randomized clinical trial
Recently Published Documents





2022 ◽  
Vol 68 ◽  
pp. 114-120
Tássia Nery Faustino ◽  
Nathália Almeida Suzart ◽  
Rebecca Neves dos Santos Rabelo ◽  
Juliete Lima Santos ◽  
Gyuliana Santana Batista ◽  

Claudia Pignatti Frederice ◽  
Luiz Gustavo Oliveira Brito ◽  
Helymar Costa Machado ◽  
Amanda Martins Reis ◽  
Juliana Oliveira Fernandes ◽  

2022 ◽  
Emilio López-Navarro

Impaired Theory of Mind (ToM) ability is a core feature of psychotic disorders that challenges psychosis treatment. We aimed to explore the effect of a Mindfulness-Based Intervention (MBI) on ToM ability in a randomized clinical trial (RCT). A sample of 36 participants diagnosed with psychotic disorder were recruited from a community center and randomly allocated to Integrated Rehabilitation Treatment (IRT) or IRT+MBI. ToM skills were assessed through the Hinting Test and the Reading the Mind in the Eyes Test (RMET). IRT+MBI scored higher in RMET than IRT at posttreatment. MBI is a promising tool for improving ToM ability in psychosis.Keywords: psychotic disorders, theory of mind, mindfulness-based-interventions.

Magdalena Napiórkowska-Orkisz ◽  
Aleksandra Gutysz-Wojnicka ◽  
Mariola Tanajewska ◽  
Iwona Sadowska-Krawczenko

Aim: The aim of the study was to assess the severity of pain experienced by a newborn during a heel puncture for screening using the Newborn Pain Scale (NIPS), measure the heart rate and compare the effectiveness of non-pharmacological methods of pain control. Design: Randomized clinical trial. No experimental factors. The test was performed during routine screening. Surroundings: Provincial Specialist Hospital in Olsztyn. Patients/Participants: Pain was assessed in 90 full-term newborns. The newborns were rooming in with their mothers in the hospital. Interventions: Newborns were divided into three groups. Three different methods of pain relief were used: breastfeeding, 20% glucose administered orally and non-nutritional sucking. Main Outcome Measures: The primary pain outcome was measured using the NIPS and the secondary pain outcome measures (heart rate, oxygen saturation) were measured using a pulse oximeter. Results: During capillary blood sampling from the heel, most newborns, n = 56 (62.2%), experienced no pain or mild discomfort, severe pain occurred in n = 23 (25.6%) and moderate pain occurred in n = 11 (12.2%). No significant statistical differences were found between the degree of pain intensity and the intervention used to minimize the pain p = 0.24. Statistically significant relationships were demonstrated between heart rate variability and the degree of pain intensity (p = 0. 01). There were no statistically significant differences between the newborn’s pain intensity and the mother’s opinion on the effectiveness of breastfeeding in minimizing pain. Conclusions: This study did not answer the question of which pain management method used during the heel prick was statistically more effective in reducing pain. However, the results indicate that each of the non-pharmacological interventions (breastfeeding, oral glucose dosing and non-nutritive sucking) applied during heel puncture resulted in effective pain management in most of the newborns enrolled in the study. The relationship between heart rate variability and the severity of pain was confirmed. Mothers of newborns in the breastfeeding group were satisfied with the pain relief methods used in the child and the opportunity to console their newborn during painful procedures in a technologically invasive environment.

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0261751
Ariadna Forray ◽  
Amanda Mele ◽  
Nancy Byatt ◽  
Amalia Londono Tobon ◽  
Kathryn Gilstad-Hayden ◽  

Introduction The prevalence of opioid use disorder (OUD) in pregnancy increased nearly five-fold over the past decade. Despite this, obstetric providers are less likely to treat pregnant women with medication for OUD than non-obstetric providers (75% vs 91%). A major reason is many obstetricians feel unprepared to prescribe medication for opioid use disorder (MOUD). Education and support may increase prescribing and overall comfort in delivering care for pregnant women with OUD, but optimal models of education and support are yet to be determined. Methods and analysis We describe the rationale and conduct of a matched-pair cluster randomized clinical trial to compare the effectiveness of two models of support for reproductive health clinicians to provide care for pregnant and postpartum women with OUD. The primary outcomes of this trial are patient treatment engagement and retention in OUD treatment. This study compares two support models: 1) a collaborative care approach, based upon the Massachusetts Office-Based-Opioid Treatment Model, that provides practice-level training and support to providers and patients through the use of care managers, versus 2) a telesupport approach based on the Project Extension for Community Healthcare Outcomes, a remote education model that provides mentorship, guided practice, and participation in a learning community, via video conferencing. Discussion This clustered randomized clinical trial aims to test the effectiveness of two approaches to support practitioners who care for pregnant women with an OUD. The results of this trial will help determine the best model to improve the capacity of obstetrical providers to deliver treatment for OUD in prenatal clinics. Trial registration Clinicaltrials.gov trial registration number: NCT0424039.

Sign in / Sign up

Export Citation Format

Share Document