scholarly journals Reduced risk of venous thromboembolism with the use of intermittent pneumatic compression after craniotomy: a randomized controlled prospective study

2019 ◽  
Vol 130 (2) ◽  
pp. 622-628 ◽  
Author(s):  
Julian Prell ◽  
Grit Schenk ◽  
Bettina-Maria Taute ◽  
Christian Scheller ◽  
Christian Marquart ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Prospective Study ◽  
Controlled Trial ◽  
Intermittent Pneumatic Compression ◽  
Control Group ◽  
Compression Stockings ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Duration Of Surgery

OBJECTIVEThe term “venous thromboembolism” (VTE) subsumes deep venous thrombosis (DVT) and pulmonary embolism. The incidence of DVT after craniotomy was reported to be as high as 50%. Even clinically silent DVT may lead to potentially fatal pulmonary embolism. The risk of VTE is correlated with duration of surgery, and it appears likely that it develops during surgery. The present study aimed to evaluate intraoperative use of intermittent pneumatic compression (IPC) of the lower extremity for prevention of VTE in patients undergoing craniotomy.METHODSA total of 108 patients undergoing elective craniotomy for intracranial pathology were included in a single-center controlled randomized prospective study. In the control group, conventional compression stockings were worn during surgery. In the treatment group, IPC of the calves was used in addition. The presence of DVT was evaluated by Doppler sonography pre- and postoperatively.RESULTSIntraoperative use of IPC led to a significant reduction of VTE (p = 0.029). In logistic regression analysis, the risk of VTE was approximately quartered by the use of IPC. Duration of surgery was confirmed to be correlated with VTE incidence (p < 0.01); every hour of surgery increased the risk by a factor of 1.56.CONCLUSIONSIntraoperative use of IPC significantly lowers the incidence of potentially fatal VTE in patients undergoing craniotomy. The method is easy to use and carries no additional risks.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class I.Clinical trial registration no.: DRKS00011783 (https://www.drks.de)

scholarly journals The effect of therapeutic listening on anxiety and fear among surgical patients: randomized controlled trial

2018 ◽  
Vol 26 (0) ◽  
Author(s):  
Ana Cláudia Mesquita Garcia ◽  
Talita Prado Simão-Miranda ◽  
Ana Maria Pimenta Carvalho ◽  
Paula Condé Lamparelli Elias ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
State Anxiety ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Physiological Variables ◽  
Randomized Controlled ◽  
Therapeutic Listening

ABSTRACT Objective: To investigate the effect of therapeutic listening on state anxiety and surgical fears in preoperative colorectal cancer patients. Method: A randomized controlled trial with 50 patients randomly allocated in the intervention group (therapeutic listening) (n = 25) or in the control group (n = 25). The study evaluated the changes in the variables state anxiety, surgical fears and physiological variables (salivary alpha-amylase, salivary cortisol, heart rate, respiratory rate and blood pressure). Results: In the comparison of the variables in the control and intervention groups in pre- and post-intervention, differences between the two periods for the variables cortisol (p=0.043), heart rate (p=0.034) and surgical fears (p=0.030) were found in the control group, which presented reduction in the values of these variables. Conclusion: There was no reduction in the levels of the variables state anxiety and surgical fears resulting from the therapeutic listening intervention, either through the physiological or psychological indicators. However, the contact with the researcher during data collection, without stimulus to reflect on the situation, may have generated the results of the control group. Clinical Trial Registration: NCT02455128.

scholarly journals The Effectiveness of Traditional Chinese Yijinjing Qigong Exercise for the Patients With Knee Osteoarthritis on the Pain, Dysfunction, and Mood Disorder: A Pilot Randomized Controlled Trial

2022 ◽  
Vol 8 ◽  
Author(s):  
Shuaipan Zhang ◽  
Guangxin Guo ◽  
Xing Li ◽  
Fei Yao ◽  
Zhiwei Wu ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Well Being ◽  
Functional Mobility ◽  
Exercise Session ◽  
Control Group ◽  
Serious Adverse Events ◽  
Clinical Trial Registration ◽  
Randomized Controlled

Background: Although traditional Chinese Yijinjing Qigong Exercise (YJJQE) is popularly used in China, to alleviate symptoms of people with knee osteoarthritis (KOA), no randomized controlled trials (RCTs) are available to evaluate the effects of YJJQE in patients with KOA. The purpose of this trial is to assess the clinical efficacy of YJJQE for patients with KOA.Methods: A total of 50 participants clinically diagnosed with KOA are randomly (1:1) assigned to the YJJQE group (n = 25) and to the stretching training exercise (STE) group (n = 25), for a 40-min exercise session twice a week for 12 weeks. All outcome measures are collected at baseline and at 12-week ending intervention, which includes the primary outcomes of Western Ontario and McMaster Universities Osteoarthritis Index Scale (WOMAC), the secondary outcomes of visual analog scale (VAS), mental component summary (MCS), physical component summary (PCS), Beck depression inventory (BDI), perceived stress scale (PSS), Berg balance scale (BBS), and the Gait functional mobility data.Results: The YJJQE group did not have any significant changes compared to the control group on the WOMAC score after the 12-week intervention (P &gt; 0.05), though the YJJQE group demonstrated better performance in MCS, BDI, and PSS (P = 0.002, P = 0.001, and P = 0.026, respectively) than the control group. No serious adverse events occurred in either group, and only mild muscle soreness was reported during both exercise treatments.Conclusion: Because no difference between both groups was shown, with regards to the primary outcome measurement (WOMAC), it can hardly explain that the YJJQE had an advantageous effect on patients experiencing the pain and dysfunction of knee osteoarthritis. However, compared to the control group, YJJQE appeared to be associated with improvements in psychological well-being including reduced stress, anxiety, depression, and mood disturbance to manage KOA. Further trials with larger sample sizes and follow-up studies will be required.Clinical Trial Registration:https://www.chictr.org.cn/edit.aspx?pid=60357&amp;htm=4, ChiCTR2000037256.

scholarly journals Pulmonary rehabilitation to improve physical capacity, dyspnea and quality of life following pulmonary embolism (the PeRehab study): Study protocol for a two-centre randomized controlled trial

2020 ◽  
Author(s):  
Stacey Haukeland-Parker ◽  
Øyvind Jervan ◽  
Hege Hølmo Johannessen ◽  
Jostein Gleditsch ◽  
Knut Stavem ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Embolism ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Physical Capacity ◽  
Control Group ◽  
Walk Test ◽  
Randomized Controlled

Abstract Background: Recently, a large group of patients with persistent dyspnea, poor physical capacity and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name “post pulmonary embolism syndrome” (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, dyspnea and HRQoL in PPS patients.Methods: A two-centre randomized controlled trial (RCT) is being performed at Østfold Hospital and Akershus University Hospital in Norway. Patients with PPS are 1:1 randomized into an intervention or a control group. The intervention consists of a supervised, outpatient rehabilitation program twice weekly (1 hour) for 8 weeks provided by experienced physiotherapists. The intervention involves individually adapted exercises based on existing pulmonary rehabilitation programs (relaxation, interval and resistance training), and an educational session including topics such as normal anatomy and physiology of the respiratory and circulatory system, information on PE/PPS, breathing strategies, and benefits of exercise/physical activity. Patients randomized to the control group receive usual care without specific instructions to exercise.Participants in the intervention and control groups will be compared based on assessments conducted at baseline, 12 weeks and 36 weeks after inclusion using the incremental shuttle walk test (primary outcome) and endurance shuttle walk test (exercise capacity), Sensewear activity monitor (daily physical activity), the Modified Medical Research Council scale, the Shortness of Breath questionnaire (dyspnea), and EQ-5D-5L and the Pulmonary Embolism Quality of Life Questionnaire (HRQoL).Recruitment of 190 patients is currently ongoing.Discussion: Results from this study may provide a currently untreated group of PPS patients with an effective treatment resulting in reduced symptoms of dyspnea, improved exercise capacity and better HRQoL following PE.Trial registration: NCT03405480, Clinical Trials (registered prospectively.Protocol version 1 (from original protocol September 2017).The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 1).

scholarly journals Effects of Father-Neonate Skin-to-Skin Contact on Attachment: A Randomized Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Er-Mei Chen ◽  
Meei-Ling Gau ◽  
Chieh-Yu Liu ◽  
Tzu-Ying Lee
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Demographic Data ◽  
Intervention Group ◽  
Active Role ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Skin Contact ◽  
Skin To Skin

This study examines how skin-to-skin contact between father and newborn affects the attachment relationship. A randomized controlled trial was conducted at a regional teaching hospital and a maternity clinic in northern Taiwan. The study recruited 83 first-time fathers aged 20 years or older. By block randomization, participants were allocated to an experimental (n=41) or a control (n=42) group. With the exception of skin-to-skin contact (SSC), participants from each group received the same standard care. Both groups also received anEarly Childcare for Fathersnursing pamphlet. During the first three days postpartum, the intervention group members were provided a daily SSC intervention with their respective infants. Each intervention session lasted at least 15 minutes in length. The outcome measure was the Father-Child Attachment Scale (FCAS). After adjusting for demographic data, the changes to the mean FCAS were found to be significantly higher in the intervention group than in the control group. We recommend that nurses and midwives use instructional leaflets and demonstrations during postpartum hospitalization, encouraging new fathers to take an active role in caring for their newborn in order to enhance father-neonate interactions and establish parental confidence. This trial is registered with clinical trial registration numberNCT02886767.

scholarly journals Does online insomnia treatment reduce depressive symptoms? A randomized controlled trial in individuals with both insomnia and depressive symptoms

2018 ◽  
Vol 49 (3) ◽  
pp. 501-509 ◽  
Author(s):  
T. van der Zweerde ◽  
A. van Straten ◽  
M. Effting ◽  
S. D. Kyle ◽  
J. Lancee
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Sleep Diary ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Post Test ◽  
Perseverative Thinking ◽  
Insomnia Severity

AbstractBackgroundInsomnia is effectively treated with online Cognitive Behavioral Therapy for Insomnia (CBT-I). Previous research has suggested the effects might not be limited to sleep and insomnia severity, but also apply to depressive symptoms. Results, however, are mixed.MethodsIn this randomized controlled trial we investigated the effects of guided online CBT-I on depression and insomnia in people suffering from symptoms of both. Participants (n = 104) with clinical insomnia and at least subclinical depression levels were randomized to (1) guided online CBT-I and sleep diary monitoring (i-Sleep) or (2) control group (sleep diary monitoring only). The primary outcome was the severity of depressive symptoms (Patient Health Questionnaire-9 without sleep item; PHQ-WS). Secondary outcomes were insomnia severity, sleep diary parameters, fatigue, daytime consequences of insomnia, anxiety, and perseverative thinking.ResultsAt post-test, participants in the i-Sleep condition reported significantly less depressive symptoms (PHQ-WS) compared with participants in the sleep-diary condition (d = 0.76). Large significant effects were also observed for insomnia severity (d = 2.36), most sleep diary parameters, daytime consequences of insomnia, anxiety, and perseverative thinking. Effects were maintained at 3 and 6 month follow-up. We did not find significant post-test effects on fatigue or total sleep time.ConclusionsFindings indicate that guided online CBT-I is not only effective for insomnia complaints but also for depressive symptoms. The effects are large and comparable with those of depression therapy. Clinical trial registration number: NTR6049 (Netherlands Trial Register).

scholarly journals Pulmonary rehabilitation to improve physical capacity, dyspnea and quality of life following pulmonary embolism (the PeRehab study): Study protocol for a two-centre randomized controlled trial.

2020 ◽  
Author(s):  
Stacey Haukeland-Parker ◽  
Øyvind Jervan ◽  
Hege Hølmo Johannessen ◽  
Jostein Gleditsch ◽  
Knut Stavem ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Embolism ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Physical Capacity ◽  
Control Group ◽  
Walk Test ◽  
Randomized Controlled

Abstract Background: Recently, a large group of patients with persistent dyspnea, poor physical capacity and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name “post pulmonary embolism syndrome” (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, dyspnea and HRQoL in PPS patients.Methods: A two-centre randomized controlled trial (RCT) is being performed at Østfold Hospital and Akershus University Hospital in Norway. Patients with PPS are 1:1 randomized into an intervention or a control group. The intervention consists of a supervised, outpatient rehabilitation program twice weekly (1 hour) for 8 weeks provided by experienced physiotherapists. The intervention involves individually adapted exercises based on existing pulmonary rehabilitation programs (relaxation, interval and resistance training), and an educational session including topics such as normal anatomy and physiology of the respiratory and circulatory system, information on PE/PPS, breathing strategies, and benefits of exercise/physical activity. Patients randomized to the control group receive usual care without specific instructions to exercise. Participants in the intervention and control groups will be compared based on assessments conducted at baseline, 12 weeks and 36 weeks after inclusion using the incremental shuttle walk test (primary outcome) and endurance shuttle walk test (exercise capacity), Sensewear activity monitor (daily physical activity), the Modified Medical Research Council scale, the Shortness of Breath questionnaire (dyspnea), and EQ-5D-5L and the Pulmonary Embolism Quality of Life Questionnaire (HRQoL).Recruitment of 190 patients is currently ongoing.Discussion: Results from this study may provide a currently untreated group of PPS patients with an effective treatment resulting in reduced symptoms of dyspnea, improved exercise capacity and better HRQoL following PE.Trial registration: NCT03405480, Clinical Trials (registered prospectively.Protocol version 1 (from original protocol September 2017).The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 1).

scholarly journals The Clinical Efficacy, Safety and Biomechanical Mechanism of Tai Chi in Patients with Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
PAN FUWEI ◽  
Min Zhang ◽  
Guoqing Du ◽  
Yuanchuan Chen ◽  
Guangyue Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Tai Chi ◽  
Controlled Trial ◽  
Joint Disease ◽  
Secondary Outcome ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Biomechanical Effect

Abstract Background: Knee osteoarthritis (KOA), one of the most common degenerative joint disease, is the leading cause of disability among elder people. Many previous studies demonstrated that Tai chi is an effective treatment in the management of KOA, but there has been a lack of study evaluated the effect of Tai chi on both clinical and biomechanical outcomes in individuals with KOA. The purpose of the study is to identify the clinical and biomechanical effect of the Tai chi, the results will help to improve the understanding of possible underlying biomechanical effects of the Tai chi. Methods: We will conduct a prospective, randomized controlled trials of 72 individuals with medial KOA. The participants with medial KOA will be randomly divided into Tai chi group or a control group. The Tai chi group will participant in Tai chi twice a week for eight weeks. The control group will receive health care education. After the 8-week intervention period there will be a 16-week follow-period with no active intervention in either group. The primary and secondary outcomes will be assessed at baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks. The primary measure will be Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcome measures will include the kinetics, kinematics changing of the knee joint at sagittal, frontal, and transverse plane, the muscle co-contraction.Discussion: This study aims to investigate the clinical and biomechanical effect of the Tai chi, and the results will help to improve the understanding of possible underlying biomechanical effects of the Tai chi in the management of KOA. Trail Registration: The study was approved by China registered clinical trial ethics review committee with No.ChiECRCT20200335. The study plan was registered on the website of China Registered Clinical Trial Registration Center with No.ChiCTR2000040769 .Registered 09 December 2020, http://www.chictr.org.cn/showprojen.aspx?proj=65571

scholarly journals Effect of Deliberate Hypotension on Regional Cerebral Oxygen Saturation During Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Ling Zhang ◽  
Yang Yu ◽  
Juan Xue ◽  
Weiping Lei ◽  
Yaqin Huang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Functional Endoscopic Sinus Surgery ◽  
Sinus Surgery ◽  
Control Group ◽  
Regional Cerebral Oxygen Saturation ◽  
Deliberate Hypotension ◽  
Randomized Controlled ◽  
Duration Of Surgery ◽  
Surgical Field

Background: Deliberate hypotension can reduce bleeding and improve visualization of the surgical field during functional endoscopic sinus surgery (FESS). However, hypotension may cause brain hypoperfusion and subsequent ischemic injuries, such as delayed awakening, stroke, postoperative delirium, and postoperative cognitive dysfunction. Near-infrared spectroscopy (NIRS) can be used to monitor real-time regional cerebral oxygen saturation (rSO2) levels to estimate brain perfusion. The present study aimed to evaluate the change in rSO2 induced by deliberate hypotension during FESS, and assess the impact of deliberate hypotension on the surgical process.Material and Methods: A randomized controlled trial was registered with the Chinese clinical trial registry (ChiCTR2000039846). A total of 40 patients were enrolled and randomly divided into the control and intervention groups, and finally, 39 patients were analyzed. Deliberate hypotension was induced in the intervention group using nicardipine and esmolol, whereas the control group received general anesthesia without deliberate hypotension. We recorded mean arterial pressure (MAP), saturation of pulse oximetry (SpO2), rSO2, and heart rate (HR) before induction of anesthesia (T0), immediately after induction of anesthesia (T1), at the beginning of the operation (corresponding with the establishment of deliberate hypotension) (T2), 10 min (T3) and 20 min (T4) after the operation began, at the end of the operation (corresponding with the end of deliberate hypotension) (T5), and 5 min (T6) and 15 min (T7) after the operation. The partial pressure of end-tidal carbon dioxide (PetCO2) was recorded at T1, T2, T3, T4, T5, and T6. The duration of surgery, intraoperative blood loss, tracheal extubation time, and the number of patients that experienced cerebral desaturation events (CDEs) were recorded. The surgical field was estimated postoperation based on the Fromme score.Results: A 30% decrease from the baseline MAP resulted in a decrease of intraoperative bleeding, improvement in the quality of the surgical field, and the shortening of the duration of surgery during FESS in the intervention group compared with the control group. In addition, rSO2 was reduced and no CDEs were experienced in the intervention group. Linear regression analysis demonstrated a correlation between the decline in rSO2 and that in MAP.Conclusions: A decrease in MAP to a certain level will cause a decrease of rSO2 in patients undergoing FESS under general anesthesia. Based on our findings, we recommend that the deliberate hypotensive target indicated by MAP be reduced by 30%, while PetCO2 is maintained at 35–40 mmHg and HR is maintained at about 60 beats per minute during FESS.

scholarly journals Effect of Capsaicin Atomization–Induced Cough on Sputum Excretion in Tracheotomized Patients After Hemorrhagic Stroke: A Randomized Controlled Trial

2021 ◽  
pp. 1-11
Author(s):  
Chao Wu ◽  
Yijie Zhang ◽  
Li Yang ◽  
Fang Shen ◽  
Chen Ma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hemorrhagic Stroke ◽  
Controlled Trial ◽  
Intervention Group ◽  
Routine Care ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Link Type ◽  
Before And After

Background Timely and effective removal of respiratory secretions is of great significance for tracheotomized patients. The purpose of this study is to investigate the effectiveness of capsaicin nebulization to stimulate cough to promote early clearance of respiratory secretions in tracheotomized patients after hemorrhagic stroke. Method This study implemented a randomized controlled design. Sixty-three patients who were tracheotomized following a hemorrhagic stroke completed this randomized controlled trial. In the control group, 33 cases were given a routine care after tracheotomy. In the intervention group, 30 cases were given a capsaicin solution nebulization in addition to the routine care. The daily sputum output and the number of sputum suctioning were observed. The differences in sputum viscosity, cough function, and Clinical Pulmonary Infection Score (CPIS) were compared between the two groups before and after the intervention. Vital sign changes during capsaicin nebulization and suctioning were compared between the two groups in a pilot study. Results The daily sputum output of the capsaicin intervention group was significantly higher than that of the control group ( p < .05). The number of sputum suctioning of capsaicin group was less than that of the control group after intervention ( p < .05). The CPIS score of the capsaicin group was lower than that of the control group ( p < .05) after a 1-week intervention. Patients' heart rate, respiratory rate, and oxygen saturation during capsaicin nebulization were not statistically different from those during routine sputum suctioning ( p > .05). Conclusions Capsaicin atomization–induced cough can effectively promote sputum excretion of hemorrhagic stroke patients undergoing tracheotomy and has a good safety profile. The Clinical Trial registration number of this study is ChiCTR2000037772 ( http://www.chictr.org.cns ). Supplemental Material https://doi.org/10.23641/asha.16821352

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