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

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 > 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].

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

10.21203/rs.3.rs-407301/v1 ◽

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.

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

Anesthesiology and Pain Medicine ◽

10.5812/aapm.117140 ◽

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.

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The Effect of Vitamin C on Pathological Parameters and Survival Duration of Critically Ill Coronavirus Disease 2019 Patients: A Randomized Clinical Trial

Frontiers in Immunology ◽

10.3389/fimmu.2021.717816 ◽

2021 ◽

Vol 12 ◽

Author(s):

Nazanin Majidi ◽

Faezeh Rabbani ◽

Somayeh Gholami ◽

Maryam Gholamalizadeh ◽

Fatemeh BourBour ◽

...

Keyword(s):

Clinical Trial ◽

Vitamin C ◽

Critically Ill ◽

Critically Ill Patients ◽

Intervention Group ◽

Survival Duration ◽

Control Group ◽

Clinical Trial Registration ◽

Arterial Blood ◽

Vitamin C Supplementation

IntroductionVitamin C has been reported to have beneficial effects on patients with coronavirus disease 2019 (COVID-19). This study aimed to investigate the effect of vitamin C supplementation on pathological parameters and survival duration of critically ill patients with COVID-19.MethodsThis clinical trial was conducted on 120 hospitalized critically ill patients infected with COVID-19. The intervention group (n = 31) received one capsule of 500 mg of vitamin C daily for 14 days. The control group (n = 69) received the same nutrition except for vitamin C supplements. Measurement of pathological and biochemical parameters was performed at baseline and after 2 weeks of the intervention.ResultsFollowing 2 weeks of vitamin C supplementation, the level of serum K was significantly lower in the patients compared with the control group (3.93 vs. 4.21 mEq/L, p < 0.01). Vitamin C supplementation resulted in a higher mean survival duration compared with that of the control group (8 vs. 4 days, p < 0.01). There was a linear association between the number of days of vitamin C intake and survival duration (B = 1.66, p < 0.001). The vitamin C supplementation had no effect on blood glucose, mean arterial pressure, arterial blood gas (ABG) parameters, Glasgow Coma Scale (GCS), kidney function, cell blood count (CBC), hemoglobin (Hb), platelet (Plt), partial thromboplastin time (PTT), albumin, hematocrit (Hct), and other serum electrolytes including sodium (Na), calcium, and phosphorus (P).ConclusionThe present study demonstrated the potential of vitamin C supplementation in enhancing the survival duration of critically ill patients with COVID-19.Clinical Trial Registrationhttps://www.irct.ir/trial/55074, identifier IRCT20151226025699N5

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

10.22541/au.160734344.45295921/v1 ◽

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

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The effect of specific nutritional modification program on specific liver findings in children with chronic liver disease: A clinical trial

10.21203/rs.3.rs-52567/v1 ◽

2020 ◽

Author(s):

SeyedAli Jafari ◽

Aramesh Rezaeian ◽

Zahra Nomjuo ◽

Majid Ghayour-Mobarhan ◽

Zahra ghaneifar

Keyword(s):

Clinical Trial ◽

Liver Disease ◽

Chronic Liver Disease ◽

Age Of Onset ◽

Intervention Group ◽

Chronic Liver ◽

Control Group ◽

Post Intervention ◽

Adjustment Program ◽

The Mean

Abstract Background: Liver disease leads to complex pathophysiological injuries that affect digestion, absorption, distribution, storage and use of food. The effect that chronic liver disease has on the nutritional status and health of the child is determined by the cause and severity of liver disease and the age of onset of liver disease. As liver disease progresses, so do the symptoms and complications of the disease. The aim of this study was to determine the effect of specific nutrition adjustment program on specific liver findings in children with chronic liver disease.Methods: In this clinical trial study, 75 children with chronic liver disease were randomly divided into two groups (45 in the intervention group and 30 in the control group). At the beginning of the study, the necessary experiments were taken from two groups. The intervention group received a nutritional adjustment program during 6 sessions of the workshop. After 12 weeks of follow-up, bilirubin level (total, direct), albumin level, PT, INR, transaminases (AST, ALT) were measured in both groups. Data analysis was performed using SPSS software version 16 and Wilcoxon and Mann-Whitney tests.Results: At the beginning of the study, both groups were homogeneous in terms of demographic variables. In the post-intervention stage compared to the pre-intervention stage in the intervention group, the mean scores of prothrombin time (P = 0/040), albumin (P = 0/007), aspartate transaminase and alanine transaminase (p˂0/001)were statistically significant:. But the mean score of total bilirubin (P = 0/063) in the post-intervention stage compared to before the intervention in the intervention group was not statistically significant.Conclusion: Nutrition education and encouragement of patients with chronic liver disease to follow a special diet can be an important factor in feeling healthy and preventing the progression of the disease.Trial registration: Name of registry: Zahra NamjouIRCT registration number: IRCT2015091424019N1 Registration date: 2016-01-30 Registration timing: retrospective

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The Effect of Family-Centered Interactive Education Using Social Networks on the Lifestyle of Patients with Acute Coronary Syndrome: A Randomized Clinical Trial

10.21203/rs.3.rs-28793/v1 ◽

2020 ◽

Author(s):

Fahimeh Shojaefar ◽

Tania Dahesh ◽

Esmat Nouhi

Keyword(s):

Clinical Trial ◽

Social Networks ◽

Acute Coronary Syndrome ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Coronary Syndrome ◽

Interactive Education ◽

Key Factor ◽

Family Centered

Abstract Background: Patient education is a key factor in promoting the health of people with acute coronary syndrome. Families are crucial to implement educational programs. Therefore, this research aimed at determining the family-centered interactive education efficacy using social networks on the lifestyle of patients with acute coronary syndrome (ACS). Materials andMethods: The present clinical trial was conducted on 96 cases with ACS, who were randomly assigned to control and intervention groups. The former only was provided with routine training before discharge, while the latter, in addition to routine training before discharge, received education on social networking and sending text/visual messages. At baseline and three months after the intervention, the Walker’s Lifestyle Questionnaire was completed. The paired t-test was employed for data analysis.Results: the average lifestyle value of the intervention group was significantly higher compared with the control group after the intervention (P˂0.001). Moreover, the lifestyle score was significantly different pre- and post- intervention in the intervention group (P˂0.001). Conclusion: Interactive education using social networks is useful to promote the lifestyle in cases with ACS, which seems effective in planning the follow-up for these patients.

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Effect of chamomile oil on cesarean section pain in primiparous women: a randomized clinical trial

Current Clinical Pharmacology ◽

10.2174/1574884715666200331133157 ◽

2020 ◽

Vol 15 ◽

Author(s):

Roghayeh Zardosht ◽

Ameneh Basir ◽

Amirhossein Sahebkar ◽

Seyed Ahmad Emami

Keyword(s):

Clinical Trial ◽

Cesarean Section ◽

Pain Intensity ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Chi Square ◽

Double Blind ◽

The Difference ◽

Primiparous Women

Background: Pain after cesarean section can turn the pleasant event of childbirth into an unpleasant experience for the mother. Pain relief through non-pharmaceutical methods, such as aromatherapy, could potentially be a useful intervention. In this study, the analgesic effect of chamomile oil was studied. Purpose: The current research was conducted to study the effect of chamomile oil on cesarean section pain in primiparous women. Materials and methods: This was a randomized double blind clinical trial wherein 128 primiparous pregnant women (who willingly selected cesarean section) took part. In the aromatherapy group, the subjects inhaled one drop of 5% chamomile oil, and in the control group the subjects inhaled one placebo drop. In both groups the subjects inhaled for 15-20 minutes at a distance of 5 cm from the nose at 4, 8, and 12 hours after surgery, and pain intensity was measured before and after half an hour after inhalation using the visual analog scale (VAS). For data analysis, the software SPSS (version 25) and descriptive statistics (frequency, frequency percentage, mean, and standard deviation) were used. In order to determine the significance, inferential statistics (Mann-Whitney, Wilcoxon, independent t-test, and Chi-square) were used. Findings: Data indicated that the intervention and placebo groups were homogeneous in terms of demographic variables. The average weights and heights of women in the intervention group were 86/5± 5/9 and 163/7 ±5/1, respectively. Corresponding values women in the control group were 84/5± 5/7 kg and 163/4± 5/8 cm. The finding of the current research indicates that the intervention and placebo groups showed no significant statistical difference in terms of baseline pain before intervention (p=0.08), while the difference between the two groups was significant in terms of pain 4, 8, and 12 hours after intervention (p<0.01). Therefore, inhalation of chamomile oil reduced pain intensity significantly compared to post-intervention. Conclusion: According to the results of the present study, inhalation of chamomile oil following caesarean section in primiparous women reduced pain and also the need for analgesics. Therefore, the use of aromatherapy with chamomile oil as a simple way without any side effects for the reduction of pain in mothers after cesarean section is recommended.

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Effect of mCIMT with and without interval on hand in patient suffering from stroke

Romanian Journal of Neurology ◽

10.37897/rjn.2021.1.8 ◽

2021 ◽

Vol 20 (1) ◽

pp. 57-65

Author(s):

Piyush Bhardwaj ◽

◽

Jaspreet Kaur ◽

Charu Gera ◽

Manoj Malik ◽

...

Keyword(s):

Clinical Trial ◽

Test Score ◽

Control Group ◽

Stroke Patients ◽

Post Intervention ◽

Clinical Trial Registration ◽

Registration Number ◽

Hand Evaluation ◽

Block Test ◽

And Control

Introduction. Paresis of hand has severe impact on the life of the stroke patients. Modified constrained induced movement therapy (mCIMT) can be used to treat the involved limb of the patient. It involves constraining of functional hand and increasing the activity of paretic hand which overcomes the “learned disuse” that develops following stroke but the constraining also creates difficulties for the patient and reduces his/her compliance to the treatment. Hence this trial aims to study the effect of mCIMT with and without interval to see if providing relaxation in between the treatment would be able to produce similar effect as mCIMT without interval protocol. Matgerial and methods. 44 patients were recruited in the study and were divided in to three groups: mCIMT without interval (n = 18), mCIMT with interval (n = 16) and control group (n = 10). Participants in three groups were examined for pain and functionality of hand through Patient rated wrist hand evaluation score and Box and Block test at pre and post intervention. The intervention was given for 6 days/week for two weeks. Therapy time was 2 hours and constrain was for 6 hours a day. Clinical trial registration number -CTRI/2019/12/022547. Results. No baseline differences were found in between the three groups. There was significant increase in box and block test score and significant decrease in PRWHE score in pre and post treatment readings for with and without interval mCIMT but non-significant changes in PRWHE score and box and block test were seen in control group. Conclusion. Both interval and without interval mCIMT was effective. Interval mCIMT was seen to be more comfortable than without interval mCIMT for the patient.

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The design and rationale of an interdisciplinary, non-prescriptive, and Health at Every Size®-based clinical trial: The “Health and Wellness in Obesity” study

Nutrition and Health ◽

10.1177/0260106017731260 ◽

2017 ◽

Vol 23 (4) ◽

pp. 261-270 ◽

Cited By ~ 4

Author(s):

Mariana D Ulian ◽

Bruno Gualano ◽

Fabiana B Benatti ◽

Patricia Lopes de Campos-Ferraz ◽

Desire Coelho ◽

...

Keyword(s):

Clinical Trial ◽

Intervention Group ◽

Exercise Program ◽

Activity Level ◽

Control Group ◽

Obese Women ◽

Structured Interviews ◽

Post Intervention ◽

Health At Every Size ◽

Group I

Background: This manuscript describes the design and rationale of a clinical trial that aims to investigate the multiple physiological, attitudinal, nutritional, and behavioral effects of a new interdisciplinary intervention based on the Health at Every Size® (HAES®) approach in obese women. Methods: This will be a prospective, 7-month, randomized (2:1), mixed-method clinical trial. Obese women will be recruited and randomly allocated into two groups. The intervention group (I-HAES®; proposed n = 40) will undertake a novel HAES®-based intervention. Participants will take part in an exercise program, nutrition counseling sessions, and philosophical workshops, all aligned with the principles of the HAES® approach. The control group (CTRL; proposed n = 20) will participate in a program using a traditional HAES®-based group format, characterized by bimonthly lectures about the same topics offered to the experimental group, encouraging the adoption of a healthy lifestyle. The following multiple quantitative outcomes will be assessed pre and post intervention: health-related quality of life, cardiovascular risk factors, anthropometric assessments, physical activity level, physical capacity and function, and psychological and behavioral assessments. Qualitative analysis will be used to evaluate the experiences of the participants throughout the intervention, as assessed by focus groups and semi-structured interviews. Conclusions: The interdisciplinary research team leading this study has varied and complementary expertise. The knowledge arising from this study will help to guide new interdisciplinary interventions with the potential to holistically improve the health of obese individuals. This trial is registered at Clinicaltrials.gov (NCT02102061).

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Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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