scholarly journals Children Listening to Music or Watching Cartoons During ER Procedures: A RCT

2019 ◽  
Vol 44 (10) ◽  
pp. 1151-1162
Author(s):  
Marianne J E van der Heijden ◽  
Hiske Mevius ◽  
Nicky van der Heijde ◽  
Joost van Rosmalen ◽  
Sebastian van As ◽  
...  
Keyword(s):  
Heart Rate ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Multivariable Analysis ◽  
Pain Scale ◽  
Secondary Outcome ◽  
Control Groups ◽  
Video Footage ◽  
Alder Hey ◽  
And Control

Abstract Objective This study aims to determine if listening to music and watching cartoons are effective to distract children from pain and distress during procedures in the emergency room (ER). Methods This study is a single-center, 3-armed, superiority randomized controlled trial comparing listening to music, watching cartoons, and standard care during ER procedures in children aged 3–13 years. The primary outcome was pain measured from video footage with the Alder Hey Triage Pain Score (AHTPS). Children older than 4 years self-reported pain with the Faces Pain Scale-Revised (FPS-R). The secondary outcome was distress measured with the Observational Scale of Behavioral Distress-revised (OSBD-r). Another indicator of distress was heart rate. Results Data of 191 participants were analyzed for the 3 groups: music (n = 75), cartoon (n = 62), and control (n = 54). The median age was 7.3 years (4.9–9.7). In multivariable analysis, pain assessed with the AHTPS was significantly lower (B = −1.173, 95% confidence interval −1.953, −0.394, p = .003) in the music group than in the control groups. Across the 3 groups, 108 children self-reported pain with the FPS-R after the procedure. The scores were lowest in the music group, but the differences between groups were not significant (p = .077). OSBD-r distress scores assigned during the procedures were not significantly different between the 3 groups (p = .55). Heart rate directly after the procedure was not statistically significantly different between the 3 groups (p = .83). Conclusions Listening to recorded music is a beneficial distraction for children experiencing pain during ER procedures, whereas watching cartoons did not seem to reduce pain or distress.

scholarly journals Effects of TangWang prescription intervention in type 2 non-proliferative diabetic retinopathy：a study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
WenJing Huang ◽  
De Jin ◽  
Xiang Meng ◽  
Fan Yang ◽  
Yu-jiao Zheng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Diabetic Retinopathy ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Groups ◽  
Random System ◽  
Randomized Controlled ◽  
And Control

Abstract Background: Presently, the efficacy of drug treatments for diabetic retinopathy (DR) is not satisfactory. This study is designed to provide evidence that a traditional Chinese medicine (TCM) formulation delays the development of DR. Methods: This study is a randomized, double-blind, placebo-controlled parallel-group, multicenter clinical trial, consisting of 384 participants to be randomized in a 1:1 ratio in the treatment and control groups, and receive a basic treatment. Furthermore, the treatment and control groups will be administered the TangWang prescription and the placebo, respectively, each at a dose of one bag twice a day. The study period will last for 48 weeks. The primary outcome measure will be the changes in the degree of retinal microvascular lesions before and after treatment. The secondary outcome will be changes in the degree of hemangioma, microvascular bleeding, microvascular leakage, macular edema, and vision. All statistical tests will be two-sided, and a P < 0.05 will be considered statistically significant. Discussion: We hypothesize that the patients with DR will benefit from TangWang prescription, and in addition to the central random system and platform of dynamic information collection, the patients’ conditions will be monitored and the data collected for analysis. If successful, this study will provide evidence that the TCM formulation delays the development of DR. Trial registration: ClinicalTrials.gov, NCT03025399. Registered on January 19 2017. Keywords: Diabetic retinopathy, TangWang prescription, randomized controlled trial, traditional Chinese medicine

scholarly journals Efficacy and Safety of TangWang Prescription for Type 2 Non-Proliferative Diabetic Retinopathy: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
De Jin ◽  
Yuehong Zhang ◽  
Yuqing Zhang ◽  
Wenjing Huang ◽  
Xiang Meng ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Statistical Tests ◽  
Controlled Trial ◽  
Microvascular Complications ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Control Groups ◽  
Double Blind ◽  
Random System ◽  
And Control

Background: Diabetic retinopathy (DR) is one of the most common and severe microvascular complications of diabetes mellitus (DM), which results in blindness among adults worldwide. Presently, the efficacy of drug treatments for diabetic retinopathy (DR) is not satisfactory, thus urgently necessitating effective drug treatment measures. TangWang prescription (TWP) has been found to have retinal protection effects in previous clinical and basic research. However, there is a lack of rigorous, randomized, and controlled studies. This study aims to evaluate the efficacy and safety of TWP in delaying the development of DR.Methods: This study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial, consisting of 384 participants to be randomized in a 1:1 ratio in the treatment and control groups. Furthermore, the treatment and control groups will be administered the TangWang prescription and the placebo, respectively, each at a dose of one bag twice a day. The study period will last for 48 weeks. The primary outcome measure will be the changes in the degree of retinal microvascular lesions before and after treatment. The secondary outcome will be changes in the degree of hemangioma, microvascular bleeding, microvascular leakage, macular edema, and vision. All statistical tests will be two-sided, and a p &lt; 0.05 will be considered statistically significant.Discussion: We hypothesize that the patients with DR will benefit from TangWang prescription, and in addition to the central random system and platform of dynamic information collection, the patients’ conditions will be monitored, and the data collected for analysis. If successful, this study will provide evidence that the TWP formulation delays in the progression of DR.Trial registration: The design of this trial has been registered with the ClinicalTrials.gov (NCT03025399).

scholarly journals Effects of an individualized analgesia protocol on the need for medical interventions after adenotonsillectomy in children: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jian Guo ◽  
Peijun Zhuang ◽  
Kun Liu ◽  
Yuanyuan Wan ◽  
Xuan Wang
Keyword(s):  
Median Duration ◽  
Controlled Trial ◽  
Pain Scale ◽  
Medical Intervention ◽  
Secondary Outcome ◽  
Sleep Study ◽  
Medical Interventions ◽  
Randomized Controlled ◽  
Obstructive Sleep ◽  
Blinded Trial

Abstract Background It has been proposed that the dose of rescue opioids should be individually titrated to the severity of obstructive sleep apnea after adenotonsillectomy. However, a sleep study is not always available before adenotonsillectomy. This randomized, controlled and blinded trial evaluated a strategy of pain control individualized to the results of a fentanyl test, rather than the results of polysomnography, in children after adenotonsillectomy. Methods A total of 280 children (3–10 years old) undergoing elective adenotonsillectomy were randomized into an individualized protocol (IP) group or a conservative protocol (CP) group. All patients received a fentanyl test before extubation. Pain was assessed every 10 min in the recovery room, and rescue morphine was given when the Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) score was > 6. In the IP group, the dose of rescue morphine was individualized to the results of the fentanyl test (10 μg/kg in the case of a positive result and 50 μg/kg in the case of a negative result). In the CP group, the dose was fixed (25 μg/kg). The primary outcome was the percentage of patients requiring at least one medical intervention. The secondary outcome was the median duration of CHEOPS scores > 6. Results Fewer patients in the IP group than in the CP group required medical interventions [11.9% (16/134) vs 22.3% (29/130), P = 0.025]. The median duration of CHEOPS scores > 6 was shorter in the IP group than in the CP group [20 (95% CI: 17 to 23) min vs 30 (95% CI: 28 to 32) min, P <  0.001]. Conclusions Compared with a conservative dosing approach, this individualized protocol may improve analgesia without a significant increase in respiratory adverse events. Trial registration ClinicalTrials.gov NCT02990910, registered on 13/12/2016.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals Alleviating psychological distress associated with a positive cervical cancer screening result: a randomized control trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yukari Isaka ◽  
Ai Hori ◽  
Rie Tanaka ◽  
Masao Ichikawa
Keyword(s):  
Cervical Cancer ◽  
Psychological Distress ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
And Control ◽  
Screening Result

Abstract Background The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress in a randomized controlled trial. Methods The participants were women aged 20–69 years who were about to undergo cervical cancer screening at health centers. Before the screening, they received hypothetical screening results, with a leaflet (intervention group, n = 493) or without it (control group, n = 479), randomly. Their psychological distress and intention to undergo further examination were then compared between the intervention and control groups. Results After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87–3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination. Conclusions Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer. Trial registration: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.

Fascial treatment versus manual therapy (HVLA) in patients with chronic neck pain: A randomized controlled trial

2021 ◽  
pp. 1-10
Author(s):  
Katrin Brück ◽  
Kirsten Jacobi ◽  
Tobias Schmidt
Keyword(s):  
Neck Pain ◽  
Manual Therapy ◽  
Repeated Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
Chronic Neck Pain ◽  
Secondary Outcome ◽  
Control Group ◽  
Industrialized Nations

BACKGROUND: Chronic neck pain (CNP) is a common health problem in western industrialized nations. In recent years, the fascial tissue has attracted the attention of therapists, and a treatment of the fasciae promises to be a meaningful approach in the therapy of patients with CNP. OBJECTIVE: The aim of this study was to investigate the effectiveness of a fascial treatment (FT) compared to manual therapy (MT) and to no intervention (control group, CG) in patients with CNP. METHODS: Sixty participants with CNP were randomized into three groups. Primary outcome parameters were pain intensity as measured by the visual analogue scale (VAS), and severity of illness as measured by the Neck Pain and Disability Scale (NPAD). Secondary outcome parameter was the range of motion (ROM) of the cervical spine. RESULTS: Repeated measures t-tests demonstrated significant decreases with medium to large effect sizes for the FT (VAS: dR⁢M= 1.14; NPAD: dR⁢M= 0.51) and for the MT (VAS: dR⁢M= 1.15; NPAD: dR⁢M= 0.72). CONCLUSION: Our results confirmed the effectiveness of MT on pain and severity of illness in the treatment of patients suffering from CNP. Furthermore, the results demonstrated the effectiveness and clinical relevance of FT for this population.

Immersive Virtual Reality Improves Labor and Delivery Experience for Women: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Elif Gizem Carus ◽  
Nazli Albayrak ◽  
Selen Gur Ozmen ◽  
Halit Mert Bildirici
Keyword(s):  
Virtual Reality ◽  
Patient Satisfaction ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Immersive Virtual Reality ◽  
Labor And Delivery ◽  
Control Groups ◽  
Randomized Controlled ◽  
Pain Scores ◽  
And Control

Abstract Objective: To evaluate the effectiveness of immersive Virtual Reality (VR) in laboring women on patient satisfaction as a distractive tool and pain relief.Methods: Randomized, controlled clinical trial with 42 laboring women allocated to VR intervention and control groups. Among the VR group, patient satisfaction with the use of VR was assessed by a Virtual Reality Satisfaction Survey and questioning whether they would choose VR in future labor. As a primary outcome patient satisfaction scores regarding the overall labor and delivery experience were compared between the two groups. A secondary outcome was pain assessed by a visual pain rating scale in the early and active phases of labor in both groups. Psychometric information was also collected from participants in each group using Beck Anxiety Inventory and Beck Depression Inventory. Results: We observed a high level of patient satisfaction with the use of immersive VR during labor. The survey revealed a mean satisfaction score of 89.6 ± 10.8 out of a maximum of 100. 20 out of 21 (95%) women in the VR group stated that they would like to use VR again in future labor. VR improved pain scores in early labor and contributed positively to overall labor and delivery experience. The mean pain score pre-VR was 2.6±1.2 compared to 2.0±1.3, post-VR, respectively (p<0.01). Anxiety and depression scores were similar in the intervention and control groups (p=0.103, p=0.13, respectively). Conclusion: Immersive VR application during labor was feasible and associated with higher patient satisfaction based on our study. VR also improved pain scores in early labor before epidural placement. Immersive VR may find a place as an adjunct in Labor and Delivery Units to improve the lengthy labor experience for women. Larger studies are needed to confirm these observations. Trial Registration: ClinicalTrials.gov: NCT05032456 / 02/09/2021https://clinicaltrials.gov/ct2/show/NCT05032456

The Efficacy of Silver-Ion Implanted Catheters in Reducing Peritoneal Dialysis-Related Infections

2003 ◽  
Vol 23 (4) ◽  
pp. 368-374 ◽  
Author(s):  
John H. Crabtree ◽  
Raoul J. Burchette ◽  
Rukhsana A. Siddiqi ◽  
Isan T. Huen ◽  
Linda L Hadnott ◽  
...  
Keyword(s):  
Ion Beam ◽  
Controlled Trial ◽  
Silver Ion ◽  
Control Group ◽  
Site Infection ◽  
Control Groups ◽  
Exit Site ◽  
Exit Site Infection ◽  
Catheter Survival ◽  
And Control

♦ Background Dialysis-related infections are the commonest cause of catheter loss and transfer to hemodialysis. Surface modifications of the catheter that reduce infections are of major importance. ♦ Objective The efficacy of silver-ion treated catheters in reducing dialysis-related infections was tested. ♦ Methods The study design was a prospective, randomized controlled trial. Patients were implanted with either a silver-treated study catheter or a control catheter. Prospective collection of data included infectious complications and catheter survival. ♦ Results The subject groups were comprised of 67 silver-treated catheters and 72 control catheters. Demographic characteristics of the study and control groups were equal. Exit-site infection rates for the study group and control group (0.52 and 0.45 episodes/patient-year of dialysis respectively) were not different by Poisson regression analysis ( p > 0.4). Peritonitis rates were identical for the two groups (0.37 episodes/patient-year) and were not different by Poisson analysis ( p > 0.9). Antibiotic-free intervals between infections for the study and control groups were not significantly different for exit-site infections ( p = 0.58), peritonitis ( p = 0.44), or both infections combined ( p = 0.47). Actuarial analyses showed no differences between the groups in the probability of remaining free of exit-site infection ( p> 0.2) or peritonitis ( p > 0.7). Similarly, catheter survival was not significantly different between the groups ( p > 0.6). ♦ Conclusion Surface modification of catheters with ion beam implantation of silver produced no clinical effect with respect to reducing dialysis-related infections.

scholarly journals Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 929
Author(s):  
Nouran Hesham El-Sherazy ◽  
Naglaa Samir Bazan ◽  
Sara Mahmoud Shaheen ◽  
Nagwa A. Sabri
Keyword(s):  
Ascorbic Acid ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Statistical Significance ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Control Groups ◽  
The Absolute ◽  
And Control

Background Antioxidants show nephroprotective effect against vancomycin associated nephrotoxicity (VAN) in animals. This study aimed to assess the ascorbic acid nephro-protective role against VAN clinically. Methods Forty-one critically ill patients were randomly assigned to one of two groups: intervention group (vancomycin IV plus ascorbic acid, n=21) or control group (vancomycin IV only, n=20). Primary outcomes were the incidence of VAN and the absolute change in creatinine parameters, while mortality rate was the secondary outcome. Nephrotoxicity was defined as an increase in serum creatinine (S.cr) by at least 0.5 mg/dL or 50% of baseline for at least two successive measurements. This study is registered at Clinicaltrials.gov (NCT03921099), April 2019. Results Mean absolute S.cr increase was significant when compared between both groups, P-value = 0.036, where S.cr increased by 0.05(0.12) and 0.34(0.55) mg/dL in the intervention and control groups, respectively. Mean absolute Cr.cl decline was significant when compared between both groups, P-value = 0.04, where Cr.cl was decreased by 5.9(17.8) and 22.3(30.4) ml/min in the intervention and control groups, respectively. Incidence of VAN was 1/21(4.7%) versus 5/20(25%) in the intervention and control groups, respectively (RR: 0.19; CI: 0.024–1.49; P-value = 0.093). Mortality was higher in the control group; however, it was not statistically significant, P-value = 0.141. Conclusion Co-administration of ascorbic acid with vancomycin preserved renal function and reduced the absolute risk of VAN by 20.3%, however, the reduction in VAN incidence didn’t reach statistical significance level. Further large multicenter prospective trials are recommended.

scholarly journals The Effectiveness of Auditory Stimuli from Murottal Quran to Improve Comfort and Weight in Low Birth Weight Infants: Randomized Controlled Trial

Jurnal NERS ◽  
2019 ◽  
Vol 14 (1) ◽  
pp. 111
Author(s):  
Desriati Devi ◽  
Yeni Rustina ◽  
Defi Efendi
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Controlled Trial ◽  
Auditory Stimuli ◽  
Control Groups ◽  
Low Birth Weight Infants ◽  
Randomized Controlled ◽  
Significant Difference ◽  
And Control

Introduction: Low birth weight (LBW) infants who have been hospitalized are exposed to various conditions that provoke discomfort, which could trigger a stress response and growth disorders. This study aimed to identify the effects of auditory stimuli from Murottal Quran when it comes to the comfort and weight of LBW infants.Methods: This study used a clinical randomized controlled trial design involving 52 low birth weight infants. The infants were randomly assigned to either the intervention group (n=26) or the control (n=26). The intervention of Murottal Quran was given using a speaker 4 times a day for 20 minutes every 3 hours. This intervention was conducted for three days.Results: The results of this study show that there is a significant difference in the comfort of  low birth weight infants after Murottal Qur’an on the first, second, and third days between the intervention and control groups (p=0.014; <0.001; <0.001). There was no significant difference in the weight between the intervention and control groups in the first, second, and third days (p=0.481; 0.481; 0.464).Conclusion: The auditory stimuli of Murottal Quran can help to improve the comfort level of low birth weight infants during hospitalization. It can therefore be used as a supportive therapy to facilitate low birth weight infant and premature infant development.

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