scholarly journals Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hong Hong ◽  
Da-Zhi Zhang ◽  
Mo Li ◽  
Geng Wang ◽  
Sai-Nan Zhu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Sleep Quality ◽  
Orthopedic Surgery ◽  
Controlled Trial ◽  
Median Difference ◽  
Randomized Controlled ◽  
Link Type ◽  
Major Orthopedic Surgery ◽  
Intravenous Analgesia

Abstract Background Dexmedetomidine promotes normal sleep architecture; the drug also improves analgesia. We therefore tested the hypothesis that supplementing intravenous analgesia with dexmedetomidine reduces delirium in older patients recovering from orthopedic surgery. Methods In this double-blinded randomized controlled trial, we enrolled 712 older (aged 65–90 years) patients scheduled for major orthopedic surgery. Postoperative analgesia was provided by patient-controlled intravenous sufentanil, supplemented by randomly assigned dexmedetomidine (1.25 μg/mL) or placebo, for up to three days. The primary outcome was the incidence of delirium assessed twice daily with the Confusion Assessment Method. Among secondary outcomes, pain severity was assessed twice daily and sleep quality once daily, each with an 11-point scale where 0 = no pain/the best possible sleep and 10 = the worst pain/the worst possible sleep. Results The incidence of postoperative delirium was 7.3% (26 of 354) with placebo and 4.8% (17 of 356) with dexmedetomidine; relative risk 0.65, 95% CI 0.36 to 1.18; P = 0.151. Dexmedetomidine reduced pain both at rest (median difference -1 to 0 points, P ≤ 0.001) and with movement (-1 points, P < 0.001) throughout the first 5 postoperative days; it also improved subjective sleep quality during the first 3 postoperative days: day one median difference -1 point (95% CI -1 to 0), P = 0.007; day two 0 point (-1 to 0), P = 0.010; and day three 0 point (-1 to 0), P = 0.003. The incidence of adverse events was similar in each group. Conclusions Supplementing sufentanil intravenous analgesia with low-dose dexmedetomidine did not significantly reduce delirium, but improved analgesia and sleep quality without provoking adverse events. Trial registration www.chictr.org.cn: ChiCTR1800017182 (Date of registration: July 17, 2018); ClinicalTrials.gov:NCT03629262 (Date of registration: August 14, 2018).

scholarly journals Determining the feasibility of a trial to evaluate the effectiveness of phototherapy versus placebo at reducing pain during physical activity for people with knee osteoarthritis: a pilot randomized controlled trial 

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Kyle Vader ◽  
Abey Bekele Abebe ◽  
Mulugeta Bayisa Chala ◽  
Kevin Varette ◽  
Jordan Miller
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Treatment Fidelity ◽  
Randomized Controlled ◽  
Link Type ◽  
Full Trial

Abstract Background Although practice guidelines recommend physical activity and exercise for the management of knee osteoarthritis, pain is a common barrier to participation. Phototherapy has been shown to reduce pain intensity for people with knee osteoarthritis, but it is unclear if it reduces pain during physical activity or contributes to improved rehabilitation outcomes. Objective The aim of this study is to assess the feasibility of performing a fully powered randomized controlled trial (RCT) comparing an active phototherapy intervention versus placebo on pain during physical activity for people with knee osteoarthritis. Methods A pilot RCT was conducted to test the feasibility of a trial comparing 8-sessions (4 weeks) of active phototherapy versus placebo. People were able to participate if they (1) were an English speaking adult (> 18 years of age), (2) had received a diagnosis of knee osteoarthritis from a physician, and (3) self-reported experiencing pain and disability related to their knee osteoarthritis for > 3 months. Primary outcomes were the feasibility of participant recruitment, retention, assessment procedures, and maintaining high treatment fidelity. Secondary outcomes piloted for a full trial included pain during physical activity (primary outcome of full trial); self-reported pain severity, physical function, stiffness, adherence to prescribed exercise, global rating of change, patient satisfaction, and adverse events; 6-min walk test; and pressure pain threshold. Results Twenty participants (4 men; 16 women) with knee osteoarthritis and a mean age of 63.95 (SD: 9.27) years were recruited over a 3-week period (6.7 participants per week). Fifteen out of 20 (75%) of participants completed the primary outcome assessment at 4 weeks and 19/20 (95%) of participants were retained and completed the final 16-week assessment. Overall, 89% of all assessment items were completed by participants across all time-points. Fifteen out of 20 participants (75%) completed all 8 treatment sessions. Treatment fidelity was 100% for all completed treatment sessions. No adverse events were reported by participants in either group. Conclusions Results suggest that the trial methodology and intervention are feasible for implementation in a fully powered randomized controlled trial to determine the effectiveness of phototherapy at reducing pain during physical activity for people with knee osteoarthritis. Trial registration ClinicalTrials.gov, NCT04234685, January 21, 2020–Retrospectively registered.

The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Lavender Oil ◽  
Entire Cohort ◽  
Randomized Controlled ◽  
Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

Water exchange-assisted vs. carbon dioxide-insufflated single-balloon enteroscopy: randomized controlled trial

Endoscopy ◽  
2021 ◽  
Author(s):  
Shaopeng Liu ◽  
Tao Dong ◽  
Yupeng Shi ◽  
Hui Luo ◽  
Xianmin Xue ◽  
...  
Keyword(s):  
Carbon Dioxide ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Water Exchange ◽  
Controlled Trial ◽  
Control Group ◽  
Balloon Enteroscopy ◽  
Randomized Controlled ◽  
Single Balloon ◽  
Single Balloon Enteroscopy

<b>Background and study aims</b> Single-balloon enteroscopy (SBE) is a valuable but difficult modality for the diagnosis and treatment of small-bowel diseases. The water exchange (WE) method has the advantage of facilitating intubation during colonoscopy. Here, we evaluated the effects of WE on procedure-related variables related to SBE. <b>Patients and methods</b> This randomized controlled trial was conducted in a tertiary-care referral center in China. Patients with attempt at total enteroscopy (ATE) were randomly allocated to undergo WE-assisted (WE group) or carbon dioxide-insufflated enteroscopy (CO<sub>2</sub> group). All patients were planned to undergo both antegrade and retrograde procedures. The primary outcome was the total enteroscopy rate (TER). Secondary outcomes included maximal insertion depth, positive findings, procedural time and adverse events. <b>Results</b> In total, 110 patients were enrolled, with 55 in each group. Baseline characteristics between the two groups were comparable. TER was achieved in 58.2% (32/55) of the WE group and 36.4% (20/55) of the control group (p=0.022). The estimated intubation depth was 521.2±101.4 cm in the WE group and 481.6±95.2 cm in the CO<sub>2</sub> group (p=0.037). The insertion time was prolonged in the WE group compared with CO<sub>2</sub> group (178.9±45.1 min vs. 154.2±27.6 min, p<0.001). Endoscopic findings and adverse events were comparable between the two groups. <b>Conclusions</b> The WE method improved TER and increased intubation depth during SBE. The use of WE did not increase complications of enteroscopy. Clinical trial registation: https://clinicaltrials.gov/， NCT01942863.

scholarly journals Effectiveness of interactive augmented reality-based telerehabilitation in patients with adhesive capsulitis: protocol for a multi-center randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Seung Mi Yeo ◽  
Ji Young Lim ◽  
Jong Geol Do ◽  
Jae-Young Lim ◽  
Jong In Lee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Therapy ◽  
Augmented Reality ◽  
Controlled Trial ◽  
Adhesive Capsulitis ◽  
Performance Measure ◽  
Home Exercise ◽  
Randomized Controlled ◽  
Link Type ◽  
Home Based

Abstract Background As the primary treatment for adhesive capsulitis, intensive and accurate home exercise is as important as physical therapy in hospitals. Augmented reality (AR)-based telerehabilitation has been implemented recently in various musculoskeletal conditions to increase patient compliance and enable patients to exercise with the correct posture. The objective of this study is to present a protocol for investigating the additive effect of interactive AR-based telerehabilitation in comparison with the usual care for patients with adhesive capsulitis. Methods This study presents the protocol of a prospective, multi-center, single-blinded, two-armed randomized controlled trial (RCT). One hundred patients with stage I or II adhesive capsulitis will be recruited at the physical medicine and rehabilitation clinic. Patients will be randomly divided into two groups with 1:1 allocation. The intervention group will receive 3 months of hospital-based physical therapy in conjunction with home-based telerehabilitation. The control group will receive 3 months of hospital-based physical therapy in conjunction with a home-based exercise described in a brochure provided by the hospital. The primary outcome will be the change in passive range of motion (ROM) of the affected shoulder joint from baseline to 12 weeks after baseline assessment. The secondary outcomes will be active ROM, pain measured with the numeric rating scale, shoulder pain and disability index, 36-Item Short Form Survey, EuroQoL-5D-5L, and Canadian Occupational Performance Measure. Discussion This will be the first RCT study protocol to investigate the effect of telerehabilitation in patients with adhesive capsulitis. The result of this RCT will determine whether AR-based telerehabilitation is more effective than a brochure-based home exercise program and will provide evidence of the usefulness of “telerehabilitation” using hardware (IoT) and software (monitoring platform) technologies to develop “digital therapeutics” for the future. Trial registration This trial was retrospectively registered at the Clinicaltrials.gov website on 20 March 2020, with the identifier NCT04316130.

scholarly journals The ACTyourCHANGE study protocol: promoting a healthy lifestyle in patients with obesity with Acceptance and Commitment Therapy—a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anna Guerrini Usubini ◽  
Roberto Cattivelli ◽  
Emanuele Maria Giusti ◽  
Francesco Vailati Riboni ◽  
Giorgia Varallo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Acceptance And Commitment Therapy ◽  
Mechanism Of Action ◽  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Psychological Flexibility ◽  
Randomized Controlled ◽  
Link Type ◽  
Commitment Therapy ◽  
Acceptance And Commitment

Abstract Background As treatment of choice in promoting psychological flexibility, Acceptance and Commitment Therapy (ACT) was found to be effective in several conditions, and among different populations, including weight management in individuals with obesity. However, the mechanism of action of psychological flexibility is less known. The aim of the present study is, within the context of a brief ACT intervention for behavioral change and behavioral maintenance of a healthy lifestyle in a sample of inpatients with obesity, to explore the effect of each subcomponent of the psychological flexibility model on treatment processes and outcomes. Methods A randomized controlled trial will be conducted. Ninety Italian adult inpatients with obesity attending a rehabilitation program for weight loss will be randomly allocated into three experimental conditions targeting respectively each subcomponent of the psychological flexibility model: group Engage focused on values-oriented behaviors, group Openness focused on acceptance and cognitive defusion, and group Awareness focused on being present and aware of thoughts, feelings, and behaviors at every moment. Weight, BMI (kg/m2), the Psychological General Well-Being Inventory (PGWBI), the Outcome Questionnaire-45.2 (OQ-45.2), the Depression Anxiety and Stress Scale (DASS-21), the Difficulties in Emotion Regulation Scale (DERS), the Dutch Eating Behaviors Questionnaire (DEBQ), the Brief Values Inventory (BVI), the Committed Action Questionnaire (CAQ), the Italian-Cognitive Fusion Questionnaire (I-CFQ), the Five Facet Mindfulness Questionnaire (FFMQ), and the Acceptance and Action Questionnaire (AAQ-II) will be assessed at the beginning (time 0), at the end of psychological intervention (time 1), and after 3 (time 2) and 6 months (time 3) and 9 months (time 4) from discharge. During the following month after discharge, outpatients will be monitored in their adherence to a healthy lifestyle, using a wearable device. To assess the effectiveness of the intervention, mixed between-within 3 (conditions) × 4 (times) repeated measure ANOVAs will be conducted to examine changes from time 0 to time 1, 2, 3, and 4 in means of weight, BMI, and means of scores PGWBI, OQ-45.2, DASS, DERS, DEBQ, AAQ-II, BVI, CAQ, I-CFQ, and FFMQ, between three groups. Discussion This study will contribute to clarify the mechanism of action of each subcomponent of the psychological flexibility model and understand its impact on the promotion of a healthy lifestyle. Trial registration ClinicalTrials.govNCT04474509. Registered on July 4, 2020

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

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