Iranian Registry Of Clinical Trials Research Articles

The Effectiveness of a Multimedia Educational Program on the Lifestyle and Perception of Patients with Atrial Fibrillation: A Study Protocol

Background: Atrial fibrillation is a globally common cardiac dysrhythmia and preventable with education. The study protocol aimed to investigate the effectiveness of a multimedia educational program on the lifestyle and perception of patients with atrial fibrillation. Methods: The present clinical trial protocol will be conducted to investigate the effect of multimedia training on the lifestyle and perception of patients with atrial fibrillation in two phases. The multimedia training (audio, video, image, and animation) was provided in the form of two 2-hour training sessions per week for patients on the coordinated date and time on a web platform. The patients also received a weekly phone call for one month through which some educational content was covered as a type of training intervention. The second phase included the administration of pre-test and post-test interventions using standard questionnaires by an intervention (who receive training) and a control (without training) group. Conclusion: The present study provides a useful protocol regarding the design of a multimedia educational intervention program on promoting the lifestyle and perception of patients with atrial fibrillation. It can also reduce treatment costs. The strategies of this program can be cost-effective therefore the success of such a program can be effective in improving the health status of atrial fibrillation patients.Registration of this randomized control trial has been completed with the Iranian Registry of Clinical Trials.

The effectiveness of multimedia mental health self-care program based on cyber space on the mental health of infertile women: a randomized controlled trial.

So far, some training interventions have been carried out to improve the mental health in women with infertility, but designing the need and evidence-based, as well as multimedia mental health self-care interventions based on cyber space has received less attention. Due to the spread of the internet and the role of self-care in improving mental disorders, this study was conducted to evaluate the effectiveness of the multimedia mental health self-care program on mental health and to assess the users' satisfaction. This study is a randomized controlled trial with pretest-posttest follow-up design. The sample was selected using a convenience sampling method (n = 90). The random number function was used to assign random numbers. The research instruments include a demographic, psychological Well-being, depression, anxiety, perceived stress, fertility problems and satisfaction with training questionnaire. Six weeks of intervention was conducted following the pre-test and the link of each session's content was sent to the participants, based on the training schedule, through Eitaa Messenger. The post-test and follow-up were conducted 1week and 1month post intervention. The data were analyzed using independent t-test and repeated measures ANOVA. A statistically significant difference was observed between the intervention and control group in the mean score of psychological well-being, perceived stress and infertility stress 1week and 1month post intervention and in the mean score of depression and anxiety 1month post intervention. The intervention group scored higher than the control in psychological well-being but lower in perceived stress, depression, anxiety and infertility stress. The intervention had a positive effect and reduced the score of perceived stress, depression, anxiety and infertility in the intervention group over time. The score reduction continued until the follow-up stage. No significant time-interaction effect was observed on psychological well-being and on the control group. Satisfaction with the program and subscales was desirable. This program could significantly reduce the depression, anxiety, perceived stress and infertility stress and desirable satisfaction with the program was observed among users. This program can be used in designing the experimental and therapeutic interventions to improve mental-health self-care behaviors. RCT Registry: Iranian Registry of Clinical Trials; RCT registration number: IRCT20210526051410N1; Registration date: 2022-11-06. Last update: 2023-01-28 https://irct.behdasht.gov.ir/trial/57874.

Therapeutic effects of acyclovir and acyclovir-clobetasol nanofibers vs. cream formulation for recurrent herpes labialis

ObjectivesThis study aims to compare the therapeutic effects of acyclovir nanofiber and acyclovir-clobetasol nanofiber formulations with their non-nano formulations (cream formulation) on recurrent labial herpes.Materials and methodsEighty patients with labial herpes lesions were divided into four groups, each receiving one of the following treatments: acyclovir-clobetasol nano patch, acyclovir-clobetasol cream, acyclovir nano patch, or acyclovir cream. Pain levels and recovery times were assessed. The Wilcoxon test compared pain levels, while the log-rank test compared healing and scabbing times.ResultsAcyclovir-clobetasol nanofiber and cream, along with acyclovir nanofiber, significantly reduced symptoms compared to the acyclovir cream. The recovery and scabbing times were shorter in patients who received acyclovir-clobetasol formulations compared to those receiving acyclovir alone.ConclusionAcyclovir-clobetasol combinations accelerated recovery times compared to acyclovir alone. Additionally, nanofiber formulations demonstrated enhanced healing efficacy over cream formulations.Trial registrationThis trial was retrospectively registered by Iranian Registry of Clinical Trials (IRCT) at 14/11/2023. Trial Registration number: IRCT20230926059521N1.

Evaluating the effects of intravenous magnesium sulfate for prevention of colistin induced acute kidney injury: an open-label, placebo-controlled, block randomized clinical trial.

Colistin, has reinstated as a last-resort antibiotic despite its known nephrotoxicity. The aim of this study was to determine the potential nephroprotective effects of Magnesium (Mg) Sulfate during colistin therapy. This study was an open-label, placebo-controlled, block-randomized clinical trial conducted from January 2023 to February 2024 involving 87 patients eligible for colistin therapy. Patients were randomly assigned to receive either Mg sulfate (16 mEq in 100 mL of normal saline) or 100 mL of normal saline as placebo before each dose of colistin. The primary outcome of the study was the incidence of Acute Kidney Injury (AKI) during the first week of colistin therapy, while the secondary outcomes included colistin dose adjustments, length of stay in the ICU and hospital, and overall mortality. This study was registered in The Iranian Registry of Clinical Trials (IRCT20130917014693N15; 2023-01-12). A total of 87 patients (46 in Mg and 41 in control group) completed the study. Fourteen patients (30.43%) in the Mg group and twenty-one patients (51.21%) in the control group developed AKI during the first week of colistin therapy (p = 0.048). Although AKI incidence was not statistically different between the groups in unadjusted Cox regression model (HR =0.51, 95% CI =0.26-1.01, P =0.057), it became significant after adjusting for confounding factors (HR =0.40,95% CI =0.18-0.86, P =0.021). The length of hospital stay was 48.62 ± 18.82 and 44.82 ± 20.23 days for Mg and control groups respectively (p=0.373). In the Mg group, 25 out of 46 patients (54.34 %) and in the control group, 24 out of 41 patients (58.53%) eventually expired (p=0.694). This study indicates that Mg sulfate significantly reduces AKI rates and prevents hypomagnesemia, optimizing dosing and enhancing patient safety during colistin therapy.

Sexual health counseling improves the sexual satisfaction of breast cancer survivors: a randomized controlled trial.

Breast cancer and its treatments can cause sexual problems both physically and psychologically by the changes it brings. This study aimed to investigate the effect of sexual health counseling based on acceptance and commitment therapy (ACT) on the sexual satisfaction of women with chemotherapy-induced menopause (CIM) in breast cancer survivors. Seventy women with CIM were randomly divided into two intervention (N = 34) and control (N = 36) groups. The intervention group attended eight sessions of 90-min sexual health counseling based on ACT. The control group received an educational booklet. The Sexual Satisfaction Scale for Women(SSS-W), the Sexual Quality of Life-Female questionnaire(SQOL-F), and the Menopause Rating Scale(MRS) were used to collect data before, after, and 1month after the intervention in both groups. The mean score of sexual satisfaction (F = 45.67, P < 0.001) and sexual quality of life (F = 33.39, P < 0.001) were significantly higher after the intervention and follow-up than before intervention in the intervention group. Also, the mean score of menopausal symptoms was significantly lower after the intervention and follow-up than before intervention in the intervention group (F = 11.80, P < 0.001). However, the mean score of sexual satisfaction (F = 0.02, P = 0.98), sexual quality of life (F = 0.05, P = 0.94), and menopausal symptoms (F = 0.08, P = 0.92) did not show significant differences before, after, and 1month after the intervention in the control group. Therefore, sexual health counseling based on ACT seems to have salutary effect on sexual satisfaction, sexual quality of life, and menopausal symptoms of women with breast cancer who experience CIM. This randomized control trial has been approved by Iranian Registry of Clinical Trials, IRCT20230105057055N1 at 2023-01-29.

Effect of topical magnesium sulfate on labor duration and childbirth experience: a randomized controlled trial

BackgroundMagnesium sulfate is used topically to reduce the duration of labor in some regions of the country. However, there is insufficient evidence about its effectiveness. This study aimed to determine whether topical magnesium sulfate reduces labor duration and improves childbirth experience (primary outcomes).MethodsIn this randomized controlled trial, the participants were 98 women with low-risk, singleton, and full-term pregnancies admitted to a teaching hospital in Iran. They were randomly assigned to the intervention group (receiving 50% magnesium sulfate) or the control group (receiving distilled water) stratified by parity and onset of labor. The participants, interventionists, and data collectors were blinded. During the vaginal examination at the beginning of the active phase of labor, 10 mL of magnesium sulfate or distilled water was poured on the cervix of the uterus. Data collection was performed by the researcher with continuous monitoring up to two hours post-delivery and follow-up at 4–5 weeks postpartum. The Childbirth Experience Questionnaire 2.0 was used to examine childbirth experience. We performed a modified intention-to-treat analysis, excluding those whose outcome of interest could not be assessed. Independent-samples t-tests were used to compare the groups in terms of the mean of the primary outcomes.ResultsParticipant recruitment took place between December 2021 and December 2022. Thirty-three percent were primiparous and 37% had induced labor. Three women in the intervention group and seven in the control group underwent emergency cesarean sections. All 49 women assigned to each group were included in the analysis of labor duration outcome, while one and two women were excluded from the analysis of childbirth experience score due to loss to follow-up. In the intervention group, compared to the control group, the mean duration of the intervention until delivery was significantly shorter (1.59 vs. 2.93 h; MD -1.34, 95% CI [-1.88 to -0.79]) and the childbirth experience score was higher (3.1 vs. 2.3, MD 0.84; 95% CI [0.59 to 1.08]).ConclusionsAccording to the results of this trial, pouring 10 mL of 50% magnesium sulfate on the cervix at the beginning of the active phase of labor probably reduces labor duration and improves the childbirth experience.Trial registrationEthics Committee of Tabriz University of Medical Sciences: IR.TBZMED.REC. 1400.726. Iranian Registry of Clinical Trials: IRCT20100414003706N40 Registration date: 21/11/2021 (https://en.irct.ir/trial/58323).

Expression of PGC-1α, PPAR-α and UCP1 genes, metabolic and anthropometric factors in response to sodium butyrate supplementation in patients with obesity: a triple-blind, randomized placebo-controlled clinical trial.

There is increasing evidence that gut metabolites have a role in the etiology of obesity. This study aimed to investigate the effects of sodium butyrate (NaB) supplementation on the expression of peroxisome proliferator-activated receptor (PPAR) gamma coactivator-1α (PGC-1α), PPAR-α, and uncoupling protein-1 (UCP-1) genes, as well as on the metabolic parameters and anthropometric indices in persons with obesity. In this triple-blind placebo-controlled randomized clinical trial, 50 individuals with obesity were randomly assigned to NaB (600 mg/day) + hypo-caloric diet or placebo group + hypo-caloric diet for 8 weeks. The study measured the participants' anthropometric characteristics, food consumption, and feelings of hunger in addition to the serum levels of metabolic indices and the mRNA expression of the PGC-1α, PPAR-α, and UCP-1 genes in peripheral blood mononuclear cells (PBMCs). PGC-1α and UCP-1 genes expression significantly increased in NaB group compared to the placebo at the endpoint. A significant decrease in weight, BMI, and waist circumference (WC) was observed in NaB group. Among the metabolic factors, NaB significantly decreased fasting blood sugar (FBS) (P = 0.04), low-density lipoprotein cholesterol (LDL-C) (P = 0.038) and increased high-density lipoprotein cholesterol (HDL-C) (P = 0.016). NaB could not significantly change serum GLP-1 level. This study unveiled NaB supplementation alone cannot have significant beneficial effects on anthropometric, and biochemical factors. NaB could affect anthropometric and metabolic risk variables associated with obesity only when prescribed, along with calorie restriction. This study was registered in the Iranian Registry of Clinical Trials ( https://en.irct.ir/trial/53968 ) on 31 January 2021 (registry number IRCT20190303042905N2).

A short-term evaluation of oral hygiene education methods in fixed orthodontics patients: a randomized clinical trial comparing assistant training, software, and social media

ObjectiveTo compare the effectiveness of different oral hygiene education strategies on periodontal health in fixed orthodontic patients in a one-month period: assistant-led instruction, social media-based education, and custom-made software.MethodsSixty orthodontic patients from Mashhad University of Medical Sciences’ Dentistry School were randomly assigned into three groups. Each group received oral health education differently: via assistant instruction, educational videos on social media, or a researcher-designed software for Android smartphones. After a month, participants’ oral health was evaluated using the plaque index (PI) and the gingival index (GI).ResultsAssistant-led education group demonstrated the highest PI (1.26 ± 0.70) and GI (0.92 ± 0.67), while the software group reported the lowest indices (PI = 0.68, GI = 0.46 ± 0.46). The social media group’s measurements fell between these extremes (PI = 0.89 ± 0.75, GI = 0.60 ± 0.52). Significant group differences were found for both PI and GI (P = 0.028 and P = 0.047, respectively). Pairwise comparison revealed significantly lower PI and GI in the software group compared to the assistant group. No significant differences were found between the social media and other groups.ConclusionOur results suggest that the use of specially designed software could be the most effective strategy for improving oral hygiene in orthodontic patients. Meanwhile, traditional assistant-led education showed the least effectiveness. The study supports the potential benefit of utilizing digital tools, such as bespoke software and social media, in oral health education for orthodontic patients.Trial registrationThe study was registered in the Iranian Registry of Clinical Trials (IRCT) database with the identification code IRCT20200609047705N2 in 13.07.2021.

Evaluating efficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial

Multiple sclerosis is an inflammatory demyelinating disease and represents a global health concern. Ocrelizumab, a humanized IgG monoclonal antibody, selectively targets CD20 on B cells and CD20-expressing T cells. This study aimed to compare the efficacy and safety of the biosimilar ocrelizumab candidate (Xacrel) to the originator product (Ocrevus) in Relapsing Multiple Sclerosis (RMS) patients. In this randomized trial, patients received either Xacrel or Ocrevus for 96 weeks. The primary endpoint was the equivalency of the medications in reducing the annualized relapse rate (ARR) at week 48. The secondary endpoints included time to the onset of disability progression confirmed at 12 and 24 weeks, the proportion of relapse-free patients, magnetic resonance imaging (MRI) evaluations, safety assessments, and immunogenicity over 96 weeks. A total of 170 patients were randomized (1:1 ratio). In the per protocol analysis, the upper and lower limits of 95% two-sided confidence intervals of difference between treatments in the 48-week ARR rate were in the predefined margin of − 0.2 to 0.2 (− 0.002; 95% CI − 0.080 to 0.075). The two products were also comparable in terms of other efficacy parameters, safety, and immunogenicity. The results confirmed that Xacrel is equivalent to Ocrevus in terms of 48-week ARR in RMS patients, with no considerable difference in other efficacy parameters and the safety profile during the 96 weeks. The trial was registered in Iranian registry of clinical trials (IRCT) on 10/06/2019 with the registration number of IRCT20150303021315N13 and in Clinicaltrials.gov on 19/07/2021 with the registration code of NCT04966338.

Peer support groups and care burden in hemodialysis caregivers: a RCT in an Iranian healthcare setting

BackgroundChronic renal failure poses a significant global health challenge, exerting a substantial burden on both patients and their caregivers. Hemodialysis, a common treatment for end-stage renal disease, imposes extensive physical, emotional, and financial pressures on caregivers, often leading to a high care burden. This study uniquely examines the impact of peer support groups on reducing the care burden among caregivers of patients receiving hemodialysis in an Iranian healthcare setting, an aspect that has not been extensively explored before.MethodsA parallel-controlled clinical trial was conducted involving 60 caregivers, divided into intervention and control groups. The intervention group participated in an 8-session peer support program tailored to their identified needs, including coping with stress, social isolation, and financial challenges. The Zarit Care Burden Interview Scale was used to measure care burden before and after the intervention.ResultsThe study revealed statistically significant reductions in care burden, particularly in physical, social, and emotional dimensions, among caregivers in the intervention group compared to the control group. The total care burden score showed a marked decrease, indicating the effectiveness of the peer support intervention. While economic challenges remained a concern, the intervention had a limited impact in this domain.ConclusionThis study demonstrates that peer support groups significantly alleviate the care burden experienced by caregivers of patients receiving hemodialysis, improving their well-being across several dimensions. The findings highlight the importance of integrating peer support strategies into healthcare programs for chronic disease management and underscore the need for supplementary economic support measures to comprehensively address caregivers’ needs. Future research should explore the scalability and long-term sustainability of such interventions and address the unique economic challenges faced by these caregivers.Trial registrationThis study was registered in the Iranian Registry of Clinical Trials (IRCT) under the registration number IRCT20220724055540N1 on 11/08/2022.

The effect of recreational therapy application on fatigue in hemodialysis patients: a randomized clinical trial

BackgroundChronic Kidney Disease (CKD) is a progressive disorder that often leads to End-Stage Renal Disease (ESRD), necessitating hemodialysis (HD) treatment. Fatigue is a prevalent and debilitating symptom among HD patients, significantly affecting their quality of life. Recreational Therapy (RT) is a therapeutic recreational service designed to maintain and restore a person’s level of performance and independence in daily activities. This study aimed to evaluate the effect of a smartphone-based recreational therapy intervention on fatigue in hemodialysis patients.MethodsThis randomized controlled trial was conducted on HD patients at a hospital in Mashhad, Iran. The intervention group received a custom-designed recreational therapy mobile application, including music, comedy, exercise, and educational content. The control group received standard care. Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20) before and after the 30-day intervention.ResultsA total of 72 patients (36 per group) participated in the study. The intervention group demonstrated a significant reduction in overall fatigue scores and improvements across various fatigue dimensions, including general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation, compared to the control group (p < 0.001).ConclusionThe smartphone-based recreational therapy intervention effectively reduced fatigue in hemodialysis patients. This approach could be a valuable complementary strategy for managing fatigue in this population. Further research is needed to explore the long-term sustainability of these benefits and the intervention’s impact on other patient-reported outcomes.Trial registrationThis study was registered in the Iranian Registry of Clinical Trials (no. IRCT20220803055608N1) on 29/08/2022.

The effect of prebiotic supplementation on serum levels of tryptophan and kynurenine in obese women with major depressive disorder: a double-blinded placebo-controlled randomized clinical trial

ObjectiveThe objective of the present study was to examine the effect of calorie restricted diet (CRD) plus inulin supplementation on serum levels of tryptophan (Trp), kynurenine (Kyn) and Trp/Kyn ratio in obese women with major depressive disorder (MDD).ResultsIn this double-blind placebo-controlled randomized clinical trial, 51 obese women (BMI = 30–40 kg/m2) with mild MDD were assessed for depression level using Hamilton depression rating scale (HDRS). The patients were randomly allocated into either “Prebiotic group” (received 10 g/day inulin) or “Placebo group” (received 10 g/day maltodextrin). All participants also received individualized CRD. Fasting serum levels of Trp, Kyn, and Trp/Kyn ratio were assessed at baseline and after 8 weeks. Results showed slightly greater increases in serum levels of Trp and Trp/Kyn ratio as well as reductions in serum level of Kyn and HDRS score in prebiotic group than placebo group. However, between group differences in these parameters as well as HDRS score were not statistically significant after adjusting for baseline variables at the end of the trial. Results indicates that CRD accompanied by inulin supplementation (10 g/day) did not influence serum levels of Trp, Kyn and Trp/Kyn ratio as well as HDRS score after 8 weeks.Trial registration: The trial was registered in the Iranian registry of clinical trials at 2018-08-02 (https://www.irct.ir/; registration number: IRCT20100209003320N15).

Clinical trial of the effects of postbiotic supplementation on inflammation, oxidative stress, and clinical outcomes in patients with CVA

Background Cerebrovascular accidents (CVAs), or strokes, are major global health concerns associated with oxidative stress, inflammation, and gastrointestinal complications. This study aimed to explore the impact of postbiotic supplementation in CVA patients, specifically in terms of oxidative stress, inflammation, and clinical outcomes, as an alternative to probiotics with potential advantages. Method A prospective, single-center, randomized, controlled trial was conducted with 120 CVA patients in Iran. These patients were admitted to the ICU to assess the severity of their strokes. Patients were randomly assigned to receive either postbiotic supplementation (n = 60) or a placebo (n = 60). Various biomarkers related to oxidative stress, inflammation, and clinical outcomes were assessed. Data on demographic characteristics, nosocomial infections, and laboratory measurements were collected. Gut microbiota analysis was also performed on fecal samples. Results After the 7-day intervention, postbiotic supplementation resulted in significant improvements in inflammatory markers, oxidative stress, and a reduced incidence of pneumonia compared with those in the control group, with the postbiotic group demonstrating notable decreases in the serum IL-1β levels (-1.79; 95% CI: = -2.9 to -0.64, p = 0.002 ), MDA levels (-30.5; 95% CI: -54.8 to -6.1, p = 0.015), Hs-CRP levels (-0.67; 95% CI:-1.1 to -0.26 mg/dl, p = 0.001) and TAC levels (62.5; 95%CI: 34.1 to 90.9, p < 0.001) compared with those in the placebo group. However, no significant differences in other clinical outcomes, including the NIHSS score, NUTRIC score, and APACHE II score, or the gut microbiota profile, were observed between the two groups. Conclusion Postbiotic supplementation improved the levels of inflammatory factors and oxidative stress markers and reduced the risk of pneumonia in CVA patients. Trial registration This trial is registered in the Iranian Registry of Clinical Trials (registration code IRCT20180712040438N7), Registration date 06122022.

The effect of Oleoylethanolamide supplementation on lipid profile, fasting blood sugar and dietary habits in obese people: a randomized double-blind placebo-control trial.

Abnormalities in biochemical parameters and changes in eating habits are considered complications of obesity. Oleoylethanolamide (OEA), an endocannabinoid-like compound, has been shown to have protective effects on many metabolic disorders. Given this evidence, the present study aimed to assess the effects of OEA on lipid profile parameters, fasting blood sugar (FBS), and dietary habits in healthy obese people. In this randomized, double-blind, placebo-controlled clinical trial, which was carried out in 2016 in Tabriz, Iran, 60 obese people were enrolled in the study based on inclusion criteria. The intervention group consumed 125mg of OEA capsules, and the placebo group received the same amount of starch twice for 8 weeks. Blood samples (5 mL) were taken at baseline and the end of the study in a fasting state. Serum concentrations of FBS, triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), and total cholesterol (TC) were measured by enzymatic methods using commercial kits. The low-density lipoprotein cholesterol (LDL-C) concentration was obtained using the Friede-Wald formula. To assess dietary habits, a food frequency questionnaire (147 items) was used at baseline and the end of the study. A value less than < 0.05 was considered to indicate statistical significance. The TG concentration decreased significantly in the intervention group (mean (SD): 166.29 (70.01) mg/dL to 142.22 (48.05) mg/dL, p = 0.047). Changes in the placebo group were not significant (p > 0.05). After adjusting for baseline values and demographic characteristics, the difference in TG between groups remained significant (p = 0.044). Changes in other biochemical parameters were not significant. There was no significant difference between or within groups in terms of food groups. OEA, as a complementary agent, plays a protective role in TG regulation. However, future studies with longer durations are needed to explore the impact of OEA on regulating dietary habits and to identify the mechanisms related to metabolic abnormalities in obese people. The study was registered in the Iranian Registry of Clinical Trials (IRCT) center as IRCT201607132017N30 with URL. www.IRCT.IR in date 03/10/2016.

Internet-based UP-A intervention on treatment of stress, anxiety, depression, and psychological flexibility among adolescents with sub-clinical diagnosis of emotional disorders during the COVID-19 pandemic: a clinical trial

This clinical trial aims to assess the effectiveness of internet-based Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) during the COVID-19 pandemic in reducing stress, anxiety, and depression, and psychological flexibility. 40 adolescents with subclinical features of emotional disorder randomly divided into two groups of intervention and control. The participants first completed DASS-21 and AAQ-2 questionnare online. Then, the intervention group received 12 sessions of UP-A through video calls on WhatsApp, 2 days per week each for 45 min. UP-A is an emotion-focused, cognitive-behavioral therapy consisting of 5 core modules or components that target temperamental characteristics, particularly neuroticism and resulting emotion dysregulation. Eventually the stress, anxiety, and depression levels decreased in intervention group and their psychological flexibility increased immediately and 3 months after the intervention.Clinical trial registration This study was registered by Iranian Registry of Clinical Trials (Prospective, ID: IRCT20210428051113N1, Registration date: 14/06/2021; https://en.irct.ir/trial/55900).

Investigating the effect of adding silymarin to the standard treatment of naloxone in methadone intoxication; a double-blind clinical trial

Introduction: In cases of methadone intoxication, the drug is mainly processed by the liver, however, its elimination through the kidneys is also crucial. On the other hand, naloxone therapy is a gold standard treatment for opioid intoxication, the addition of other drugs can improve its benefits and reduce side effects. Objectives: This study aimed to assess the effectiveness of adding silymarin to the standard treatment of naloxone in patients with methadone intoxication, to improve patient outcomes and reduce the risk of complications associated with alone naloxone therapy. Patients and Methods: This clinical trial study aimed to investigate the efficacy of silymarin in combination with standard treatment for methadone intoxication patients. The study employed a control group, which received standard treatment with naloxone, and an intervention group, which received both naloxone and silymarin. Liver functional tests (LFTs), kidney functional tests, malondialdehyde (MDA), and ferric-reducing ability of plasma (FRAP) were measured at admission and post-intervention times to compare the outcomes between the two groups. Statistical analyses, including chi-square, independent and paired t tests, Wilcoxon, and Mann-Whitney tests were conducted to identify significant differences between the groups. Results: Results indicated that 32 and 33 patients were included in the naloxone and naloxone + silymarin groups, respectively. The results showed that the changes in kidney functional tests such as blood urea nitrogen (BUN) and creatinine (Cr), MDA, and FRAP were not statistically significant between the two groups. However, the changes in LFTs, including, aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP), were statistically significant. Notably, the LFT changes were more pronounced in the group receiving both naloxone and silymarin, indicating a greater reduction in liver enzymes in this combined treatment group. Conclusion: The addition of silymarin to standard naloxone treatment for methadone intoxication patients could improve liver function, as the combined therapy showed a more pronounced reduction in liver enzyme levels compared to standard treatment alone; however, this combination treatment could not change the kidney function and oxidative stress markers. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20210216050377N1; ethical code from Shahrekord University of Medical Sciences; IR.SKUMS.REC.1400.048). This study was also registered in Research Registry website with Unique Identifying Number (UIN) of researchregistry10395.

The effect of atomoxetine efficacy on freezing of gait in patient with Parkinson’s disease: a double-blinded randomized clinical trial

Introduction: Freezing of gait (FOG) is a debilitating symptom experienced by many individuals with Parkinson’s disease, characterized by an abrupt and transient inability to initiate or continue locomotion. Despite extensive research, effective pharmacological interventions targeting FOG remain elusive. Atomoxetine, a selective norepinephrine reuptake inhibitor, has shown promise in alleviating FOG in small-scale studies. However, the efficacy of atomoxetine in larger cohorts remains underexplored. Objectives: This study aims to assess the impact of atomoxetine on Parkinson’s disease-related FOG in a larger study population than currently reported in the literature. Patients and Methods: This randomized clinical trial was performed in Golestan Hospital, Ahvaz, Iran, in 2022. The participants were divided into group A comprising 16 patients subjected to atomoxetine treatment, and group B consisting of 16 patients administered a placebo. Three scheduled visits were conducted. Freezing of Gait Questionnaire (FOGQ) scores was documented during each visit. Results: The mean age of all participants was 62.4 ± 8.3 years, with no significant intergroup age disparity and no statistically significant gender-based distinctions between the two groups. The average disease duration in the atomoxetine group was 8.2 ± 3.1 years, while in the placebo group, it was 7.2 ± 3.4 years, with no significant divergence between the two groups. The study findings indicated no significant distinction in FOGQ scores between the treatment and placebo groups. Conclusion: Though atomoxetine did not significantly improve improvement in freezing of the gait of studied patients with Parkinson’s disease, it may cause a modest improvement in the gait freezing of some patients. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20211008052695N1; https://irct.behdasht.gov.ir/trial/59643, ethical code; #IR.AJUMS.HGOLESTAN. REC.1400.026).

Comparison of Clinical Effects and Physical Examination of Transforaminal and Caudal Steroid Injection With Targeted Catheter in Lumbar Radiculopathy: A Single-Blind Randomized Clinical Trial.

Transforaminal and caudal epidural injections are two methods of steroid injection in lumbar radiculopathy. Using a targeted catheter with the possibility of accessing the involved spinal roots and steroid administration selectively next to them during the caudal procedure may achieve the benefits of both transforaminal and caudal procedures. The aim of this study was to investigate the clinical effects and physical examinations of transforaminal steroid injection compared to caudal through a targeted catheter in lumbar radiculopathy. Fifty patients with lumbar radiculopathy candidates for epidural steroid injection were divided into transforaminal (T) and caudal (C) groups. Steroid injection under fluoroscopic guidance was performed in group T with the transforaminal method and in group C with the caudal method using a targeted catheter for each involved spinal nerve root. Pain intensity visual analog scale (VAS), Oswestry Disability Index (ODI), daily analgesic consumption, and physical examinations on four follow-ups (before injection, second week, first and third month) were evaluated. Pain score (VAS) and functional disability index (ODI) were similar in both groups, and there was no significant difference between the two groups (p>0.05). The positive Lasègue test was significantly higher in the caudal group than in the transforaminal group only in the third month (p<0.05). Other physical examinations in both groups did not have significant differences in all the follow-ups. Moreover, there was no difference in the amount of analgesic consumption in the two groups. No complications were observed in both groups. This study showed that transforaminal and caudal steroid injection (with a targeted catheter) in patients with lumbar radiculopathy had similar effects in controlling pain and improving functional disability of patients in the short term. Cases of recurrence of positive Lasègue test in physical examinations in the long term (third month) in the caudal group may indicate the preference of the transforaminal approach. Iranian Registry of Clinical Trials (IRCT) number: IRCT20111102007984N31.

Naproxen adjunct to fluoxetine for moderate-to-severe obsessive-compulsive disorder: A randomized, double-blind, placebo-controlled trial.

Current treatments for obsessive-compulsive disorder (OCD) encounter resistance and limiting adverse events, necessitating novel therapeutic strategies. This study aimed to investigate the benefits of naproxen, a medication with effects on inflammation and neuronal function, on OCD. One hundred and four OCD outpatients with a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of >21 were equally assigned to receive fluoxetine plus either naproxen 250 mg or matched placebo q12hr. Patients were assessed using the Y-BOCS by recording the subscale scores at baseline and weeks 5 and 10 to evaluate efficacy. They were also assessed in terms of tolerability. Data from 96 patients were analyzed. The baseline characteristics were comparable between the groups. There were significant time-treatment interaction effects on the obsession subscale ( = 0.055) and total ( = 0.043) scores of Y-BOCS. Reductions in the obsession subscale and total scores of Y-BOCS were significantly greater in the fluoxetine plus naproxen group until the endpoint (Cohen's d = 0.560 and Cohen's d = 0.477, respectively). However, the difference in compulsion subscale score changes between the groups was not significant. Respondents with a reduction of ≥35% in Y-BOCS total scores were significantly more in the fluoxetine plus naproxen group (80.0% versus 47.8%). The side effect frequencies were comparable between the groups. Naproxen, adjunct to fluoxetine, outperformed adjunctive placebo in treating obsession and total symptoms of OCD patients in a safe and tolerable manner. The study protocol was registered and published in the Iranian Registry of Clinical Trials (http://www.irct.ir; registration number IRCT20090117001556N139).

Educational Intervention Impact On Nurses' Emotional Intelligence And Leadership Models: A Longitudinal Randomized Trial

Background: Emotional intelligence plays a critical role in nursing leadership, influencing organizational dynamics and patient care. However, there is limited understanding of the impact of emotional intelligence on leadership in Primary Health Care within the Greek context. Materials and Methods: A longitudinal experimental design was used to assess the effects of an educational intervention on emotional intelligence and leadership among Greek Primary Health Care nurses. Questionnaires, including the Wong and Law Emotional Intelligence Scale and the Multifactor Leadership Questionnaire, were administered pre- and post-intervention. Results: The results of the study revealed that, during the second measurement, the intervention group exhibited significant improvements in emotional intelligence, whilst adopting a more transformational style of leadership, compared to the control group. However, between the two measurements, no significant changes were observed in the transformational and transactional leadership models, with the exception of Management by Exception (Passive) and Laissez-Faire Leadership. However, in between the two measurements, no substantial changes in measurements were observed regarding the implementation of transformational or transactional models of leadership in neither of the groups. The only exception was the adoption of a Management by Exception (Passive) approach and that of a Laissez-Faire style of leadership. The tables highlighted nuanced changes in leadership dynamics, post-intervention. Conclusion: The empirical study supports that initiatives in education effectively enhance the emotional intelligence of nurses, while they also influence leadership styles. This suggests and highlights the need for tailored professional development programs in nursing education, in order to develop both the emotional intelligence and the leadership skills of those involved. Trial registration: Iranian Registry of Clinical Trials, registration reference: IRCT 20240126060816N1