scholarly journals A Randomized Controlled Study of Caudal Dexmedetomidine for the Prevention of Postoperative Agitation in Children Undergoing Urethroplasty

2021 ◽  
Vol 9 ◽  
Author(s):  
Weichao Zhu ◽  
Jie Sun ◽  
Jianhua He ◽  
Wangping Zhang ◽  
Meng Shi
Keyword(s):  
Controlled Study ◽  
Postanesthesia Care Unit ◽  
Control Group ◽  
Sedation Scale ◽  
Caudal Block ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Ramsay Sedation Scale ◽  
Group D ◽  
Excessive Sedation

Background: Postoperative agitation is a common complication in children undergoing general anesthesia. This study aimed to investigate the effect of caudal dexmedetomidine for the prevention of postoperative agitation in children undergoing urethroplasty.Materials and Methods: Eighty children were prospectively recruited to this study and randomized to two groups (40 cases in each group), specifically, a dexmedetomidine group (group D) who received 0.2% ropivacaine + 0.5 μg/kg dexmedetomidine for caudal block, and a control group who received 0.2% ropivacaine alone. The time to wake up, the time to discharge from the postanesthesia care unit (PACU), the duration of the caudal block, and the Ramsay sedation scale (RSS) were evaluated in the patients. Adverse events such as postoperative agitation, respiratory depression, bradycardia, hypotension, excessive sedation, nausea, and vomiting were also recorded during the first postoperative 24 h.Results: The incidence of postoperative agitation was lower in group D compared with patients in the control group (2.5 vs. 22.5%, p = 0.007). The time to wake up and the time to discharge from PACU were longer in group D than in the control group (15.2 ± 2.6 vs. 13.4 ± 1.3 min, 48.2 ± 7.7 vs. 41.5 ± 8.0 min, respectively, p < 0.001). However, the extubation times were similar between the two groups. The duration of the caudal block was longer in group D compared with the control group (8.8 ± 1.6 vs. 4.6 ± 0.7 h, p < 0.001).Conclusions: Caudal dexmedetomidine prolongs the duration of caudal block and decreases the incidence of postoperative agitation in children undergoing urethroplasty.Clinical Trial Registration: ChiCTR1800016828.

A Randomized Controlled Trial: The Effect of Acupressure and Foot Reflexology on Pain During Heel-Lancing in Neonates

2021 ◽  
pp. 105477382110618
Author(s):  
Ayşe Özge Deniz ◽  
Ayfer Açikgöz
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Procedural Pain ◽  
Control Group ◽  
Intergroup Difference ◽  
Inclusion Criteria ◽  
Sedation Scale ◽  
Neonatal Pain ◽  
Randomized Controlled ◽  
Pain Scores

This randomized controlled study aimed to determine the effects of acupressure and foot reflexology on procedural pain during heel-lancing in newborns. This study was conducted with 105 neonates (35 foot reflexology group, 35 acupressure group, and 35 control group) who met the inclusion criteria and who were delivered by cesarean section between October 2017 and March 2018 at a state hospital in Turkey. A “Newborn Information Form” and a “Neonatal Pain, Agitation, and Sedation Scale” (N-PASS) were used to collect data. The study found a significant intergroup difference between pain scores of neonates during the procedures ( p < .05). Advanced analyses found that the pain scores in the acupressure and foot reflexology groups were similar, whereas the pain scores in the control group were higher than in the other two groups. Acupressure and foot reflexology administered during heel lancing in newborns are effective methods for reducing pain.

scholarly journals Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to the glo Tobacco Heating Product: A Randomized, Controlled Ambulatory Study

2020 ◽  
Author(s):  
Nathan Gale ◽  
Michael McEwan ◽  
Oscar M Camacho ◽  
George Hardie ◽  
James Murphy ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Cigarette Smoking ◽  
Tobacco Product ◽  
Ambulatory Setting ◽  
Controlled Study ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Biomarkers Of Exposure ◽  
Never Smokers

Abstract Introduction Tobacco heating products (THPs) generate lower machine yields of toxicants compared to those found in conventional cigarette smoke. During use, these products are likely to expose users to lower levels of particulate matter and harmful and potentially harmful compounds compared with smoking cigarettes. Aims and Methods This randomized, controlled study is investigating whether biomarkers of exposure (BoE) to smoke toxicants are reduced when smokers switch from smoking cigarettes to using the glo THP in a naturalistic, ambulatory setting. Control groups include smokers who are abstaining from cigarette smoking and never-smokers. At a baseline study visit, 24-hour urine samples and spot blood samples were taken for BoE analysis, and exhaled carbon monoxide was also measured. N-(2-cyanoethyl) valine (CEVal) was used as a marker of compliance in subjects asked to refrain from combustible cigarette smoking. Subjects are being followed up at periodic intervals for 360 days; this article presents data following a planned interim analysis at day 90. Results In continuing smokers, BoE remained stable between baseline (day 1) and day 90. In both per-protocol and CEVal-compliant analysis populations, reductions in BoE were observed in subjects switching to using glo or undergoing smoking cessation. These reductions were statistically significant for a number of BoE when switching to glo was compared with continued smoking. Furthermore, in both populations, reductions observed in subjects switching to using glo were comparable to those seen with smoking cessation and were also to levels similar to those seen in never-smokers. Conclusion glo is a reduced-exposure tobacco product. Implications This clinical study builds on a previous 5-day confinement study and demonstrates that when smokers switched from smoking combustible cigarettes to using the glo THP in a naturalistic, ambulatory setting, their exposure to tobacco smoke toxicants was significantly decreased. For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls. This indicates that glo is a reduced-exposure product with the potential to be a reduced-risk tobacco product, when used by smokers whose cigarette consumption is displaced completely. Clinical trial registration ISRCTN81075760.

scholarly journals Effects of various methods of dexmedetomidine administration for sedation in elderly patients undergoing spinal anesthesia: a randomized controlled study

2020 ◽  
Vol 15 (3) ◽  
pp. 297-304
Author(s):  
Jeong Jeong ◽  
So Hee Jin ◽  
Dong Yeon Kim ◽  
Sooyoung Cho ◽  
Heeseung Lee ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Continuous Infusion ◽  
Spinal Anesthesia ◽  
Initial Dose ◽  
The Other ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Ramsay Sedation Scale ◽  
Effect Level ◽  
Group D

Background: The purpose of this study was to investigate the degree of sedation and the incidence of adverse effects resulting from various methods of administering the initial dose followed by continuous infusion of dexmedetomidine (DEX) for sedation in elderly patients undergoing spinal anesthesia.Methods: In total, 72 patients aged over 65 years who were to be administered spinal anesthesia were randomly allocated into three groups. The initial doses were injected to the groups as follows: group DD, DEX 0.5 μg/kg for 10 min; group MD, midazolam 0.02 mg/kg; and group D, no initial dose. This was followed immediately by infusing a maintenance dose of DEX 0.5 μg/kg/h to all groups.Results: The Bispectral index (BIS) in the D group was significantly higher than in the other two groups. There were no significant differences in the Ramsay sedation scale (RSS) among the groups. The RSS 3 level was reached in 10 min from the start of sedation in MD and DD groups and in 20 min from the start of sedation in D group. Neither bradycardia nor hypotension was observed in any of the groups.Conclusions: Patients in all three groups reached the RSS 3 sedating-effect level. However, the group that received continuous infusion only without the initial dose showed higher BIS than the other two groups and reached the RSS 3 later. No adverse events were observed in any of the groups.

scholarly journals Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study

2021 ◽  
Vol 18 (4) ◽  
pp. 1528
Author(s):  
Héctor Guerrero-Tapia ◽  
Rodrigo Martín-Baeza ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Repeated Measures ◽  
Gluteus Medius ◽  
Soccer Players ◽  
Controlled Study ◽  
Control Group ◽  
Extrinsic Factors ◽  
Randomized Controlled ◽  
Limb Injuries ◽  
Experimental Group

Background. Abdominal and lumbo-pelvic stability alterations may be the origin of lower limb injuries, such as adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: In this randomized controlled trial over 8 weeks, 25 female footballers were randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). Evaluations were performed at baseline, at the end of the intervention and after a 4-week follow-up period. The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbar-pelvic stability and adductor strength. Results: After the intervention, there was an increase in lumbo-pelvic stability in both groups, being greater in the control group than in the experimental group (mean differences [MD]: 4.84 vs. MD: 9.58; p < 0.01) with differences in the analysis of repeated measures (p < 0.001), but not in group interaction (p = 0.26). Changes were found in adductor strength in the experimental group (MD: −2.48; p < 0.001 in the left adductor; MD: −1.48; p < 0.01 in right adductor) and control group (MD: −1.68; p < 0.001 in the left adductor; MD: −2.05; p < 0.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p < 0.001) and right (p < 0.001) adductor strength. Conclusions: An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength, while improvements in both variables are maintained at four weeks follow-up.

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 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 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.

Self-Managed Music-Guided Exercise Intervention Improved Upper and Lower Extremity Muscle Strength for ICU Survivors—A Pilot Randomized Controlled Study

2021 ◽  
pp. 109980042110502
Author(s):  
Zhan Liang ◽  
Hilary Yip ◽  
Kimberly Sena Moore ◽  
Tanira Ferreira ◽  
Ming Ji ◽  
...  
Keyword(s):  
Muscle Strength ◽  
Lower Extremity ◽  
Active Control ◽  
Exercise Intervention ◽  
Controlled Study ◽  
Control Group ◽  
Active Control Group ◽  
Randomized Controlled ◽  
Left And Right ◽  
The Mean

Objective The objective of this study was to evaluate effects of a self-managed music-guided exercise intervention on muscle strength among intensive care unit (ICU) survivors. Methods We used a two-arm randomized-controlled trial. Following ICU discharge, eligible participants were assigned to one of two groups: music group ( n = 13) or active control group ( n = 13). The music group was taught to self-manage upper and lower extremity exercise movements by listening to an individualized music-guided playlist twice daily for 5 days. The active control group was provided an exercise brochure and advised to perform the same exercises at the same intervals. Dynamometers were used to measure muscle strength. T-tests and Weighted GEE models were used for testing the intervention effect between groups. Results Twenty-six subjects were enrolled. The mean age was 62.8 ( SD = 13.8), 53.8% were male, 65.4% were Caucasian, and the mean APACHE severity of illness score was 59 ( SD = 23.4). Reasons for ICU admission were mainly cardiac and medical. The music group showed significant improvements in handgrip, plantar flexion, leg extension, elbow flexion, and shoulder adduction strengths on left and right sides. Additionally, left and right leg extensor and left plantar flexor strengths showed significant post-differences, and small to moderately large effect sizes, between the music group and control group. Conclusion These findings suggest that a music-guided exercise intervention has the potential to improve muscle strength in ICU survivors and prevent further post-ICU deterioration in ICU survivors. Future trials should build upon these preliminary findings.

Postoperative analgesia by adding acupuncture to conventional therapy, a non-randomized controlled trial

2018 ◽  
Vol 16 (2) ◽  
Author(s):  
Ilana Levy ◽  
Samuel Attias ◽  
Lior Cohen ◽  
Nadav Stoppelmann ◽  
Dan Steinberger ◽  
...  
Keyword(s):  
Side Effects ◽  
Postoperative Pain ◽  
Analgesic Effect ◽  
Pain Treatment ◽  
Standard Of Care ◽  
Acupuncture Group ◽  
Controlled Study ◽  
Control Group ◽  
Pain Level ◽  
Randomized Controlled

Abstract Background Postoperative pain is common in patients hospitalized in surgical departments, yet it is currently not sufficiently controlled by analgesics. Acupuncture, a complementary medical practice, has been evaluated for its benefits in postoperative pain with heterogeneous results. We tested the feasibility of a controlled study comparing the postoperative analgesic effect of acupuncture together with standard-of-care to standard-of-care only. Methods In this pilot non-randomized controlled study conducted at a tertiary medical center in Israel, patients received either acupuncture with standard-of-care pain treatment (acupuncture group) or standard-of-care treatment only (control group) following surgery. Visual Analogue Scale (VAS) ratings for pain level at rest and in motion were evaluated both at recruitment and two hours after treatment. Acupuncture-related side effects were reported as well. Results We recruited 425 patients; 336 were assigned to the acupuncture group and 89 to the control group. The acupuncture group exhibited a decrease of at least 40% in average level of pain both at rest (1.8±2.4, p<0.0001) and in motion (2.1±2.8, p<0.0001) following acupuncture, whereas the control group exhibited no significant decrease (p=0.92 at rest, p=0.98 in motion). Acupuncture's analgesic effect was even more prominent in reducing moderate to severe pain at baseline (VAS ≥4), with a decrease of 49% and 45% of pain level at rest and in motion respectively (p<0.001), compared with no significant amelioration in the control group (p=0.20 at rest, p=0.12 in motion). No major side effects were reported. Conclusion Integrating acupuncture with standard care may improve pain control in the postoperative setting.

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