scholarly journals A randomised controlled trial of a code-word enuresis alarm

2015 ◽  
Vol 101 (4) ◽  
pp. 326-331 ◽  
Author(s):  
Patrina H Y Caldwell ◽  
Premala Sureshkumar ◽  
Marianne I Kerr ◽  
Sana Hamilton ◽  
Armando Teixeira-Pinto ◽  
...  
Keyword(s):  
Adverse Events ◽  
Controlled Trial ◽  
Code Word ◽  
Control Group ◽  
Median Percentage ◽  
Registration Number ◽  
Satisfaction With Treatment ◽  
Randomised Controlled ◽  
Enuresis Alarm ◽  
Experimental Group

ObjectiveTo compare a novel code-word alarm with a commercially available wireless alarm for treating enuresis.SettingA tertiary paediatric centre.PatientsChildren aged 6–18 with at least 3 wet nights per week in the previous 6 months referred by doctors.OutcomesPrimary outcome: the proportion who achieved a full response (14 consecutive dry nights) by 16 weeks. Secondary outcomes: change in frequency of wetting, duration of alarm training, percentage of wet nights that the child woke to the alarm, adherence to treatment, adverse events and satisfaction with treatment.ResultsOf the 353 participants, 176 were assigned to the code-word alarm and 177 to control. At 16 weeks, 54% (95% CI 47% to 61%) in the experimental group and 47% (95% CI 40% to 55%) in the control group had achieved a full response (p=0.22), with 74% and 66%, respectively, attaining a 50% or more reduction in wetting frequency (p=0.14). The experimental group woke more often than the control group (median percentage of waking 88% vs 77%, p=0.003) and had a greater reduction in wet nights (median reduction of 10 vs 9 nights per fortnight). Fewer in the experimental group discontinued therapy before achieving a full response (27% vs 37% discontinued, p=0.04). There were no significant differences in relapse rates at 6 months, adverse events or satisfaction between the two alarms.ConclusionsAlthough the code-word alarm increased waking, no difference in full response rates was demonstrated between the two alarms.Trial registration numberACTRN12609000070235.

scholarly journals The CARESSES Randomised Controlled Trial: Exploring the Health-Related Impact of Culturally Competent Artificial Intelligence Embedded Into Socially Assistive Robots and Tested in Older Adult Care Homes

2021 ◽  
Author(s):  
Chris Papadopoulos ◽  
Nina Castro ◽  
Abiha Nigath ◽  
Rosemary Davidson ◽  
Nicholas Faulkes ◽  
...  
Keyword(s):  
Older Adult ◽  
Controlled Trial ◽  
Control Group ◽  
Culturally Competent ◽  
Adult Care ◽  
Assistive Robots ◽  
Sf 36 ◽  
Randomised Controlled ◽  
Experimental Group ◽  
Group 1

AbstractThis trial represents the final stage of the CARESSES project which aimed to develop and evaluate a culturally competent artificial intelligent system embedded into social robots to support older adult wellbeing. A parallel group, single-blind randomised controlled trial was conducted across older adult care homes in England and Japan. Participants randomly allocated to the Experimental Group or Control Group 1 received a Pepper robot for up 18 h across 2 weeks. Two versions of the CARESSES artificial intelligence were tested: a fully culturally competent system (Experimental Group) and a more limited version (Control Group 1). Control Group 2 (Care As Usual) participants did not receive a robot. Quantitative outcomes of interest reported in the current paper were health-related quality of life (SF-36), loneliness (ULS-8), and perceptions of robotic cultural competence (CCATool-Robotics). Thirty-three residents completed all procedures. The difference in SF-36 Emotional Wellbeing scores between Experimental Group and Care As Usual participants over time was significant (F[1] = 6.614, sig = .019, ηp2 = .258), as was the comparison between Any Robot used and Care As Usual (F[1] = 5.128, sig = .031, ηp2 = .146). There were no significant changes in SF-36 physical health subscales. ULS-8 loneliness scores slightly improved among Experimental and Control Group 1 participants compared to Care As Usual participants, but this was not significant. This study brings new evidence which cautiously supports the value of culturally competent socially assistive robots in improving the psychological wellbeing of older adults residing in care settings.

scholarly journals Analgesic effects of intravenous flunixin and intrafunicular lidocaine or their combination for castration of lambs

2018 ◽  
Vol 5 (1) ◽  
pp. e000266 ◽  
Author(s):  
Paola Straticò ◽  
Vincenzo Varasano ◽  
Riccardo Suriano ◽  
Massimo Mariscoli ◽  
Domenico Robbe ◽  
...  
Keyword(s):  
General Anaesthesia ◽  
Controlled Trial ◽  
Serum Cortisol ◽  
Cortisol Concentration ◽  
University Teaching ◽  
Control Group ◽  
Lidocaine Group ◽  
Analgesic Effects ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo analyse the effectiveness of intrafunicular lidocaine and intravenous flunixin for reducing pain and signs of stress in lambs undergoing surgical castration.DesignRandomised controlled trial.SettingOne university teaching hospital in Italy.Participants30 healthy male lambs, 9–12 weeks old.InterventionAllocation to five groups: a control group (C), undergoing general anaesthesia but not castration; a surgery group (S), undergoing orchiectomy without analgesic treatment; a surgery-lidocaine group (SL), undergoing orchiectomy and receiving intrafunicular 2 per cent lidocaine solution; a surgery-flunixin group (SF), undergoing orchiectomy and receiving intravenous flunixin; a surgery-flunixin-lidocaine group (SFL), undergoing orchiectomy and receiving both intrafunicular lidocaine and intravenous flunixin.Main outcome measuresNociception and stress were assessed through intraoperative indicators, serum cortisol concentration, glycaemia, behaviour, immune response and clinical evaluation of the heart rate (HR), respiratory rate and rectal temperature after surgery.ResultsGroups S and SL showed increased values of intraoperative HR, mean arterial pressure and postoperative cortisol concentration. In group SFL, cortisol values were similar to those of group C. No other difference could be detected.ConclusionsThe combination of intravenous flunixin and intrafunicular lidocaine reduced the pain and discomfort of lambs castrated under general anaesthesia. Intrafunicular lidocaine alone did not prevent pain or discomfort associated with castration.Trial registration number30/2012/CEISA/COM.

A Controlled Trial of Home-Based Acute Psychiatric Services

1993 ◽  
Vol 163 (1) ◽  
pp. 49-54 ◽  
Author(s):  
Tom Burns ◽  
Alan Beadsmoore ◽  
Ashok V. Bhat ◽  
Andrew Oliver ◽  
Carola Mathers
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Community Based ◽  
Home Based ◽  
Randomised Controlled Study ◽  
One Year ◽  
Randomised Controlled ◽  
Clinical Measures ◽  
Experimental Group

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).

scholarly journals Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

2020 ◽  
Vol 7 (1) ◽  
pp. e000376
Author(s):  
Sivakami Janahiraman ◽  
Chan Yen Tay ◽  
Jie Min Lee ◽  
Wen Ling Lim ◽  
Chun Hoe Khiew ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Educational Programme ◽  
Control Group ◽  
Randomised Controlled ◽  
The Impact ◽  
Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

scholarly journals Effectiveness of mental simulations on the early mobilization of patients after cesarean section: a randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna Prokopowicz ◽  
Katarzyna Byrka
Keyword(s):  
Process Simulation ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Mental Simulation ◽  
Controlled Study ◽  
Control Group ◽  
Simulation Group ◽  
Randomised Controlled ◽  
Experimental Group

AbstractWe aimed to investigate whether psychological intervention (single mental simulation) among women after cesarean surgery (CC) can affect their willingness to verticalize, actual verticalization, and the duration of the first mobilization. In this prospective randomised, controlled study, 150 women after CC were divided into 3 groups: experimental group with process-simulation with elements of relaxation, experimental group with outcome-simulation with elements of relaxation and control group with elements of relaxation only. After a 5-h stay in the post-operative room, women listened to a recording with a stimulation. Pain and anxiety of verticalization were measured before and after listening to the recording and after verticalization. Almost 12% more patients verticalized in the process-simulation group than in the control group. Percentages of mobilized patients were: 39.4% the process-simulation group; 32.8% in the outcome-simulation group; 27.7% controls (p = 0.073). Mobilization was 5 min longer in the process-simulation group then in control (p < 0.01). Anxiety after the simulation was a significant covariate of the willingness to verticalize, actual verticalization and time spent in mobilization. We conclude that a single mental simulation can effectively motivate patients for their first verticalization after CC. Perceived anxiety before verticalization may affect the effectiveness of interventions, so we recommend to check it at the postoperative care.ClinicalTrials.gov Identifier: NCT04829266.

scholarly journals Family education for people with schizophrenia in Beijing, China

2005 ◽  
Vol 187 (4) ◽  
pp. 339-345 ◽  
Author(s):  
Zheng Li ◽  
David Arthur
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Family Education ◽  
Control Group ◽  
Large Hospital ◽  
Significant Difference ◽  
Symptom Scores ◽  
Randomised Controlled ◽  
Beijing China ◽  
Experimental Group

BackgroundMuch of China lacks well-developed services for people with schizophrenia and their families, and most of the existing services focus on hospitals. There is a need for culturally sensitive family treatments offered by nurses.AimsTo conduct a longitudinal experimental study examining the effect of patient and family education in a sample of Chinese people with schizophrenia.MethodA randomised controlled trial was conducted in a large hospital with a sample of 101 patients with schizophrenia and their families. Data were collected at admission and at discharge, and then at 3 and 9 months after discharge. The intervention group received family education, and data on their knowledge about schizophrenia, symptoms, functioning, psychosocial behaviour, relapse and medication adherence were collected and compared with the control group.ResultsThere was a significant improvement in knowledge about schizophrenia in the experimental group and a significant difference in symptom scores and functioning at 9 months after discharge. Patients who were non-adherent to medication regimens were more likely to relapse.ConclusionsFamily education on schizophrenia by nurses in China was effective in improving knowledge and promoting improvement in patients' symptoms.

scholarly journals A randomised controlled trial of innovative specialised meat product for patients with cardiovascular and metabolic disorders

10.5219/1298 ◽  
2020 ◽  
Vol 14 ◽  
pp. 458-464
Author(s):  
Irina Chernukha ◽  
Elena Kotenkova
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Meat Product ◽  
Meat Products ◽  
Density Lipoprotein ◽  
Control Group ◽  
Low Calorie Diet ◽  
Calorie Diet ◽  
Randomised Controlled ◽  
Experimental Group

Cardiovascular diseases remain one of the leading causes of death globally. A lot of dietary patterns for CVD prevention have been proposed, but special attention is paid to functional foods. Bioactive proteins and peptides from animal sources are also considered tools for the prevention of CVDs. Here, 40 overweight or obese adult men and women aged between 61 and 66 years, with a body-mass index between 28 and 61 kg.m-2, were enrolled into a randomised controlled trial of new meat products for specialised nutrition. Participants in the control group (n = 20) consumed a standard hyponatric low-calorie diet for 28-30 days (10 days inpatient and 18-20 days outpatient), and in the experimental group – a low-calorie diet and 100g developed meat product (ratio of the porcine aorta to hearts 1:3) per day. Total cholesterol, triglyceride, cholesterol low-density lipoprotein, and cholesterol high-density lipoprotein levels were measured in the serum; from this, the atherogenic index was calculated. The positive effect of developed meat products on the serum lipid profile of patients during the trial was mild but noticeable. A significant reduction in cholesterol levels was noticed in the experimental group, by 18.2% and 14.0% after 7 – 10 and 28 – 30 days, respectively, while the cholesterol level in the control group returned to its original level after 28 – 30 days of dieting. The difference between the control and experimental groups was not significant, while data in the percentiles were. Therefore, it is more preferable to use a developed product as a component in diet therapy for hyperlipidaemic humans for over 28 – 30 days. Pronounced effects of the product could be linked to the unique proteome and peptidome of heart and aorta tissues based on organ-specific gene expression and the presence of tissue-specific substances.

scholarly journals Reducing antipsychotic medication in people with a learning disability

2000 ◽  
Vol 176 (1) ◽  
pp. 42-46 ◽  
Author(s):  
Zahir Ahmed ◽  
William Fraser ◽  
Michael P. Kerr ◽  
Chris Kiernan ◽  
Eric Emerson ◽  
...  
Keyword(s):  
Learning Disabilities ◽  
Learning Disability ◽  
Antipsychotic Drugs ◽  
Controlled Trial ◽  
Control Group ◽  
Psychotic Illness ◽  
Antipsychotic Medications ◽  
Maladaptive Behaviour ◽  
Randomised Controlled ◽  
Experimental Group

BackgroundThe use of antipsychotic drugs in people with learning disabilities is currently receiving intensified scrutiny and attempts are being made to reduce it.AimsA randomised controlled trial was designed to investigate factors influencing antipsychotic drug reduction among people with learning disabilities prescribed such medication for behavioural problems.MethodThirty-six participants randomly allocated to the experimental group underwent four, monthly 25% drug reduction stages. There were no planned drug changes for the control group (n = 20).ResultsTwelve participants (33%) completed full withdrawal; afurther seven (19%) achieved and maintained at least a 50% reduction. Drug reduction was associated with increased dyskinesia and higher activity engagement but not increased maladaptive behaviour. Some setting characteristics were associated with drug reinstatement.ConclusionsA substantial proportion of people with learning disability prescribed antipsychotic medications for behavioural purposes rather than for treating psychotic illness can have their drugs reduced or withdrawn.

Improvised music to support Intensive Interaction for children with complex needs: A feasibility study of brief adjunctive music therapy

2021 ◽  
pp. 135945752110280
Author(s):  
John Strange
Keyword(s):  
Service Learning ◽  
Music Therapy ◽  
Child Support ◽  
Controlled Trial ◽  
Control Group ◽  
Support Worker ◽  
Complex Needs ◽  
Improvised Music ◽  
Randomised Controlled ◽  
Experimental Group

This study investigates Triadic Support of Interaction by Improvisation, an application of music therapy as a brief adjunctive therapy for children with complex needs who are receiving Intensive Interaction. A small randomised controlled trial measured changes in child-support worker interaction between the 4th and the 12th of 12 weekly sessions of Intensive Interaction. In each of two special schools, a control group of four children with complex needs received Intensive Interaction only and an experimental group of four children additionally received improvised music in sessions 5 through 8. Experienced Speech and Language Therapists made blind assessments from video recordings of sessions 4 and 12 using an adaptation of an instrument developed by a National Health Service learning disability service for tracking progress in Intensive Interaction. The experimental group at one research site showed significantly enhanced interaction (p = 0.02). This offers provisional proof of concept, provided environmental factors identified as impacting results at the other site can be resolved in future studies.

scholarly journals Comparison of autologous osteoperiosteal cylinder and osteochondral graft transplantation in the treatment of large cystic osteochondral lesions of the talus (OLTs): a protocol for a non-inferiority randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033850 ◽  
Author(s):  
En Deng ◽  
Weili Shi ◽  
Yanfang Jiang ◽  
Qinwei Guo
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Donor Site ◽  
Donor Site Morbidity ◽  
Control Group ◽  
Osteochondral Lesions ◽  
Osteochondral Transplantation ◽  
Autologous Osteochondral Transplantation ◽  
Randomised Controlled ◽  
Experimental Group

IntroductionLarge cystic osteochondral lesions of the talus (OLTs) have been shown to have inferior clinical outcomes after reparative techniques such as bone marrow stimulation. Autologous osteochondral transplantation has been viewed as an alternative choice for treating these lesions, but donor-site morbidity has limited its application. Excellent clinical outcomes have been shown in repairing these types of lesions with autologous osteoperiosteal grafts, and these outcomes are achieved at a low cost and without donor-site morbidity in the normal knee joint. This will be the first randomised controlled trial to compare the two surgical techniques, and recommendations for the treatment of patients with large cystic OLTs will be provided.Methods and analysisA non-inferiority randomised controlled trial will be conducted. A total of 70 participants with clinically diagnosed large cystic OLTs will be randomly allocated to either the experimental group or the control group at a ratio of 1:1. The experimental group will be treated with autologous osteoperiosteal cylinder graft transplantation, while the control group will be treated with autologous osteochondral transplantation. The primary outcome measure will be the American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Score and the Short Form 12 (SF-12) questionnaire. Secondary outcome measures will include the secondary arthroscopy International Cartilage Repair Society score, the Magnetic Resonance Observation of Cartilage Repair Tissue score, the Tegner activity level score, the visual analogue scale, routine X-rays, CT and complications. These parameters will be evaluated preoperatively, as well as at 3, 6, 12, 24, 36 and 60 months postoperatively. In this trial, we hypothesised that both procedures offer good results for the treatment of patients with large cystic OLTs, and occurrence of donor-site morbidity in autologous osteoperiosteal cylinder graft transplantation group is less than that in autologous osteochondral transplantation group.Ethics and disseminationThe current study was approved by the board of research ethics of Peking University Third Hospital Medical Science Research Ethics Committee. The results of this study will be presented at national and international conferences and published in peer-reviewed journals.Trial registration numberNCT03347877.

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