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Behavior, Child clinical trials

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NCT ID: NCT05681832 Recruiting - Physical Inactivity Clinical Trials

Developing a Physical Activity Program Based on Behavior Change Models in Children and Investigation of Its Efficiency

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

The aim of our study is to develop a physical activity program based on behavioral change models for children and to investigate the effectiveness of the physical activity program we have developed for children attending primary school. There is a limited number of studies in the literature on exercise habits in children, and there is no evidence on which model will provide better results when integrated into school or training programs. Although behavioral modification-based physical activity programs for children have been established and their effectiveness has been investigated in many different countries, there are limited randomized controlled studies on this subject. Currently, there are no randomized control studies on the topic in Turkey. Our study will be the first study in which a school-based physical activity program based on behavioral change models in Turkish children is developed and its effectiveness is investigated. We believe that our study will contribute to the development of new models and protocols to improve the health of children in Turkey and the world and to provide behavior change methods that are research-based to combat physical inactivity.

NCT ID: NCT05608720 Completed - Behavior, Child Clinical Trials

Preparation Protocol for the First Pediatric Dental Visit

PREP
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

To date, not enough attention has been paid to the role of communication before the first dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The dentist can provide parents with the information they need to adequately prepare the child for treatment. The present study aims to investigate the effectiveness of an infor-mation booklet to promote pediatric patients' cooperation during the first dental visit

NCT ID: NCT05592587 Completed - Anesthesia, Local Clinical Trials

Pain and Anxiety Reduction Using a Vibrating Eye Massage Device With Relaxing Nature Sounds

Start date: June 15, 2022
Phase: N/A
Study type: Interventional

This study aims to evaluate the effectiveness and acceptance of an eye massage device that produces nature sounds and vibratory stimulations in the management of anxious pediatric patients during inferior alveolar nerve block Group A (Control group): inferior alveolar nerve block will be administrated with basic behavior guidance techniques and without distraction aids. Group B: inferior alveolar nerve block will be administrated with the usage of the eye massage device producing both vibrations and nature sounds Group C: inferior alveolar nerve block will be administrated with the eye massage device producing vibratory stimulations only. All of the children who experienced an inferior alveolar block with/without distraction will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") Acceptance will be measured using a two-point Likert scale.

NCT ID: NCT05585905 Recruiting - Behavior, Child Clinical Trials

Virtual Reality in Pediatric Dentistry

Start date: March 17, 2023
Phase: N/A
Study type: Interventional

Dental Fear and Anxiety is an emotional experiences affecting many children and adolescents which can lead to behavioral problems in the dental setting. The purpose of the proposed study is to investigate the effect of virtual reality on anxiety, behavior, and pain in children undergoing restorative dental procedures. Children enrolled in the study will include patients ages 6-18 who are healthy and require two or more dental sealants (at least one sealant per side). The participants in the study will serve as their own control using a split-mouth cross-over randomized control clinical trial design and will be randomly assigned to receive virtual reality or traditional behavior guidance techniques first during dental sealant placement. The objectives of this study are to explore the associations between the use of virtual reality distraction during dental sealant placement with Frankl score, FLACC scale, and anxiety based on the change in heart rate, and pain based on self-reported FPS-R when compared with to the control group. The crossover design will be assessed by a linear mixed model with patient treated as a random effect. This model will include treatment, visit, treatment by visit interaction term as well as a treatment sequence variable. Prior to analysis, the primary outcome measures will be assessed for normality using a Shapiro-Wilk statistic as well as quantile-quantile (QQ) plots. Should the data deviate sharply from a normal distribution, normalizing transformations will be sought and applied to the data.

NCT ID: NCT05525962 Recruiting - Child Development Clinical Trials

Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.

EvolASE-PEA
Start date: September 29, 2022
Phase:
Study type: Observational

Assess the prevalence of medico-psychological characteristics at the time of placement (M0), their appearance / disappearance and during the two years following placement (M12 and M24) by age group in children / adolescents in Child Protective Services and placed full-time in the structures of Seine-Maritime and Eure as well as in nursery in Le Havre or Rouen

NCT ID: NCT05476549 Completed - Cognitive Change Clinical Trials

Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children

Start date: August 4, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of 15 mg/kg lemon verbena, in comparison to placebo, on the attention deficit hyperactivity disorder (ADHD) type behaviour and cognitive function of children who do not have a diagnosis of ADHD, but who exhibit high scores (highest tertile) on ADHD behaviour parameters. Multiple aspects of mood will also be assessed. The proposed randomised, double-blind, placebo-controlled, parallel groups design methodology will assess the psychological effects of 15 mg/kg lemon verbena extract and a matched placebo prior to and after 4 and 8 weeks of supplementation. The trial will utilise the COMPASS cognitive assessment system (Northumbria University) and a range of mood measures during laboratory testing visits. Parents and children will also take part in a concomitant smartphone study, comprising the collection of the parent's assessment of the child's behaviour/cognitive function and the child's self-report of the same, plus their mood. These assessments will take place on Days -1, 14, 28, 42 and 56.

NCT ID: NCT05470621 Completed - Physical Inactivity Clinical Trials

A Playground Training to Improve Children's Health After-school and During Recess: The PLAYground Project

Start date: August 22, 2022
Phase: N/A
Study type: Interventional

Schools are critical settings to foster children's health. The purpose of this two-year cluster-randomized trial is to enhance both the after-school and recess settings to provide children with knowledge and skills to facilitate active and inclusive play. The primary aim of the project is to assess the impact of a playground curriculum intervention on children's physical, social, emotional, and behavioral health. The secondary aim of the project to understand the appropriateness, feasibility, fidelity, and sustainability of implementing a playground curriculum in after-school and recess settings.

NCT ID: NCT05403996 Active, not recruiting - Health Behavior Clinical Trials

Effects of an Active Break Program at Primary School

Activa-Mente
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effectiveness of an active break program at school on physical activity levels and enjoyment, and on-task behavior in children.

NCT ID: NCT05302154 Completed - Behavior, Child Clinical Trials

Effect of Virtual Reality on Dental Anxiety in Children

Start date: March 11, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to reduce dental anxiety in children by using virtual reality glasses (VRG) with a special content and innovative interactive methods, to determine the level of stress experienced by patients during dental treatment and to ease the workload of dentists. Within the scope of the study, the participants being examined are in a controlled manner from the practice environment. They are attached a VRG and headphones throughout the treatment. With the help of VRG, it is ensured that participants are ready for the treatment. During the treatment, the participant's focus is on various contents in terms of spectacles. Contents include visual (video surveillance) and auditory stimuli (listening to music). They also provide information about treatment to the patient with the help of avatars (characters) and environmental elements that are placed into the VRG application. In addition, dental anxiety is reduced by the fun contents. The goal is to increase the rate of dental treatment success in child patients. The effectiveness of virtual reality system is tested by comparing evaluation metrics of three groups of children. In the first group, the dentist carries out the treatment alone. In the second group participants watch cartoons on a screen mounted dental unit during the treatment. In the third group, dental treatment is carried out with VRG. In the course of these experiments, the effects of VRG on dental treatment (vital pulpotomy and dental filling) that require local anesthesia is examined in order to measure the effects of VRG on the level of stress on dental treatment. Corresponding measures are; (1) the child's anxiety; (2) the child's pain perception during local anaesthesia and treatment; (3) the child's cooperation and general behaviour. The outcomes of the child's anxiety, pain perception, cooperation and general behaviour for three groups were evaluated by statistical analysis.

NCT ID: NCT05264415 Active, not recruiting - Depression Clinical Trials

Intergenerational Transmission of Traumatic Stress

Start date: October 6, 2021
Phase: N/A
Study type: Interventional

Millions of U.S. parents have experienced trauma, putting them at risk for maladaptive parenting practices, which then confer vulnerabilities to their children. This study aims to enhance understanding of how parental emotional dysregulation associated with traumatic stress impedes effective parenting. The study employs neurophysiological methods (electroencephalogram; EEG) to address some of the challenges inherent in the study of emotion (particularly in trauma-exposed individuals) and to identify potential biomarkers of traumatic stress and response to intervention.