Iranian Red Crescent Medical Journal
Volume:17 Issue: 8, Aug 2015

Context: A well-structured protocol for a clinical trial may be able to answer clinical questions, but it cannot be deemed enough to ensure success in the face of incompetent management of time as well as human and economic resources. To address this problem, in this article, we present our literature review on evidence as to how a good knowledge of proper management among researchers can enhance the likelihood of the success of clinical trial projects..Evidence Acquisition: Using multiple search strategies, we conducted a literature review on published studies in the English language from 2002 to 2012 by searching the Cochrane Database of Systematic Reviews, MEDLINE, Google Scholar, and EMBASE.. Our review suggests that a successful trial requires a work plan or work scope as well as a timeline. The trial manager should subsequently manage the study in accordance with the plan and the timeline. Many research units have called for a clinical project manager with scientific background and regulatory skills to effect coordination among various aspects of a clinical trial.. Project management may benefit both the managerial and scientific aspects of medical projects and reduce fund waste. However, little has been written to date on project management in the context of clinical research. The suggestions represent the views of the individual authors. To provide a high level of evidence in this regard, we recommend that a randomized controlled trial be performed to compare trial projects progressed with and without the use of project management..

Elevated concentration of serum total homocysteine usually occurs in vitamin B-12 deficiency. This metabolite can be measured and used for screening functional vitamin B-12 deficiency.. We assessed functional vitamin B12 deficiency in Tehranian elderly admitted to elderly research center, University of Social Welfare and Rehabilitation Sciences..Patients and Materials: A cross-sectional study was performed on 232 elderly admitted to elderly research center in Tehran, Iran in 2012. According to other studies, individuals were classified into two groups: high risk of vitamin B-12 deficiency (< 220 pmol/L) and borderline vitamin B-12 (220–258 pmol/L) accompanied by elevated homocysteine (> 15 micmol/L).. Cut-off of 15.0 pmol/L for homocysteine was identified for persons with normal or elevated concentrations. Among persons aged 65–74 and ≥ 75 years, respectively, 56% and 93% were at high risk of vitamin B-12 deficiency.. The prevalence of B12 deficiency was higher in this study compared to other studies, so more attention and massive efficacious policy should be designed to reduce the deficiency of this vitamin..

Some pregnant women discontinue iron supplements consumption due to Gastrointestinal (GI) complications, whereas pregnancy induces the same complications physiologically.. The aim of the present study was to assess GI complications of ferrous sulfate in pregnant women..Patients and This randomized, double-blind, placebo-controlled clinical trial was performed on 176 pregnant women referred to prenatal care clinic of Maryam Hospital from April 2011 to February 2012. Pregnant women with Hb ≥ 13.2 gr/dL at 13th - 18th weeks of gestation were selected based on the inclusion criteria and were randomly assigned to the ferrous sulfate and placebo groups. The ferrous sulfate group (n = 90) received a 50-mg ferrous sulfate tablet daily from the 20th week to the end of pregnancy and the placebo group (n = 89) received one placebo tablet in the same way. All participants were visited twice at 24th - 28th and 32nd - 36th weeks to assess the GI complications as well as Hb level to determine the Hb changes in two groups. Chi-square test, t-test and Kolmogorov-Smirnov test were used to analyze the data. P value of < 0.05 and confidence level of 95% were considered as statistically significant.. None of the GI complications were significantly different between the ferrous sulfate and placebo groups at 24th - 28th and 32nd - 36th weeks. Hemoglobin drop lower than 10.5 gr/dL at 24th - 28th weeks or lower than 11 g/dL at 32nd - 36th weeks was not observed in any cases.. It can be concluded that GI complications in pregnant women using ferrous sulfate are mostly caused by physiologic changes of pregnancy rather than ferrous sulfate; therefore, it is not reasonable to stop using ferrous sulfate due to GI complications.

Fundamental problems with Personality Disorders (PD) diagnostic system in the previous version of DSM, led to the revision of DSM. Therefore, a multidimensional system has been proposed for diagnosis of personality disorder features in DSM-5. In the dimensional approach of DSM-5, personality disorders diagnosis is based on levels of personality functioning (Criteria A) and personality trait domains (Criteria B).. The purpose of this study was firstly, to examine the DSM-5 levels of personality functioning in antisocial and borderline personality disorders, and second, to explore which levels of personality functioning in patients with antisocial and borderline personality disorders can better predicted severity than others..Patients and This study had a cross sectional design. The participants consisted of 252 individuals with antisocial (n = 122) and borderline personality disorders (n = 130). They were recruited from Tehran prisoners, and clinical psychology and psychiatry centers of Razi and Taleghani Hospitals, Tehran, Iran. The sample was selected based on judgmental sampling. The SCID-II-PQ, SCID-II and DSM-5 levels of personality functioning were used to diagnose and assess personality disorders. The data were analyzed by correlation and multiple regression analysis. All statistical analyses were performed using the SPSS 16 software.. Firstly, it was found that DSM-5 levels of personality functioning have a strong correlation with antisocial and borderline personality symptoms, specially intimacy and self-directedness (P < 0.001). Secondly, the findings showed that identity, intimacy and self-directedness significantly predicted antisocial personality disorder severity (P < 0.0001). The results showed that intimacy and empathy were good predictors of borderline personality disorder severity, as well (P < 0.0001).. Overall, our findings showed that levels of personality functioning are a significant predictor of personality disorders severity. The results partially confirm existing studies..

One of the important reasons behind termination of breast-feeding in the first six months after childbirth is insufficient production of breast milk.. The aim of this study was to determine the effect of herbal tea containing fenugreek seed on the signs of breast milk sufficiency in Iranian girl infants aged 0 - 4 months, at the medical health centers of Tehran university of medical sciences..Patients and This study was a clinical trial with a control group. Seventy-eight girl infants, 0 - 4 months old that were exclusively breastfed by their mothers, were randomly assigned to the intervention group (received herbal tea containing 7.5 g fenugreek seed powder in addition to 3 g of black tea, three times a day) and the control group (received herbal tea containing 3 g of black tea powder, three times a day). Before and during the four weeks of study, the signs of breast milk sufficiency were evaluated through measurement of growth parameters and use of follow-up forms for measuring the number of wet diapers in one day, frequency of defecation and infant breast-feeding times in a day.. Before the intervention there was no significant difference between weight, height, head circumference, the number of wet diapers and frequency of defecation between the two groups (P > 0.05), yet the number of breast feeding times of the control group was more than the Fenugreek group. At the end of the fourth week in proportion to the pre-intervention conditions, the weight of the infants in the fenugreek group increased significantly from 5282.0513 ± 1021.51121 to 6383.0769 ± 952.06190, while head circumference increased from 38.3103 ± 1.62736 to 39.9256 ± 1.50660, number of wet diapers from 5.2821 ± 0.93044 to 8.1648 ± 1.20620, frequency of defecation from 1.8846 ± 1.08495 to 2.7326 ± 0.94771 and the number of breast feeding times from 9.1795 ± 1.39778 to 15.9597 ± 1.45056 (P < 0.001). However, there was no significant effect on height variation (P = 0.078). While in the control group there was no significant difference between the mentioned variables (P > 0.05).. Herbal tea of fenugreek seed in comparison to the control group improves the signs of breast milk sufficiency..

Although in many countries child abuse reporting is mandated, Iranian nurses report abused cases voluntary. Some of the cases are reported to the police and others are referred to welfare organizations or other non-governmental organizations. Absence of a uniform reporting system along with a lack of legal support in the specific cultural context of Iran has resulted challenges for the reporters of child abuse.. The aim of this study was to explore the Iranian nurses’ experiences of reporting child abuse as well as to explore the existing barriers..Patients and A qualitative study with conventional content analysis was conducted to explore the barriers of reporting child abuse. Individual interviews between 30 and 45 minutes in duration were conducted with a purposive sample of 16 nurses with direct experience of dealing with children who had been abused. Graneheim and Lundman’s method was used for data analysis.. The data were classified to five themes including “knowledge deficit”, “previous unpleasant experiences about child abuse reporting”, “ethical challenges”,” legal challenges” and “cultural beliefs”.. According to the findings, enhancement of nurses and public knowledge about child abuse, legal issues and jurisprudence along with legislation of clear and simple laws, are mandatory to protect abused children in Iran..

Waiting time is an index assessing patient satisfaction, managerial effectiveness and horizontal equity in providing health care. Although heart surgery centers establishment is attractive for politicians. They are always faced with the question of to what extent they solve patient’s problems.. The objective of this study was to evaluate factors influencing waiting time in patients of heart surgery centers, and to make recommendations for health-care policy-makers for reducing waiting time and increasing the quality of services from this perspective..Patients and This cross-sectional study was performed in 2013. After searching articles on PubMed, Elsevier, Google Scholar, Ovid, Magiran, IranMedex, and SID, a list of several criteria, which relate to waiting time, was provided. Afterwards, the data on waiting time were collected by a researcher-structured checklist from 156 hospitalized patients. The data were analyzed by SPSS 16. The Kolmogorov Smirnov and Shapiro tests were used for determination of normality. Due to the non-normal distribution, non-parametric tests, such as Kruskal-Wallis and Mann-Whitney were chosen for reporting significance. Parametric tests also used reporting medians.. Among the studied variables, just economic status had a significant relation with waiting time (P = 0.37). Fifty percent of participants had diabetes, whereas this estimate was 43.58% for high blood pressure. As the cause of delay, 28.2% of patients reported financial problems, 18.6% personal problem and 13.5% a delay in providing equipment by the hospital.. It seems the studied hospital should review its waiting time arrangements and detach them, as far as possible, from subjective and personal (specialists) decisions. On the other hand, ministries of health and insurance companies should consider more financial support. It is also recommend that hospitals should arrange preoperational psychiatric consultation for increasing patients’ emotionally readiness..

Urinary tract infection (UTI) is the most common disorder caused by bacterial agents in pregnancy, which can lead to important complications in newborn of such mothers in case of inappropriate diagnosis and treatment.. The purpose of this study was to study the prevalence of UTI among pregnant women and its complications in their newborns during the birth in the hospitals of Dezful City, Iran, during 2012 - 2013..Patients and In this cross-sectional retrospective study, 1132 women admitted to Dr. Ganjavian and Ayatollah Nabavi Hospitals in Dezful City, Iran, during 2012 - 2013 were randomly allocated into the case and control groups and were matched based on their age, numbers of pregnancy, sex and diseases of their children. UTI was the only difference between the two groups.. Twenty-two thousand six hundred deliveries occurred within the course of this study. Due to UTI, 5% of deliveries led to hospitalization of mothers (1132 patients).Weight and height of newborn infants of mothers afflicted with UTI (P < 0.001) were significantly lower compared to newborns of healthy women (P < 0.001). There was a significant association between the two groups of pregnant women with UTI in terms of type of delivery (normal and caesarean section) (P < 0.008).. The lower incidence of UTI in pregnant women compared to other areas of Iran represents the role of climate and weather in the prevalence of UTI. In addition, the increased number of low-birth-weight infants had a remarkable correlation with UTI, which can influence the health of the next generation..

Alpha-amanitin (α-AMA) plays a major role in Amanita phalloides poisoning, showing toxic effects on multi-organs, particularly on the liver and kidneys. Studies have shown a relationship between α-AMA-related injuries and reactive oxygen species.. We aimed to investigate whether there is renal injury and its relationship with oxidative stress after intraperitoneal injection of α-AMA in mice experimental poisoning models.. There were 37 male BALB/c laboratory mice treated with α-AMA, according to the study groups: control group (n = 7); low dose (0.2 mg/kg) (n = 10); moderate dose (0.6 mg/kg) (n = 10), and high dose (1 mg/kg) (n = 10). The sample size was detected according to the ethical committee’s decision as well as similar studies in the literature. After a 48-hour follow-up period, all the subjects were sacrificed for pathological and biochemical assays. The study was held in Turkey.. α-AMA poisoning in mice results in inflammatory changes and necrosis in renal structures. There were statistically significant differences between the study groups regarding measured levels of catalase, superoxide dismutase, glutathione peroxidase, total antioxidant status (TAS), total oxidant status (TOS) and malonyl dialdehyde in renal homogenates of mice (P < 0.001, P < 0.001, P < 0.001, P < 0.001, P < 0.001, and P = 0.001, respectively). The TOS and TAS measurements helped to eliminate cumbersome analysis of diverse oxidant and antioxidant molecules. The TOS levels in renal homogenate of mice were significantly higher in all the intoxication groups compared to the control group (5.73, 7.02, 7.77, and 9.65 mmol trolox eq/g protein and P = 0.002, P = 0.001, and P = 0.001, respectively). The TAS levels in moderate and high-dose groups were significantly lower than all the other groups treated with α-AMA (0.130, 0.152, 0.065, and 0.087 mmol trolox eq/g protein and P = 0.031, P = 0.001, and P = 0.001, respectively).. Our results indicated that α-AMA poisoning in mice led to inflammatory changes and necrosis in renal structures. Biochemical analysis showed a shift in the oxidative/anti-oxidative balance towards the oxidative status..

Considering the higher activity of mirror neuron system in females, they frequently have better performance in empathy, interpersonal sensitivity, and emotional recognition compared to males.. The purpose of this study was to assess whether gender difference in neuroanatomy of the human mirror neuron system has any impact on functional recovery of ischemic hemiparetic patients..Patients and This single-blind clinical trial was conducted on 24 patients with cerebrovascular accident (CVA) in the age range of 45 - 60 years, referring at a rehabilitation center in Tehran, Iran, during 2013 - 2014. Sampling method was stratified random sampling. The subjects were assigned to 2 groups of 12 males and 12 females. Then, each group was randomly divided into 2 groups (totally 4 groups, n = 6 for each group): women watching functional movies, control women, men watching functional movies, and control men. Movies were shown to patients and then, they were evaluated by Timed Up and Go (TUG), Six-minute walk test (SMW), Barthel index (BI), and Berg balance scale (BBS).. Comparison of all variables related to functional activities of all groups before and after watching movies revealed significant differences. The highest percentage of change and improvement was observed in groups 1 and 3 watching the functional movies (P = 0.0001). Percentage of improvement in women of groups 1 and 2 was higher than men in groups 3 and 4 (P = 0.0003). The changes in group of females watching the functional movies (group 1) were significantly greater than in other groups (P < 0.0001).. The Sex differences in the neuroanatomy of the human mirror neuron system affect functional recovery of patients with hemiparesis. The improvement in studied women was found to be significantly greater than studied men. The results indicate a higher chance of recovery among hemiparetic women, especially those watching functional movies..

Laryngoscopy and tracheal intubation can cause serious cardiovascular responses in patients such as hypertension, tachycardia, and arrhythmias. Alternative airway maintenance techniques may attenuate these hemodynamic stress responses.. This study aimed to compare the immediate hemodynamic effects of the insertion of laryngeal mask airway supreme (LMA-S) and classic (LMA-C) with laryngoscopy and Endotracheal Intubation (ETT)..Patients and This study was a prospective, double-blind, and randomized clinical trial conducted on 150 patients aged 18 to 50 years with ASA I (American Society of Anesthesiologists), in the general operating room of Shahid Mohammadi hospital, Hormozgan university of medical sciences, Bandar Abbas, Iran. In the ETT group, endotracheal intubation was performed using the Macintosh laryngoscope; while for the LMA-C and LMA-S groups, LMA Classic and LMA Supreme were inserted, respectively. The induction and maintenance of anesthesia were similar in all patients. The hemodynamic parameters such as heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) were measured before (baseline) and after induction of anesthesia at 4 different time points. The statistical analysis was done and P value less than 0.05 was considered significant.. Participants in all groups were similar in terms of gender, age, weight, height, and Mallampati class. The mean ± SD of SBPs (105.62 ± 12.12, 112.90 ± 12.2, and 112.48 ± 15.14 mm Hg, respectively for ETT, LMA-C, and LMA-S) and DBPs (64.64 ± 10.23, 73.78 ± 9.70, and 71.20 ± 12.27 mm Hg, respectively for ETT, LMA-C, and LMA-S) were significantly lower in the ETT group compared to LMA groups 5 minutes after device insertion (P < 0.01 for SBPs and P < 0.001 for DBPs); however these values were lower than the baseline values in all groups. There were no differences in the mean SBP and DBPs between the three groups at the other time points. The mean ± SD heart rates in the ETT group, compared to the LMA-C and LMA-S groups, were considerably higher in the first minute (100.06 ± 18.27, 82.50 ± 10.52, and 82.00 ± 13.60 bpm, respectively for ETT, LMA-C, and LMA-S), third minute (91.04 ± 17.12, 78.84 ± 11.23, and 78.90 ± 13.41 bpm, respectively for ETT, LMA-C, and LMA-S) and fifth minute (85.82 ± 16.01, 75.78 ± 11.73, and 75.04 ± 13.90 bpm, respectively for ETT, LMA-C, and LMA-S) after intubation (P < 0.001). There were no significant differences between the LMA-C and LMA-S groups in terms of hemodynamic parameters.. Maintaining the airway using laryngeal mask airway is associated with less cardiovascular responses compared to direct laryngoscopy and tracheal intubation..

Cervical ripening is one of the main stages of initiation labor. Acupressure in Chinese medicine is considered as an invasive technique, which through reliving oxytocin ripens the cervix. Acupoint Sanyinjiao (SP6) was selected in this study because it is the acupoint selected in gynecology and it is easy for women to locate and apply pressure without medical assistance.. The aim of this study was to determine the effect of acupressure on cervical ripening..Patients and In this randomized clinical trial, 150 primigravida with term pregnancy who had referred to Deziani hospital in Gorgan were chosen and divided to three groups: in the first group acupressure was done by the researcher while in the second groups this was performed by the mother her self, and the third group served as a control and only received routine care. For both intervention groups the pressure was applied on Sp6 for about 20 minutes during one to five days. Elements were checked from cervical ripening at 48 and 96 hours after intervention and at the time of hospitalization. The tools for gathering information included demographic characteristics and midwifery history questionnaire, daily records and follow up forms. Content validity was used for validity of tools. Reliability of the observation check-list and physical examination was confirmed by inter-rater scores (inter observer), and daily records by test-re-test. Data was analyzed by analysis of variance (ANOVA), Kruskal-Wallis and Chi-squared tests (P ≤ 0.05).. There was a significant difference between mothers’ educations in the three groups. Most of the mothers (59.5%) in the researcher-performed acupressure group had secondary education. Cervical ripening was significantly different between the three groups after 48 hours (P ≤ 0.05), yet there was no significant difference after 96 hours and at the time of admission. Mean Bishop score was enhanced after 48 hours in the researcher-performed acupressure group (P ≤ 0.021) and the self-performed acupressure group (P ≤ 0.007) in comparison to the control group.. The results showed that acupressure is a safe technique and leads to cervical ripening. Thus, regarding the desired results that were achieved when mothers applied acupressure themselves, it could be suggested that it is beneficial for mothers to be trained to apply this method at home..