Developmental Moderators of a Single-Session Incremental Theory of Personality Intervention on Aggressive Behavior

2020 ◽  
pp. 088626052096923
Author(s):  
Esther Calvete ◽  
Liria Fernández-González ◽  
Ainara Echezarraga ◽  
Izaskun Orue ◽  
Javier Muga ◽  
...  
Keyword(s):  
Aggressive Behavior ◽  
Controlled Trial ◽  
Control Group ◽  
Aggressive Behaviors ◽  
Single Session ◽  
Double Blind ◽  
Incremental Theory ◽  
Preventative Interventions ◽  
To Receive ◽  
Trial Participants

This study examines two indicators of developmental level (testosterone and grade) as moderators of the effects of a single-session incremental theory of personality intervention on both traditional and online aggressive behaviors. A sample of 535 Spanish adolescents (boys: 50%; age: 12–17 years) participated in a double-blind, randomized controlled trial. Participants were randomized to receive the incremental theory of personality intervention or an alternative educational control condition. The intervention consisted of teaching the belief that people can change. Aggressive behaviors were measured at baseline, one-week posttest, and six-month and twelve-month follow-ups. Testosterone level moderated the effectiveness of the intervention for online aggressive behavior so that, among adolescents with low and medium testosterone levels, those in the control group increased online aggressive behavior, whereas adolescents receiving the intervention remained at similar levels of perpetration. Grade moderated the effectiveness of the intervention on both forms of aggressive behavior, being only effective in Grade 8. Overall, the findings indicate that some preventative interventions can be more effective among adolescents with lower levels of development.

scholarly journals The Effect of Multimedia Message Reminders on Oral Hygiene Promotion during Removable Orthodontic Treatment

2020 ◽  
Author(s):  
Tahereh Baherimoghadam ◽  
Navid Naseri ◽  
Maliheh Mokhtar ◽  
Shahram Hamedani
Keyword(s):  
Oral Hygiene ◽  
Orthodontic Treatment ◽  
Controlled Trial ◽  
Control Group ◽  
Orthodontic Appliances ◽  
Significant Difference ◽  
Tooth Surfaces ◽  
Age Range ◽  
To Receive ◽  
Trial Participants

Abstract Background Orthodontic appliances complicate daily oral hygiene maintenance and enhance the formation of microbial biofilm on tooth surfaces and orthodontic appliances. Any tool that enhances the oral hygiene of patients during orthodontic treatment would be of imperative beneficial. This trial was conducted to assess the effect of message reminders on oral hygiene of patients during removable orthodontic treatment.Methods In this 2-arm parallel randomized controlled trial, participants were randomly allocated to two groups; one receiving messages reminder and one as the control group. The patients in the messaging group received one or two message reminders and educational videos weekly during the course of treatment. The patients with removable maxillary appliance who were in the age range of 8 to 12 years old and had daily access to Internet to receive message reminders were recruited in this study. A single blinded examiner measured the plaque index (PI), gingival index (GI) and dental caries index of patients in both groups at baseline (T0) and one (T1), three (T2) and six (T3) months after the first day of treatment to assess their oral hygiene status during the course of treatment in both groups.Results A total of 50 patients were enrolled and randomized to two even groups (n = 25) but only 46 patients completed the study; 22 in control group, and 24 in message reminder group. The PI and GI scores were increased neither in control group nor in message reminder group during T0 and T1, significantly. The PI and GI scores in message reminder group were significantly lower than those in the control group at T2 (PI: P = 0.003, GI: P = 0.001) and T3 (PI: P = 0.044, GI: P = 0.012). However, slight significant increasing in the PI and GI score were found during T2 and T3 during in message reminder group. Caries index showed no significant difference between two group during study.Conclusion It seems that message reminders can efficiently promote oral hygiene of patients undergoing removable orthodontic treatment. Although, this promotion wasn’t progressive.Trial registration: Iranian Registry of Clinical Trials (IRCT), IRCT20180923041092N2. Registered 25 July 2020 - Retrospectively registered, https://www.irct.ir/user/trial/47612.

scholarly journals Do prebiotics reduce the number of fever episodes in healthy children in their first year of life: a randomised controlled trial

2011 ◽  
Vol 106 (11) ◽  
pp. 1740-1748 ◽  
Author(s):  
Margriet van Stuijvenberg ◽  
Annemieke M. Eisses ◽  
Christoph Grüber ◽  
Fabio Mosca ◽  
Sertac Arslanoglu ◽  
...  
Keyword(s):  
Reference Group ◽  
Controlled Trial ◽  
Formula Feeding ◽  
Control Group ◽  
First Year ◽  
Healthy Children ◽  
Double Blind ◽  
Standard Formula ◽  
First Year Of Life ◽  
To Receive

The objective of the present study was to assess the effect of adding specific prebiotics to standard formula feeding on the number of fever episodes in the first year of life. In the present randomised, double-blind, placebo-controlled trial in seven centres in five West European countries, 830 healthy term infants, without a first-degree family history of allergic disease, of mothers who indicated to give only formula feeding were randomised either to receive a standard non-hydrolysed cows' milk-based formula to which a mixture of specific oligosaccharides was added (prebiotics group (PG)), or to receive a similar formula without oligosaccharides (control group (CG)). A separate reference group consisted of 300 breast-fed infants. The primary outcome was the number of fever episodes prospectively documented by the parents. There was no difference in the number of fever episodes between the PG (median value 1·19; 25th–75th percentile 0·09–2·34) and CG (1·16; 25th–75th percentile 0·06–2·38). The median number of fever episodes in the separate breast-feeding reference group was 1·24 (25th–75th percentile 0·51–3·45). There was no effect of adding specific prebiotics to standard formula feeding in reducing the number of fever episodes in the present study.

Laser Acupuncture for Migraine and Muscle Tension Headache: A Double-Blind Controlled Trial

1998 ◽  
Vol 16 (2) ◽  
pp. 73-76 ◽  
Author(s):  
Nicholas G Lavies
Keyword(s):  
Treatment Period ◽  
Controlled Trial ◽  
Muscle Tension ◽  
Placebo Response ◽  
Tension Headache ◽  
Active Group ◽  
Laser Acupuncture ◽  
Control Group ◽  
Double Blind ◽  
To Receive

Twelve patients with chronic migraine recruited from a neurology clinic or a self-help group were randomly allocated to receive either 6 weeks active laser acupuncture or 6 weeks dummy laser acupuncture. Patients completed headache diaries for the 6 weeks prior to treatment and for 6 weeks following. They were then crossed over to receive the alternative treatment for a further 6 weeks. Neither patients nor operator knew which unit was the active one. There was a reduction in mean total headache score (combining duration and severity) of 18% in the active group and 43% in the control group following the first treatment period. This difference was not significant. Following the second treatment period, mean scores increased by 50% in the active group and 5% in the control group but again this difference was not significant due to inconsistent responses by some patients. When active and placebo treatments were computed for all patients, there were still no significant differences. It is concluded that laser acupuncture does not have an important clinical effect in migraine over and above the expected placebo response.

scholarly journals Effect of a Mobile-based Intervention on Mental Health in Frontline Healthcare Workers Against COVID-19: Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Maria J. Serrano-Ripoll ◽  
Ignacio Ricci-Cabello ◽  
Rafael Jiménez ◽  
Rocío Zamanillo-Campos ◽  
Aina M. Yañez Juan ◽  
...  
Keyword(s):  
Mental Health ◽  
Mobile Health ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Intervention Group ◽  
Health Interventions ◽  
Control Group ◽  
The Impact ◽  
To Receive ◽  
Trial Participants

ABSTRACTAimTo evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness-based approaches on the mental health of healthcare workers at the frontline against COVID-19 in Spain.DesignWe will carry out a two-week, individually randomised, parallel group, controlled trial. Participants will be individually randomised to receive the PsyCovidApp intervention or control App intervention.MethodsThe PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended COVID-19 patients will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the two weeks intervention period. Measures will include stress, depression and anxiety (DASS-21 questionnaire – primary endpoint), insomnia (ISI), burnout (MBI-HSS), post-traumatic stress disorder (DTS), and self-efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation.DiscussionDespite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence regarding the effectiveness of this type of intervention on this specific population and context.ImpactDespite the lack of solid evidence about their effectiveness, mobile-based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits.Clinical trial registrationNCT04393818 (ClinicalTrials.gov identifier)

scholarly journals The Effect of Prophylactic Dexmedetomidine on Hemodynamic Disturbances to Double-Lumen Endotracheal Intubation: A Prospective, Randomized, Double-Blind, and Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8
Author(s):  
Tanyong Pipanmekaporn ◽  
Yodying Punjasawadwong ◽  
Somrat Charuluxananan ◽  
Worawut Lapisatepun ◽  
Pavena Bunburaphong
Keyword(s):  
Blood Pressure ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Rate Pressure Product ◽  
Control Group ◽  
Hemodynamic Responses ◽  
Double Blind ◽  
The Mean ◽  
Mean Differences ◽  
To Receive

The purpose of this study was to determine the effect of dexmedetomidine on hemodynamic responses to DLT intubation compared to placebo and to assess the adverse effects related to dexmedetomidine. Sixty patients were randomly allocated to receive 0.7 μg/kg dexmedetomidine (n=30) or normal saline (n=30) 10 minutes before general anesthesia. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), and rate pressure product (RPP) between groups were recorded. During intubation and 10 minutes afterward (T1-T10), the mean SBP, DBP, MAP, HR, and RPP in the control group were significantly higher than those in the dexmedetomidine group throughout the study period except at T1. The mean differences of SBP, DBP, MAP, HR, and RPP were significantly higher in the control group, with the value of 15.2 mmHg, 10.5 mmHg, 14 mmHg, 10.5 beats per minute, and 2,462.8 mmHg min−1. Four patients in the dexmedetomidine group and 1 patient in the control group developed hypotension, while 2 patients in the dexmedetomidine group had bradycardia. Prophylactic dexmedetomidine can attenuate the hemodynamic responses to laryngoscopy and DLT intubation with minimal adverse effects. This trial is registered with ClinicalTrials.govNCT01289769.

The Effects of a Caffeine Placebo and Experimenter Expectation on Blood Pressure, Heart Rate, Well-Being, and Cognitive Performance

2001 ◽  
Vol 6 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Harald Walach ◽  
Stefan Schmidt ◽  
Yvonne-Michelle Bihr ◽  
Susanne Wiesch
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cognitive Task ◽  
Well Being ◽  
Control Group ◽  
Double Blind ◽  
Main Effect ◽  
The Difference ◽  
Being There ◽  
To Receive

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.

Frühgeborene unter maschineller Beatmung: Immunmodulatorischer Effekt der präventiven Gabe von Azithromycin

2020 ◽  
pp. 1-3
Author(s):  
Maximilian Jorczyk
Keyword(s):  
Very Low Birth Weight ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Double Blind ◽  
Mechanically Ventilated ◽  
Before And After ◽  
Anti Inflammatory ◽  
To Receive ◽  
Therapeutic Possibilities ◽  
Inflammatory Effect

<b>Introduction:</b> Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. <b>Objective:</b> The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. <b>Methods:</b> This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for <i>Ureaplasma</i>. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). <b>Results:</b> Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O<sub>2</sub> dependency at 28 days/death in azithromycin-treated patients regardless of the detection of <i>Ureaplasma</i> in blood. <b>Conclusions:</b> Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O<sub>2</sub> dependency at 28 days/death in mechanically ventilated preterm neonates.

scholarly journals Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽  
2021 ◽  
Vol 41 (3) ◽  
pp. 294-304 ◽  
Author(s):  
Messoud Ashina ◽  
Uwe Reuter ◽  
Timothy Smith ◽  
Judith Krikke-Workel ◽  
Suzanne R Klise ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Statistical Testing ◽  
Control Group ◽  
Double Blind ◽  
Treatment Groups ◽  
Primary Endpoints ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

scholarly journals Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1280
Author(s):  
Jan Mieszkowski ◽  
Andżelika Borkowska ◽  
Błażej Stankiewicz ◽  
Andrzej Kochanowicz ◽  
Bartłomiej Niespodziński ◽  
...  
Keyword(s):  
Vitamin D ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Oncostatin M ◽  
Control Group ◽  
High Dose ◽  
Double Blind ◽  
Single High Dose ◽  
High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

scholarly journals Consumption of a Double-Fortified Salt Affects Perceptual, Attentional, and Mnemonic Functioning in Women in a Randomized Controlled Trial in India

2017 ◽  
Vol 147 (12) ◽  
pp. 2297-2308 ◽  
Author(s):  
Michael J Wenger ◽  
Laura E Murray-Kolb ◽  
Julie EH Nevins ◽  
Sudha Venkatramanan ◽  
Gregory A Reinhart ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Status ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Deficiency Anemia ◽  
Control Group ◽  
Attention And Memory ◽  
Double Blind ◽  
Iron Deficient ◽  
Mnemonic Function

Abstract Background: Iron deficiency and iron deficiency anemia have been shown to have negative effects on aspects of perception, attention, and memory. Objective: The purpose of this investigation was to assess the extent to which increases in dietary iron consumption are related to improvements in behavioral measures of perceptual, attentional, and mnemonic function. Methods: Women were selected from a randomized, double-blind, controlled food-fortification trial involving ad libitum consumption of either a double-fortified salt (DFS) containing 47 mg potassium iodate/kg and 3.3 mg microencapsulated ferrous fumarate/g (1.1 mg elemental Fe/g) or a control iodized salt. Participants' blood iron status (primary outcomes) and cognitive functioning (secondary outcomes) were assessed at baseline and after 10 mo at endline. The study was performed on a tea plantation in the Darjeeling district of India. Participants (n = 126; 66% iron deficient and 49% anemic at baseline) were otherwise healthy women of reproductive age, 18–55 y. Results: Significant improvements were documented for iron status and for perceptual, attentional, and mnemonic function in the DFS group (percentage of variance accounted for: 16.5%) compared with the control group. In addition, the amount of change in perceptual and cognitive performance was significantly (P < 0.05) related to the amount of change in blood iron markers (mean percentage of variance accounted for: 16.0%) and baseline concentrations of blood iron markers (mean percentage of variance accounted for: 25.0%). Overall, there was evidence that the strongest effects of change in iron status were obtained for perceptual and low-level attentional function. Conclusion: DFS produced measurable and significant improvements in the perceptual, attentional, and mnemonic performance of Indian female tea pickers of reproductive age. This trial was registered at clinicaltrials.gov as NCT01032005.

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