Single-blind Randomized Clinical Trial Research Articles

Telemanagement of Home-Isolated COVID-19 Patients Using Oxygen Therapy With Noninvasive Positive Pressure Ventilation and Physical Therapy Techniques: Randomized Clinical Trial.

BackgroundWith the growing stress on hospitals caused by the COVID-19 pandemic, the need for home-based solutions has become a necessity to support these overwhelmed hospitals.ObjectiveThe goal of this study was to compare two nonpharmacological respiratory treatment methods for home-isolated COVID-19 patients using a newly developed telemanagement health care system.MethodsIn this single-blinded randomized clinical trial, 60 patients with stage 1 pneumonia caused by SARS-CoV-2 infection were treated. Group A (n=30) received oxygen therapy with bilevel positive airway pressure (BiPAP) ventilation, and Group B (n=30) received osteopathic manipulative respiratory and physical therapy techniques. Arterial blood gases of PaO2 and PaCO2, pH, vital signs (ie, temperature, respiratory rate, oxygen saturation, heart rate, and blood pressure), and chest computed tomography scans were used for follow-up and for assessment of the course and duration of recovery.ResultsAnalysis of the results showed a significant difference between the two groups (P<.05), with Group A showing shorter recovery periods than Group B (mean 14.9, SD 1.7 days, and mean 23.9, SD 2.3 days, respectively). Significant differences were also observed between baseline and final readings in all of the outcome measures in both groups (P<.05). Regarding posttreatment satisfaction with our proposed telemanagement health care system, positive responses were given by most of the patients in both groups.ConclusionsIt was found that home-based oxygen therapy with BiPAP can be a more effective prophylactic treatment approach than osteopathic manipulative respiratory and physical therapy techniques, as it can impede exacerbation of early-stage COVID-19 pneumonia. Telemanagement health care systems are promising methods to help in the pandemic-related shortage of hospital beds, as they showed reasonable effectiveness and reliability in the monitoring and management of patients with early-stage COVID-19 pneumonia.Trial RegistrationClinicalTrials.gov NCT04368923; https://clinicaltrials.gov/ct2/show/NCT04368923

Effect of caffeine gel and caffeine gel associated with iontophoresis in women gynoidlipodystrophy: A pilot randomized trial

Caffeine has been widely used to treat gynoid lipodystrophy (GLD). Despite caffeine has been considered as a promise treatment, there is a lack of scientific evidences regarding its effect on GLD when associated with iontophoresis or others equipment. We aimed to evaluate the effects of a caffeine gel alone and associated with iontophoresis in GLD treatment. In a single-blind randomized clinical trial, women with mild/moderate GLD in the buttocks were randomized to topical caffeine gel group (CG; n=10); caffeine gel plus iontophoresis group (CIG; n=11) or iontophoresis group (IG; n=10). The groups were treated with 10 sessions, two times/week, 20 min/session. The subjects were evaluated pre and post treatment by photonumeric GLD severity scale, ultrasound image, thermography and quality of life questionnaire with a blind evaluator. There were statistical reduction in subcutaneous tissue thickness (P≤0.046) as well as in subcutaneous tissue plus dermis thickness (P≤0.044) in buttocks both in CG and CIG. GLD reduction was similar between CG and CIG, and these reductions were more pronounced than in IG (P&lt;0.0001). Furthermore, quality of life improved in all groups (P&lt;0.017). We concluded that caffeine alone and associated with iontophoresis were effective for decreasing the subcutaneous fat layer in women with GLD.

What Are the Effects of Methylprednisolone Injection Into the Masseter and Gluteal Muscle on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery? A Randomized Clinical Trial

Methylprednisolone is widely administered after impacted third molar surgery. This study compared the effect of methylprednisolone injection into the masseter and gluteal muscle on pain, edema, and trismus after impacted lower third molar surgery. This was a single-blind placebo-controlled randomized clinical trial. Sixty patients with an impacted lower third molar were included and randomly assigned into 3 groups. Each group received 1 of the following medications half an hour before surgery: Group I: 40 mg methylprednisolone injected into masseter muscle; Group II: 40 mg methylprednisolone injected into gluteal muscle; Group III: considered as control group with no intervention. The level of pain was recorded 1, 5, and 7 days after surgery using visual analog scale, and the amount of edema was measured 5 and 7 days after surgery using ultrasound imaging. The amount of trismus was measured 5 and 7 days after surgery based on the distance between incisor edge of upper and lower centrals. Friedman test was used to compare the level of pain, trismus and edema in each group at different times. Kruskal-Wallis test was used to compare the level of pain, trismus and edema among different groups at each time. Significance level was set at P < .05. There was no significant difference among the 3 groups (a total of 60 patients (31 females and 29 males), aged 19 to 35 years) considering edema (P = .250, CI = 0.22 ± 0.42), trismus (P = .337, CI = -5.93 ± 2.22) and pain (P = .285, CI = -2.91 ± 0.40) relief. Postsurgical pain, edema, and trismus were not reduced by intramuscular injection of methylprednisolone before third molar surgery.

Evaluation of a New Tubular Finger Oxygen-Enriched Oil Inside-Coated Dressing Device in Pediatric Patients Undergoing Distal Hypospadias Repair: A Prospective Randomized Clinical Trial Part II.

Background: This study was the second part of a prospective randomized clinical trial and aimed to evaluate the use of a tubular finger oxygen-enriched oil inside-coated dressing device and its effect on the post-operative outcome of children undergoing distal hypospadias repair.Methods: A prospective single-blinded randomized clinical trial was carried out between September 2019 and September 2020. We included all patients with distal hypospadias, who received Snodgrass urethroplasty and preputioplasty. The patients were randomized in two groups according to the type of dressing: tubular finger oxygen-enriched oil inside-coated device (G1) and elastic net bandage with application of oxygen-enriched oil-based gel (G2). The patients were evaluated at 7, 14, 21, 30, and 60 post-operative day (POD).Results: Sixty-four patients (median age 14 months) were included in the study and randomized in two groups, each of 32 patients. Post-operative preputial edema rate was significantly lower in G1 (3/32, 9.3%) compared with G2 (10/32, 31.2%) (p = 0.001). The median duration of preputial edema was significantly shorter in G1 compared with G2 (6 vs. 10.5 days) (p = 0.001). Penile diameter measurements at 4th, 7th, 14th POD proved that entity and duration of post-operative swelling were objectively decreased using the new dressing. The wound healing was significantly faster in G1 compared with G2 (14.2 vs. 18.5 days) (p = 0.001). The post-operative complications rate was significantly lower in G1 (0%) compared with G2 (3/32, 9.3%) (p = 0.001). Foreskin dehiscence occurred in two G2 patients (6.2%) whereas, breakdown of urethroplasty and preputioplasty occurred in one G2 patient (3.1%) due to scratching injuries. The dressing management was subjectively assessed by nurses to be easier in G1 patients compared with G2 ones (median score 1.2 vs. 3.5) (p = 0.001). The median treatment costs were significantly lower in G1 compared with G2 (55 vs. 87 eur) (p = 0.001). No adverse skin reactions occurred.Conclusions: Post-operative dressing using tubular finger oxygen-enriched oil inside-coated device was highly effective, easy to manage, cheaper and associated with a lower rate of foreskin and urethral complications compared with the standard dressing method in pediatric patients undergoing distal hypospadias repair. It was also clinically safe without allergy or intolerance to the product.

Efficacy of Photobiomodulation Therapy for Orthodontic Pain Control Following the Placement of Elastomeric Separators: A Randomized Clinical Trial.

Introduction: Controlling pain in orthodontic patients has gained special attention. This study assessed the efficacy of photobiomodulation therapy (PBMT) for pain control following the placement of elastomeric separators. Methods: This split-mouth single-blind randomized clinical trial evaluated 30 orthodontic patients who required posterior elastomeric separators. The two maxillary quadrants were randomized into the laser and control groups. In the laser quadrant, an 808 nm diode laser (400 mW, 15.60 J/cm2 , 11 seconds, continuous-wave, contact mode) was irradiated to the cervical third of the maxillary first molar roots 24 hours prior to the placement of separators. The control quadrant received placebo radiation by a light-curing unit. The patients received the second laser cycle right before the placement of separators 24 hours later. The level of self-perceived pain was recorded at 0, 2, 6, 24, and 72 hours and 5 days after the intervention in the laser and control quadrants using a visual analog scale (VAS). Data were analyzed using the analysis of variance (ANOVA) and paired-samples t test. Results: The trend of change in the pain score was similar in both groups. The pain score was significantly lower in the laser group than the control group at all-time points (P <0.05) except at time 0. The pain score increased in the first 6 hours and reached its maximum level in 24 hours in both groups. Conclusion: PBMT by an 808 nm diode laser can effectively decrease pain following the placement of elastomeric separators.

The effect of inhaling mother\u2019s breast milk odor on the behavioral responses to pain caused by hepatitis B vaccine in preterm infants: a randomized clinical trial

BackgroundNowadays, it is generally assumed that non-pharmacologic pain relief in preterm infants is an important measure to consider. Research findings suggest that familiar odors have soothing effects for neonates. The aim of this study was to compare the effect of maternal breast milk odor (MBMO) with that of another mother’s breast milk odor (BMO) on the behavioral responses to pain caused by hepatitis B (HB) vaccine injection in preterm infants.MethodsThis single-blind randomized clinical trial was performed over the period between February 2019 and March 2020 in the neonatal intensive care unit of Babol Rouhani Hospital, Iran. Ninety preterm infants, who were supposed to receive their HB vaccine, were randomly assigned into three groups: MBMO (A), another mother’s BMO (B), and control with distilled water(C). Oxygen saturation (SaO2), blood pressure (BP) and heart rate (HR) were recorded for all participants through electronic monitoring. In addition, premature infant pain profiles (PIPP) were determined through video recording for all three groups during intervention. The chi-square, ANOVA and ANCOVA were used for analyzing the data, and P < 0.05 was considered significant in this study.ResultsNo significant differences were found between the three groups in mean ± SD of HR, BP, and Sao2 before the intervention (P > 0.05). After the intervention, however, the means for heart rate in groups A, B, and C were 146 ± 14.3, 153 ± 17.5 and 155 ± 17.7, respectively (P = 0.012). Moreover, the means for PIPP scores in groups A, B and C were 6.6 ± 1.3, 10 ± 2, and 11.4 ± 1.9, respectively (P < 0.001). There was no significant difference found between groups in their means of SaO2, systolic and diastolic blood pressure after the intervention (P > 0.05).ConclusionsThe results indicate that stimulation with MBMO is effective in reducing pain in preterm infants; therefore, it can be postulated that this technique can be considered in less invasive procedures such as needling.Trial registrationIRCT, IRCT20190220042771N1. Registered 18 May 2019- Retrospectively registered,

Effect of deep breathing exercise on oxygenation of patients under major abdominal surgery: randomized clinical trial

Introduction: The number of major abdominal surgical procedures is increasing around the world. A large number of the patients complain about postoperative pulmonary complications (PPCs) after abdominal surgery and show symptoms of breathing pattern disorder. Therefore, this study aimed to investigate the effect of deep breathing exercise on the oxygenation of patients undergoing major abdominal surgery. Methods: This single-blind randomized clinical trial was conducted on 40 patients who needed major abdominal surgery in Qom, Iran, in 2014. The participants were divided into two equal experimental (n=20) and control (n=20) groups. The cases in both groups received routine care, however, those in the experimental group exercised repeated deep breathing four times per hour for two consecutive hours after the surgery as well. The condition of the patients in both groups was similar in terms of position, mobility, and oxygen therapy. The patient’s oxygen saturation, respiratory rate (RR), heart rate, and the severity of pain in the surgery site were measured. The collected data were analyzed in SPSS software (Version. 18) using paired t-test, independent t-test, Mann-Whitney U test, Wilcoxon rank-sum test, Multiple regression analyses, Chi-square test, and Fischer’s exact test. A p-value less than 0.05 was considered statistically significant. Results: Based on the study findings, the deep breathing exercise significantly reduced the surgery site pain and mean blood pressure and increased O2 saturation in the experimental group after the intervention (P&lt;0.05). Moreover, there was a statistically significant difference between the experimental and control groups, and a significantly higher O2 saturation was observed in the experimental group after deep breathing exercise post-operation (β=2.01, P&lt;0.001). Conclusion: Deep breathing exercises can reduce the severity of pain in the surgery site and mean arterial blood pressure and increase O2 saturation in patients after major abdominal surgery.

The effect of mother’s voice on pain and physiological parameters during arterial blood sampling in children hospitalized in PICUs

Introduction: Arterial blood sampling is a painful procedure, and is frequently performed in PICUs. Listening to mother's voice may be effective in reducing pain during arterial blood sampling in children. This study was aimed to determine the effect of mother’s recorded voice on pain and physiological parameters during arterial blood sampling in children hospitalized in PICUs.&#x0D; Methodology: This study was a single blind randomized clinical trial with crossover design. Fifty children hospitalized in PICUs participated in this study. The participants were selected through “sequential sampling” and randomly allocated into two groups; e.g., Group AB (n = 25) and Group BA (n = 25). Physiological parameters and pain in each child were measured before and during arterial blood sampling with (B) and without (A) listening to their mothers’ voices with a minimum of 24 hrs interval. To measure the pain, COMFORT pain scale was used and the physiological parameters were measured using the monitoring devices connected to the children. Data were analyzed with SPSS version 22, repeated measure test, paired and non-paired t-test, Wilcoxon and Mann-Whitney test.&#x0D; Results: Means of pain scores and physiologic parameters did not show a significant difference before the intervention on the first and second day between the two groups (AB-BA). The results showed the period effect (f = 0.581 and p = 0.89) and carry over effect (f = 0.055, p-value = 0.881) were not significant. Results of paired t-test showed that the mean pain score during arterial blood sampling with (B: 21.82 ± 5.53) and without (A: 22.40 ± 4.76) listening to their mothers’ voices was significantly different (p = 0.002). That is, with the mother’s voice, the children felt a lower level of pain. The SpO2 decline during the sampling was less with the mother’s voice. Additionally, the heart rate declined less during the sampling compared to the rate before the sampling with the mother’s voice; still, the difference was not significant (p &gt; 0.05).&#x0D; Conclusion: Listening to mothers’ recorded voice was effective to alleviate pain during arterial blood sampling in children hospitalized in PICUs. The use of this method to reduce pain during this painful procedure is effective even in the absence of the mother.&#x0D; Key words: Pain; Mother’s voice; Arterial blood sampling; Physiological indices; PICU&#x0D; Citation: Shoghi M, Ahmadi M, Rasouli M. The effect of mother’s voice on pain and physiological parameters during arterial blood sampling in children hospitalized in PICUs. Anaesth. pain intensive care 2021;25(1):40-47.DOI: 10.35975/apic.v25i1.1440&#x0D; Received: 20 June 2020, Reviewed: 16 September 2020, Accepted: 25 November 2020

The Effect of Elastic Resistance Bands Training on Vascular Aging Related Serum microRNA-146 Expression and Atherosclerosis Risk Factors in Elderly Women with Osteosarcopenic Obesity: A Randomized Clinical Trial

Objective: Vascular aging and osteosarcopenic obesity (OSO) refers to age-related endothelial cells and body composition disorders. The purpose of this study was to investigate the effect of 12 weeks resistance training with elastic bands on vascular aging-related serum miR-146 expression level and atherosclerosis risk factors in elderly women with OSO.&#x0D; Materials and Methods: In the present single-blind randomized clinical trial, 48 elderly women with OSO (according to Dual energy X-ray absorptiometry (DEXA) method results), were divided randomly into two groups of control (n=22) and experimental (n=26). The experimental group performed resistance training with elastic bands for 12 weeks and three sessions per week for all major muscle groups. Statistical analyses were carried out using SPSS statistical software version 22.&#x0D; Results: Between-group comparisons showed a significant decrease in serum miR-146 expression (P-value= 0.005) and total cholesterol (P-value= 0.034) in the experimental group compared to the control group. There was no significant difference in body weight (P-value= 0.440), BMI (P-value= 0.553), total fat (P-value= 0.093), BMC (P-value= 0.862), BMD (P-value= 0.564), Hs-CRP (P-value= 0.065), HDL-C (P-value= 0.515) and LDL-C (P-value= 0.889).&#x0D; Conclusion: Resistance trainings decrease miR-146 expression in elderly women with OSO, which was associated with decreased LDL levels and increased HDL levels, though BMI, body fat percentage, total cholesterol and HS-CRP were not significantly different probably due to the type and intensity of the exercises that require further investigation.

Effects of Community-based Exercise Prehabilitation for Patients Scheduled for Colorectal Surgery With High Risk for Postoperative Complications: Results of a Randomized Clinical Trial.

Objective:To assess the effects of a 3-week community-based exercise program on 30-day postoperative complications in high-risk patients scheduled for elective colorectal resection for (pre)malignancy.Summary Background Data:Patients with a low preoperative aerobic fitness undergoing colorectal surgery have an increased risk of postoperative complications. It remains, however, to be demonstrated whether prehabilitation in these patients reduces postoperative complications.Methods:This 2-center, prospective, single-blinded randomized clinical trial was carried out in 2 large teaching hospitals in the Netherlands. Patients (≥60 years) with colorectal (pre)malignancy scheduled for elective colorectal resection and with a score ≤7 metabolic equivalents on the veterans-specific activity questionnaire were randomly assigned to the prehabilitation group or the usual care group by using block-stratified randomization. An oxygen uptake at the ventilatory anaerobic threshold <11 mL/kg/min at the baseline cardiopulmonary exercise test was the final inclusion criterion. Inclusion was based on a power analysis. Patients in the prehabilitation group participated in a personalized 3-week (3 sessions per week, nine sessions in total) supervised exercise program given in community physical therapy practices before colorectal resection. Patients in the reference group received usual care. The primary outcome was the number of patients with one or more complications within 30 days of surgery, graded according to the Clavien-Dindo classification. Data were analyzed on an intention-to-treat basis.Results:Between February 2014 and December 2018, 57 patients [30 males and 27 females; mean age 73.6 years (standard deviation 6.1), range 61–88 years] were randomized to either prehabilitation (n = 28) or usual care (n = 29). The rate of postoperative complications was lower in the prehabilitation group (n = 12, 42.9%) than in the usual care group (n = 21, 72.4%, relative risk 0.59, 95% confidence interval 0.37–0.96, P = 0.024).Conclusions:Exercise prehabilitation reduced postoperative complications in high-risk patients scheduled to undergo elective colon resection for (pre)malignancy. Prehabilitation should be considered as usual care in high-risk patients scheduled for elective colon, and probably also rectal, surgery.

Effect of Auriculotherapy on Sleep Quality in Elderly With Chronic Low Back Pain: A Single-blind Randomized Clinical Trial

Objective: One of the common problems that leads to poor sleep quality in the elderly is low back pain. This study aims to evaluate the effect of auriculotherapy (ear acupressure) on the sleep quality of elderly people with chronic low back pain. Methods: This single-blind randomized clinical trial was conducted in 2019 on 70 older adults with chronic low back pain in Kashan, Iran, who were selected using a convenience sampling technique. After obtaining a written informed consent, they were assigned into intervention and sham groups using the block randomization method. In the intervention group, the pressure was applied to ShenMen, sympathetic, subcortex and low back points of the ear, while in the sham group, the pressure was applied to the points that were not associated with the low back pain. The Pittsburgh Sleep Quality Index (PSQI) and McGill Pain Questionnaire (MPQ) were completed at the beginning of the study, at the end of intervention, and one month after the end of intervention. Six patients from the Sham group and 2 patients from the intervention group were excluded from the study. The data of 62 elderly (in sham group 29 and in intervention group 33) according to Per-Protocol (PP) and data of all samples as Intention to Treat (ITT) were analyzed using covariance analysis and repeated measures ANOVA. Results: There was a statistically significant difference between the intervention and sham groups in terms of the duration of disease at baseline (P=0.012). The interaction effect of time and group on the sleep quality was significant (P&lt;0.0001). Sleep quality in the intervention group was significantly better than in the sham group at the end of the intervention and also during the one-month follow-up period (P&lt;0.0001). Within-group comparison results reported a significant difference in the sleep quality between three evaluation times in the intervention group (P&lt;0.0001). Conclusion: Auriculotherapy can improve sleep quality in the elderly with chronic low back pain. It is recommended to use auriculotherapy as a complementary therapy for treating these elderly groups.

Effects of whole-body vibration therapy among type II diabetes mellitus-A pilot single blind randomized clinical trial

Introduction: Diabetes mellitus is a disease characterized by elevated glucose level in the blood. This study focused to find out the effects of whole-body vibration therapy and resisted exercise among type II diabetes mellitus. Materials and Methods: Total 36 subjects both male and female were selected for this study with age group between (35–50 years). Subjects were divided into three groups. Group A received whole body vibration therapy and Group B received resisted exercise. Group C underwent conventional exercises. All three groups received an intervention for 12 weeks. Pre and post HbA1c and lipid profile were measured. Results: The study shows that there is a significant reduction in HbA1c level and lipid profile in whole body vibration therapy followed by resisted exercise group and conventional therapy group. Conclusion: This study concluded that whole body vibration therapy can recommend for controlling blood glucose level effectively among type II diabetes mellitus subjects.

The efficacy of magnesium sulphate as an adjunct to local anaesthetics for perineal pain relief after episiotomy.

Episiotomy is a deliberate surgical incision of the perineum with the aim of increasing the vulval outlet to facilitate childbirth. However, it could be associated with some complications, such as pain, hemorrhage, and wound infection. It is a surgical procedure that requires adherence to basic surgical principles of providing adequate analgesia. To determine the efficacy of magnesium sulphate (MgSO4) as an adjunct to local anesthetics for analgesia during episiotomy repair among women that had vaginal delivery at Usmanu Danfodiyo University Teaching Hospital Sokoto, Sokoto, Nigeria. This was a single-blind randomized clinical trial. Pregnant women who had episiotomy during the study period were randomized into two groups. Those in Group A had xylocaine administered alone, whereas those in Group B had xylocaine + MgSO4 administered for repair of episiotomy. Pain was assessed by numeric rating scale at commencement of the repair, at 2 and 6 h after the repair. Patient's level of satisfaction, request for additional analgesia, and side effects were also assessed. The pain score in the xylocaine + MgSO4 group was lower throughout the period of assessment. There was no significant difference in the pain scores between the two groups at 0 and 6 h. However, there was significant difference in the mean pain scores between the two groups at 2 h (P < 0.001). There was no significant difference in the level of satisfaction, request for additional analgesia, and side effects between the two groups. Both xylocaine alone and xylocaine with MgSO4 provide adequate perineal pain relief during episiotomy repair. MgSO4 improves the analgesic effect of xylocaine at 2 h after episiotomy repair without any significant side effect.

Correlation of pain score with ulcer size in oral aphthous ulcers using 2% curcumin gel and 0.1% triamcinolone oral paste - A parallel comparison study

Background: Recurrent aphthous stomatitis (RAS) is a common inflammatory condition affecting the oral mucosa causing interference with mastication and speech with significant impact on quality of life. The use of topical steroids remains the mainstay as the primary therapeutic approach and they are often considered to be the first choice of treatment. Turmeric has been used in the Indian traditional medicine for centuries. Its anti-inflammatory and wound healing activities are demonstrated by the rapid healing of the ulcers. Aim: The primary aim of this study was to assess and correlate pain score with ulcer size using topical curcumin 2% gel and triamcinolone acetonide oral paste 0.12% in recurrent minor oral aphthous ulcerations. Methodology: Following convenient sampling, 60 volunteered students with oral aphthous ulcers were included to take part in this single-blinded randomised study. Randomization was done by flip coin method. Group I received Topical Curcumin oral gel 2% and Group II received Topical Triamcinolone acetonide 0.1%. Statistical Analysis: Qualitative data was expressed in percentage and quantitative in mean (SD). Independent sample t test and correlation was done. Results: The ulcer size was smaller initially and gradually increased in the next few days and the size decreased upon ulcer healing. Initially, the pain score was higher and gradually decreased as the ulcer healed. Positive correlation of ulcer size and pain score was obtained in Group I on the 1st day, 4th day and 5th day with statistical significance of P

Clinical efficacy of Narayan Churna in alcohol addiction: a single-blinded randomized clinical trial

Background: Alcohol, alcoholism, and alcohol withdrawal have been mentioned in Ayurveda under the heading of Madya (alcohol), Madatya (alcoholism), and Panapkaram (alcohol withdrawal), respectively. Alcohol abuse is widespread in most parts of the world, and alcohol addiction is one of the major problems in society. According to the WHO, 38.3% of the population in the world consumes alcohol. An individual older than 15 years of age consumed 6.2 liters of alcohol annually. In fact, there are dozens of risk factors that play a role in the development of alcohol addiction. Aim: To assess the clinical efficacy of Narayan Churna, Tagaradi Kwath Ghan Vati, and Bhumyamalaki Ghan Vati in alcohol addiction and withdrawal symptoms. Materials and Methods: The clinical studies were conducted by the single-blinded random control method; this method compared the clinical efficacy of Narayan Churna with Ashtang Lavan Churna. Supportive drugs such as Tagaradi Kwath Ghan vati and Bhumyamalaki Ghanvati have been given in both groups to manage the hepatotoxicity and they control the withdrawal effects such as insomnia anxiety and agitation, respectively. The clinical manifestations of alcohol withdrawal were assessed by the Clinical Institute Withdrawal Assessment-Alcohol revised (CIWA-Ar) scale before and after treatment. Clinical manifestation of alcohol withdrawals observed in between 5 and 10h of stoppage of alcohol was considered as a baseline for before treatment; clinical manifestation of withdrawals was considered after the completion of one month for after treatment. Result: In both the study and control groups, 13.3% of the patients showed excellent relief. In both the control and study groups, 26.6 % and 13.3% of patients showed moderate relief, respectively. Conclusion: Overall, 36.66% of patients were found to be de-addicted during the entire clinical trial, which is a big achievement for Ayurveda science.

Protocol for a randomized clinical trial: telephone-based psychoeducation and support for female informal caregivers of patients with dementia

OBJECTIVE: The burden felt by informal caregivers of patients with dementia is a source of physical, emotional, and financial problems. Face-to-face interventions for caregivers have accessibility limitations that may prevent them from receiving adequate care. Telehealth tools can be a solution to this problem. We will compare a telephone psychoeducational and support intervention protocol to usual care for informal female caregivers of patients with dementia treated at specialized outpatient clinics. METHODS: In this single-blind randomized clinical trial, the intervention group will receive one weekly call for 8 weeks that addresses issues such as disease education, communication with the patient, and problematic behaviors. The control group will receive printed material on problematic behaviors in dementia. The primary outcome will be the difference in caregiver burden between baseline and 8 weeks, which will be assessed by blinded investigators through the Zarit Burden Interview scale. Caregiver burden at 16 weeks after baseline, depression, anxiety, and quality of life at 8 and 16 weeks are secondary outcomes. CONCLUSIONS: We expect the intervention to reduce caregiver burden. These results could lead to public health programs for improving dementia care in lower-middle-income countries. Ethics and dissemination: This trial was approved by an independent ethics committee. The results will be published in an international peer-reviewed medical journal. Trial registration number: NCT03260608.

The effect of aromatherapy with lavender essential oil on sleep quality in patients with major depression

Context: Depression is one of the most common psychiatric disorders, and poor sleep quality is a risk factor for it. Aims: This study aimed at determining the effect of aromatherapy with lavender essential oil on sleep quality of patients with major depression. Settings and Design: This single-blinded randomized clinical trial in Psychiatric Clinic in Yahya Nejad Hospital, Babol, Iran, during 2019. Materials and Methods: Eighty major depressive patients with sleep disorder were recruited from those referred to Psychiatric Clinic in Babol City, Iran. They were assigned into intervention and control groups (forty participants in each group). The intervention group inhaled lavender essential oil and the control group received almond oil as placebo. Sleep quality of the participants was measured before and after the intervention. Statistical Analysis Used: Data analysis was performed employing statistical tests including Chi-square, Kolmogorov–Smirnov, ANCOVA, independent t-test, and paired t-test. Results: The intervention and control groups were homogeneous in terms of demographic characteristics and the mean score of sleep quality before the intervention (P > 0.05). The patients in the intervention group had a better quality of sleep comparing to that in the control group, and the difference was statistically meaningful (P = 0.001). Conclusion: Aromatherapy with lavender essential oil has positive effects on sleep quality in depressed patients. It can be used as a noninvasive complementary method to improve sleep quality in patients with major depression.

Effect of Virtual Reality on Relieving Pain and Anxiety of Circumcision in Children

Background: Circumcision is a common surgery and causes severe pain and anxiety in children. Today, virtual reality is used as an easy and cost-effective non-pharmacological method to manage pain and anxiety with no side effects. Aim: This study aimed to investigate the effect of virtual reality on the reduction of pain and anxiety in children who underwent circumcision. Method: This single-blind randomized clinical trial was performed on 40 children in 2019. The research instruments included the demographic survey, the Observational Scale of Behavioral Distress, and the Oucher pain scale which were completed in both groups 30 min before and after the circumcision (immediately after dressing the surgical wound). Anxiety immediately before circumcision. The children�s pain was assessed during anesthesia in both groups. A two-step intervention was performed on the experimental group. A preoperative virtual reality training video and a virtual reality animation were presented to distract the patients during the circumcision. All these steps except virtual reality were performed in the control group. Data were analyzed using SPSS software (version 16). Results: Virtual reality as a distraction technique significantly reduced anxiety and pain at the onset of circumcision (p <0.001) and during anesthesia (p <0.001) as well as pain (P=0.005) and anxiety (p <0.001) at the end of the circumcision in the intervention group compared to the control group. Implications for Practice: Clinical use of virtual reality can be used for the reduction of pain and anxiety in children during the circumcision process.

Dexamethasone 5 mg versus dexmedetomidine 20 μg as adjuvants to 0.5% levobupivacaine and 2% lidocaine for peribulbar block anesthesia

Background: The addition of adjuvants to local anesthetics in the peribulbar block might be a method to elevate block quality. This study aimed to determine the effectiveness of peribulbar local anesthesia adjuvants using dexmedetomidine 20 mcg and dexamethasone 5 mg. Patients and Methods: This study was a single-blind randomized clinical trial. Patients were divided into three groups who received peribulbar group: Group C (4 ml of levobupivacaine 0.5% and 4 ml of 2% lidocaine added with 1 ml of normal saline), Group D (4 ml of levobupivacaine 0.5% and 4 ml of 2% lidocaine added with 1 ml of dexamethasone 5 mg), and Group M (received 4 ml of levobupivacaine 0.5% and 4 ml of 2% lidocaine added with 1 ml of dexmedetomidine 20 mcg). Sensory and motor block onsets and durations were assessed. Results: There were 42 patients included. The sensory block onset was 70.7 s in Group M and the slowest in Group C (152.1 s). The longest sensory block duration was found in Group D (259.3 min) and the shortest in Group C (143.2 min). Conclusion: Dexamethasone 5 mg adjuvant affected sensory block onset, sensory, and motor block duration but did not affect motor block onset, while dexmedetomidine 20 mcg adjuvant affected sensory and motor block onsets as well as sensory and motor block durations.

Comparison of Insulin Glargine and Detemir Effects on Hormones of Appetite and Metabolic Control in Patients with Type 1 Diabetes: A Randomized Clinical Trial.

The aim of this study was to compare the insulin glargine and detemir effects on hormons affecting appetite and metabolic control of patients with type 1 diabetes. This single-blind randomized clinical trial was conducted on patients aged 2 to 18 years with type 1 diabetes who were referred to the endocrinology department of Ali-Asghar Children Hospital in Tehran, from April to September 2019. Patients were randomly allocated to receive insulin Glargine or insulin Detemir. Before starting treatment, blood samples were obtained for routine biochemical tests and factors affecting appetite, including Leptin, Ghrelin, Aguti-Related Peptide (AGRP), and Peptide-YY3-36 (PYY 3-36). Patients were evaluated monthly and insulin dose was adjusted based on target glucose and carbohydrate counting. At the end of three months, the anthropometric values , HbA1C and factors that influence appetite were measured again in both groups, and the results were compared. A total of 40 children with a new onset of type 1 diabetes under 18 years who were hospitalized in Ali Asghar Children Hospital were randomly assigned into two groups as Glargine (n = 20) and Detemir (n = 20). The mean age of patients in the Glargine group was 11.07 ±4.18 years and in the Detemir group was 8.06 ± 3.56. In Glargine group HbA1C, Cholesterol, LDL, AGRP significantly decreased and leptin increased after treatment., while the change of BMI Z-score was not significant. There was a significant decrease of HbA1C in the Detemir group after treatment but there was no significant change of other variables. There was no significant difference for all the variables between two groups after treatment. There was no significant difference for BMI, metabolic control and appetite hormones between Glargine and Detemir groups. BMI-z score did not change in Glargine group while leptin increased and AGRP decreased after treatment. HbA1C decreased significantly after treatment in both groups.