Effect of acupuncture on heart rate variability in individuals with multiple sclerosis: a protocol for a double-blinded randomized controlled trial / Efeito da acupuntura na variabilidade da frequência cardíaca em indivíduos com esclerose múltipla: um protocolo para ensaio randomizado controlado duplo cego

Introdução: o crescimento de pacientes com esclerose múltipla que procuram tratamento com acupuntura é baseado em relatos clínicos de melhora dos sintomas. Considerando que o comprometimento autonômico, incluindo a disfunção autonômica cardiovascular, não é incomum em pacientes com EM a neuromodulação com acupuntura pode ser uma ferramenta interessante para alterar a variabilidade da frequência cardíaca nessa população.Objetivo: avaliar a variabilidade da frequência cardíaca em pacientes com esclerose múltipla, durante a aplicação da Acupuntura, a fim de analisar o comportamento do sistema nervoso autônomo antes, durante e após a terapia e as mudanças na condição após uma intervenção longitudinal.Métodos: será realizado um ensaio clínico cruzado, randomizado, placebo-controlado, duplo-cego, com proporção de alocação de 1:1, com 40 indivíduos sem doença prévia, que constituirão o grupo controle, e 40 indivíduos com Esclerose Múltipla, que constituirão o grupo experimental. grupo, pareado por idade e sexo. Todos os participantes realizarão sessões de acupuntura ativas ou simuladas.Discussão: de acordo com os estudos encontrados, é esperada disfunção autonômica cardiovascular, com alterações na variabilidade da frequência cardíaca. Embora a neuromodulação com acupuntura possa controlar a dor e a inflamação, ainda há dificuldades em afirmar se o equilíbrio entre os sistemas simpático e parassimpático pode ser alterado pela acupuntura.

Backgroung: the growing of patients with multiple sclerosis seeking acupuncture treatment is based on clinical reports of improvements in symptoms. Considering that autonomic impairment, including cardiovascular autonomic dysfunction, is not uncommon in patients with MS, neuromodulation with acupuncture could be an interesting tool to change heart rate variability in this population.Objective: to evaluate heart rate variability in patients with multiple sclerosis, during the application of acupuncture, in order to analyze the behavior of the autonomic nervous system before, during and after therapy and changes in condition after a longitudinal intervention.Methods: a double-blinded randomized sham-controlled crossover trial with a 1:1 allocation ratio will be conducted, with 40 individuals without a previous illness, who will constitute the control group, and 40 individuals with Multiple Sclerosis, who will constitute the experimental group, paired by age and sex. All participants will undertake active or sham acupuncture sessions.Discussion: according to the studies found, cardiovascular autonomic dysfunction is expected, with alterations in heart rate variability. Although neuromodulation with acupuncture can control pain and inflammation, there are still difficulties in affirming whether the balance between the sympathetic and parasympathetic systems can be changed by acupuncture

The use of a task through virtual reality in cerebral palsy using two different interaction devices (concrete and abstract) - a cross-sectional randomized study.

BACKGROUND: Cerebral Palsy (CP) is characterised by variable difficulties in muscular action, resulting in inability of the individual to perform functional movement. An option to provide functionality to the individual with CP is the use of computer innovation. The aim of this paper was to verify if there was any performance improvement in a task performed in a virtual environment and if there was transfer to the task performed in the real environment and vice versa in this population. METHODS: A computer program was developed comprising a motor task, but with two possibilities of user interaction: a) concrete interface (with physical contact): in which the individual touches the computer screen to finish the task and b) abstract interface (no physical contact): in which the individual performs a hand movement in front of the Kinect device. Participants were split into two groups. The experimental group consisted of 28 individuals with CP within the ages of 6 and 15 years old. The control group included 28 typically developing individuals mirroring the age and sex of the experimental group. RESULTS: Individuals from both groups were able to improve task performance and retain acquired information. The CP group presented worse performance than the control group in all phases of the study. Further findings showed that the CP group presented better performance in the abstract interface than in the concrete interface, whereas, in the control group, the opposite occurred: their best performance was in the concrete. CONCLUSIONS: Motor tasks performed by individuals with CP through an interface with a more virtual environment feature (abstract interface: Kinect) provided better performance when compared to an interface with a more real characteristic (concrete interface: Touchscreen). TRIAL REGISTRATION: ClinicalTrials.gov Identifier - NCT03352440; Date of registration - November 17, 2017.

Autonomic responses of premature newborns to body position and environmental noise in the neonatal intensive care unit. / Respostas autonômicas de recém-nascidos prematuros ao posicionamento do corpo e ruídos ambientais na unidade de terapia intensiva neonatal.

OBJECTIVE: Evaluate the physiological and autonomic nervous system responses of premature newborns to body position and noise in the neonatal intensive care unit. METHODS: A quasi-experimental study. The autonomic nervous system of newborns was evaluated based on heart rate variability when the newborns were exposed to environmental noise and placed in different positions: supine without support, supine with manual restraint and prone. RESULTS: Fifty premature newborns were evaluated (gestational age: 32.6 ± 2.3 weeks; weight: 1816 ± 493g; and Brazelton sleep/awake level: 3 to 4). A positive correlation was found between environmental noise and sympathetic activity (R = 0.27, p = 0.04). The mean environmental noise was 53 ± 14dB. The heart rate was higher in the supine position than in the manual restraint and prone positions (148.7 ± 21.6, 141.9 ± 16 and 144 ± 13, respectively) (p = 0.001). Sympathetic activity, represented by a low frequency index, was higher in the supine position (p < 0.05) than in the other positions, and parasympathetic activity (high frequency, root mean square of the sum of differences between normal adjacent mean R-R interval and percentage of adjacent iRR that differed by more than 50ms) was higher in the prone position (p < 0.05) than in the other positions. The complexity of the autonomic adjustments (approximate entropy and sample entropy) was lower in the supine position than in the other positions. CONCLUSION: The prone position and manual restraint position increased both parasympathetic activity and the complexity of autonomic adjustments in comparison to the supine position, even in the presence of higher environmental noise than the recommended level, which tends to increase sympathetic activity.

OBJETIVO: Avaliar as respostas fisiológicas e do sistema nervoso autônomo de recém-nascidos prematuros ao posicionamento do corpo e ruídos ambientais na unidade de terapia intensiva neonatal. MÉTODOS: Este foi um estudo quasi-experimental. O sistema nervoso autônomo de recém-nascidos foi avaliado com base na variabilidade da frequência cardíaca quando os recém-nascidos foram expostos ao ruído ambiental e colocados em diferentes posições: supina sem suporte, supina com restrição manual e prona. RESULTADOS: Cinquenta recém-nascidos prematuros foram avaliados (idade gestacional de 32,6 ± 2,3 semanas, peso de 1.816 ± 493g e nível Brazelton de sono/vigília de 3 a 4). Identificou-se correlação positiva entre o ruído ambiental e a atividade simpática (R = 0,27; p = 0,04). O ruído ambiental médio foi de 53 ± 14dB. A frequência cardíaca foi mais elevada na posição supina do que nas posições com restrição manual e prona (148,7 ± 21,6; 141,9 ± 16 e 144 ± 13, respectivamente; p = 0,001). A atividade simpática, representada por um índice de baixa frequência, foi mais elevada na posição supina (p < 0,05) do que nas demais posições, e a atividade parassimpática (alta frequência, raiz quadrada da média dos quadrados das diferenças entre os intervalos RR normais adjacentes e porcentagem dos intervalos R-R adjacentes com diferença de duração maior que 50ms) foi mais elevada na posição prona (p < 0,05) do que nas demais posições. A complexidade dos ajustes autonômicos (entropia aproximada e entropia da amostra) foi mais baixa na posição supina do que nas demais posições. CONCLUSÃO: A posição prona e a posição com restrição manual aumentaram tanto a atividade parassimpática quanto a complexidade dos ajustes autonômicos em comparação com a posição supina, mesmo na presença de ruído ambiental maior do que o nível recomendado, o que tende a aumentar a atividade simpática.

Respostas autonômicas de recém-nascidos prematuros ao posicionamento do corpo e ruídos ambientais na unidade de terapia intensiva neonatal / Autonomic responses of premature newborns to body position and environmental noise in the neonatal intensive care unit

RESUMO Objetivo: Avaliar as respostas fisiológicas e do sistema nervoso autônomo de recém-nascidos prematuros ao posicionamento do corpo e ruídos ambientais na unidade de terapia intensiva neonatal. Métodos: Este foi um estudo quasi-experimental. O sistema nervoso autônomo de recém-nascidos foi avaliado com base na variabilidade da frequência cardíaca quando os recém-nascidos foram expostos ao ruído ambiental e colocados em diferentes posições: supina sem suporte, supina com restrição manual e prona. Resultados: Cinquenta recém-nascidos prematuros foram avaliados (idade gestacional de 32,6 ± 2,3 semanas, peso de 1.816 ± 493g e nível Brazelton de sono/vigília de 3 a 4). Identificou-se correlação positiva entre o ruído ambiental e a atividade simpática (R = 0,27; p = 0,04). O ruído ambiental médio foi de 53 ± 14dB. A frequência cardíaca foi mais elevada na posição supina do que nas posições com restrição manual e prona (148,7 ± 21,6; 141,9 ± 16 e 144 ± 13, respectivamente; p = 0,001). A atividade simpática, representada por um índice de baixa frequência, foi mais elevada na posição supina (p < 0,05) do que nas demais posições, e a atividade parassimpática (alta frequência, raiz quadrada da média dos quadrados das diferenças entre os intervalos RR normais adjacentes e porcentagem dos intervalos R-R adjacentes com diferença de duração maior que 50ms) foi mais elevada na posição prona (p < 0,05) do que nas demais posições. A complexidade dos ajustes autonômicos (entropia aproximada e entropia da amostra) foi mais baixa na posição supina do que nas demais posições. Conclusão: A posição prona e a posição com restrição manual aumentaram tanto a atividade parassimpática quanto a complexidade dos ajustes autonômicos em comparação com a posição supina, mesmo na presença de ruído ambiental maior do que o nível recomendado, o que tende a aumentar a atividade simpática.

ABSTRACT Objective: Evaluate the physiological and autonomic nervous system responses of premature newborns to body position and noise in the neonatal intensive care unit. Methods: A quasi-experimental study. The autonomic nervous system of newborns was evaluated based on heart rate variability when the newborns were exposed to environmental noise and placed in different positions: supine without support, supine with manual restraint and prone. Results: Fifty premature newborns were evaluated (gestational age: 32.6 ± 2.3 weeks; weight: 1816 ± 493g; and Brazelton sleep/awake level: 3 to 4). A positive correlation was found between environmental noise and sympathetic activity (R = 0.27, p = 0.04). The mean environmental noise was 53 ± 14dB. The heart rate was higher in the supine position than in the manual restraint and prone positions (148.7 ± 21.6, 141.9 ± 16 and 144 ± 13, respectively) (p = 0.001). Sympathetic activity, represented by a low frequency index, was higher in the supine position (p < 0.05) than in the other positions, and parasympathetic activity (high frequency, root mean square of the sum of differences between normal adjacent mean R-R interval and percentage of adjacent iRR that differed by more than 50ms) was higher in the prone position (p < 0.05) than in the other positions. The complexity of the autonomic adjustments (approximate entropy and sample entropy) was lower in the supine position than in the other positions. Conclusion: The prone position and manual restraint position increased both parasympathetic activity and the complexity of autonomic adjustments in comparison to the supine position, even in the presence of higher environmental noise than the recommended level, which tends to increase sympathetic activity.

A didactic approach to presenting verbal and visual information to children participating in research protocols: the comic book informed assent.

OBJECTIVE: When children participate in research protocols, consent (by a parent or legal guardian) and assent (by the children) must be given. Understanding research protocols can be challenging for an adult and even more difficult for a child. The aim of this study was to describe the development of a comic book created to facilitate children's understanding of informed assent with clear and simple language. METHODS: Five researchers with scores above seven according to the Fehring criteria developed the comic book, avoiding the use of technical terminology. Twenty children between 7 and 12 years old, and enrolled in a larger study, responded using a Likert scale and questions about the clarity of texts and illustrations. The final version met National Health System Resolutions (Resoluções do Conselho Nacional da Saúde - CNS n° 196/1996 and 466/2012). RESULTS: The comic book assent presents a short story containing information about a real study: the invitation to participate, objectives, methods, instruments, procedures, risks, benefits, and the researchers' contact information. Most of the participants answered that they perceived the content of the text to be "Excellent" (40%) and "Very good" (40%), and the illustrations were perceived as "Excellent" (45%) and "Very good" (55%). CONCLUSION: The construction of a simple and clear model of informed assent is possible, and this model should be used in experiments with children.

A didactic approach to presenting verbal and visual information to children participating in research protocols: the comic book informed assent

OBJECTIVE: When children participate in research protocols, consent (by a parent or legal guardian) and assent (by the children) must be given. Understanding research protocols can be challenging for an adult and even more difficult for a child. The aim of this study was to describe the development of a comic book created to facilitate children's understanding of informed assent with clear and simple language. METHODS: Five researchers with scores above seven according to the Fehring criteria developed the comic book, avoiding the use of technical terminology. Twenty children between 7 and 12 years old, and enrolled in a larger study, responded using a Likert scale and questions about the clarity of texts and illustrations. The final version met National Health System Resolutions (Resoluções do Conselho Nacional da Saúde - CNS n° 196/1996 and 466/2012). RESULTS: The comic book assent presents a short story containing information about a real study: the invitation to participate, objectives, methods, instruments, procedures, risks, benefits, and the researchers' contact information. Most of the participants answered that they perceived the content of the text to be "Excellent" (40%) and "Very good" (40%), and the illustrations were perceived as "Excellent" (45%) and "Very good" (55%). CONCLUSION: The construction of a simple and clear model of informed assent is possible, and this model should be used in experiments with children.