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NCT ID: NCT06319833 Active, not recruiting - Physical Activity Clinical Trials

Effects of Brain Breaks on Educational Achievement in School Settings: The Break4Brain Project

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

A total of 600 children between 10 and 12 years of age will be randomized among two experimental conditions: physical activity interacting with a video (n = 300), and sedentary activity (n = 300). The experimental condition will take place in the school settings during the school day through a between-subject design with a total of two measurements, pre, and post-test. Using the latest advances, the transient effects of the experimental conditions on cognitive and academic performance will be measured. The experimental condition was crafted through a qualitative design involving semi-structured interviews with teachers (n = 41) and members of the management team (n = 16), along with questionnaires administered to students (n = 600). To enhance and ensure its sustainability, the same process will be replicated after the intervention. Interviews and questionnaires were meticulously crafted by the RE-AIM framework, and subsequently validated through a rigorous process involving an expert panel (n = 30) utilizing the Delphi methodology. This project has the potential to substantially contribute to the field of acute physical activity and could have a meaningful transference on the educational system. This method might be prescribed as an effective teaching strategy.

NCT ID: NCT06317883 Active, not recruiting - Child Obesity Clinical Trials

Childhood Obesity Risk Assessment Longitudinal Study

CORALS
Start date: May 27, 2019
Phase:
Study type: Observational

Childhood obesity is a major public health problem worldwide. Europe has a high prevalence of obesity, which is accentuated in Mediterranean countries. Spain has a high prevalence of both overweight (percentage: 21.5 in boys and 22.2 in girls) and obesity (percentage: 10.6 in boys and 11.8 in girls) in children aged 6-9 years. From childhood, obesity is associated with an increased risk of diseases such as insulin resistance, type 2 diabetes, hypertension, metabolic syndrome, musculoskeletal problems, sleep disorders and mental health problems. Obesity is a complex, multi-causal problem involving individual risk factors such as behavior and genetics. Behavioral factors include diet, physical activity, sedentary lifestyle, sleep, and others. It is therefore important to study each of the individual risk factors for obesity. There are few large sample studies in European/Spanish children and no longitudinal studies estimating the incidence of obesity in preschool children based on exposure to different risk factors, considering not only the effect of food consumption but also dietary habits and patterns. The aim of the present study is to identify risk factors for childhood obesity through long-term longitudinal follow-up.

NCT ID: NCT06304454 Active, not recruiting - Clinical trials for Kindergarten Children

Board Games at Kindergarten (5 Years Old) to Improve Cognitive and Emotional Processes

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Cognitive (i.e. executive functions, memory) and socio-emotional (i.e. affection recognition) processes emerges at first years. These processes have been frequently related to adequate academic performance in the scientific literature (Passolunghi et al, 2015). Current research aimed at training cognitive processes found promising results using board game as a cognitive tool in children (Passolunghi & Costa, 2016). Considering the growing interest of teachers in this playful and possibly educational, cognitive and socio-emotional resource, a game program for these purposes has been designed to be used in kindergarten classrooms. The main aim of the present study is to test the efficacy of a cognitive and emotional training program in the classroom based on board games in kindergarten students (5 years old). For this, there will be an experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers, and a control group that will be on board games that do not directly activate cognitive and emotional processes. At the end of the interventions, the groups will be compensated by carrying out inversely both board game programs. The classes will be randomly assigned to an experimental group and a passive control group.

NCT ID: NCT06303791 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders

INPSYD
Start date: September 7, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to implement a structured psychosocial intervention program with digital support (randomized and with a control group) that will be conducted virtually and synchronously to families of children with autism spectrum disorder (ASD) and families of children with Attention Deficit with hyperactivity Disorder (ADHD). The main questions it aims to answer are: 1. Will the program impact on different variables in the parents' domain (parental stress variables, quality of life/social support and coping skills), 2. Will the program impact on different variables in the children's domain (daily life functioning, social behavioral variables, and executive functioning). 3. Treatment outcomes will be assessed at pre-test, post-test, and 6-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress, coping skills, social support, and children's dysfunctional outcomes Parents and teachers will complete different questionnaires to see if there are improvements on parent's and children outcomes. Researchers will compare intervention group and control group to see if there are improvements on parent's domains (parenting stress, coping skills, social support) and children's dysfunctional outcomes (daily life functioning, social behavioral variables, and executive functioning).

NCT ID: NCT06303674 Active, not recruiting - ADHD Clinical Trials

Effects of Brain Breaks on Educational Achievement in Laboratory Settings: The Break4Brain Project

Start date: February 27, 2023
Phase: N/A
Study type: Interventional

Advancement in teaching methods, together with the frenetic change in the lifestyles of the school population, provides a unique opportunity to advance scientific knowledge. The current project, called "The Break4Brain Project", aims to examine the acute (transient) effects of physical activity on brain function, cognition, and academic performance in children with and without Attention Deficit Hyperactivity Disorder (ADHD). Specifically, a total of 60 children between 10 and 12 years old will be included with (n=30) and without (n=30) ADHD. The study will use an intra-subject design of isolated conditions with four measurement moments where the children will perform three different experimental conditions lasting 10 minutes, which will be randomized in a counterbalanced manner. These experimental conditions will be based on physical activity engaging cognitively, physical activity without engaging cognitively, and cognitively engaging control condition. This project could have a significant impact in the educational field, since, if brain function, cognition, and academic performance prove to be favorably stimulated, acutely, by physical activity through active breaks, these could be prescribed as an effective teaching strategy for children with and without ADHD in the school setting.

NCT ID: NCT06298240 Active, not recruiting - Nurse's Role Clinical Trials

Implementation of Nursing Demand Management as a Factor for Improvement in a Primary Care Emergency Center.

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Background: Nurse Demand Management was born in 2009 out of the need to address the growth of spontaneous acute demand in primary care. But it is not until 2013 that guidelines for the exercise of nursing actions in demand management were established in Catalonia, Spain. Nurses trained specifically to solve acute and low complexity health problems generate a quality of care comparable to that provided by family medicine doctors. On the other hand, it is worth highlighting the need to rationalise medical resources in primary care centres, primary care emergency centres or points of continuous care (different emergency facilities in the territory in terms of size and services) in order to give priority to doctors being able to dedicate more time to medium or high complexity pathology. Although nurse demand management has been implemented in primary care teams for years, it is being carried out in different intensities according to the needs or priorities of each health territory. The promotion of the autonomous role of nursing through the implementation of nurse demand management in the urgent spontaneous demand of low complexity can be transcendent, both in the optimisation of health resources in primary care and in the management of the demand for care. Hypothesis: The implementation of nurse demand management is a factor of improvement in the efficiency and quality of care in the Primary Care Emergency Centre of the city of Mataró (Barcelona, Spain). Objectives: The main objective of this study was to determine whether the implementation of nurse demand management is a factor in improving efficiency and quality of care in the CUAP of Mataró. Methodology: Non-randomised controlled experimental intervention study. Application of a consensual guide with 5 reasons for health consultations where demand management nursing can be applied.

NCT ID: NCT06297460 Active, not recruiting - Self Harm Clinical Trials

Adaptation of STEPPS Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The overall objective of this study is to assess the feasibility, within the Penitentiary Centers of Catalonia, of adapting the STEPPS program for addressing and preventing emotional dysregulation and self-harming behaviors through an implementation study.

NCT ID: NCT06290882 Active, not recruiting - Achalasia Cardia Clinical Trials

Endoscopic Versus Robotic Myotomy for Treatment of Achalasia

ERMA
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, resulting in impaired relaxation of the esophagogastric junction (EGJ), along with loss of peristalsis in the esophageal body. The standard criteria for diagnosing achalasia is high-resolution esophageal manometry, which shows incomplete relaxation of the EGJ along with absence of esophageal body peristalsis. These anomalies usually cause dysphagia and regurgitation as the main symptoms of this pathology. Different treatment options have been described for this pathology, with pneumatic dilation (PD) and myotomy being considered first-line, whether surgical (laparoscopic Heller myotomy, LHM) or endoscopic (peroral endoscopic myotomy, POEM). The arrival of POEM as a less invasive alternative for the treatment of achalasia has revolutionized expectations to the point that it has become a routine procedure in many centers around the world. In recent years, a large amount of data examining the effectiveness of POEM have appeared, including several meta-analyses. The success rate of POEM in prospective cohorts has been greater than 90%. Two randomized studies have been published comparing POEM with LHM, providing a framework to evaluate the comparative efficacy and safety of these two interventions and to determine which should be first-line for the treatment of these patients. According to these data, it seems that the two procedures offer the same clinical results in the medium term. On the other hand, in recent years, there has been a growing expansion of the application of robot-assisted technology. Robotic Heller myotomy (RHM) has been proposed as an alternative minimally invasive approach to traditional laparoscopy with a lower complication rate. Based on the evidence, POEM and RHM could have comparable results in short term, but there is no clear certainty about the results in medium-long term. Likewise, there is a lack of studies that confirm postoperative reflux results in both procedures. The purpose of the study is to evaluate the clinical and quality of life results of the RHM and compare them with the results of POEM in treatment of achalasia.

NCT ID: NCT06288061 Active, not recruiting - Clinical trials for Inflammatory Bowel Diseases

Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain.

Start date: March 20, 2024
Phase: N/A
Study type: Interventional

Inflammatory bowel diseases (IBD) are chronic relapsing diseases that generate an autoimmune response against the bowel and its microbiota. Its prevalence is increasing worldwide. These include Ulcerative Colitis (UC) and Crohn's Disease(CD). The Phrenic nerve originates at the roots C3-C4-C5 carrying motor and sensory information. Directly or through connections it innervates the diaphragm, pleura, right atrium, pericardium, oesophagus, peritoneum, stomach, falciform and coronary ligaments of the liver, Glisson's capsule, hepatic and inferior vena cava, liver (parenchyma), gallbladder and the rest of the biliary tract, pancreas, small intestine and adrenal glands. It also has fibres of the autonomic nervous system. Studies show that there is a link between people suffering from IBD and hepatopancreato-biliary diseases. It can therefore generate referred pain to the C3-C4-C5 dermatomes. Based on the above, the main objective would be to analyse whether non-invasive neuromodulation of the Phrenic nerve reduces neck pain in people with IBD. Secondary objectives were to assess the impact of treatment on quality of life and to study the relationship between IBD and cervical pain. Hypothesis: Non-invasive Phrenic nerve neuromodulation in subjects suffering from inflammatory bowel disease and neck pain will improve their quality of live, disability and sensitisation, as well as neck pain and mobility.

NCT ID: NCT06288048 Active, not recruiting - Lateral Elbow Pain Clinical Trials

Effect of Mirror Therapy on Post-Needling Pain Following Deep Dry Needling of Myofascial Trigger Point in Lateral Elbow Pain

Start date: April 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this randomized, controlled pilot trial is to investigate the immediate effects of incorporating Mirror Visual Feedback Therapy (MFT) on pain sensitivity and motor performance in individuals experiencing Post-needling pain associated with lateral elbow pain. The main questions it aims to answer are: - Does incorporating Mirror Visual Feedback Therapy reduce Post-needling pain intensity? - Does incorporating Mirror Visual Feedback Therapy improve pressure pain threshold? - Does incorporating Mirror Visual Feedback Therapy improve maximum grip strenght? Participants will be asked to undergo pre- and post-treatment evaluations, which include assessments of Post-needling pain intensity, pressure pain threshold, two-point discrimination threshold, and maximum hand grip strength. Participants in the Experimental Group will receive Deep Dry Needling in the m. Brachioradialis, Ischemic Compression, Cold Spray, Stretching, and Mirror Visual Feedback Therapy. Those in the Control Group will not receive Mirror Visual Feedback Therapy. Researchers will compare the Experimental Group to the Control Group to see if the incorporation of Mirror Visual Feedback Therapy results in a reduction in Post-needling pain intensity and improvement in pressure pain threshold.