scholarly journals Revisit the Effectiveness of Educational Kinesiology on Stress and Anxiety Amelioration in Kindergarteners With Special Needs: A Nonrandomized Trial

2021 ◽  
Author(s):  
Pui Lun Alan TAI ◽  
Kwok Wai Way LAU
Keyword(s):  
Clinical Trial ◽  
Special Needs ◽  
Scientific Evidence ◽  
Intervention Group ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Post Intervention ◽  
Educational Kinesiology ◽  
Registration Number

Abstract Although educational kinesiology is a popular intervention aims to improve brain functioning via physical movements, it lacks supporting scientific evidence. This study explores the effect of educational kinesiology on the changes in stress and anxiety markers in kindergarteners with special needs using psychometrics and biological measures. This open label non-randomized clinical trial was registered retrospectively in the Chinese Clinical Trial Registry (registration number: ChiCTR2000036305, url: http://www.chictr.org.cn/showproj.aspx?proj=58067, registration date: 22/08/2020). Thirty-seven kindergarteners with special needs (3.5-6.5 years old) were assigned to either the intervention group, which received one-hour educational kinesiology intervention weekly for a total of 10 weeks, or the wait-list control group. Scores of Parent-rated Preschool Anxiety Scale (PAS-TC), salivary cortisol and oxytocin levels were obtained pre- and post-intervention. After controlling baseline, the changes in oxytocin levels remained significantly different between groups (F1,35 = 5.590, p = 0.020, eta2 = 0.145), but not in cortisol levels (F1,35 = 0.364, p = 0.550, eta2 = 0.01). PAS-TC showed significant improvement in anxiety levels after the intervention in the intervention group (X2 = 4.367, p = 0.037, φ = 0.344, p = 0.037). Findings from both subjective and objective measures indicate a plausible anti-stress and anxiety effect in kindergarteners with special needs.

scholarly journals Revisit the Effectiveness of Educational Kinesiology on Stress and Anxiety Amelioration in Kindergarteners With Special Needs Using Biological Measures

2021 ◽  
Vol 12 ◽  
Author(s):  
Alan Pui-Lun Tai ◽  
Way Kwok-Wai Lau
Keyword(s):  
Special Needs ◽  
Scientific Evidence ◽  
Intervention Group ◽  
Small Samples ◽  
Control Group ◽  
Intervention Programme ◽  
Post Intervention ◽  
Brain Functioning ◽  
Educational Kinesiology ◽  
Quasi Experimental

Background: Educational kinesiology is a popular intervention that aims to improve brain functioning via physical movements. Yet, it lacks supporting scientific evidence and is regarded as pseudoscience. Given the popularity of educational kinesiology in school settings, it is important to revisit its effectiveness through scientific research. Previous studies that evaluated the effectiveness of educational kinesiology relied mainly on subjective measures, in which subjective bias is inevitable. Cortisol and oxytocin levels in saliva have been reported to be reliable stress and anxiety markers that provide unbiased objective data. This study explores the effect of educational kinesiology on the changes in salivary cortisol and oxytocin levels in kindergarteners with special needs.Methods: A quasi-experimental design was adopted in this study. Thirty-seven kindergarteners (3.5–6.5 years old) who were either diagnosed with one type of special needs or referred by school principals due to the requirement of special supports at school were assigned to either the intervention group, which received 1-h educational kinesiology intervention weekly for a total of 10 weeks, or the wait-list control group. Saliva samples were collected at baseline and after the completion of intervention programme for the measurement of cortisol and oxytocin levels. Scores of Parent-rated Preschool Anxiety Scale (PAS-TC) were also collected at pre- and post-intervention. Because of the small samples, non-parametric tests such as Mann-Whitney U test, Quade test, and Fisher's exact tests were used in this study where appropriate.Results: After controlled for the effect at baseline, gender and types of special needs, the changes in oxytocin levels were significantly higher in the intervention group compared with control [F(1, 35) = 4.747, p = 0.036, eta2 = 0.119], whereas no significant between-group difference in changes of cortisol levels was observed [F(1, 35) = 0.306, p = 0.584, eta2 = 0.009]. Results from PAS-TC showed significant improvement in anxiety levels after the intervention in the intervention group (p = 0.048, ϕ = 0.344, p = 0.037).Conclusions: Our findings suggest a plausible anti-anxiety effect of educational kinesiology in kindergarteners with special needs by elevating the oxytocin levels. Future studies are warranted to further confirm our findings with a larger sample.

scholarly journals Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Yu-yang Pang ◽  
Yan Li ◽  
Gang Kui ◽  
Yong Tang ◽  
Ming-juan Liao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Myeloproliferative Neoplasms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Complete Healing ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Leg Ulcers ◽  
Open Label ◽  
Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

scholarly journals Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation

2020 ◽  
Vol 17 (13) ◽  
pp. 4882 ◽  
Author(s):  
Manuel Pabón-Carrasco ◽  
Aurora Castro-Méndez ◽  
Samuel Vilar-Palomo ◽  
Ana María Jiménez-Cebrián ◽  
Irene García-Paya ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Scientific Evidence ◽  
Control Group ◽  
Initial State ◽  
Post Intervention ◽  
Before And After ◽  
Training Post ◽  
Foot Posture ◽  
Statics And Dynamics

Background: There is little scientific evidence regarding the effectiveness of strengthening exercises on the foot’s intrinsic musculature in improving the lower limb on the statics and dynamics in healthy individuals. Method: To evaluate the effect on foot posture with regard to the reinforcement of the short foot exercise (SFE) compared to another without a recognized biomechanical action, which we called the “non-biomechanical function” (NBF) exercise. A randomized clinical trial was carried out with 85 asymptomatic participants with a bilateral Foot Posture Index (FPI) greater than 6 points. An experimental group (n = 42) did SFE training and a control group (n = 43) carried out NBF exercises. The foot posture was evaluated twice via the navicular drop (ND) test, and the FPI was assessed on the day of inclusion in the study (pre-intervention) and after four weeks of training (post-intervention). Results: Statistically significant values were not found in foot posture between the experimental and the control groups when comparing before and after the training. However, the foot posture was modified in both groups with respect to its initial state, and the ND value decreased. Conclusions: SFE could be considered a useful tool to deal with pathologies whose etiology includes excessive pronation of the foot.

scholarly journals Safety and efficacy of hydroxychloroquine for treatment of non-severe COVID-19 among adults in Uganda: a randomized open label phase II clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Pauline Byakika-Kibwika ◽  
Christine Sekaggya-Wiltshire ◽  
Jerome Roy Semakula ◽  
Jane Nakibuuka ◽  
Joseph Musaazi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Viral Load ◽  
Adverse Events ◽  
Phase Ii ◽  
Intervention Group ◽  
Viral Clearance ◽  
Control Group ◽  
Rt Pcr ◽  
Open Label ◽  
Open Label Phase

Abstract Background Several repurposed drugs such as hydroxychloroquine (HCQ) have been investigated for treatment of COVID-19, but none was confirmed to be efficacious. While in vitro studies have demonstrated antiviral properties of HCQ, data from clinical trials were conflicting regarding its benefit for COVID-19 treatment. Drugs that limit viral replication may be beneficial in the earlier course of the disease thus slowing progression to severe and critical illness. Design We conducted a randomized open label Phase II clinical trial from October–December 2020. Methods Patients diagnosed with COVID-19 using RT-PCR were included in the study if they were 18 years and above and had a diagnosis of COVID-19 made in the last 3 days. Patients were randomized in blocks, to receive either HCQ 400 mg twice a day for the first day followed by 200 mg twice daily for the next 4 days plus standard of care (SOC) treatment or SOC treatment alone. SARS COV-2 viral load (CT values) from RT-PCR testing of samples collected using nasal/orapharyngeal swabs was performed at baseline, day 2, 4, 6, 8 and 10. The primary outcome was median time from randomization to SARS COV-2 viral clearance by day 6. Results Of the 105 participants enrolled, 55 were assigned to the intervention group (HCQ plus SOC) and 50 to the control group (SOC only). Baseline characteristics were similar across treatment arms. Viral clearance did not differ by treatment arm, 20 and 19 participants respectively had SARS COV-2 viral load clearance by day 6 with no significant difference, median (IQR) number of days to viral load clearance between the two groups was 4(3–4) vs 4(2–4): p = 0.457. There were no significant differences in secondary outcomes (symptom resolution and adverse events) between the intervention group and the control group. There were no significant differences in specific adverse events such as elevated alkaline phosphatase, prolonged QTc interval on ECG, among patients in the intervention group as compared to the control group. Conclusion Our results show that HCQ 400 mg twice a day for the first day followed by 200 mg twice daily for the next 4 days was safe but not associated with reduction in viral clearance or symptom resolution among adults with COVID-19 in Uganda. Trial registration: NCT04860284.

scholarly journals Evaluation of the Effect of Atorvastatin Administration on the Outcomes of Patients with Traumatic Brain Injury: A Double-Blinded Randomized Clinical Trial

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Farhad Soltani ◽  
Farahzad Janatmakan ◽  
Sara Jorairahmadi ◽  
Fatemeh Javaherforooshzadeh ◽  
Pooyan Alizadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Disability Rating Scale ◽  
Double Blinded

Background: Traumatic brain injury (TBI) is one of the common causes of long-term disabilities and mortality. This study aimed to evaluate the effect of atorvastatin administration on the Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), and Disability Rating Scale (DRS) in patients with TBI. Methods: This double-blinded randomized clinical trial included 60 patients with TBI in Golestan Hospital of Ahvaz, Iran. After obtaining an informed consent from all patients, the patients were randomly assigned into two groups. For the intervention group, atorvastatin with a daily dose of 20 mg was used. The control group was administered the same amount of placebo for 10 days. Changes in the level of consciousness were measured using the GCS, and functional recovery rate in patients was measured by GOS and DRS in the third follow-up month. Results: According to the obtained results, compared with the control group, the atorvastatin administration significantly increased the level of GCS and DRS within 2 - 3 months post-intervention and improved GOS since the tenth day after the study (P < 0.05). Conclusions: The results revealed the positive effect of atorvastatin on the improvement of outcomes measurements such as GCS, DRS, and GOS in patients after moderate and severe TBI.

scholarly journals Telephone intervention to promote maternal breastfeeding self-efficacy: randomized clinical trial

2021 ◽  
Vol 55 ◽  
Author(s):  
Hilana Dayana Dodou ◽  
Raylla Araújo Bezerra ◽  
Anne Fayma Lopes Chaves ◽  
Camila Teixeira Moreira Vasconcelos ◽  
Lorena Pinheiro Barbosa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Educational Intervention ◽  
Self Efficacy ◽  
Short Form ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Telephone Intervention ◽  
Clinical Trial Registry

ABSTRACT Objective: To analyze the effects of an educational intervention via telephone on maternal breastfeeding self-efficacy. Method: Randomized controlled clinical trial including 240 puerperae from a secondary care hospital randomized into two groups: control and intervention. The educational intervention took place at seven, 30, 90, and 150 days postpartum and centered on self-efficacy and motivational interviewing principles. Self-efficacy was measured by the Breastfeeding Self-Efficacy Scale – Short Form. The data followed the abnormal distribution, so non-parametric tests were used. Results: The intervention group obtained higher median breastfeeding self-efficacy scores across the three outcome measures when compared to the control group (p < 0,001). Furthermore, the intervention group showed increased self-efficacy scores at all monitoring moments, which shows that the educational intervention was able to raise and maintain women’s confidence in breastfeeding their child over time. Conclusion: The use of a telephone-based intervention focused on self-efficacy principles and delivered by trained nurses effectively promoted maternal confidence in breastfeeding. Brazilian Clinical Trial Registry: RBR-7m7vc8.

scholarly journals Voices 2: Improving Prosodic Recognition in Schizophrenia With an Online Rehabilitation Program

2021 ◽  
Vol 12 ◽  
Author(s):  
María Lado-Codesido ◽  
Rosa María Rey Varela ◽  
Marina Larios Quiñones ◽  
Luis Martínez Agulleiro ◽  
Julieta Ossa Basanes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emotion Recognition ◽  
Intervention Group ◽  
Rehabilitation Program ◽  
Clinical State ◽  
Control Group ◽  
Post Intervention ◽  
Clinical Trial Registration ◽  
Training Tool ◽  
On Line

Introduction: Emotion recognition of voices may play an important role in interpersonal communication and patients with schizophrenia present alterations in this regard. Several on-line rehabilitation tools have been developed for treatment in this area. Voices is an on-line prosodic recognition program consisting of identifying different emotional tones in neutral phrases, in different sessions of gradually increasing difficulty. This training tool has previously reported benefits, and a new version has been created called Voices 2. The main aim of this study is to test the capacity of the Voices 2 program to improve emotion recognition through prosody for adults with schizophrenia. Secondly, it seeks to observe durability effects 1 month after intervention.Method: A randomized, single-blind, multicenter clinical trial was conducted with 44 outpatients diagnosed with schizophrenia or schizoaffective disorder. The intervention group (also called Voices) was treated with Voices 2, whereas the control group was treated with auditory training that was not related to emotions. Sociodemographic and clinical data, clinical state (PANSS), Intelligence Quotient and prosodic recognition (RMV-SV) were measured at baseline. After intervention, RMV-SV and PANSS were assessed. One month later, the RMV-SV measure was repeated.Results: The control group (n = 19) and the Voices group (n = 22) did not differ on χ2, t or U tests in sociodemographic, clinical and psychometric variables at baseline or post-intervention (all p-values &gt; 0.05). In the Voices group, statistically significant differences were observed in the RMV-SV scale applied post-intervention vs. that applied pre-intervention (Z = 2.47, p = 0.013). Similar results were observed in the 1-month follow-up RMV-SV vs. the pre-intervention RMV-SV (Z = 1.97, p = 0.049). PANSS scale was also assessed with no significant differences between pre vs. post measures in both groups. Lastly, Voices 2 was rated relatively higher, based on its ease of understanding, entertainment value, usefulness and the appropriateness of use of its emotional glossary.Discussion: Improvements were observed in prosodic recognition following intervention with Voices 2 in the Voices group. Although these results are similar to other clinical trial rehabilitation programs, specific research on the matter remains scarce. Certain aspects, such as the durability of effects or adherence should be thoroughly studied and clarified.Clinical Trial Registration: [https://doi.org/10.17605/OSF.IO/G95C4].

scholarly journals Diets enriched with whole grains reduce premenstrual syndrome scores in nurses: an open-label parallel randomised controlled trial

2019 ◽  
Vol 121 (09) ◽  
pp. 992-1001 ◽  
Author(s):  
Mozhgan Esmaeilpour ◽  
Sedigheh Ghasemian ◽  
Mohammad Alizadeh
Keyword(s):  
Clinical Trial ◽  
Premenstrual Syndrome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Whole Grains ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Daily Consumption ◽  
Open Label ◽  
Refined Grains

AbstractAlthough previous studies have demonstrated the beneficial effects of some components of whole grains on premenstrual syndrome (PMS), our literature review shows that no clinical trial has studied the effect of whole grain consumption on PMS so far. Therefore, the present study was designed to study the effect of diets rich in whole grains on PMS among nurses. This study is a parallel controlled clinical trial with a 3-month intervention period in which, after following two menstrual cycles among nurses, 100 nurses diagnosed with PMS were randomly divided into two groups of intervention and control, with fifty individuals in each. Those in the intervention group replaced at least four servings of refined grains in their daily diets with whole grains. To supply four servings, 120 g of bread made with whole flour was given to the intervention group on a daily basis. Those in the control group, however, continued their regular daily consumption of grains. The two groups were compared regarding PMS symptoms after adjusting the confounding variables. The repeated measurement test showed that the interaction between the time factor and the experimental group on the mean score of PMS symptoms was significant. That is, the intervention group showed a significant decrease in the general, mood, physical and behavioural symptoms of PMS compared with the controls (P&lt;0·001, P=0·01, P&lt;0·001 and P=0·003, respectively). Therefore, daily consumption of whole grains in place of refined grains can contribute to improvement in PMS symptoms. Further studies are needed to confirm our findings.

scholarly journals Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in Hospitalized Patients with COVID-19: A Randomized, Double-blind Clinical Trial

2020 ◽  
Author(s):  
Gholamreza Farnoosh ◽  
Mostafa Akbariqomi ◽  
Taleb Badri ◽  
Mahdi Bagheri ◽  
Morteza Izadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adjunctive Therapy ◽  
Clinical Symptoms ◽  
Intervention Group ◽  
Standard Of Care ◽  
Hospitalized Patients ◽  
Control Group ◽  
Post Intervention ◽  
Double Blind ◽  
Baseline Health

Abstract Aim: To evaluate the clinical efficacy of adjuvant use of melatonin in patients with coronavirus disease 2019 (COVID-19). Methods: This single-center, double-blind, randomized clinical trial included 74 hospitalized patients with confirmed mild to moderate COVID-19 at Baqiyatallah Hospital in Tehran, Iran, from April 25, 2020 to June 5, 2020. Patients were randomly assigned in a 1:1 ratio to receive standard of care and standard of care plus melatonin at a dose of 3 mg three times daily for 14 days. Clinical characteristics, laboratory, and radiological findings were assessed and compared between two study groups at baseline and post-intervention. Safety and clinical outcomes were followed up for four weeks. Results: A total of 24 patients in the intervention group and 20 patients in the control group completed the treatment. Compared with the control group, the clinical symptoms such as cough, dyspnea, and fatigue, as well as the level of CRP and the pulmonary involvement in the intervention group had significantly improved (P < 0.05). The mean time of hospital discharge of patients and return to baseline health was significantly shorter in the intervention group compared to the control group (P < 0.05). No deaths and adverse events were observed in both groups during this study. Conclusions: Adjuvant use of melatonin has a potential to improve clinical symptoms of COVID-19 patients and contribute to a faster return of patients to baseline health. Keywords: COVID-19, Melatonin, Clinical trial, Adjunctive therapy Trial Registration: ClinicalTrials.gov Identifier: NCT04409522

scholarly journals Whey Protein (Ma’aljobon) as a Complementary Therapy for Treatment of Attention-deficit/ Hyperactivity Disorder (ADHD): A Randomized Open-label Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. 1690
Author(s):  
Zeinab Mostajeran ◽  
Seyed Hamdollah Mosavat ◽  
Mostafa Najafi ◽  
Majid Emtiazy ◽  
Mohammad Hashem Hashempur
Keyword(s):  
Clinical Trial ◽  
Attention Deficit Hyperactivity Disorder ◽  
Whey Protein ◽  
Attention Deficit ◽  
Performance Test ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Hyperactivity Disorder

Background: Attention deficit hyperactivity disorder (ADHD) is a common, chronic, neurodevelopmental disorder that manifests in childhood with symptoms of hyperactivity, inattention, and impulsivity. Ma’aljobon (a kind of whey protein) that is derived from milk during cheese producing process is a popular dietary traditional product supposed to provide immune modulation and prevent neuropsychiatric disorder. We aimed to evaluate the efficacy of ma’aljobon in management of Attention-deficit/hyperactivity disorder (ADHD). Materials and Methods: In this open-label randomized, double arm, and controlled clinical trial, sixty four patients with ADHD who referred to out-patient child and adolescent clinic of Khorshid Hospital of Isfahan, Iran, were randomly assigned in the intervention group (ma’aljobon 25 g once daily plus standard conventional treatment (SCT)) or control group (SCT only) for a period of 8 weeks. Scores of the Strengths and Difficulties Questionnaire (SDQ) and Conners’ Continuous Performance Test (CPT) were set as the outcome measures. Results: Parent reported hyperactivity scale of SDQ showed a significant decrease in the intervention group compared to the control group (P=0.04). However, no significant between groups differences were observed in other scales of parent-reported SDQ. Also, according to the results of CPT, there was a significant improvement in the intervention group regarding attention and focus score (P=0.01). Conclusion: Ma’aljobon might be considered as a complementary remedy for improving hyperactivity, attention and focus of children with ADHD. However, further researches with larger sample size and longer duration should be done for achieving more reliable results. [GMJ.2020;9:e1690]

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