scholarly journals Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Ira Kantrowitz-Gordon ◽  
Susan M. McCurry ◽  
Carol A. Landis ◽  
Rachel Lee ◽  
Dahee Wi
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Pregnant Women ◽  
Outcome Measures ◽  
Mindfulness Meditation ◽  
Controlled Trial ◽  
Self Management ◽  
Secondary Outcome ◽  
Post Intervention ◽  
Randomized Controlled

Abstract Background Sleep deficiency affects a majority of pregnant women with significant impact on daily function, mood, and pregnancy and birth outcomes. This ongoing study combines two evidence-based strategies for improving sleep and mood, mindfulness meditation and cognitive-behavioral therapy for insomnia (CBT-I), in a unique online format to address the particular needs of pregnant women. The purpose of this study is to test the feasibility and estimate the efficacy of this novel 6-week online mindfulness meditation intervention to help pregnant women in remission from depression self-manage insomnia. Methods This is a two-arm, parallel group randomized controlled trial. A total of 50 pregnant women between 12 and 28 weeks gestation will be recruited from the community and randomly assigned to a mindfulness or education-only control group in a 1:1 ratio. During the study, all participants will complete six weekly online modules, daily sleep diaries, and optional participation in a treatment-specific online discussion forum. Feasibility outcome measures will include study recruitment, retention, intervention adherence (number of online modules completed, number of meditation days per week), and intervention acceptability (8-item questionnaire). The primary clinical outcome measure will be sleep quality measured with the Pittsburgh Sleep Quality Index. Secondary outcome measures will include sleep measured with actigraphy and diaries (sleep efficiency, total sleep time, total wake time), Patient-Reported Outcomes Measurement Information System (PROMIS) measures (fatigue, sleep-related impairment, sleep disturbance); mood (depression, anxiety, positive affect, quality of life); and self-management and behavior change (potential self-efficacy, self-regulation, sleep problem acceptance, and trait mindfulness). Assessments will occur at baseline and post-intervention; an additional acceptability survey will be completed 4 weeks postpartum. Analyses will examine within-group differences in outcome change scores from baseline to post-intervention. Open-ended feedback will be analyzed using qualitative content analysis. Discussion This research is innovative in addressing sleep in pregnancy using a self-management research design and methods that can be accessible and cost-effective for large numbers of pregnant women. The results from this study will inform intervention refinement and efficacy testing of the intervention in a larger randomized controlled trial. Trial registration ClinicalTrials.gov, NCT04016428. Registered on 11 July 2019. Updated version registered on 26 July 2019.

scholarly journals PREWARMING FOR PREVENTION OF PERIOPERATIVE HYPOTHERMIA IN PATIENTS WITH COMBINED EPIDURAL AND GENERAL ANESTHESIA: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
General Anesthesia ◽  
Outcome Measures ◽  
Medical Center ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Perioperative Hypothermia ◽  
Randomized Controlled ◽  
Physical Status Classification ◽  
American Society

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.

scholarly journals Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Vincent CM Cox ◽  
Vera PM Schepers ◽  
Marjolijn Ketelaar ◽  
Caroline M van Heugten ◽  
Johanna MA Visser-Meily
Keyword(s):  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Acquired Brain Injury ◽  
Secondary Outcome ◽  
Face To Face ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Blended Care

BACKGROUND Support programs for partners of patients with acquired brain injury are necessary since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psychoeducation, skill building, problem solving, and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. OBJECTIVE This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. METHODS A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. RESULTS The effect of the intervention on the primary and secondary outcome measures will be determined. Additional a process evaluation will be conducted. CONCLUSIONS The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. CLINICALTRIAL Dutch Trial Register NTR6197; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197 (Archived by WebCite at http://www.webcitation.org/6xHBAxx0y)

scholarly journals Walking in pregnancy and prevention of insomnia in third trimester using pedometers: study protocol of Walking_Preg project (WPP). A randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
C. Amezcua-Prieto ◽  
M. Naveiro-Fuentes ◽  
N. Arco-Jiménez ◽  
R. Olmedo-Requena ◽  
R. Barrios-Rodríguez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Third Trimester ◽  
Randomized Controlled ◽  
In Pregnancy

Abstract Background Previous studies in pregnancy have not focused in evaluating the effect of walking during pregnancy and prevention of insomnia. Our general objective is to determine the effect of a walking program in preventing the appearance of insomnia in the third trimester of pregnancy, increasing sleep quality and improving quality of life throughout pregnancy. Methods Randomized Controlled trial in parallel in healthy sedentary pregnant women (n = 265), Walking_Preg Project (WPP), from university hospital in Granada, Spain. At 12th gestational week (GW), they will be invited to participate and randomly assigned to one of the three arms of study: the intervention group I1 (pedometer, goal of 11,000 steps/day), intervention group I2 (pedometer, no goal) and control (no pedometer). Duration of intervention: 13–32 GW. At 12th, 19th and 31st GW the average steps/day will be measured in groups I1 and I2. At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected. Student t test or Mann-Whitney U will be used to compare 19th and 31st GW mean of daily steps between I1 and I2 groups. To compare differences between groups in terms of frequency of insomnia/quality of life for each trimester of pregnancy, Pearson’s Chi-square test or Fisher’s exact test will be used. To determine differences in hours of sleep and quality of sleep throughout each trimester of pregnancy, analysis of variance or Friedman test will be used. McNemar-Bowker test will be used to assess differences in life quality in pre-post analyses in the 3 arms. We will use Stata 15 statistical software. Discussion promoting walking in second half of pregnancy through use of pedometer and health pre-registration of a goal to be achieved –'10,000–11,000 steps a day’– should prevent appearance of insomnia in third trimester, will increase sleep quality and quality of life in pregnant women. Trial registration ClinicalTrials.gov Identifier: NCT03735381. Registered 8th November, 2018.

Tinnitus Management: Randomized Controlled Trial Comparing Extended-Wear Hearing Aids, Conventional Hearing Aids, and Combination Instruments

2017 ◽  
Vol 28 (06) ◽  
pp. 546-561 ◽  
Author(s):  
James A. Henry ◽  
Garnett McMillan ◽  
Serena Dann ◽  
Keri Bennett ◽  
Susan Griest ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Hearing Aids ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Point Reduction ◽  
Clinically Significant

Background: Whereas hearing aids have long been considered effective for providing relief from tinnitus, controlled clinical studies evaluating this premise have been very limited. Purpose: The purpose of this study was to systematically determine the relative efficacy of conventional receiver-in-the-canal hearing aids (HA), the same hearing aids with a sound generator (HA+SG), and extended-wear, deep fit hearing aids (EWHA), to provide relief from tinnitus through a randomized controlled trial. Each of these ear-level devices was a product of Phonak, LLC. Research Design: Participants were randomized to HA, HA+SG, or EWHA and wore bilaterally fit devices for about 4 months. Fittings, adjustments, and follow-up appointments were conducted to comply with company guidelines and to ensure that all participants attended appointments on the same schedule. At 4–5 months, participants returned to complete final outcome measures, which concluded their study participation. Study Sample: Participants were 55 individuals (mean age: 63.1 years) with mild to moderately-severe hearing loss who: (a) did not currently use hearing aids; (b) reported tinnitus that was sufficiently bothersome to warrant intervention; and (c) were suitable candidates for each of the study devices. Data Collection and Analysis: The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary outcome measures included hearing-specific questionnaires and the Quick Speech in Noise test (QuickSIN). The goal of the analysis was to evaluate efficacy of the EWHA and HA+SG devices versus the HA standard device. Results: There were 18 participants in each of the HA and EWHA groups and 19 in the HA+SG group. Gender, age, and baseline TFI severity were balanced across treatment groups. Nearly all participants had a reduction in tinnitus symptoms during the study. The average TFI change (improvement) from baseline was 21 points in the HA group, 31 points in the EWHA group, and 33 points in the HA+SG group. A “clinically significant” improvement in reaction to tinnitus (at least 13-point reduction in TFI score) was seen by 67% of HA, 82% of EWHA, and 79% of HA+SG participants. There were no statistically significant differences in the extent to which the devices reduced TFI scores. Likewise, the hearing-specific questionnaires and QuickSIN showed improvements following use of the hearing aids but these improvements did not differ across device groups. Conclusions: There is insufficient evidence to conclude that any of these devices offers greater relief from tinnitus than any other one tested. However, all devices appear to offer some improvement in the functional effects of tinnitus.

scholarly journals C1 inhibitor in canine intravascular hemolysis (C1INCH): study protocol for a randomized controlled trial

2019 ◽  
Vol 15 (1) ◽  
Author(s):  
Robert Goggs ◽  
Erica Behling-Kelly
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Complement Activation ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Pharmacokinetic Analysis ◽  
Intravascular Hemolysis ◽  
Randomized Controlled ◽  
Transfusion Requirements ◽  
Duration Of Hospitalization

Abstract Background Immune-mediated hemolytic anemia (IMHA) is a common disease that affects all breeds of dogs and is associated with significant morbidity and mortality. Intravascular hemolysis of erythrocytes in IMHA is caused by complement activation and is often fatal. No current treatments target complement activation in canine IMHA. Human C1 esterase (C1-INH) reduces canine complement-mediated hemolysis in vitro, and a recent pharmacokinetic analysis of an FDA licensed formulation of C1-INH in dogs confirmed that a 50 IU/kg dose of C1-INH is safe to administer to dogs, and effectively inhibits canine complement mediated hemolysis ex-vivo. The C1INCH randomized controlled trial will evaluate the efficacy of this drug in dogs with intravascular hemolysis. Methods We will conduct a multicenter, placebo-controlled double-blind randomized clinical trial of C1-INH in dogs with intravascular hemolysis due to IMHA. We will randomize 18 dogs to receive three doses of intravenous C1-INH or saline in 24 h. Immunosuppressive and antithrombotic therapies will be standardized. Primary outcome measures will be changes in plasma free hemoglobin, serum concentrations of LDH, bilirubin, and haptoglobin. Using patient samples, we will evaluate complement activation in canine IMHA using a novel C5b-9 ELISA assay, flow cytometric detection of C3b on RBC, and by measurement of residual plasma complement activity. Secondary outcome measures will be survival to hospital discharge, duration of hospitalization, number and volume of red blood cell transfusions, and rescue therapy requirements. We will monitor dogs for adverse drug reactions. Sample size was estimated from pilot data on LDH and hemolysis index (HI) in dogs with IMHA. To detect 2-way differences between the upper and lower 50% of the LDH and HI values of equivalent size with 80% power at P < 0.05 will require 9 dogs in each arm. Discussion We anticipate that IV administration of C1-INH will significantly inhibit complement mediated hemolysis in dogs with intravascular IMHA, as determined by blood biomarker measurements (decreased plasma hemoglobin, LDH and bilirubin, increased haptoglobin). We expect this will translate into significant reductions in transfusion requirements and duration of hospitalization. Trial registration This trial has been prospectively registered with the AVMA registry (AAHSD005025).

scholarly journals Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Marquis Hawkins ◽  
Favorite Iradukunda ◽  
Mary Paterno
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Self Management ◽  
Poor Sleep ◽  
Grant Application ◽  
Sleep Education ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Pilot Randomized Controlled Trial

BACKGROUND Sleep disruptions are common during pregnancy and associated with increased risk of adverse maternal outcomes such as preeclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitor (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown. OBJECTIVE The goal of the paper is to describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability, and preliminary efficacy of using a PHM device (Shine 2, Misfit) to promote sleep during pregnancy. METHODS The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at a 1:1 ratio to a 12-week sleep education plus PHM device group or a sleep education alone comparison group. The primary outcomes will be measures of feasibility (ie, recruitment, enrollment, adherence) and acceptability (ie, participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, and depressive symptoms. RESULTS Recruitment for this study began in September 2017 and ended in March 2018. Data collection for the primary and secondary aims was completed in August 2018. We anticipate that the data analysis for primary and secondary aims will be completed by December 2019. The results from this trial will inform the development of a larger National Institutes of Health grant application to test the efficacy of an enhanced version of the sleep intervention that we plan to submit in the year 2020. CONCLUSIONS This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions because they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women. CLINICALTRIAL ClinicalTrials.gov NCT03783663; https://clinicaltrials.gov/ct2/show/NCT03783663 (Archived by WebCite at http://www.webcitation.org/779Ou8hon) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12455

scholarly journals Immediate effect of an acupressure strap simulating wrist-ankle acupuncture on menstrual pain in young women: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Shu-jie Zhai ◽  
Yi Ruan ◽  
Yue Liu ◽  
Zhen Lin ◽  
Chen Xia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Analgesic Effect ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Pain Intensity Score ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled

Abstract Background: Dysmenorrhea seriously affects the ability to perform normal social activities and decreases quality of life. Primary dysmenorrhea can be effectively treated with acupuncture. Based on the wrist-ankle acupuncture (WAA) theory, we designed a portable WAA point compression treatment strap that treats diseases by automatically applying pressure to acupuncture points. The proposed study aims to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. Methods: The study will be a randomized controlled trial conducted from 1 May 2019 30 May 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria. Participants will be randomly divided into two groups in a 1:1 allocation ratio. The intervention group will use the acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the non-acupressure wrist-ankle strap with the tip compression parts removed. All participants will be treated for 30 min on the first day of menstruation. The main outcome measures are the pain intensity score measured by the visual analogue scale, and the onset time of analgesia. The secondary outcome measures are the pain threshold at Yinlingquan (SP 9) , skin temperature at Guanyuan (CV 4) , and expectations and satisfaction of patients as investigated via the Expectation and Treatment Credibility Scale. Discussion: This trial will be the first study to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. The quality of this study is ensured by the strict randomization, non-acupressure control, and blinded design. The results may provide a potential alternative treatment for primary dysmenorrhea and evidence-based proof of the analgesic effect of WAA. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1900021727. Registered on 7 March 2019. http://www.chictr.org.cn/listbycreater.aspx

scholarly journals Reducing physical and emotional violence by teachers using the intervention Interaction Competencies with Children – for Teachers (ICC-T): study protocol of a multi-country cluster randomized controlled trial in Ghana, Tanzania, and Uganda

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Florian Scharpf ◽  
Anette Kirika ◽  
Faustine Bwire Masath ◽  
Getrude Mkinga ◽  
Joseph Ssenyonga ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Academic Performance ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Well Being ◽  
Cluster Randomized Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Violence has severe and long-lasting negative consequences for children’s and adolescents’ well-being and psychosocial functioning, thereby also hampering communities’ and societies’ economic growth. Positive attitudes towards violence and the lack of access to alternative non-violent strategies are likely to contribute to the high levels of teachers’ ongoing use of violence against children in sub-Saharan African countries. Notwithstanding, there are currently very few school-level interventions to reduce violence by teachers that a) have been scientifically evaluated and b) that focus both on changing attitudes towards violence and on equipping teachers with non-violent discipline strategies. Thus, the present study tests the effectiveness of the preventative intervention Interaction Competencies with Children – for Teachers (ICC-T) in primary and secondary schools in Tanzania, Uganda, and Ghana. Methods The study is a multi-site cluster randomized controlled trial with schools (clusters) as level of randomization and three data assessment points: baseline assessment prior to the intervention, the first follow-up assessment 6 months after the intervention and the second follow-up assessment 18 months after the intervention. Multi-stage random sampling will be applied to select a total number of 72 schools (24 per country). Schools will be randomly allocated to the intervention and the control condition after baseline. At each school, 40 students (stratified by gender) in the third year of primary school or in the first year of secondary/junior high school and all teachers (expected average number: 20) will be recruited. Thus, the final sample will comprise 2880 students and at least 1440 teachers. Data will be collected using structured clinical interviews. Primary outcome measures are student- and teacher-reported physical and emotional violence by teachers in the past week. Secondary outcome measures include children’s emotional and behavioral problems, quality of life, cognitive functioning, academic performance, school attendance and social competence. Data will be analyzed using multilevel analyses. Discussion This study aims to provide further evidence for the effectiveness of ICC-T to reduce teacher violence and to improve children’s functioning (i.e., mental health, well-being, academic performance) across educational settings, societies and cultures. Trial registration The trial was registered at clinicaltrials.org under the ClinicalTrials.gov identifier NCT04948580 on July 2, 2021.

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