflammatory biomarkers have been associated with adverse outcome after major abdominal surgery. Remote ischemic preconditioning (RIPC) may protect organs from ischemic insults during and after cardiac surgery, but the effect in major abdominal surgery is largely unknown.ObjectiveTo study the effect of RIPC on cardiac and inflammatory biomarkers in patients undergoing pancreatic resection.MethodsSingle-center, double-blind, randomized controlled trial in ninety patients undergoing elective pancreatic resection between March 2017 and February 2019. Three cycles of upper-limb ischemia and reperfusion (each 5 minutes) were applied before surgery. The primary endpoint was the maximum postoperative high-sensitive cardiac troponin (hs-cTn) T concentration within 48 hours after surgery. Secondary endpoints were postoperative myocardial injury (PMI, defined as a postoperative hs-cTnT ≥14 ng L-1), the maximum concentration of interleukin (IL)-6 within 48 hours after surgery, and postoperative complications within 30-days of surgery.ResultsRIPC did not reduce the maximum hs-cTnT concentration after surgery (12.6 ng L-1 vs 16.6 ng L-1 in the control group (P=0.23), nor did it lessen the incidence of PMI (15 (33.3%) patients in the RIPC group versus 19 (42.2%) controls, P=0.93). The maximum postoperative IL-6 concentration was 239 pg mL-1 [115-360] in the RIPC group, as compared to 317 pg mL-1 [174-909] in the control group (P=0.13). A postoperative complication occurred in 23 (51%) RIPC patients and 24 (53%) controls.ConclusionsRemote ischemic preconditioning did not reduce the maximum postoperative hs-cTnT concentration. Postoperative myocardial injury, IL-6 concentrations and postoperative complications were not statistically different between RIPC patients and controls.Trial RegistrationClinicaltrials.gov identifier NCT03460938FundingFunding for biomarker analysis was provided by Roche Diagnostics. Roche Diagnostics had no role in design and conduct of the study, analysis and interpretation of the data, preparation and approval of the manuscript.Article summaryStrengths and limitations of this studyWell-designed clinical trial in a selected group of high-risk abdominal surgery patients.Serial assessment of high-sensitive cardiac troponin T and interleukin-6 concentrations.Postoperative cardiac biomarker concentrations were relatively low.This trial was not primarily designed to detect differences in IL-6 concentrations and postoperative complications.

PS01.118: THE EFFECTS OF THE HERBAL MEDICINE DAIKENCHUTO (TJ-100) AFTER ESOPHAGEAL CANCER RESECTION, OPEN-LABEL, RANDOMIZED CONTROLLED TRIAL

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 83-83
Author(s):  
Akira Tangoku ◽  
Takeshi Nishino ◽  
Seiya Inoue ◽  
Takahiro Yoshida
Keyword(s):  
Randomized Controlled Trial ◽  
Esophageal Cancer ◽  
Body Weight ◽  
Herbal Medicine ◽  
Hospital Stay ◽  
Controlled Trial ◽  
Control Group ◽  
Gastrointestinal Function ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background Daikenchuto (TJ-100), a traditional Japanese herbal medicine, is widely used in Japan. Its effects on gastrointestinal motility, microcirculation and its anti-inflammatory effect are known. The purpose of this prospective randomized controlled trial was to investigate the effect of TJ-100 after esophagectomy in esophageal cancer patients. Methods Forty patients to whom subtotal esophagectomy for esophageal cancer was planned at our institute from March 2011 to August 2013 were enrolled and divided into two groups at the point of determination of the operation schedule after informed consent: TJ-100 treated group (n = 20) and Control group (n = 20). The primary end-points were maintenance of the nutrition condition and the recovery of gastrointestinal function. The secondary end-points were the serum C-reactive protein (CRP) level and adrenomedullin level during the postoperative course, the incidence of postoperative complications, and the length of hospital stay after surgery. Results We examined 39 patients because one patient in TJ-100 group couldn’t perform a curative surgery. The mean age of the TJ-100 group patients was significantly older than that of the control group. The rate of body weight decrease at postoperative day 21 was significantly suppressed in the TJ-100 group (3.6% vs. 7.0%, P = 0.014), but the serum albumin levels were not significantly different between the groups. The recovery of gastrointestinal function regarding flatus, defecation, and oral intake showed no significant between the groups, but postoperative bowel ill symptoms tended to be rare in the TJ-100 group. There was no significant difference in hospital stay after surgery. The serum CRP levels at postoperative day 3 tended to be suppressed in the TJ-100 group (P = 0.126). The rate of increase in adrenomedullin levels tended to be high postoperatively in the TJ-100 group, but there was no significant difference. Conclusion TJ-100 treatment after esophagectomy prompts the recovery of gastrointestinal motility and minimizes body weight loss. Those effects might suppress the excess inflammatory reaction related to surgery Disclosure All authors have declared no conflicts of interest.

scholarly journals Effects of daily mindfulness practice on fatigue, kinesiophobia, and quality of life in patients with acute myocardial infarction: a randomized controlled trial

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
C Karadas ◽  
M Oksul ◽  
N Ozer ◽  
L Ozdemir
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Mindfulness Practice ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Quality Of Life Scale ◽  
Tampa Scale For Kinesiophobia

Abstract Funding Acknowledgements Type of funding sources: None. Background and Aim Mindfulness meditation (MM) leads to controlled blood pressure and positive improvements in other symptoms which may trigger acute coronary diseases. The present randomized controlled study was aimed to investigate the effect of the MM on fatigue, kinesiophobia, and the quality of life (QoL) in patients with acute MI. Method The study was carried out with 56 MI patients. Participants were randomly assigned to meditation group (MG; n = 28) or control group (CG; n = 28).  The MG patients received a 15 min MM session comprising sitting and breathing for a total of eight weeks, while the CG patients received only a single-time attention-matched education. Piper Fatigue Intervention, Tampa Scale for Kinesiophobia-Heart and MacNew Quality of Life scales were utilized for data collection. Results After completion of the 8-week MM, any significant difference was not found in the fatigue scores of the patients (p &gt; 0.05). On the other hand, kinesiophobia scores in the MG were significantly lower in the 4th, 8th and 12th weeks (p &lt; 0.05). Similarly, the QoL scores were significantly higher in the MG in 8th week (p &lt; 0.05). Significant change in the emotional function sub-dimension of QoL continued in the follow-up assessment at 12th week (p &lt; 0.05). Conclusion The MM can significantly improve the QoL and decrease kinesiophobia in patients with MI. Beneficial effect of MM is maintained particularly in the emotional aspect. Based on the results of the study, MM may be recommended as a mind-body based complementary approaches within the scope of secondary protection after MI. Comparison of the study groupsGroupBaseline(Mean ± SD)4th week(Mean ± SD)8th week(Mean ± SD)12th week(Mean ± SD)PFSMM2.08 ± 1.870.90 ± 0.990.47 ± 0.780.44 ± 0.76CG1.56 ± 2.011.12 ± 1.590.98 ± 1.520.76 ± 1.33tp1.004 0.32-0.6210.54-1.5840.12-1.0850.28TSK-HMM40.25 ± 5.0436.18 ± 4.4934.39 ± 4.6134.96 ± 4.71CG41.71 ± 7.2841.89 ± 6.7441.82 ± 5.8441.00 ± 5.54tp-0.8750.39-3.7340.001-5.279 0.000-4.3900.00MacNewMM5.04 ± 0.715.53 ± 0.455.76 ± 0.475.77 ± 0.47CG5.17 ± 0.855.32 ± 0.605.37 ± 0.525.53 ± 0.46t; p-0.640; 0.531.436; 0.162.933; 0.0051.964; 0.06(Mean ± SD): Mean ± Standard Deviation; PFS: Piper Fatigue Scores; TSK-H: Tampa Scale for Kinesiophobia-Heart; MacNew: MacNew Quality of life Scale; EFS: emotional functioning sub-dimension; PFS: physical functioning sub-dimension; SFS: social functioning sub-dimension; t= Student T Test value; p&lt; 0.05

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

scholarly journals Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

scholarly journals Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Group Data ◽  
Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

scholarly journals Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

ISRN Nursing ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Paul Ratanasiripong ◽  
Nop Ratanasiripong ◽  
Duangrat Kathalae
Keyword(s):  
Nursing Students ◽  
Stress Level ◽  
Clinical Training ◽  
Intervention Program ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Moderate Increase ◽  
Randomized Controlled ◽  
The Impact

Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession.

scholarly journals Foam Rolling Elicits Neuronal Relaxation Patterns Distinct from Manual Massage: A Randomized Controlled Trial

2021 ◽  
Vol 11 (6) ◽  
pp. 818
Author(s):  
Yann Kerautret ◽  
Aymeric Guillot ◽  
Sébastien Daligault ◽  
Franck Di Rienzo
Keyword(s):  
Skin Conductance ◽  
Muscle Pain ◽  
Controlled Trial ◽  
Muscle Relaxation ◽  
Well Being ◽  
Self Report ◽  
Controlled Study ◽  
Control Group ◽  
Foam Rolling ◽  
Randomized Controlled

The present double-blinded, randomized controlled study sought to compare the effects of a full-body manual massage (MM) and a foam rolling (FR) intervention on subjective and objective indexes of performance and well-being. A total of 65 healthy individuals were randomly allocated to an FR, MM, or a control group who received a cognitively oriented relaxation routine. Self-report ratings of perceived anxiety, muscle relaxation, and muscle pain were used to index changes in affect and physical sensations. The sit-and-reach and toe-touch tests, as well as a mental calculation task, were used to index motor and cognitive performances, respectively. We also conducted resting-state electroencephalography and continuous skin conductance recordings before and after the experimental intervention. Both FR and MM groups exhibited neural synchronization of alpha and beta oscillations during the posttest. Skin conductance increased from the pretest to the posttest in the relaxation group, but decreased in the FR group. All interventions improved range of motion, although only the MM group outperformed the relaxation group for the toe-touch performance. MM was associated with reduced muscle pain and increased muscle relaxation. Reduced perceived anxiety after the intervention was observed in the FR group only. Overall, MM and FR both improved objective and subjective indexes of performance and well-being. Differences between the two massage interventions are discussed in relation to the effects of pressure stimulation on autonomic regulations and the proactive vs. retroactive nature of FR, compared to MM.

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