Music Therapy vs. Music Listening for Negative Symptoms in Schizophrenia: Randomized, Controlled, Assessor- and Patient-Blinded Trial

Objective: To investigate the efficacy of music therapy for negative symptoms in patients with schizophrenia.Methods: Randomized, participant- and assessor-blinded, multicenter, controlled trial including patients diagnosed with schizophrenia according to ICD-10 with predominantly negative symptoms, between 18 and 65 years. Participants were randomized to 25 successive weekly individual sessions (excluding holidays, including cancellation by the participant) of either music therapy conducted by trained music therapists, or music listening together with a social care worker. The primary outcome was reduction in negative symptoms as measured by The Positive and negative Syndrome Scale (PANSS) negative subscale total score, assessed by a blinded rater, utilizing mixed-effects model analysis.Results: In total, 57 participants were randomized; 39 completed the study's initial 15 weeks, and 30 completed follow-up at 25 weeks. On the primary outcome of PANSS negative subscale, no significant difference was observed between groups with a coefficient of −0.24 (95% CI −1.76 to 1.27, P = 0.754) in the intention to treat analysis, and −0.98 (95% CI −5.06 to 3.09, P = 0.625) when only analyzing completers. Both interventions showed significant reduction from baseline to 25 weeks on PANSS negative subscale. On secondary outcomes, no between group differences were observed in The Brief Negative Symptom Scale, WHOQOL-Bref (Quality of Life), The Helping Alliance Questionnaire and The Global Assessment of Functioning in the intention to treat or completers populations utilizing Mixed Effects Models.Conclusion: No difference between groups randomized to music therapy vs. musical listening was observed resulting in no clear recommendation for which intervention to use as the first choice for treatment of patients diagnosed with schizophrenia and predominantly having negative symptoms.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02942459.

Download Full-text

High-flow nasal oxygen cannula vs. noninvasive mechanical ventilation to prevent reintubation in sepsis: a randomized controlled trial

Annals of Intensive Care ◽

10.1186/s13613-021-00922-5 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Surat Tongyoo ◽

Porntipa Tantibundit ◽

Kiattichai Daorattanachai ◽

Tanuwong Viarasilpa ◽

Chairat Permpikul ◽

...

Keyword(s):

Mechanical Ventilation ◽

Respiratory Failure ◽

Primary Outcome ◽

Controlled Trial ◽

Spontaneous Breathing Trial ◽

High Flow ◽

Noninvasive Mechanical Ventilation ◽

Clinical Trial Registration ◽

Significant Difference ◽

Randomised Controlled

Abstract Background High-flow nasal oxygen cannula (HFNC) and noninvasive mechanical ventilation (NIV) can prevent reintubation in critically ill patients. However, their efficacy in post-extubated sepsis patients remains unclear. The objective of this study was to compare the efficacy of HFNC vs. NIV to prevent reintubation in post-extubated sepsis patients. Methods We conducted a single-centre, prospective, open-labelled, randomised controlled trial at the medical intensive care unit of Siriraj Hospital, Mahidol University, Bangkok, Thailand. Sepsis patients who had been intubated, recovered, and passed the spontaneous breathing trial were enrolled and randomly assigned in a 1:1 ratio to receive either HFNC or NIV support immediately after extubation. The primary outcome was rate of reintubation at 72 h after extubation. Results Between 1st October 2017 and 31st October 2019, 222 patients were enrolled and 112 were assigned to the HFNC group and 110 to the NIV group. Both groups were well matched in baseline characteristics. The median [IQR] age of the HFNC group was 66 [50–77] vs. 65.5 [54–77] years in the NIV group. The most common causes of intubation at admission were shock-related respiratory failure (57.1% vs. 55.5%) and acute hypoxic respiratory failure (34.8% vs. 40.9%) in the HFNC and NIV groups, respectively. The duration of mechanical ventilation before extubation was 5 [3–8] days in the HFNC group vs. 5 [3–9] days in the NIV group. There was no statistically significant difference in the primary outcome: 20/112 (17.9%) in the HFNC group required reintubation at 72 h compared to 20/110 (18.2%) in the NIV group [relative risk (RR) 0.99: 95% confidence interval (CI) (0.70–1.39); P = 0.95]. The 28-day mortality was not different: 8/112 (7.1%) with HFNC vs. 10/110 (9.1%) with NIV (RR 0.88: 95% CI (0.57–1.37); P = 0.59). Conclusions Among sepsis patients, there was no difference between HFNC and NIV in the prevention of reintubation at 72 h after extubation. Clinical Trial Registration ClinicalTrials.gov Identifier: NCT03246893; Registered 11 August 2017; https://clinicaltrials.gov/ct2/show/NCT03246893?term=surat+tongyoo&draw=2&rank=3

Download Full-text

Comparison of Simulation-Based versus Cadaveric-Tissue-Based Ocular Trauma Training on Novice Ophthalmologists: Repair of Corneal Laceration Model

Journal of Academic Ophthalmology ◽

10.1055/s-0041-1725093 ◽

2021 ◽

Vol 13 (01) ◽

pp. e57-e65

Author(s):

Boonkit Purt ◽

Timothy Ducey ◽

Sean Sykes ◽

Joseph F. Pasternak ◽

Denise S. Ryan ◽

...

Keyword(s):

Primary Outcome ◽

Wound Closure ◽

Ocular Trauma ◽

Controlled Trial ◽

Preliminary Evaluation ◽

Skills Acquisition ◽

Visual Axis ◽

Significant Difference ◽

Skills Laboratory ◽

Corneal Laceration

Abstract Purpose The aim of this study was to evaluate whether the simulated tissue models may be used in place of animal-based model for corneal laceration repair for surgical skills acquisition. Design Prospective randomized controlled trial. Participants Seventy-nine military and civilian 2nd- and 3rd-year ophthalmology residents and 16 staff ophthalmologists participating in the Tri-Service Ocular Trauma Skills Laboratory at the Uniformed Services University (Bethesda, MD). Methods Resident ophthalmologists underwent preliminary evaluation of their ability to close a 5-mm linear, full-thickness corneal laceration involving the visual axis. They then were randomized to undergo 90 to 120 minutes of either simulator-based (SIM) or swine cadaveric-tissue-based (CADAVER) corneal laceration repair. The same evaluation was performed post training. On a more limited basis, the study was repeated for attending ophthalmologists to act as a pilot for future analysis and test efficacy for “refresher” training. Main Outcome Measures Successful wound closure with secondary outcomes of suture length, tension, depth, and orientation, as graded by attending ophthalmologists. Results No significant difference in CADAVER versus SIM groups in the primary outcome of watertight wound closure of the corneal laceration. CADAVER group performed better than SIM group for certain metrics (suture depth, p = 0.009; length, p = 0.003; and tension, p = 0.043) that are associated with poor wound closure and increased amount of induced corneal astigmatism. For attending ophthalmologists, six of the eight in each group (SIM and CADAVER) retained or improved their skills. Conclusions For resident ophthalmologists, SIM training is sufficient for achieving the primary outcome of watertight wound closure. However, CADAVER training is superior for wound metrics for the ideal closure. For attending ophthalmologists, SIM training may be useful for retention of skills.

Download Full-text

Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial

Perfusion ◽

10.1177/0267659117715507 ◽

2017 ◽

Vol 32 (7) ◽

pp. 591-597 ◽

Cited By ~ 5

Author(s):

Geoff G. Lockwood ◽

Leilani Cabreros ◽

Dorota Banach ◽

Prakash P. Punjabi

Keyword(s):

Cardiac Surgery ◽

Primary Outcome ◽

Controlled Trial ◽

Morphine Consumption ◽

Controlled Study ◽

Double Blind ◽

Clinical Trial Registration ◽

Subcutaneous Infusion ◽

Randomised Controlled Study ◽

Randomised Controlled

Background: Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Method: Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg-1.hr-1) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. Results: There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l-1. There were no adverse events as a consequence of the study. Conclusion: Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. Clinical trial registration: ISRCTN13424423 ( https://www.isrctn.com )

Download Full-text

The Effect of Sevoflurane Anesthesia for Dental Procedure on Neurodevelopment in Children: A Prospective, Equivalence, Controlled Trial

10.21203/rs.3.rs-78114/v1 ◽

2020 ◽

Author(s):

Pinping Zhou ◽

Chao Zhang ◽

Guijin Huang ◽

Yuan Hu ◽

Wenzhu Ma ◽

...

Keyword(s):

General Anesthesia ◽

Local Anesthesia ◽

Primary Outcome ◽

Controlled Trial ◽

Age Groups ◽

Outcome Data ◽

Clinical Trial Registry ◽

General Anesthesia Group ◽

Anesthesia Group ◽

Significant Difference

Abstract Background: Dental procedures under general anesthesia (DGA) was found to improve the oral health-related quality of children's life. However, some parents and pediatricians expressed concern about the neurotoxicity of general anesthesia. The purpose of this trial was to investigate whether DGA in children has an adverse effect on neurodevelopment.Methods: In this prospective, assessor-masked, controlled, equivalence trial, we recruited 340 children younger than 7 years who were undergoing caries treatment between Feb 1, 2019, and Aug 31, 2019, without factors affecting neurodevelopment. They received either sevoflurane-based general anesthesia or awake-local anesthesia. The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition was used to evaluate the neurodevelopment of children at six months after surgery, and the Full-Scale IQ (FSIQ) was selected as the primary outcome. Predefine the 95% CI of a difference in means within five (1/3 SD) as the equivalence margin.Results: The outcome data were obtained from 129 children in the general anesthesia group and 144 in the local anesthesia group. The median length of general anesthesia was 130 min (IQR 110 – 160). There was equivalence in means of FSIQ score between the general anesthesia group and the local anesthesia group (local minus general anesthesia 0.46, 95% CI -2.35 to 1.61). There was no significant difference in FSIQ scores between different age groups and different anesthesia durations. Only the mother's education could affect the primary outcome.Conclusions: In this trial, prolonged DGA with a sevoflurane-only anesthetic in preschool children, does not adversely affect neurodevelopment at six months after surgery compared with awake-local anesthesia. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800015216. Registered Mar 15 2018, http://www.chictr.org.cn/showproj.aspx?proj=24830.

Download Full-text

The Effectiveness of a Community-Based Mentoring Program for Children Aged 5–11 Years: Results from a Randomized Controlled Trial

Prevention Science ◽

10.1007/s11121-020-01132-4 ◽

2020 ◽

Vol 22 (1) ◽

pp. 100-112 ◽

Cited By ~ 1

Author(s):

Nick Axford ◽

Gretchen Bjornstad ◽

Justin Matthews ◽

Laura Whybra ◽

Vashti Berry ◽

...

Keyword(s):

Primary Outcome ◽

Causal Effect ◽

Controlled Trial ◽

Well Being ◽

Mentoring Program ◽

Post Intervention ◽

Intention To Treat ◽

Randomized Controlled ◽

Average Causal Effect ◽

Superiority Trial

AbstractThe study, a two-arm, randomized controlled, parallel group, superiority trial, aimed to evaluate the implementation and effectiveness of a 12-month one-to-one volunteer mentoring program designed to improve behavioral and emotional outcomes in children aged 5 to 11 years who have teacher- and parent/carer-reported behavioral difficulties. Participants were 246 children (123 intervention, 123 control; mean age 8.4 years; 87% boys) in five sites in London, UK, scoring in the “abnormal” range on the teacher-rated Strengths and Difficulties Questionnaire (SDQ) Total Difficulties measure and in the “borderline” or abnormal range on the parent-rated SDQ Total Difficulties measure. Randomization on a 1:1 ratio took place using a computer-generated sequence and stratifying by site. Data collectors and statisticians were blind to participant allocation status. Outcome measures focused on parent- and teacher-rated child behavior and emotions, and child-rated self-perception and hope. Intention-to-treat analysis on all 246 randomized participants (using imputed data where necessary) showed that at post-intervention (16 months after randomization), there were no statistically significant effects on the primary outcome—parent-rated SDQ Total Difficulties (adjusted standardized mean difference = − 0.12; 95% CI: −0.38 to 0.13; p = 0.33)—or any secondary outcomes. Results from complier average causal effect (CACE) analysis using the primary outcome indicated the intervention was not effective for children who received the recommended duration of mentoring. Exploratory analyses found no sub-group effects on the primary outcome. The article concludes that the mentoring program had no effect on children’s behavior or emotional well-being, and that program content needs revising to satisfactorily address key risk and protective factors.

Download Full-text

A randomized controlled trial of 25 sessions comparing music therapy and music listening for children with autism spectrum disorder

Psychiatry Research ◽

10.1016/j.psychres.2020.113377 ◽

2020 ◽

Vol 293 ◽

pp. 113377

Author(s):

Thomas Rabeyron ◽

Juan-Pablo Robledo del Canto ◽

Emmanuelle Carasco ◽

Vanessa Bisson ◽

Nicolas Bodeau ◽

...

Keyword(s):

Autism Spectrum Disorder ◽

Randomized Controlled Trial ◽

Music Therapy ◽

Controlled Trial ◽

Children With Autism ◽

Autism Spectrum ◽

Spectrum Disorder ◽

Music Listening ◽

Randomized Controlled

Download Full-text

Exercise as migraine prophylaxis: A randomized study using relaxation and topiramate as controls

Cephalalgia ◽

10.1177/0333102411419681 ◽

2011 ◽

Vol 31 (14) ◽

pp. 1428-1438 ◽

Cited By ~ 125

Author(s):

Emma Varkey ◽

Åsa Cider ◽

Jane Carlsson ◽

Mattias Linde

Keyword(s):

Controlled Trial ◽

Scientific Evidence ◽

Randomized Study ◽

Exercise Group ◽

Migraine Prophylaxis ◽

Primary Efficacy Variable ◽

Primary Efficacy ◽

Intention To Treat ◽

Significant Difference

Aim: Scientific evidence regarding exercise in migraine prophylaxis is required. Therefore this study aimed to evaluate the effects of exercise in migraine prevention. Methods: In a randomized, controlled trial of adults with migraine, exercising for 40 minutes three times a week was compared to relaxation according to a recorded programme or daily topiramate use, which was slowly increased to the individual’s highest tolerable dose (maximum 200 mg/day). The treatment period lasted for 3 months, and migraine status, quality of life, level of physical activity, and oxygen uptake were evaluated. The primary efficacy variable was the mean reduction of the frequency of migraine attacks during the final month of treatment compared with the baseline. Results: Ninety-one patients were randomized and included in the intention-to-treat analysis. The primary efficacy variable showed a mean reduction of 0.93 (95% confidence interval (CI) 0.31–1.54) attacks in the exercise group, 0.83 (95% CI 0.22–1.45) attacks in the relaxation group, and 0.97 (95% CI 0.36–1.58) attacks in the topiramate group. No significant difference was observed between the groups ( p = 0.95). Conclusion: Exercise may be an option for the prophylactic treatment of migraine in patients who do not benefit from or do not want to take daily medication.

Download Full-text

Outcomes and safety of concomitant topiramate or metformin for antipsychotics-induced obesity: a randomized-controlled trial

Annals of General Psychiatry ◽

10.1186/s12991-020-00319-x ◽

2020 ◽

Vol 19 (1) ◽

Author(s):

Congjie Wang ◽

Wenjie Shi ◽

Jianyang Xu ◽

Chengbing Huang ◽

Jiannan Zhu

Keyword(s):

Missing Values ◽

Psychiatric Patients ◽

Controlled Trial ◽

Intention To Treat ◽

Waist Hip Ratio ◽

Reduced Body ◽

Metformin Group ◽

Significant Difference ◽

The Impact ◽

Baseline Bmi

Abstract Background Although there are some existing data describing the usage of topiramate in patients with antipsychotic-induced obesity, study on its comparison with metformin is limited. This study aimed to explore the effectiveness and safety of concomitant topiramate on antipsychotic-induced obesity as well as its comparison with metformin. Methods 62 stabilized outpatients with antipsychotic-induced obesity were randomized into the topiramate group and the metformin group with 16-week treatment. The patients’ weight, body mass index (BMI), waist–hip ratio, and their side effects were assessed and compared. Intention-to-treat and completer analyses were performed. Meanwhile, covariance analysis was conducted to control the impact of the significant difference in BMI between the two groups. Results The two groups had comparable characteristics, though their difference in baseline BMI was significant. (1) Intention-to-treat analyses: the random missing values were replaced using the last observation carried forward method when intention-to-treat analyses were conducted. Compared with the baseline, the weight, BMI, and waist–hip ratio in the topiramate group markedly decreased at each follow-up, whereas, in the metformin group, only waist–hip ratio significantly decreased at 4 weeks after treatment. Compared with the metformin, only weight and BMI in the topiramate group were significantly decreased at week 4 after treatment, and at week 8–16, weight, BMI and waist–hip ratio were remarkably declined. (2) Completer analyses: compared with the baseline, the weight, BMI, and waist–hip ratio in the topiramate group at week 4–16 were markedly decreased, whereas only waist–hip ratio with metformin was significantly decreased at week 4. Compared with the metformin, all BMI with topiramate were markedly decreased at week 4–16. Moreover, its weight and waist–hip ratio also were notably lowered at week 8. No significant differences in adverse events were found between the two groups. Conclusions Topiramate, similar to metformin in reducing obesity as previously reported, also significantly reduced body weight, BMI, and waist–hip ratio in patients with antipsychotic-induced obesity and demonstrated well tolerance in psychiatric patients. Trialregistration The trial was registered at http://www.chictr.org.cn, and the number was ChiCTR-IPR-17013122.

Download Full-text

Impact of a 1-day versus 3-day low-residue diet on bowel cleansing quality before colonoscopy: a randomized controlled trial

Endoscopy ◽

10.1055/a-0864-1942 ◽

2019 ◽

Vol 51 (07) ◽

pp. 628-636 ◽

Cited By ~ 4

Author(s):

Antonio Z. Gimeno-García ◽

Raquel de la Barreda Heuser ◽

Cristina Reygosa ◽

Alberto Hernandez ◽

Isabel Mascareño ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Dietary Recommendations ◽

Detection Rates ◽

Split Dose ◽

Intention To Treat ◽

Level Of Satisfaction ◽

Adenoma Detection ◽

Bowel Cleansing ◽

Low Residue Diet

Abstract Background The aim of this study was to assess whether a 3-day low-residue diet (LRD) improved bowel cleansing quality compared with a 1-day LRD regimen. Methods Consecutive patients scheduled for outpatient colonoscopy were randomized to the 1-day LRD or 3-day LRD groups. All patients received a 2-L split-dose of polyethylene glycol plus ascorbic acid. The primary outcome was bowel cleansing quality as evaluated using the Boston Bowel Preparation Scale (BBPS) (adequate cleansing ≥ 2 points per segment). Secondary outcomes were adherence to and level of satisfaction with the LRD, difficulty following the dietary recommendations, and willingness to repeat the same LRD in the future. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the primary outcome. A superiority analysis was performed to demonstrate that a 3-day LRD regimen was superior to a 1-day LRD regimen with a margin of 10 %. Results 390 patients (1-day LRD group = 196, 3-day LRD = 194) were included. The cleansing quality was not significantly different between the groups: ITT analysis 82.7 % (95 % confidence interval [CI] 77.4 to 88.0) vs. 85.6 % (95 %CI 80.7 to 90.5), with odds ratio (OR) 1.2 (95 %CI 0.72 to 2.15); PP analysis 85.0 % (95 %CI 79.9 to 90.1) vs. 88.6 % (95 %CI 84.0 to 93.2), with OR 1.4 (95 %CI 0.88 to 2.52). No differences were found regarding adherence to the diet or cleansing solution, satisfaction or difficulty with the LRD, and the polyp/adenoma detection rates. Conclusion 3-day LRD did not offer advantages over 1-day LRD in preparation for colonoscopy.

Download Full-text

Educational nurse-led telephone intervention shortly before colonoscopy as a salvage strategy after previous bowel preparation failure: a multicenter randomized trial

Endoscopy ◽

10.1055/a-1178-9844 ◽

2020 ◽

Vol 52 (11) ◽

pp. 1026-1035 ◽

Cited By ~ 1

Author(s):

Marco Antonio Alvarez-Gonzalez ◽

Miguel Ángel Pantaleón Sánchez ◽

Belén Bernad Cabredo ◽

Ana García-Rodríguez ◽

Santiago Frago Larramona ◽

...

Keyword(s):

Bowel Preparation ◽

Protocol Analysis ◽

Controlled Trial ◽

Intervention Group ◽

Telephone Intervention ◽

Intention To Treat ◽

Bowel Cleansing ◽

Significant Difference ◽

Inadequate Bowel Preparation ◽

And Control

Background The most important predictor of unsuccessful bowel preparation is previous failure. For those patients with previous failure, we hypothesized that a nurse-led educational intervention by telephone shortly before the colonoscopy appointment could improve cleansing efficacy. Methods We performed a multicenter, endoscopist-blinded, randomized controlled trial. Consecutive outpatients with previous inadequate bowel preparation were enrolled. Both groups received the same standard bowel preparation protocol. The intervention group also received reinforced education by telephone within 48 hours before the colonoscopy. The primary outcome was effective bowel preparation according to the Boston Bowel Preparation Scale. Intention-to-treat (ITT) analysis included all randomized patients. Per-protocol analysis included patients who could be contacted by telephone and the control cases. Results 657 participants were recruited by 11 Spanish hospitals. In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %; P = 0.12). In the intervention group, 267 patients (82.9 %) were contacted by telephone. Per-protocol analysis revealed significantly improved bowel preparation in the intervention group (83.5 % vs. 72.0 %; P = 0.001). Conclusion Among all patients with previous inadequate bowel preparation, nurse-led telephone education did not result in a significant improvement in bowel cleansing. However, in the 83 % of patients who could be contacted, bowel preparation was substantially improved. Phone education may therefore be a useful tool for improving the quality of bowel preparation in those cases.

Download Full-text