Iranian Clinical Research Articles

Effect of brimonidine on visual indices in patients with acute optic neuritis: A single blind randomized clinical trial

PurposeThis study investigates brimonidine's potential effect on visual functions, particularly contrast sensitivity (CS), an indicator of retinal ganglion cell function. MethodsIn this single-blind, randomized clinical trial, 60 patients (aged 23–56) with first-episode acute optic neuritis within seven days of symptom onset were randomly assigned to brimonidine or control groups. The intervention group received brimonidine three times daily for three months, while the control group received synthetic tears with the same dosage and frequency. Primary outcomes were changes in CS, visual acuity (VA), and color vision at one and three months post-treatment. Repeated measures ANOVA was used to assess statistically significant and partial eta squared (η2) values, mean differences, and clinically significance important were reported. ResultsAll participants completed the study without complications. VA improved significantly in both groups by follow-up end (p < 0.001), with significant improvement from first to third month only in the brimonidine group (p < 0.001). The mean VA difference between groups was not statistically and clinically significant. CS showed statistically significant improvement within both groups (p < 0.001) and between groups (p < 0.001), with a large effect size (partial η2 = 0.28). The mean CS difference between groups (14.5) was clinically considerable. No significant changes in color vision were observed between groups (p = 0.96). ConclusionBrimonidine significantly improved contrast sensitivity compared to placebo and was well-tolerated. Its neuroprotective effects suggest it may be beneficial in treating optic neuritis and preserving retinal ganglion cell function. Trial registrationProspectively registered at Iranian Clinical Trial Registration; Registration date 3 December 2022; Registration number: IRCT20221127056631N1

Analysis of clinical study registration characteristics of traditional medicine for the treatment of type 2 diabetes mellitus based on the International Clinical Trials Registry Platform

Objective: To analyze clinical trials of traditional medicine (including Chinese herbal medicine and nonpharmacological therapies) for the treatment of type 2 diabetes mellitus (T2DM) registered in the International Clinical Trials Registry Platform (ICTRP), and accordingly to explore their clinical trial registration characteristics, development trend and intervention status, in an attempt to provide references for future research design, diagnosis and management of traditional Chinese medicine therapy for T2DM. Methods: The clinical trials related to Chinese herbal medicine and nonpharmacological therapies for treating T2DM were retrieved on the ICTRP online from the time of database construction to August 13, 2023, to analyze the time of registration, country and institution of the study, source of funding, type and design of the study, randomization and blinding methods, clinical staging, therapeutic measures, and main therapeutic effect indexes. Descriptive statistical analysis was performed using R4.3.0 and Excel software. Results: A total of 774 clinical trials for T2DM treatment were included, of which 127 were traditional herbal therapies and 647 were nonpharmacological therapies. The T2DM clinical trial registration institutions were distributed in 50 countries worldwide involving 15 clinical registration platforms, with the most registrations in Iran, China, and Australia, and the top 3 registration platforms were the Iranian Clinical Trial Registry, the Australian New Zealand Clinical Trials Registry, and the ICTRP. Universities (551, 71.19%) were the main funding sources. Intervention studies (750, 96.90%) were the primary study type, including randomized controlled trials (432, 56. 4%), and 225 studies mentioned the blinding method. A total of 530 (68.48%) with a sample size ≤100 were included. Study phases were predominantly phase 2 and phase 3 (108, 51.43%). The interventions of traditional medicine for T2DM were composed of Chinese herbal medicines (mainly ginseng and astragalus compound), nonpharmacological therapies (mainly exercise and diet therapies), and 2 or more comprehensive treatment regimes. According to the type of study design, the first 3 main therapeutic indexes were fasting blood glucose (286 times), glycated hemoglobin (282 times), and insulin resistance (120 times), and the top 3 secondary therapeutic indexes were body mass index (179 times), fasting blood glucose (175 times), and glycated hemoglobin (134 times). Conclusion: The study dissects the current status and trend of registration of clinical trials on traditional medicine for T2DM treatment. The number of trial registrations is on the rise year by year, and there are obvious geographical differences in the countries and platforms of registration. The trial design is mainly randomized controlled blind trials with a sample size of &lt;100, and the main interventions are nonpharmacological therapies. Correct and standardized registration of clinical trials and timely reporting of study results are greatly important to facilitate the implementation of clinical trials, reduce publication bias, provide high-level diagnostic and therapeutic bases for clinical practice guidelines, and develop effective treatment strategies. This study is expected to help other scholars, health care professionals, patients, and the public to understand the latest research trends and hotspots in this field and provide certain references and inspirations for the future research design and clinical practice of traditional Chinese medicine in the treatment of T2DM.

The Validation of the Rumination on Obsessions and Compulsions Scale (ROCS) in an Iranian Clinical and Non-Clinical Sample

The Validation of the Rumination on Obsessions and Compulsions Scale (ROCS) in an Iranian Clinical and Non-Clinical Sample

The effects of grape seed extract supplementation on cardiovascular risk factors, liver enzymes and hepatic steatosis in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled study.

Despite the high antioxidant potential of grape seed extract (GSE), very limited studies have investigated its effect on non-alcoholic fatty liver disease (NAFLD). Therefore, this study was conducted with the aim of investigating the effect of GSE on metabolic factors, blood pressure and steatosis severity in patients with NAFLD. In this double-blind randomized clinical trial study, 50 NAFLD patients were divided into two groups of 25 participants who were treated with 520mg/day of GSE or the placebo group for 2 months. The parameters of glycemic, lipid profile, blood pressure and steatohepatitis were measured before and after the intervention. The GSE group had an average age of 43.52 ± 8.12 years with 15 women and 10 men, while the placebo group had an average age of 44.88 ± 10.14 years with 11 women and 14 men. After 2 months of intervention with GSE, it was observed that insulin, HOMA-IR, TC, TG, LDL-c, ALT, AST, AST/ALT, SBP, DBP and MAP decreased and QUICKi and HDL-c increased significantly (p-value for all < 0.05). Also, before and after adjustment based on baseline, the average changes indicated that the levels of insulin, HOMA-IR, TC, TG, LDL-c, SBP, DBP, MAP in the GSE group decreased more than in the control group (p for all < 0.05). Furthermore, the changes in HDL-c were significantly higher in the GSE group (p < 0.05). The between-groups analysis showed a significant decrease in the HOMA-β and AST before and after adjustment based on baseline levels (p < 0.05). Moreover, the changes in QUICKi after adjustment based on baseline levels were higher in the GSE group than in the control group. Also, between-groups analysis showed that the severity of hepatic steatosis was reduced in the intervention group compared to the placebo group (P = 0.002). It seems that GSE can be considered one of the appropriate strategies for controlling insulin resistance, hyperlipidemia, hypertension and hepatic steatosis in NAFLD patients. The clinical trial was registered in the Iranian Clinical Trial Registration Center (IRCT20190731044392N1). https://irct.behdasht.gov.ir/trial/61413 . (The registration date: 30/03/2022).

Effect of nifedipine administration before embryo transfer on reproductive outcome in ICSI cycles, a double-blind control trial study.

Nifedipine is a calcium channel blocker with smooth muscle relaxing properties. This study set out to investigate the efficacy of nifedipine administered orally before embryo transfer (ET) on the improvement of theintracytoplasmic sperm injection (ICSI) outcome. This randomized, double-blind, comparator-controlled, was carried out between 2019 and 2020 in the infertility center of Babol, Iran. 200 women candidates for ICSI and recipients of frozen-thawed ET aged 18-40years were randomly assigned in the ratio 1:1 to an intervention group that received nifedipine 20mg tablets orally 30min before ET (n = 100) or to a group of placebo (n = 100). A randomization center in Babol University of Medical Science used computer-generated numbers to allocate treatments. The allocation treatment was blind to the participants, the sonographer of endometer monitoring, the staff of the ICSI laboratory, and the outcome assessor. The primary analysis was based on the intention-to-treat principle done on 200 participants, (n = 100), comparing chemical pregnancy rates in the two comparing groups at 14days' follow-up after ET. Implantation rate and clinical pregnancy were considered secondary outcomes. 200 participants were analyzed. There is no significant difference in the number of oocytes and the quality of embryos in the nifedipine and placebo groups. Despite a numerical increase in the rate of chemical pregnancy, there were no statistical differences in the study group versus the comparison group (24% vs 14%, P = 0.1, rate ratio 0.88, 95% CI 0.77 to 1.01), respectively. Also, no significant increase in clinical pregnancy was found compared with the placebo (17% vs 8%, P = 0.26, rate ratio 0.90, 0.81 to 1.00). Nifedipine administered orally 30min before embryo transfer did not improve the chemical pregnancy rate, and clinical pregnancy rate in infertile women undergoing ICSI. This trial has been registered on the Iranian Clinical Trials Registration Site (IRCT) with the number IRCT20180417039338N3.

Adopting strategies with menopausal experiences: A systematic review.

Menopause is one of the most significant stages in women's life. It is accompanied by many complications and a serious challenge. This study aimed to assess the menopause experiences of Iranian women and compatibility strategies. We searched PubMed, Web of Science (ISI), Scopus, Ovid, and the Iranian Clinical Trial Registry and Magiran, SID, from January 1990 to January 2021. Psychological effects, sexual disorders, physical problems, bone pain, insomnia, fatigue, and hot flashes are all menopause experiences. Cultural factors, lifestyle, social factors, education level, employment and economic status, marital status, and the number of pregnancies and births can influence this experience. It is important that menopausal women are aware how menopausal compatibility and prepare for this period. Many factors have affected menopausal adopting strategies. Negative emotions, negative attitudes, worry, and anxiety, and their psychological effects exacerbate the annoying experiences of menopause and decelerate menopausal adoption. Social support and educational intervention were the practical menopausal adopting strategies. It will guarantee the health of menopausal women in the last third of their lives.

Psychometric Properties of the Persian Version of the Yale Food Addiction Scale 2.0 (P-YFAS 2.0) in an Iranian Clinical Sample

Background: The aim of this study was to assess the psychometric aspects of Persian version of Yale Food Addiction Scale 2.0 (YFAS 2.0) and the prevalence of Food Addiction (FA) among Iranian obese population seeking bariatric surgery. Methods: In this cross-sectional study, psychometric aspects of the YFAS 2.0 including validity and reliability were assessed. Convergent and discriminant validity of the YFAS 2.0 was evaluated using Eating Disorder Inventory-3, Referral form (EDI-3 RF), Dutch Eating Behavior Questionnaire (DEBQ), Difficulties in Emotion Regulation Scale (DERS), and Barratt Impulsiveness Scale (BIS-15) and reliability of the scale was examined by test-retest analysis and internal consistency. Results: Among 124 patients (48.6%) who met FA criteria, 2 patients (1.6%) received a mild, 12 (9.6%) a moderate, and 110 (88.7%) a severe FA diagnosis. FA was more prevalent and severe in females, unmarried individuals, unemployed patients, and those with higher Body Mass Index (BMI) or binge eating disorder/bulimia nervosa diagnoses. Reliability analysis showed high internal consistency (Cronbach’s α = 0.89) and test-retest reliability (ICC = 0.88). Content validity was 0.8 or higher in terms of convergent validity. Except for one criterion, a one-factor structure was confirmed for the P-YFAS 2.0 (above 0.42). FA prevalence was higher in participants with BED or bulimia nervosa, and FA severity was correlated with scores on measures of impulsivity, emotion regulation difficulties, eating behaviors and psychopathology. Conclusion: These findings support the reliability and validity of the P-YFAS 2.0 in assessing FA as defined by Diagnostic and Statistical Manual of Mental Disorders-fifth (DSM-5). The high rate of FA identified highlights the need for targeted interventions in this clinical population.

Professional Quality of Life among Iranian Clinical Nurses at the Forefront of the Fight against COVID-19: A Multicenter Cross-Sectional Study.

With the prolonged COVID-19 disease control time, concerns about the caring ability of clinically exposed nurses have increased. This study aimed to investigate Compassion Satisfaction (CS), Burnout (BO), and Secondary Traumatic Stress (STS) as elements of Professional Quality of Life among nurses in COVID-19 settings. In this descriptive online national survey, 427 clinical nurses who had worked in the COVID-19 wards from all Iran provinces answered the Persian version of the Professional Quality of Life Scale as the profile tool with three subscales, including CS, BO, and STS. Data were collected using email, Short Message Service (SMS), and social networks from December 2020 to February 2021. The mean (SD) score of CS was 38.86 (9.00), the mean (SD) score of BO was 18.60 (4.08), and STS was 34.74 (7.02). STS was substantially more prevalent among married nurses whose Polymerase Chain Reaction (PCR) tests were positive for themselves or at least one family member (p < 0.05). Clinical nurses who respond to the COVID-19 crisis are at risk of STS and BO. In pandemic situations like COVID-19, it is necessary to consider supportive interventions to increase satisfaction and reduce burnout and secondary traumatic stress in nurses.

A comparative study of the local effect of tranexamic acid and phenylephrine on the amount of bleeding in rhinoplasty: A randomized clinical trial.

Bleeding during nose surgery is very important, because it can cause a problem in the surgeon's field of view and lead to an increase in the probability of surgical complications. The aim of this study was to compare the local effects of tranexamic acid and phenylephrine on bleeding in rhinoplasty. The present study is a double-blind clinical trial in which 98 patients who were candidates for rhinoplasty Shiraz were randomly divided into 49 groups of phenylephrine and tranexamic acid. In the first group, 1 cc of phenylephrine and in the second group, 1 cc of tranexamic acid was used locally and then the variables in the two groups were compared. The current study was approved by the Iranian Clinical Trial Registration Center with code IRCT20201205049602N1. The average blood pressure and heart rate in the phenylephrine group first increased and then decreased, but in the tranexamic acid group decreased from the beginning to 30 minutes. Based on the results of the test, there was a difference between the two groups in terms of the amount of bleeding, and a statistically significant relationship was observed. The average bleeding volume was lower in the phenylephrine group (p<0.0001). Results of this study showed that the amount of bleeding in the phenylephrine group was lower than that of tranexamic acid. It is recommended to use phenylephrine in rhinoplasty surgery to reduce bleeding and improve the surgeon's vision.

Effectiveness of oral clonidine and gabapentin on peripheral neuropathy in diabetic patients in southwestern Iran: a randomized clinical trial

BackgroundPeripheral neuropathy is not only the most prevalent consequence of diabetes but also the main reason for foot ulceration, disability, and amputation. Therefore, the current study aims to determine the effectiveness of oral clonidine and gabapentin on peripheral neuropathy in diabetic patients.MethodsThis 12-week, randomized, and parallel-group trial was conducted to compare the efficacy of oral clonidine and gabapentin with gabapentin alone in diabetic patients in southwest Iran during the first half of 2021. Thirty patients with type 2 diabetes with peripheral neuropathy as assessed by a visual analog scale (VAS) and divided into two groups of 15 patients, treated for up to three months. The data were analyzed using SPSS-21 software. In order to report the results, descriptive indices, independent t-test, one-way analysis of covariance (ANCOVA) and analysis of variance with repeated measures were used.ResultsThe mean and standard deviation of the age of the participants in the clonidine + gabapentin group was equal to 50.20 ± 7.44, and in the gabapentin group was equal to 50.47 ± 7.57 (t = 0.10, P-value = 0.923). This research showed a significant difference between the clonidine + gabapentin group and with gabapentin group in terms of neuropathic pain and the severity of neuropathic pain (P < 0.001).ConclusionsAccording to this research results, clonidine + gabapentin can reduce neuropathic pain and the severity of neuropathic pain in diabetic patients. Therefore, it is recommended that healthcare professionals with diabetes expertise prescribe these medications to reduce neuropathic pain and its severity.Trial registrationThis study was registered in the Iranian Clinical Trials System with the ID (IRCT20211106052983N1) on 14/01/2022.

Psychosis of Epilepsy: A 10-Year Iranian Clinical Survey.

Objective: Psychoses of epilepsy usually have an acute onset, accompanied by brief symptom duration and a risk of recurrence. Managing these conditions can be challenging due to the potential for seizures associated with certain antipsychotic medications, as well as exacerbating psychosis resulting from some antiepileptic medications. Our objective in this study was to assess the occurrence of psychosis among patients with epilepsy, as well as identify the factors linked to the presence and severity of psychosis in this population. Method : In this study, we included a total of 514 subjects diagnosed with epilepsy referring to our neuropsychiatry clinic affiliated with Tehran University of Medical Sciences from April 2011 to December 2021, among whom 57 patients showed psychotic presentations. We compared baseline and clinical characteristics between patients with psychosis of epilepsy and non-psychosis patients who also had epilepsy. Results: Marital status was the sole demographic factor that displayed a statistically significant difference between the psychosis and non-psychosis groups (P = 0.019). There was no significant difference observed between the two groups regarding family history of epilepsy and age at the onset of the epilepsy. Patients with psychosis experienced significantly more frequent seizures and generalized type (P < 0.001). Participants were matched for demographics and other clinical factors between the refractory and controlled psychosis groups, except for the psychosis frequency (P = 0.007). The type of epilepsy was significantly associated with psychosis when adjusted for the covariates (P < 0.001). Conclusion: Patients with psychosis of epilepsy experienced more episodes of epilepsy than non-psychotics. We identified generalized epilepsy as an independent risk factor for the development of psychosis. Additional cohorts are warranted to explore the factors associated with epilepsy-related psychosis across diverse populations.

Efficacy and safety of inhaled heparin in asthmatic and chronic obstructive pulmonary disease patients: a systematic review and a meta-analysis

Asthma and chronic obstructive pulmonary disease (COPD) are prevalent chronic respiratory disorders that cause significant morbidity and mortality. Some studies evaluated the use of inhaled unfractionated heparin (UFH) in the treatment of asthma and COPD. We aimed to synthesize the available evidence for the efficacy and safety of inhaled heparin in improving lung functions among asthmatic and COPD patients. A comprehensive search was performed using Pubmed, Embase, EBSCO, Scopus, Web of Science, Cochrane CENTRAL, WHO Clinical trials, clinicaltrials.gov, Iranian Clinical trials, Google Scholar, Research Gate, ProQuest Thesis, OVID, and medRxiv databases. Two independent reviewers included all pertinent articles according to PRISMA guidelines, and extract data independently. The two reviewers checked the quality of studies using the ROB2 tool. To determine the pooled effect estimate of the efficacy and safety of inhaled heparin, a meta-analysis was carried out using the R programming language. Publication bias was evaluated using Egger’s regression test. The heterogeneity was explained using a meta-regression, and the quality of evidence was assessed by the GRADE approach. Twenty-six studies with a total of 581 patients were included in the qualitative analysis and 16 in the meta-analysis. The primary outcome was treatment success (improvement of lung function) that was measured by standardized mean differences (SMD) of the forced expiratory volume per second (FEV1) either per ml or percentage. Heparin has a large effect on both FEV1% and FEV1 ml when compared to the control group (SMD 2.7, 95% CI 1.00; 4.39; GRADE high, SMD 2.12, 95% CI − 1.49; 5.72: GRADE moderate, respectively). Secondary outcomes are other lung functions improving parameters such as PC20 (SMD 0.91, 95% CI − 0.15; 1.96). Meta-regression and subgroup analysis show that heparin type, dose, year of publication, study design, and quality of studies had a substantial effect. Regarding safety, inhaled heparin showed a good coagulation profile and mild tolerable side effects. Inhaled heparin showed improvement in lung functions either alone or when added to standard care. More large parallel RCTs are needed including COPD patients, children, and other types, and stages of asthmatic patients.

Association between Human Papillomavirus and Oral Cancer in Iranian Clinical Samples: A Meta-Analysis Review.

Oral squamous cell carcinoma (OSCC) is one of the most common malignancies and is a serious problem worldwide. The role of HPV in oral cavity squamous cell carcinoma has been studied in several researches. This present review and meta-analysis aimed to investigate the relation between human papillomavirus (HPV) and oral cancer. Relevant studies were found using online international databases including Science direct, Web of science (ISI), PubMed, Scopus, Embase, and Google scholar, to determine relevant studies published between 2000 and Jan 2020. Suitable studies were selected and assessed by two independent researchers. The quality of all papers were determined by a checklist. Heterogeneity assay among the primary studies was evaluated by Cochran's Q test and I2 index. The statistical analyses were done using Stata SE, V.11 software. Trim and Fill method was applied to confirm the validity of the results. This meta-analysis consists of 8 primary studies on the incidence of HPV infection in Iranian patients with oral diseases. The odds ratio between HPV infection and risk of oral cancer was 4.00 (95%CI: 2.31, 6.93). This meta-analysis showed associations between prevalence of HPV infection and oral cancer among Iranian patients. The chance of developing oral cancer among HPV positive patients was higher than that in HPV negative patients.

Effect of green cardamom on the expression of genes implicated in obesity and diabetes among obese women with polycystic ovary syndrome: a double blind randomized controlled trial

BackgroundPolycystic ovary syndrome (PCOS) is an endocrine disease in which related to obesity, metabolic disorders and is considered as one of the main causes of infertility in women. This trial was investigated the effects of green cardamom on the expression of genes implicated in obesity and diabetes among obese women with PCOS.MethodsOne hundred ninety-four PCOS women were randomly divided two groups: intervention (n = 99; 3 g/day green cardamom) and control groups (n = 95). All of them were given low calorie diet. Anthropometric, glycemic and androgen hormones were assessed before and after 16-week intervention. The reverse transcription-polymerase chain reaction (RT-PCR) method was used to measure fat mass and obesity-associated (FTO), peroxisome proliferative activating receptor- (PPAR-), carnitine palmitoyltransferase 1A (CPT1A), acetyl-CoA carboxylase beta (ACAB), leptin receptor (LEPR), ghrelin, and lamin A/C (LAMIN) genes expression in each group.ResultsAnthropometric indices were significantly decreased after intervention in both two studied groups. Glycemic indices and androgen hormones were significantly improved in the intervention group compared to the control group. The expression levels of FTO, CPT1A, LEPR, and LAMIN were significantly downregulated compared to control group (P < 0.001), as well as, PPAR-y was significantly upregulated in the intervention group after intervention with green cardamom compared to control group (P < 0.001).ConclusionThis current study showed that the administration of green cardamom is a beneficial approach for improving anthropometric, glycemic, and androgen hormones, as well as obesity and diabetes genes expression in PCOS women under the low-calorie diet.Trial registrationThis trial was registered with the Iranian Clinical Trials Registry (registration number: IRCT20200608047697N1). 1 August, 2020; https://www.irct.ir/trial/48748

Comparing the effect of body wash with marshmallow plant and lukewarm water on reducing the temperature of febrile children: a randomized clinical trial

BackgroundFever is the most common reason for children’s visits to medical centers. Its management is an essential duty of a pediatric nurse. The aim of this study was to determine the effect of body wash with Marshmallow plant on children’s fever.MethodsThis parallel clinical trial was performed on 92 children aged 6 months to 10 years with a tympanic temperature above 38.3 °C. Participants were randomly assigned to groups. Simultaneously with receiving acetaminophen, body wash was performed in the control group with lukewarm water and in the intervention group with white Marshmallow extract. The children’s temperature; from the beginning of the study was checked and recorded every 15 min in the first hour and in the 4th and 6th hours. The time duration to resolve fever, the frequency of afebrile children at different times of the study, and the value of temperature reduction were primary outcomes. Heart rate, the need to administer the next dose of acetaminophen, and the time of fever recurrence were recorded as secondary outcomes.ResultsThe mean time duration to resolve fever in the intervention group was shorter than in the control group (B = 8.181, 95% CI 3.778–12.584, p < 0.001). The frequency of the children without fever was higher in the intervention group during different times of the study (p < 0.001). The mean value of temperature reduction in the intervention group was higher than the control group (B = -0.27 °C, 95% CI: -0.347 to -0.193, P < 0.001), although, after adjusting the effect of confounding variables it was not significant (P = 0.127). The mean of adjusted heart rate change (p = 0.771), the time of fever recurrence (P = 0.397), and the frequency of children requiring the next dose of acetaminophen (p = 0.397) did not show a significant difference between the groups.ConclusionBody wash with Marshmallow extract reduced children’s fever in a shorter period of time and to some extent a greater extent than the control group without side effects. Therefore, it can be used as an effective and safe complementary method to help reduce fever. However, more studies are necessary for this field.Trial registrationRegistration in Iranian Clinical Trials (RCTs) on 31.08.2020 with registration code: IRCT20200809048345N1.

Preoperative Incentive Spirometer to Prevent Postoperative Pulmonary Complications following Open Heart Surgeries: A Randomized Single Blinded Multi-Centric Clinical Trial

Objectives: To determine the effect preoperative use of an Incentive Spirometer (IS) has on preventing postoperative pulmonary complications among patients undergoing open heart surgeries.&#x0D; Methods: A prospective, randomized, controlled single-blinded parallel-group design. Data were collected from January 9th 2022 to April 1st 2022. A total of n = 64 eligible patients were equally randomized to either intervention or control group. Patients in the intervention group performed preoperative IS training for two days before the scheduled surgery. The primary endpoint was the incidence of in-hospital PPCs. The secondary endpoints were postoperative Peak Expiratory Flow Rate (PEFR), Intensive Care Unit (ICU) stay, Hospital Length of Stay (HLOS).&#x0D; Results: Patients in the intervention group had a lower incidence of postoperative pulmonary complications compared to the control group (12.5% and 21.8%). There was a statistical significant difference between the two groups regarding postoperative PEFR, HLOS and intensive care unit stay.&#x0D; Conclusions: Preoperative rehabilitation (involving incentive spirometer is related to a lower incidence of postoperative pulmonary complications for the group that received the intervention. Training with preoperative incentive spirometer resulted in a shortening of hospital length of stay and Intensive Care Unit (ICU) stay.&#x0D; Trial registration: The study was registered in the Iranian Clinical Trial Registry, this at https://www.irct.ir/ reference number (IRCT20211224053503N1).

Comparison of the effectiveness of the electronic portfolio and online discussion forum methods in teaching professional belonging and ethical behaviors to nursing students: a randomized controlled trial

BackgroundNursing is a profession that has had many ethical aspects and understanding professional belonging and ethics as a deep and complex process is one of the basic concepts in this field. This study aimed to compare the effectiveness of training professional belonging and ethical behaviors in two methods: electronic portfolio and online discussion forum in nursing students.MethodsThis study is a single-blinded randomized-controlled trial (RCT) with two parallel intervention groups and a third control group. The sample size was 90 selected by block randomization method. The educational contents of professional belonging and ethical behaviors were presented to the participants in two ways: electronic portfolio and online discussion forum. Demographic information form, professional belonging questionnaire, and ethical behaviors questionnaire were applied to collect data. Data were analyzed using SPSS version 24 software. Respectively mean, standard deviation and repeated measured, analysis of variance tests was used in descriptive and analytic statistic. (P value < 0.05).ResultsComparison of the mean score of professional belonging and ethical behavior in the three stages of pretest, immediately after the test and four weeks after the test in all three groups was significant (P < 0.001). The control group had a higher mean score of professional belonging immediately after the test (108.18 ± 48.9) compared to the other two groups. Also, the online discussion forum group had a higher mean score on ethical behavior in four weeks after the test (104.2 ± 0.8) compared to the other two groups.ConclusionTraining based on two methods of the electronic portfolio and online discussion forum increases and enhances the level of ethical behaviors in students. Therefore, the implementation of such methods of training can be useful in improving, promoting, and learning ethical behaviors in nursing students. On the other hand, training based on the two methods had a negative impact on professional belonging. Therefore, it is suggested that future studies be conducted with a greater focus on areas of professional belonging.Trial registrationThis research has been registered in Iranian Clinical Trial Registration Center (IRCT) with registration number "IRCT20180612040063N1" and registration date "16/07/2018".

Alterations of liver enzymes and lipid profile in response to exhaustive eccentric exercise: vitamin D supplementation trial in overweight females with non-alcoholic fatty liver disease

BackgroundEccentric exhaustive exercise (EEE) training has been known as a promising training modality to enhance performance and stimulate adaptation in healthy individuals or patients that might also cause abnormal liver enzymes and lipid profiles. Vitamin D (Vit D) supplementation is believed to improve the condition of Non-Alcoholic Fatty Liver Disease (NAFLD) patients. However, there is limited evidence on the effect of Vit D supplementation on the EEE-induced alterations. This study aimed to investigate the effect of short-term supplementation of Vit D on the liver enzymes and lipid profile alterations following EEE in overweight women with NAFLD.MethodsIn this clinical trial, 22 overweight women with NAFLD were randomly divided into experimental and control (n = 11 in each). The experimental group consumed 2000 IU of Vit D per day for six weeks; the control group consumed a lactose placebo daily with the same color, shape, and warmth percentage. Two treadmill EEE sessions were performed before and after the six-week Vit D supplementation. Blood was taken from the antecubital vein to measure the liver enzymes, lipid profile, and Vit D at four stages: Pre 1(before the first EEE session), Post 1(after the first EEE session), Pre 2 (before the second EEE session), and Post 2 (after the second EEE session).ResultsThe results indicate that Vit D supplementation significantly reduced Bodyweight (BW; P = 0.047), Body Mass Index (BMI; P = 0.044), Body Fat Percentage (BFP; P = 0.001), and Waist Hip Ratio (WHR; P = 0.001) in the experimental group. Additionally, the results showed increased liver enzymes (ALT, AST, and GGT) and lipid profile (TC, TG, and LDL) following EEE. While the HDL levels decreased significantly after EEE. Compared with control, the results of the independent t-test showed significantly lower ALT (P = 0.001; P = 0.001), AST (P = 0.001; P = 0.001), and GGT (P = 0.001; P = 0.001); while significantly higher Vit D (P = 0.001, P = 0.001) in the experimental in both Pre 2 and Post 2; receptively. Also, significantly lower TC (P = 0.001; P = 0.001), TG (P = 0.048; P = 0.001), and LDL (P = 0.001; P = 0.001); while significantly higher HDL (P = 0.001, P = 0.001) were observed in the experimental group compared to the control in both Pre 2 and Post 2; receptively.ConclusionsVit D supplementation reduces the liver enzymes and improves lipid profile alterations following EEE in overweight women with NAFLD. Thus, Vit D supplementation can be considered a functional supplement to improve the EEE-induced alteration.Trial registration: The trial was in the Iranian Clinical Trial Registration Center under the (IRCT20201130049538N1) on 05/07/2021.

Maternal and infant probiotic administration for morbidity of very low birth weight infants: a three-arm randomized placebo-controlled trial.

To determine whether oral probiotic administration (1.5 × 109CFU/g Lacticaseibacillus paracasei subsp. paracasei) to breastfeeding mothers or to their very low birth weight (VLBW) infants reduces total serum bilirubin (TSB) level and increases weight gain of the infants. In this double-blind trial, breastfeeding mothers and their VLBW infants at 48-72h of age were allocated into three groups using stratified block randomization; administrating probiotic to the mothers and placebo to their infants, probiotic to the infants and placebo to their mothers, or placebo to the both. The intervention continued for 28days. All 25 mothers and their 26 infants allocated into each group were fully followed up. There were three positive blood culture only in the placebo group. On the 3rd day of intervention, TSB level was not significantly different among the groups but on the 7th day, it was significantly lower in the both probiotic groups compared with the placebo group (mean difference -2.4mg/dL [95% confidence interval -3.6 to -1.2] in the both comparisons). Mean rank of infant weight gain during the first 7days of intervention was significantly higher in the both maternal and infant probiotic groups compared with the placebo group (p = 0.007 and p = 0.003, respectively), but there was no statistically significant difference among the groups during the 8th-28th days. Administration of Lacticaseibacillus paracasei to breastfeeding mothers of VLBW infants or to their infants reduces infant TSB level but has no significant effect on weight gain after the first week of the intervention. The Iranian Clinical Trials Registry IRCT20100414003706N38. protrospectively registered 24/01/2021.

Comparing the Relationship between Iranian Clinical Educators' Teaching Behaviors and Undergraduate Nursing Students' Professional Behaviors.

Background:The effectiveness and efficacy of teaching behaviors by clinical educators need to be determined and applied in caring environments, wherein students' seminal Professional Behaviors (PBs) are being shaped. Here, we endeavor to compare the relationship between Iranian clinical educators' teaching behaviors and undergraduate nursing students' PBs.Materials and Methods:This descriptive correlational study was conducted on 189 students enrolled in the second, third, and fourth academic years at Urmia University of Medical Science in 2019. The instruments were the Nursing Students' PBs Scale (NSPBS) and the Nursing Clinical Teacher Effectiveness Inventory (NCTEI). Data were analyzed by Pearson correlations test and linear regression model.Results:A significant positive correlation between the NSPB and NCTE in the fourth year (r = 0.42, p = 0.001) was about twice as much as the second (r = 0.28, p = 0.017) and third ones (r = 0.28, p = 0.033). Nursing competency, teaching skills, and communication domains were respectively the most effective ones related to the second- (r = 0.35, p = 0.003), third- (r = 0.32, p = 0.015), and fourth-year NSPBs (r = 0.46, p < 0.001). Teaching skills and nursing competency domains had the lowest significant relationships with the second- (r = 0.25, p = 0.034) third- (r = 0.30, p = 0.023) and fourth-year NSPBs (r = 0.35, p = 0,006), respectively.Conclusions:The comparison between the two mentioned variables in the academic year can provide appropriate information about potential problems of clinical education to develop clinical facilitation models.