scholarly journals The COPE-Trial—Communicating prognosis to parents in the neonatal ICU: Optimistic vs. PEssimistic: study protocol for a randomized controlled crossover trial using two different scripted video vignettes to explore communication preferences of parents of preterm infants

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fiona A. Forth ◽  
Florian Hammerle ◽  
Jochem König ◽  
Michael S. Urschitz ◽  
Philipp Neuweiler ◽  
...  
Keyword(s):  
Online Survey ◽  
Crossover Trial ◽  
Medical Center ◽  
Patient Questionnaire ◽  
Online Questionnaire ◽  
Post Intervention ◽  
Parent Communication ◽  
Communication Preferences ◽  
Randomized Controlled ◽  
Video Vignettes

Abstract Background One of the numerous challenges preterm birth poses for parents and physicians is prognostic disclosure. Prognoses are based on scientific evidence and medical experience. They are subject to individual assessment and will generally remain uncertain with regard to the individual. This can result in differences in prognostic framing and thus affect the recipients’ perception. In neonatology, data on the effects of prognostic framing are scarce. In particular, it is unclear whether parents prefer a more optimistic or a more pessimistic prognostic framing. Objective To explore parents’ preferences concerning prognostic framing and its effects on parent-reported outcomes and experiences. To identify predictors (demographic, psychological) of parents’ communication preferences. Design, setting, participants Unblinded, randomized controlled crossover trial (RCT) at the Division of Neonatology of the University Medical Center Mainz, Germany, including German-speaking parents or guardians of infants born preterm between 2010 and 2019 with a birth weight < 1500 g. Inclusion of up to 204 families is planned, with possible revision according to a blinded sample size reassessment. Intervention Embedded in an online survey and in pre-specified order, participants will watch two video vignettes depicting a more optimistic vs. a more pessimistic framing in prognostic disclosure to parents of a preterm infant. Apart from prognostic framing, all other aspects of physician-parent communication are standardized in both videos. Main outcomes and measures At baseline and after each video, participants complete a two-part online questionnaire (baseline and post-intervention). Primary outcome is the preference for either a more optimistic or a more pessimistic prognostic framing. Secondary outcomes include changes in state-anxiety (STAI-SKD), satisfaction with prognostic framing, evaluation of prognosis, future optimism and hope, preparedness for shared decision-making (each assessed using customized questions), and general impression (customized question), professionalism (adapted from GMC Patient Questionnaire) and compassion (Physician Compassion Questionnaire) of the consulting physician. Discussion This RCT will explore parents’ preferences concerning prognostic framing and its effects on physician-parent communication. Results may contribute to a better understanding of parental needs in prognostic disclosure and will be instrumental for a broad audience of clinicians, scientists, and ethicists. Trial registration German Clinical Trials Register DRKS00024466. Registered on April 16, 2021.

Communicating prognosis to parents in the neonatal ICU: Optimistic vs. PEssimistic – “The “COPE”-Trial“ – Study protocol of a randomized controlled trial using scripted video-vignettes to explore communication preferences of parents of preterm infants

2021 ◽  
Author(s):  
Fiona A. Forth ◽  
Florian Hammerle ◽  
Jochem König ◽  
Michael S. Urschitz ◽  
Philipp Neuweiler ◽  
...  
Keyword(s):  
Online Survey ◽  
Medical Center ◽  
Controlled Trial ◽  
Patient Questionnaire ◽  
Online Questionnaire ◽  
Post Intervention ◽  
Parent Communication ◽  
Communication Preferences ◽  
Randomized Controlled ◽  
Video Vignettes

Abstract Background: One of the numerous challenges preterm birth poses for parents and physicians is prognostic disclosure. Prognoses are based on scientific evidence and medical experience. They are subject to individual assessment and, hence, will generally remain uncertain with regard to the individual. This can result in differences in prognostic framing and thus affect the recipients’ perception. In neonatology, data on the effects of prognostic framing are scarce. In particular, it is unclear whether parents prefer a more optimistic or a more pessimistic prognostic framing.Objective: To explore parents’ preferences concerning prognostic framing and its effects on parent reported outcomes and experiences. To identify predictors (demographic, psychological) of parents’ communication preferences.Design, setting, participants: Unblinded, randomized-controlled cross-over trial (RCT) at the Division of Neonatology of the University Medical Center Mainz, Germany, including German-speaking parents or guardians of infants born preterm between 2009 and 2019 with a birth weight <1500g. Inclusion of up to 204 families is planned, with possible reduction according to a blinded sample size reassessment after enrollment of 50 to 70 families, depending on the number of participants per family.Intervention: Embedded in an online-survey and in pre-specified order, participants will watch two video-vignettes depicting a more optimistic vs. a more pessimistic framing in prognostic disclosure to parents of a preterm infant. Apart from prognostic framing, all other aspects of physician-parent communication are standardized in both videos.Main outcomes and measures: At baseline and after each video, participants complete a two-part online-questionnaire (baseline and post-intervention). Primary outcome is the preference for either a more optimistic or a more pessimistic prognostic framing. Secondary outcomes include changes in state-anxiety (STAI-SKD), satisfaction with framing, evaluation of prognosis, future optimism and hope, preparedness for shared decision-making (each assessed using customized questions), and general impression (customized question), professionalism (adapted from GMC Patient Questionnaire) and compassion (Physician Compassion Questionnaire) of the consulting physician.Discussion: This RCT will explore parents’ preferences concerning prognostic framing and its effects on physician-parent communication. Results may contribute to a better understanding of parental needs in prognostic disclosure and will be instrumental for a broad audience of clinicians, scientists and ethicists.Trial registration: drks.de DRKS00024466. Registered on April 16, 2021

scholarly journals Meditation Monologue can Reduce Clinical Injection-Related Anxiety: Randomized Controlled Trial

2021 ◽  
Vol 26 ◽  
pp. 2515690X2110060
Author(s):  
Dai Sugimoto ◽  
Nathalie R. Slick ◽  
David L. Mendel ◽  
Cynthia J. Stein ◽  
Emily Pluhar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
New England ◽  
Trait Anxiety ◽  
Mobile Application ◽  
Sports Medicine ◽  
Medical Center ◽  
Controlled Trial ◽  
Intervention Group ◽  
Post Intervention ◽  
Randomized Controlled

Background. Strategies to reduce anxiety prior to injection procedures are not well understood. The purpose is to determine the effect of a meditation monologue intervention delivered via phone/mobile application on pre-injection anxiety levels among patients undergoing a clinical injection. The following hypothesis was tested: patients who listened to a meditation monologue via phone/mobile application prior to clinical injection would experience less anxiety compared to those who did not. Methods. A prospective, randomized controlled trial was performed at an orthopedics and sports medicine clinic of a tertiary level medical center in the New England region, USA. Thirty patients scheduled for intra- or peri-articular injections were randomly allocated to intervention (meditation monologue) or placebo (nature sounds) group. Main outcome variables were state and trait anxiety inventory (STAI) scores and blood pressure (BP), heart rate, and respiratory rate. Results. There were 16 participants who were allocated to intervention (meditation monologue) while 14 participants were assigned to placebo (nature sounds). There was no interaction effect. However, a main time effect was found. Both state anxiety (STAI-S) and trait anxiety (STAI-T) scores were significantly reduced post-intervention compared to pre-intervention (STAI-S: p = 0.04, STAI-T: p = 0.04). Also, a statistically significant main group effect was detected. The pre- and post- STAI-S score reduction was greater in the intervention group (p = 0.028). Also, a significant diastolic BP increase between pre- and post-intervention was recorded in the intervention group (p = 0.028), but not in the placebo group (p = 0.999). Conclusion. Listening to a meditation monologue via phone/mobile application prior to clinical injection can reduce anxiety in adult patients receiving intra- and peri-articular injections. Registration: ClinicalTrials.gov NCT02690194

scholarly journals Promoting COVID-19 vaccination among healthcare personnel: a multifaceted intervention at a tertiary care center in Japan

2021 ◽  
pp. 1-26
Author(s):  
Akane Takamatsu ◽  
Hitoshi Honda ◽  
Tomoya Kojima ◽  
Kengo Murata ◽  
Hilary Babcock
Keyword(s):  
Medical Center ◽  
Care Center ◽  
Tertiary Care ◽  
Vaccination Rate ◽  
Multifaceted Intervention ◽  
Vaccine Hesitancy ◽  
Healthcare Personnel ◽  
Tertiary Care Center ◽  
Post Intervention ◽  
Post Vaccination

Abstract Objective The COVID-19 vaccine may hold the key to ending the pandemic, but vaccine hesitancy is hindering the vaccination of healthcare personnel (HCP). Design Before-after trial Participants and setting Healthcare personnel at a 790-bed tertiary care center in Tokyo, Japan. Interventions A pre-vaccination questionnaire was administered to HCP to examine their perceptions of the COVID-19 vaccine. Then, a multifaceted intervention involving (1) distribution of informational leaflets to all HCP, (2) hospital-wide announcements encouraging vaccination, (3) a mandatory lecture, (4) an educational session about the vaccine for pregnant or breastfeeding HCP, and (5) allergy testing for HCP at risk of allergic reactions to the vaccine was implemented. A post-vaccination survey was also performed. Results Of 1,575 HCP eligible for enrollment, 1,224 (77.7%) responded to the questionnaire, 43.5% (n =533) expressed willingness to be vaccinated, 48.4% (n = 593) were uncertain, and 8.0% (n=98) expressed unwillingness to be vaccinated. The latter two groups were concerned about the vaccine’s safety rather than its efficacy. Post-intervention, the overall vaccination rate reached 89.7% (1,413/1,575), with 88.9% (614/691) of the pre-vaccination survey respondents who answered “unwilling” or “unsure” eventually receiving a vaccination. In the post-vaccination questionnaire, factors contributing to increased COVID-19 vaccination included information and endorsement of vaccination at the medical center (26.4%; 274/1,037). Conclusions The present, multifaceted intervention increased COVID-19 vaccinations among HCP at a Japanese hospital. Frequent support and provision of information were crucial for increasing the vaccination rate and may be applicable to the general population as well.

scholarly journals Boxing vs Sensory Exercise for Parkinson’s Disease: A Double-Blinded Randomized Controlled Trial

2021 ◽  
pp. 154596832110231
Author(s):  
Kishoree Sangarapillai ◽  
Benjamin M. Norman ◽  
Quincy J. Almeida
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Randomized Controlled Trial ◽  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Motor Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Double Blinded

Background. Exercise is increasingly becoming recognized as an important adjunct to medications in the clinical management of Parkinson’s disease (PD). Boxing and sensory exercise have shown immediate benefits, but whether they continue beyond program completion is unknown. This study aimed to investigate the effects of boxing and sensory training on motor symptoms of PD, and whether these benefits remain upon completion of the intervention. Methods. In this 20-week double-blinded randomized controlled trial, 40 participants with idiopathic PD were randomized into 2 treatment groups, (n = 20) boxing or (n = 20) sensory exercise. Participants completed 10 weeks of intervention. Motor symptoms were assessed at (week 0, 10, and 20) using the Unified Parkinson’s Disease Rating Scale (UPDRS-III). Data were analyzed using SPSS, and repeated-measures ANOVA was conducted. Results. A significant interaction effect between groups and time were observed F(1, 39) = 4.566, P = .036, where the sensory group improved in comparison to the boxing group. Post hoc analysis revealed that in comparison to boxing, the effects of exercise did not wear off at washout (week 20) P < .006. Conclusion. Future rehabilitation research should incorporate similar measures to explore whether effects of exercise wear off post intervention.

scholarly journals Time Waits for No One: Longitudinal Study on the Effects of an Anti-Stigma Seminar on the Psychology Student Population

2021 ◽  
Vol 18 (10) ◽  
pp. 5441
Author(s):  
Luca Pingani ◽  
Sara Evans-Lacko ◽  
Sandra Coriani ◽  
Silvia Ferrari ◽  
Maria Filosa ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Online Survey ◽  
Student Population ◽  
Post Intervention ◽  
People With Mental Illness ◽  
T1 And T2 ◽  
One Year ◽  
Intended Behaviour

The primary aim is to describe the changes in the knowledge of mental health conditions, the attitudes toward the mentally ill, and the intended behaviour towards people with mental illness among the entire student population of the third year of a degree course in Psychology. A total of 570 students attended a seminar on stigma towards mental illness and were invited to complete an online survey which collected data on sociodemographic characteristics and three validated questionnaires evaluating different aspects of stigma at three different time points (pre-intervention, post-intervention, and at one year follow up). A total of 253 students (44.39%) completed the questionnaires at t0, t1, and t2. The mean age of the sample was 23.7 (SD = ±5.89), and 86.96% (n = 220) were females. Between t0 and t1, a statistically significant improvement was observed for all three outcomes, while the intended behaviour outcome was no longer significant between t1 and t2 (Z = −0.70; p = 0.48). Females and who participated live at the seminar maintained a significant knowledge of mental illness and a better attitude toward community mental health care. The effects of the seminar focused on reducing stigma tended to diminish over time at one year follow-up, particular in relation to intended behaviour.

scholarly journals Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

2021 ◽  
Vol 18 (14) ◽  
pp. 7510
Author(s):  
Guillermo García Pérez de Sevilla ◽  
Olga Barceló Guido ◽  
María de la Paz De la Cruz ◽  
Ascensión Blanco Fernández ◽  
Lidia B. Alejo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nutrition Intervention ◽  
Sitting Time ◽  
Post Intervention ◽  
University Employees ◽  
Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

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