scholarly journals Increase in the folate level can decrease the intensity of disorder in patients with depression who use citalopram: a randomized clinical trial

2020 ◽  
Author(s):  
Masume Morovati ◽  
Yousef Morsali ◽  
Saeed Rezaee ◽  
Ayoub Pezeshki ◽  
Abdolreza Esmaeilzadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Controlled Clinical Trial ◽  
Depression Symptoms ◽  
High Dose ◽  
World Population ◽  
Hamilton Depression Scale ◽  
Folate Level ◽  
Long Term Treatment

Abstract Background Depression is one of the most common mental health disorders, which affiliated more than four percent of world population. Several antidepressant agents, including citalopram were developed. High dose and long-term treatment with these agents along with their side effects decrease the treatment adherence. Using supplements such as acid folic is a way to increase these drug’s efficacy. The aim of this study was to assess the effect of acid folic supplement and increase in blood folate level of the intensity of depression symptoms.Methods This was a randomized-controlled clinical trial. Twenty-four patients with major depression were randomly assigned to two groups. Both groups received citalopram as their standard treatment. The intervention group received acid folic supplement (1mg/daily). The folate levels of blood, Beck's depression inventory and Hamilton depression scale scores were measured. The measurements were conducted before intervention, and in 45 and 90 days follow ups. Data were analyzed using Mann-Whitney U and Friedman tests.Results The blood level of folate was increased for the intervention group. The Hamilton depression scale and Beck Depression Inventory Scores were reduced significantly in both groups after 90 days follow up. There were no significant differences between two groups in the reduction of depression scores. In the intervention group, the decrease of Hamilton's depression scale score was negatively correlated to the increase of blood folate level.Conclusions The increase in blood folate level may be correlate with the decrease in depression symptoms. The use of 1mg/d supplement of acid folic was not effective in the reduction of depression symptoms in patients with major depression.Registered in Iranian Registry of Clinical Trials (IRCT20180115038373N1)

scholarly journals Efficacy of acupuncture and its influence on the emotional network in adult insomnia patients: protocol for a randomized controlled clinical trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Tongfei Jiang ◽  
Qi Zhang ◽  
Fang Yuan ◽  
Fan Zhang ◽  
Jing Guo
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Negative Emotions ◽  
Alternative Therapy ◽  
Depression Scale ◽  
Sleep Diary ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Poor Sleep ◽  
Hamilton Depression Scale

Abstract Introduction Insomnia disorder (ID) is characterized by dissatisfaction with the quantity or quality of sleep and is often accompanied by negative emotions such as anxiety and depression. Patients with insomnia become trapped in a vicious circle of bad moods and poor sleep. Resting-state functional magnetic resonance imaging (r-fMRI) studies have shown abnormalities in emotion-related brain networks in patients with ID. And it has been proven that reducing negative emotions improves sleep quality. As a traditional alternative therapy, acupuncture has been demonstrated to be effective not only in improving sleep quality but also in stabilizing emotions; however, the mode of action needs to be further explored. Therefore, a clinical trial was designed to explore the effect of acupuncture in improving sleep and mood and to intuitively investigate the regulation of the emotional network using fMRI. Methods and analysis A total of 60 participants with ID will be randomly allocated to a spirit-regulating group or a control group using non-effective acupoints acupuncture at a ratio of 1:1. All participants will receive 3 acupuncture treatment sessions per week for 4 weeks. In addition, 30 healthy individuals will be included in the healthy group. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes are the Hamilton Anxiety Scale (HAMA), the Hamilton Depression Scale (HAMD), the Hyperarousal Scale (HAS), and the Fatigue Scale-14 (FS-14), r-fMRI data, sleep diary, and actigraphy. The data will be collected prior to treatment, following treatment, and during the 12-week follow-up period; a sleep diary will be kept during the entire process. Ethics and dissemination This protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine (Bejing TCM Hospital). The results will be published in peer-reviewed journals or presented at academic conferences. Trial registration Chinese Clinical Trials Register ChiCTR1800015282. Protocol version: Version 1.0. Date: Dec.2020

scholarly journals Efficacy of Acupuncture and Its Influence on the Emotional Network in Insomnia Disorder: Protocol for a Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Tongfei Jiang ◽  
Jing Guo ◽  
Qi Zhang ◽  
Fan Zhang ◽  
Fang Yuan
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Negative Emotions ◽  
Depression Scale ◽  
Sleep Diary ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Poor Sleep ◽  
Hamilton Depression Scale ◽  
Insomnia Disorder

Abstract IntroductionInsomnia disorder (ID) is characterized by dissatisfaction with the quantity or quality of sleep and is often accompanied by negative emotions such as anxiety and depression. Patients with insomnia become trapped in a vicious circle of bad moods and poor sleep. Resting-state functional magnetic resonance imaging (r-fMRI) studies have shown abnormalities in emotion-related brain networks in patients with ID. And it has been proven that reducing negative emotions improves sleep quality. As a traditional alternative therapy, acupuncture has been demonstrated to be effective not only in improving sleep quality but also in stabilizing emotions; however, the mode of action needs to be further explored. Therefore, a clinical trial was designed to explore the effect of acupuncture in improving sleep and mood, and to intuitively investigate the regulation of the emotional network using fMRI. Methods and AnalysisA total of 60 participants with ID will be randomly allocated to a spirit-regulating group or a control group using non-effective acupoints acupuncture at a ratio of 1:1. All participants will receive 3 acupuncture treatment sessions per week for 4 weeks. In addition, 30 healthy individuals will be included in the healthy group. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes are the Hamilton Anxiety Scale (HAMA), the Hamilton Depression Scale (HAMD), the Hyperarousal Scale (HAS), and the Fatigue Scale-14 (FS-14), r-fMRI data, sleep diary, and actigraphy. The data will be collected prior to treatment, following treatment, and during the 12 weeks follow-up period; a sleep diary will be kept during the entire process. Ethics and Dissemination This protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine (Bejing TCM Hospital). The results will be published in peer-reviewed journals or presented at academic conferences. Trial registration: Chinese Clinical Trials Register, ChiCTR1800015282.

scholarly journals Does atorvastatin have augmentative effects with sodium valproate in prevention of migraine with aura attacks? A triple-blind controlled clinical trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Reza Ganji ◽  
Nastaran Majdinasab ◽  
Saeed Hesam ◽  
Nazanin Rostami ◽  
Mehdi Sayyah ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Sodium Valproate ◽  
Migraine With Aura ◽  
Vitamin D3 ◽  
Vascular Function ◽  
Intervention Group ◽  
Pain Severity ◽  
Controlled Clinical Trial ◽  
Prophylactic Regimen

Abstract Background Migraine is a painful and disabling nervous disorder which negatively affects the quality of life. Migraineurs may suffer from a generalized vasomotor dysfunction. Statins improve vasomotor and vascular function, with their pleiotropic effects. We aimed to assess efficacy and safety of adding Atorvastatin to prophylactic regimen in better control of migraine with aura. Methods This triple-blind controlled clinical trial was on 68 patients with migraine with aura. An interval of at least 1 month was given to evaluate vitamin D3 level and eligibility. In patients with vitamin D3 deficiency, the correction with vitamin D supplementation was provided. The patients were randomly assigned to receive atorvastatin 20 mg plus sodium valproate 500 mg or placebo plus sodium valproate 500 mg once a day for 2 months. The patients were evaluated based for the number of attacks and pain severity based on Visual Analogue Scale. Results There was a significant (p = 0.0001) improvement in severity of pain and number of migraine attacks by adding Atorvastin to the prophylactic regimen of patients with migraine with aura. After controlling for variable parameters, the differences between two arms of the study was yet statistically significant (p = 0.0001). A significant number of participants in intervention group were satisfied by their treatment (p = 0.001) with no remarkable side effects (P = 0.315). Conclusions Adding atorvastatin to migraine with aura preventive regimen may help reduce the number of acute attacks and pain severity without causing considerable side effects and led to a better patient satisfaction. Trial registration IRCT20180106038242N1. Registered: 7 February 2018.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

Pilot randomized placebo‐controlled clinical trial of high‐dose gabapentin for alcohol use disorder

2021 ◽  
Author(s):  
John J. Mariani ◽  
Martina Pavlicova ◽  
Cale Basaraba ◽  
Agnieszka Mamczur‐Fuller ◽  
Daniel J. Brooks ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Controlled Clinical Trial ◽  
High Dose

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Nursing consultation protocol for patients after myocardial revascularization: influence on anxiety and depression

2010 ◽  
Vol 18 (3) ◽  
pp. 331-338 ◽  
Author(s):  
Francisca Elisângela Teixeira Lima ◽  
Thelma Leite de Araújo ◽  
Edilma Casimiro Gomes Serafim ◽  
Ires Lopes Custódio
Keyword(s):  
Clinical Trial ◽  
Outpatient Clinic ◽  
Public Hospital ◽  
Intervention Group ◽  
Myocardial Revascularization ◽  
Depression Scale ◽  
Lower Percentage ◽  
Anxiety And Depression ◽  
Control Group ◽  
Hospital Anxiety

The objective was to evaluate the influence of the Nursing Consultation Protocol in aspects of anxiety and depression in patients after myocardial revascularization using the Hospital Anxiety and Depression scale (HAD). A randomized clinical trial developed in the outpatient clinic of a public hospital in Fortaleza-Ceará. One hundred and forty six patients, who underwent myocardial revascularization, composed the population, providing the sample of 39 patients in the control group (CG) and 39 in the intervention group (IG). The results were presented in tables. Anxiety had a mean of 5.41 in the CG and a median of 5 and a mean in the IG of 5.21 and a median of 4. Depression predominated in the CG, with a mean 4.82 and a median of 4, while the IG had a mean of 3.79 and a median of 3. It was found that people monitored in accordance with the Nursing Consultation Protocol had a lower percentage of anxiety and depression after six months.

scholarly journals The Effect of Rhythmic Breathing on the Severity of Sternotomy Pain after Coronary Artery Bypass Graft Surgery: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Hassan Babamohamadi ◽  
Masoumeh Karkeabadi ◽  
Abbasali Ebrahimian
Keyword(s):  
Clinical Trial ◽  
Pain Control ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Artery Bypass Graft ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Mean

Background. Moderate-to-severe pain is reported in up to 75% of the patients in the first 48 hours after cardiac surgery. Evidence suggests that distraction is an effective nursing intervention for controlling short-term and transient pain. Distraction can be achieved by various techniques, including progressive muscle relaxation, meditation, and rhythmic breathing (RB). The present research aimed at evaluating the impacts of RB on the severity of sternotomy pain after Coronary Artery Bypass Graft (CABG). Methods. This randomized, controlled clinical trial was conducted on 60 patients after CABG surgery at the open-heart surgery Intensive Care Unit (ICU) of Kowsar Hospital, affiliated to Semnan University of Medical Sciences in Semnan, Iran. The patients were selected through convenience sampling and randomly assigned to two groups, including (1) intervention or RB and (2) control groups. RB was performed in the intervention group every 12 hours (9 a.m. and 9 p.m.) for three consecutive days after the surgery. The control group received only routine care for pain control (opioid analgesics) with no additional interventions. The severity of pain was measured every day in both groups of patients before and after the interventions using the Visual Analog Scale (VAS). Results. The mean postintervention pain scores were significantly different from the mean preintervention scores in the intervention group ( p  < 0.05). The changes in the mean pain score in the intervention group were also significantly different from the corresponding changes in the controls ( p  < 0.05). Conclusion. Based on the results, the severity of pain after the intervention was significantly lower in the RB group compared to the control. RB was found to be an effective technique for reducing the patients’ pain and is therefore recommended as a post-CABG pain control technique. Iranian Registry of Clinical Trials: this trial is clinically registered with IRCT20120109008665N7, registered 3 September 2018.

scholarly journals Effect of hand reflexology on anxiety and physiological variables among patients hospitalized in the cardiac care unit: A randomized placebo controlled clinical trial

2017 ◽  
Vol 8 (4) ◽  
pp. 35 ◽  
Author(s):  
Zohre Rahmani ◽  
Nahid Rejeh ◽  
Majideh Heravi-Karimooi ◽  
Seyed Davood Tadrisi ◽  
Mojtaba Vaismoradi
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Intervention Group ◽  
Anxiety Level ◽  
Cardiac Care ◽  
Controlled Clinical Trial ◽  
Female Patients ◽  
Coronary Syndrome ◽  
Physiological Variables ◽  
Cardiac Care Unit

Background and objective: Admission to the cardiac care unit may cause physiological and psychological problems in patients. This study aimed to investigate the effect of hand reflexology on anxiety and physiological variables among female patients with acute coronary syndrome hospitalized in the cardiac care unit.Methods: This randomized placebo controlled clinical trial was conducted on 90 female patients hospitalized in the cardiac care unit in an urban area of Iran. The patients were chosen using a convenient sampling method and then were randomly assigned into intervention (n = 45) and placebo (n = 45) groups. While the intervention group received hand reflexology for 20 minutes, the placebo group received a simple touch of hand without the stimulation of reflexology points.  Demographic data was collected at the beginning of the study using face-to-face interviews with the patients. The anxiety level was assessed using the Spielberger’s State-Trait Anxiety Inventory (STAI) immediately after the intervention and 30 min after the intervention. Also, physiological variables including respiratory rate, heart rate, blood pressure and oxygen saturation were measured before, immediately after the intervention and 30 minutes after the intervention. Descriptive and inferential statistics were used for data analysis.Results: There was no statistically significant difference between the intervention and placebo groups before the intervention (p > .05). The anxiety level in the intervention group was significantly lower than that of the placebo group immediately after the intervention and 30 minutes after the intervention (p < .05, η = 0.090). However, no statistically significant differences in physiological variables between the groups were observed (p > .05).Conclusions: Hand reflexology influenced the level of anxiety. Therefore, nurses can use hand reflexology as a method for reducing patients’ anxiety along with other nursing interventions.

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