Single-blind Randomized Clinical Trial Research Articles

Simple mucopexy and hemorrhoidal arterial ligation with and without Doppler guide: a randomized clinical trial for short-term outcome.

Hemorrhoids are the most common benign anorectal diseases. Mucopexy strengthens the anal canal mucosa, which can be performed alone or in combination with Doppler-guided hemorrhoidal artery ligation (DG-HAL). In this study, we compared the postoperative complications between simple mucopexy plus HAL with and without a Doppler guide. This study was performed as a single-blinded randomized clinical trial. Patients referred to a tertiary colorectal referral clinic with grades 3 and 4 hemorrhoids who were candidates for surgical intervention entered the study. Thirty-six patients were randomly divided into 2 groups. Group A including 18 patients underwent mucopexy and DG-HAL and the other 18 patients (group B) underwent standard mucopexy and HAL without a Doppler guide. Postoperative pain score and the duration of oral analgesic consumption were recorded. Additionally, postoperative symptoms and complications were recorded and compared between the 2 methods. There was no significant difference between the 2 groups in terms of pain score and the duration of postoperative analgesic consumption as well as the incidence of postoperative complications. Besides, the primary grade of hemorrhoids was not significantly associated with recurrence, but there was a significant association between body mass index and Wexner score (WS) with recurrence. The mean WS of patients showed a significant decrease in both groups postoperatively. However, the rate of WS reduction was not remarkably different between the 2 groups. Simple mucopexy with blind HAL (without Doppler guide) might be considered for the treatment of grades 3 and 4 hemorrhoids effectively.

Effect of using an innovative tool for organizing surgical sutures on the self-efficacy of the scrub nurse during surgery

BackgroundApplying workplace organization methods can improve staff self-efficacy which leads to the desirable outcome and proper performance. The aim of this study was to investigate the effect of using an innovative tool for organizing surgical sutures on the self-efficacy of the surgical technologists during surgery in the operating room of Al-Zahra hospital in Isfahan. MethodsThis single-blind randomized clinical trial was conducted in 2020–2021 on 44 surgical technologists conveniently recruited from Al-Zahra hospital in Isfahan, Iran. Then, by random allocation, they were divided into two intervention (22 people) and control (22 people) groups. In order to organize the surgical sutures during the surgery, the control group used the routine method and the experimental group used the tool of organizing surgical sutures invented by the researcher. The data collection tool was a researcher-made self-efficacy questionnaire that was completed between July 2020 and January 2021. The data were analyzed through the independent t -test, Paired t-test, Chi-square test and Mann-Whitney test. ResultsParticipant's age was in the range of 23–50 years (mean 37.20±6.45), they were mostly female (75%). There was no significant difference in demographic characteristics between the two groups. The results showed that there was a statistically significant difference between the mean score of self-efficacy after the intervention in the experimental group (66.5 ± 3.36) and the control group (48.81± 8.49) (p <0.001). ConclusionThe use of surgical suture management tool during surgery can improve the self-efficacy of the surgical technologists. Hence, its use as an efficient tool is suggested.

The effectiveness of scaling and root planing with combined application of air polishing and Nd:YAG laser in periodontal pockets of stage III grade C periodontitis patients: a single-blinded randomized clinical trial.

Evaluating the efficiency of combined air polishing and Nd:YAG laser application in addition to scaling and root planning (SRP) in treatment of periodontal pockets of stage III grade C periodontitis patients was the aim of this clinical trial. Twenty-four systemically healthy, stage III grade C periodontitis patients were recruited for this clinical trial. In this split-mouth study, the quadrants were randomly allocated to either SRP with combined air polishing (erythritol/chlorhexidine powder) and Nd:YAG laser (2W, 200mJ/pulse, 10Hz) therapy (test group) or SRP alone (control group). A masked examiner recorded clinical parameters such as plaque index (PI), gingival index (GI), bleeding on probing (%) (BOP %), probing depth (PD), and clinical attachment level (CAL) on periodontal charts at baseline, 1month and 3months after treatment. The clinical parameters had significantly reduced 1 and 3months after treatment compared to baseline for both study groups (p < 0.05). Considering PI, GI, and BOP (%) parameters, there were no significant differences between the study groups at any time points (p > 0.05). While PD and CAL reductions were similar in study groups for moderately deep pockets (5 to 6mm) (p > 0.05), PD and CAL reductions were significantly greater in test group compared to control group for deep pockets (PD ≥ 7mm) (p < 0.05). The present clinical trial demonstrated that SRP with combined application of air polishing and Nd:YAG laser may be advantageous in sites where mechanical debridement alone cannot access, such as deep pockets in the short term. Long-term, well-designed future studies including clinical, biochemical, and microbiological analyses are needed to determine the effectiveness of this procedure. SRP with combined application of air polishing and Nd:YAG laser provided more reductions in probing depth and clinical attachment level parameters in deep pockets compared to SRP alone.

Remote versus face-to-face home-based exercise programme in people with amyotrophic lateral sclerosis: protocol for a randomised clinical trial

IntroductionAmyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease with variable and complex clinical manifestations that requires a multidisciplinary approach. However, face-to-face treatment in this population may experience barriers, such...

Effectiveness of Vestibular Stimulation on Balance Using Swing Therapy in Children with Hypotonic Cerebral Palsy

Background: Hypotonic cerebral palsy is the non-progressive neurodevelopmental disorder of the immature brain that covers a board spectrum of syndromes which is related to motor and postural impairment, and balance problems during both gross and fine motor activities.Objective: To assess the effectiveness of vestibular stimulation on balance using swing therapy in children with hypotonic cerebral palsy. Methods: A single-blinded randomized clinical trial was conducted on sample of 52 patients with level-II motor functions on gross motor function classification system (GMFCS). All other types of cerebral palsy like Spastic, Athetoid and Ataxic were excluded from the study. Simple random sampling technique was used, data was collected from subjects visiting to Pediatric Physical Therapy Department, and randomly allocated into two groups; comprising 26 patients in each via lottery method. The Group A was treated with vestibular stimulation for balance by swing therapy and conventional methods of rehabilitation including; walking on parallel bars, proper positioning and stretching exercises and while in group B only conventional techniques was used. Swing therapy was given for total 8 weeks on alternate days for 15 minutes and post intervention effect was recorded on pediatric balance scale. Results: The mean age of patients was 5.83±1.92 years. For Group A and B, pre-treatment mean on pediatric balance scale was 3.07±1.24 and 3.03±1.31 and post-treatment mean was 1.51±1.72 and 2.69±1.61. The measured value of “t” score was (-3.76) and “P” value was (0.001) showing significant change, as this was less than the reference value 0.05. Conclusion: The current study concluded that swing therapy when integrated with other conventional methods of rehabilitation proved to be effective in improving balance in children with hypotonic cerebral palsy.

Effect of customised preformed foot orthoses on gait parameters in children with juvenile idiopathic arthritis: A multicentre randomised clinical trial

BackgroundChildren with juvenile idiopathic arthritis (JIA) can experience significant physical impairment of the lower extremity. Prolonged joint disease and symptoms may cause gait alterations such as reduced walking speed and increased plantar pressures in diseased areas of their feet. There is limited robust clinical trials investigating the effect of non-invasive mechanical therapies such as foot orthoses (FOs) on improving gait parameters in children with JIA. Research questionAre customised preformed FOs effective in improving gait parameters in children with JIA? MethodsA multicentre, parallel design, single-blinded randomised clinical trial was used to assess the gait impacts of customised preformed FOs on children with JIA. Children with a diagnosis of JIA, exhibiting lower limb symptoms and aged 5–18 were eligible. The trial group received a low-density full length, Slimflex Simple device which was customised chair side and the control group received a sham device. Peak pressure and pressure time integrals were used as the main gait outcomes and were measured using portable Tekscan gait analysis technology at baseline, 3 and 6 months. Differences at each follow-up were assessed using the Wilcoxon rank sum test. Results66 participants were recruited. Customised preformed FOs were effective in altering plantar pressures in children with JIA versus a control device. Reductions of peak pressures and pressure time integrals in the heel, forefoot and 5th metatarsophalangeal joint were statistically significant in favour of the trial group. This was associated with statistically significant increased midfoot contact with the trial device at baseline, 3 and 6-month data collections. The trial intervention was safe and well accepted by participants, which is reflected in the high retention rate (92%). SignificanceClinicians may prescribe customised preformed FOs in children with JIA to deflect pressure from painful joints and redistribute from high pressure areas such as the rearfoot and forefoot.

A randomised controlled clinical trial to assess the benefits of a telecare tool delivered prior to the initial hearing assessment

Objective To assess the benefits of the Ida Institute’s Why improve my hearing? Telecare Tool used before the initial hearing assessment appointment. Design A prospective, single-blind randomised clinical trial with two arms: (i) Why improve my hearing? Telecare Tool intervention, and (ii) standard care control. Study sample Adults with hearing loss were recruited from two Audiology Services within the United Kingdom’s publicly-funded National Health Service. Of 461 individuals assessed for eligibility, 57 were eligible to participate. Results Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids (primary outcome) scores did not differ between groups from baseline to post-assessment (Mean change [Δ]= −2.28; 95% confidence interval [CI]= −6.70, 2.15, p= .307) and 10-weeks follow-up (Mean Δ= −2.69; 95% CI= −9.52, 4.15, p = .434). However, Short Form Patient Activation Measure scores significantly improved in the intervention group compared to the control group from baseline to post-assessment (Mean Δ= −6.06, 95% CI= −11.31, −0.82, p = .024, ES= .61) and 10-weeks follow-up (Mean Δ= −9.87, 95% CI= −15.34, −4.40, p = .001, ES= −.97). Conclusions This study demonstrates that while a patient-centred telecare intervention completed before management decisions may not improve an individual’s self-efficacy to manage their hearing loss, it can lead to improvements in readiness.

Efficacy of using walnuts as statin adjuvants in hypertension management

ABSTRACT Background Due to the widespread unorthodox use of nuts to improve cardiovascular health, this clinical trial was carried out to evaluate the efficacy of walnut as an adjuvant statin in hypertensive subjects. Method A single-blind placebo-controlled randomized clinical trial that lasted for 3 months. Forty-five screened hypertensive subjects on treatment, aged 45–65 years, were randomized into intervention and placebo groups according to their blood pressure defined by the American Heart Association criteria. Fifteen (15) normotensive subjects were also recruited for this study. The participants in the intervention group included daily 7 g of boiled walnut taken as snacks. The study was not controlled for type of diet and frequency of meals in a day. Low-density lipoprotein cholesterol (LDLc) was the primary endpoint for this study. Results The mean LDLc levels of the intervention groups (84.6 mg/dl and 79.7 mg/dl, respectively) were significantly (p < .005) lower than the placebo (137.6 mg/dl). The high-density lipoprotein cholesterol (HDLc) levels of the intervention groups were significantly higher than the placebo. The mean total cholesterol levels of the intervention groups were significantly lower than the placebo group. The intervention groups recorded a significantly lower systolic and diastolic blood pressure compared to the placebo. The supplementation of walnut significantly decreased the apolipoprotein E (APOE), proprotein convertase subtilisin kexin 9 (PCSK9), and cholesteryl ester transfer protein (CETP) activities relative to the placebo. Conclusion The use of walnut as a statin adjuvant during hypertension treatment reduced LDLc levels within 42.1% and improved HDL levels by 33.6%, and the LDLc decrease related to reduced PCSK9 and APOE activities while the HDLc increase related to reduced CETP activities.

Comparison of two different anesthesia methods on the quality of surgical condition in transvaginal natural-orifice transluminal endoscopic surgery (vNOTES): A prospective single-blind randomized clinical trial

BackgroundThe purpose of the current study is to compare the quality of surgical condition of combined epidural-general anesthesia (EGA) versus general anesthesia (GA) in patients undergoing transvaginal natural orifice transluminal endoscopic surgery (vNOTES). MethodsPatients undergoing vNOTES were randomly allocated to receive GA or EGA. The primary outcome was evaluate the quality of surgical condition. We further assessed patients’ medical data regarding the need and consumption of intraoperative analgesics and vasoactive drugs. The visual analogue scale (VAS) and postoperative nausea and vomiting (PONV) scores were assessed at 2 h and 24 h postoperatively. We have registered the number of patients who needed rescue analgesics and antiemetics within 24 h after surgery. ResultsThe scores of the quality of surgical condition was 1.9 ± 0.8 in the GA group and 1.4 ± 0.7 (P = 0.001) in the EGA group. The PONV scores were not significantly different in the first two 2 h following surgery between the groups. The obviously differences in the PONV scores between the EGA group and GA group were detected at the 24th postoperatively. Moreover, there were no significant differences in the consumption of atropine, sufentanil, cisatracurium, propofol, sevoflurane and neostigmine between the two groups. Regarding the duration of extubated time, operative time, duration of anesthesia time and postoperative length of hospital stay (PLOS), our findings did not showcase significant differences between the two groups. Similarly, we did not detect significant changes in the postoperative pain at the two time points between the groups. ConclusionOur results showed that compared with GA, EGA improved the quality of surgical condition in patients undergoing vNOTES. As epidural block is an additional invasive procedure with its attendant risks, we should weigh the pros and cons when combined epidural-general anesthesia is used for vNOTES in the future. Trial registrationThis study was registered at Chinese Clinical Trial Registry chictr.org.cn (http://www.chictr.org.cn/) with No. 2000032406 on April 27, 2020.

Lumbopelvic stabilization versus Pilates exercises on spatiotemporal gait parameters in chronic nonspecific low back pain

Aim of the work: The purpose of the current study is to trace and investigate how lumbopelvic stabilization and Pilates exercises affect the spatiotemporal aspects of gait in persistent nonspecific low back pain cases (NS-CLBP). Methods: Patients with NS-CLBP (N=90) were randomly assigned to one of three groups: group A (stabilization + traditional therapy), group B (Pilates plus traditional therapy), and group C (conventional therapy) in a single-blinded randomized clinical trial with 12 treatments over six weeks. A Walkway pressure measurement system was used to determine both spatial and temporal parameters. The Visual Analog Scale, Modified Oswestry Disability Questionnaire, Biering–Sorensen test, and trunk flexion endurance test were adopted successfully to assess pain, function, and isometric endurance of trunk extensor and flexor. Results: According to a cross-group analysis, a statistically significant effect was found when p = 0.001 and f-value = 3.12. Also, a statistically clear interaction was figured out between treatment and time when p = 0.0001 and f-value = 3.44. Following therapy, the Pilates group showed a decrease in temporal parameters, pain, and functional impairment, as well as an increase in cadence and velocity (p 0.05).

Effectiveness of Individual Feedback and Coaching on Shared Decision-making Consultations in Oncology Care: Protocol for a Randomized Clinical Trial.

BackgroundShared decision-making (SDM) is particularly important in oncology as many treatments involve serious side effects, and treatment decisions involve a trade-off between benefits and risks. However, the implementation of SDM in oncology care is challenging, and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM but is considered time consuming.ObjectiveThis study aims to address the effectiveness of an individual SDM training program using the concept of deliberate practice.MethodsThis multicenter, single-blinded randomized clinical trial will be performed at 12 Dutch hospitals. Clinicians involved in decisions with oncology patients will be invited to participate in the study and allocated to the control or intervention group. All clinicians will record 3 decision-making processes with 3 different oncology patients. Clinicians in the intervention group will receive the following SDM intervention: completing e-learning, reflecting on feedback reports, performing a self-assessment and defining 1 to 3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group will not receive the SDM intervention until the end of the study. The primary outcome will be the extent to which clinicians involve their patients in the decision-making process, as scored using the Observing Patient Involvement–5 instrument. As secondary outcomes, patients will rate their perceived involvement in decision-making, and the duration of the consultations will be registered. All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand.ResultsThis trial was retrospectively registered on August 03, 2021. Approval for the study was obtained from the ethical review board (medical research ethics committee Delft and Leiden, the Netherlands [N20.170]). Recruitment and data collection procedures are ongoing and are expected to be completed by July 2022; we plan to complete data analyses by December 2022. As of February 2022, a total of 12 hospitals have been recruited to participate in the study, and 30 clinicians have started the SDM training program.ConclusionsThis theory-based and blended approach will increase our knowledge of effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target the knowledge, attitude, and skills of clinicians. The patients will also be involved in the design and implementation of the study.Trial RegistrationNetherlands Trial Registry NL9647; https://www.trialregister.nl/trial/9647International Registered Report Identifier (IRRID)DERR1-10.2196/35543

Combination of doxycycline, streptomycin and hydroxychloroquine for short-course treatment of brucellosis: a single-blind randomized clinical trial

PurposePrevious studies have shown the effect of hydroxychloroquine in the treatment and prevention of recurrence of brucellosis. The aim of this study was to compare the effect of 4 and 6 week regimen containing hydroxychloroquine in the treatment of brucellosis.MethodsIn a single-blind randomized clinical trial, 92 patients with acute brucellosis were randomly divided in two treatment groups who received a triple drug regimen including doxycycline, streptomycin, and hydroxychloroquine (DSH] for 4 and 6 weeks. All patients were followed up for up to 6 months. Response to treatment, relapse rate, complications, and results of serological tests were compared in both groups. Data were analyzed by SPSS software version 16.ResultsOf the 92 patients studied, 46 received a 4 week course and 46 received a 6 week course of therapy. There were no significant differences between the two groups in terms of age and sex distribution. The response rate, treatment failure, and relapse in the 4 week treatment group were 82.6%, 17.3%, and 7.89%, respectively, and in the 6 week treatment group were 91.3%, 8.7%, and 9.52%. The frequency of negative 2ME test at 24 weeks after treatment was 11.1% in the 4 week group and 8.7% in the 6 week group. No significant differences were found between the two groups in terms of response to treatment, treatment failure, relapse, and negative 2ME test.ConclusionThe 4 week and 6 week courses of the combination of DSH are equally effective in treating brucellosis. We recommend further studies to support the use of the short-course 4 week regimen for the treatment of uncomplicated brucellosis.

Effect of Vitamin E on Renal Scarring in Children With Acute Pyelonephritis: A Randomized Controlled Clinical Trial

Background: Urinary tract infection (UTI) is among the most common infections in children and acute pyelonephritis (APN) is the most important type of UTI. Late diagnosis and treatment of APN can result in severe complications. This study aimed to evaluate the effect of vitamin E on renal scars in children aged three months to 14 years. Methods: This single-blinded randomized clinical trial (RCT) included all children aged three months to 14 years admitted to tBandar Abbas Children’s Hospital, Bandar Abbas, Iran due to APN in 2017-2018. Patients with renal scars were alternately randomized into two groups. The control group included 41 patients who received 50-75 mg/kg/d intravenous ceftriaxone during hospital stay and the intervention group included 37 cases who received 20 U/kg/d vitamin E tablets in addition to the previous treatment for a total duration of 4 months. Dimercaptosuccinic acid (DMSA) scan was performed at baseline and at the end of 4 months. Results: Out of a total of 78 patients, 34 (43.6%) were boys. Participants of both groups were comparable regarding age and gender. The median of decrease in photopenic areas was insignificantly higher in girls in the vitamin E group compared to girls in the control group (1.26 vs. 1.17, P=0.459). Regardless of gender, decrease in photopenic areas was insignificantly higher in patients aged 1-3 years in the vitamin E group compared to those in the control group (1.40 vs. 1.22, P=0.451). Conclusion: Treatment with vitamin E for at least 4 months may reduce renal scarring in children aged 1-3 years and girls with APN.

The Effectiveness of GRADIOR: A Neuropsychological Rehabilitation Program for People with Mild Cognitive Impairment and Mild Dementia. Results of a Randomized Controlled Trial After 4 and 12 Months of Treatment.

Background: Computer-based cognitive training programs have been developed with promising results on the maintenance/improvement of cognitive performance in people with dementia.Objective: The objective was to evaluate the effectiveness of the cognitive rehabilitation program “GRADIOR” in people with mild cognitive impairment and mild dementia.Method: This study was a single-blind multicenter randomized clinical trial. Participants were recruited from hospitals/day centers. The experimental group (EG) and control group (CG) received computer-based cognitive training (CCT) and routine daily care, respectively. Outcome measures at T0: baseline, T1: at 4 months, T2: at 12 months were compared within and between-groups.Results: Significant differences or important effect sizes were detected at the intragroup and intergroup level for most variables, observing a trend of improvement and/or maintenance at 4 months by Visual Reasoning of Cambridge Cognitive Examination (CAMCOG), Digit and Arithmetic of WAIS-III, Semantic Verbal Fluency, Mini-Mental State Exam (MMSE), Trail Making Test (TMT)-A-Mistakes and at 12 months by Visual Reasoning of CAMCOG, Digit Symbol of WAIS-III, TMT-B-mistakes, Visual Memory of Rivermead Behavioural Memory Test, Lexical Verbal Fluency-P, Yesavage’s Geriatric Depression Scale (GDS), TMT-A-time scales whose objective was to evaluate some executive functions and/or the memory. The CG presented a worsening trend for most of the measures towards 12 months. There was also a significant interaction between “time and group” for MMSE (F = 8.971; p = 0.03; η2 = 0.019) and the GDS (F = 3.414; p = 0.04; η2 = 0.041), as well as small effect sizes for TMT-A-time (F = 1.641; p = 0.21; η2 = 0.021) and TMT-A-mistakes (F = 0.908; p = 0.41; η2 = 0.019).Conclusion: CCT with GRADIOR has been proved to benefit cognitive functions (ISRCTN:15742788).

Effect of Medical Marijuana Card Ownership on Pain, Insomnia, and Affective Disorder Symptoms in Adults

Despite the legalization and widespread use of cannabis products for a variety of medical concerns in the US, there is not yet a strong clinical literature to support such use. The risks and benefits of obtaining a medical marijuana card for common clinical outcomes are largely unknown. To evaluate the effect of obtaining a medical marijuana card on target clinical and cannabis use disorder (CUD) symptoms in adults with a chief concern of chronic pain, insomnia, or anxiety or depressive symptoms. This pragmatic, single-site, single-blind randomized clinical trial was conducted in the Greater Boston area from July 1, 2017, to July 31, 2020. Participants were adults aged 18 to 65 years with a chief concern of pain, insomnia, or anxiety or depressive symptoms. Participants were randomized 2:1 to either the immediate card acquisition group (n = 105) or the delayed card acquisition group (n = 81). Randomization was stratified by chief concern, age, and sex. The statistical analysis followed an evaluable population approach. The immediate card acquisition group was allowed to obtain a medical marijuana card immediately after randomization. The delayed card acquisition group was asked to wait 12 weeks before obtaining a medical marijuana card. All participants could choose cannabis products from a dispensary, the dose, and the frequency of use. Participants could continue their usual medical or psychiatric care. Primary outcomes were changes in CUD symptoms, anxiety and depressive symptoms, pain severity, and insomnia symptoms during the trial. A logistic regression model was used to estimate the odds ratio (OR) for CUD diagnosis, and linear models were used for continuous outcomes to estimate the mean difference (MD) in symptom scores. A total of 186 participants (mean [SD] age 37.2 [14.4] years; 122 women [65.6%]) were randomized and included in the analyses. Compared with the delayed card acquisition group, the immediate card acquisition group had more CUD symptoms (MD, 0.28; 95% CI, 0.15-0.40; P < .001); fewer self-rated insomnia symptoms (MD, -2.90; 95% CI, -4.31 to -1.51; P < .001); and reported no significant changes in pain severity or anxiety or depressive symptoms. Participants in the immediate card acquisition group also had a higher incidence of CUD during the intervention (17.1% [n = 18] in the immediate card acquisition group vs 8.6% [n = 7] in the delayed card acquisition group; adjusted odds ratio, 2.88; 95% CI, 1.17-7.07; P = .02), particularly those with a chief concern of anxiety or depressive symptoms. This randomized clinical trial found that immediate acquisition of a medical marijuana card led to a higher incidence and severity of CUD; resulted in no significant improvement in pain, anxiety, or depressive symptoms; and improved self-rating of insomnia symptoms. Further investigation of the benefits of medical marijuana card ownership for insomnia and the risk of CUD are needed, particularly for individuals with anxiety or depressive symptoms. ClinicalTrials.gov Identifier: NCT03224468.

The effect of participating in support groups on relocation stress syndrome in residents of a nursing home: A single-blind randomized clinical trial

Background &amp; Aim: Relocation stress syndrome is one of the consequences of moving someone to a nursing home; it causes unbearable feelings of loneliness, anxiety, and depression. However, it can be prevented by conducting proper and timely nursing interventions. The present study aimed to examine the effect of participation in support groups on relocation stress syndrome in residents of nursing homes.&#x0D; Methods &amp; Materials: In this single-blind randomized clinical trial, 32 elderly residents of Kahrizak nursing home were randomly assigned to control and intervention groups. The intervention included holding support groups. Demographic information questionnaires, the short form of Geriatric Depression Scale (15-GDS), Geriatric Anxiety Scale (GAS), and the short form of University of California, Los Angeles, UCLA loneliness scale (ULS-8) were used to collect data. The data were then analyzed using statistical tests in SPSS software version 16.&#x0D; Results: There was no statistically significant difference between the mean scores of loneliness, depression, and anxiety between the two groups in the pre-test (p&gt; 0.05). The results of the ANCOVA test to compare the mean scores of loneliness, depression, and anxiety in the post-test with controlling pre-test scores revealed that the intervention was effective on depression (p&lt;0.001) and anxiety (p= 0.003), but it had no effects on loneliness (p= 0.156).&#x0D; Conclusion: The development and implementation of support group programs for the elderly in a nursing home could improve the outcomes of relocation stress syndrome in terms of depression and anxiety. Nonetheless, it had no effects on the outcome of loneliness. Therefore, it is recommended to implement this intervention for the elderly in a nursing home if the cost-benefit analysis is positive.

Survival After Hyperthermic Intraperitoneal Chemotherapy and Primary or Interval Cytoreductive Surgery in Ovarian Cancer

Ovarian cancer has the highest mortality rate among gynecologic malignant tumors. Data are lacking on the survival benefit of hyperthermic intraperitoneal chemotherapy (HIPEC) in women with ovarian cancer who underwent primary or interval cytoreductive surgery. To assess the clinical benefit of HIPEC after primary or interval maximal cytoreductive surgery in women with stage III or IV primary advanced ovarian cancer. In this single-blind randomized clinical trial performed at 2 institutions in South Korea from March 2, 2010, to January 22, 2016, a total of 184 patients with stage III or IV ovarian cancer with residual tumor size less than 1 cm were randomized (1:1) to a HIPEC (41.5 °C, 75 mg/m2 of cisplatin, 90 minutes) or control group. The primary end point was progression-free survival. Overall survival and adverse events were key secondary end points. The date of the last follow-up was January 10, 2020, and the data were locked on February 17, 2020. Hyperthermic intraperitoneal chemotherapy after cytoreductive surgery. Progression-free and overall survival. Of the 184 Korean women who underwent randomization, 92 were randomized to the HIPEC group (median age, 52.0 years; IQR, 46.0-59.5 years) and 92 to the control group (median age, 53.5 years; IQR, 47.5-61.0 years). After a median follow-up of 69.4 months (IQR, 54.4-86.3 months), median progression-free survival was 18.8 months (IQR, 13.0-43.2 months) in the control group and 19.8 months (IQR, 13.7-55.4 months) in the HIPEC group (P = .43), and median overall survival was 61.3 months (IQR, 34.3 months to not reported) in the control group and 69.5 months (IQR, 45.6 months to not reported) in the HIPEC group (P = .52). In the subgroup of interval cytoreductive surgery after neoadjuvant chemotherapy, the median progression-free survival was 15.4 months (IQR, 10.6-21.1 months) in the control group and 17.4 months (IQR, 13.8-31.5 months) in the HIPEC group (hazard ratio for disease progression or death, 0.60; 95% CI, 0.37-0.99; P = .04), and the median overall survival was 48.2 months (IQR, 33.8-61.3 months) in the control group and 61.8 months (IQR, 46.7 months to not reported) in the HIPEC group (hazard ratio, 0.53; 95% CI, 0.29-0.96; P = .04). In the subgroup of primary cytoreductive surgery, median progression-free survival was 29.7 (IQR, 17.2-90.1 months) in the control group and 23.9 months (IQR, 12.3-71.5 months) in the HIPEC group, and the median overall survival was not reached in the control group and 71.3 months (IQR, 45.6 months to not reported) in the HIPEC group. The addition of HIPEC to cytoreductive surgery did not improve progression-free and overall survival in patients with advanced epithelial ovarian cancer. Although the results are from a subgroup analysis, the addition of HIPEC to interval cytoreductive surgery provided an improvement of progression-free and overall survival. ClinicalTrials.gov Identifier: NCT01091636.

Effects of an immersive psychosocial training program on depression and well-being: A randomized clinical trial

Psychiatry stands to benefit from brief non-pharmacological treatments that effectively reduce depressive symptoms. To address this need, we conducted a single-blind randomized clinical trial assessing how a 6-day immersive psychosocial training program, followed by 10-min daily psychosocial exercises for 30 days, improves depressive symptoms. Forty-five adults were block-randomized by depression score to two arms: (a) the immersive psychosocial training program and 10-min daily exercise group (36 days total; total n = 23; depressed at baseline n = 14); or (b) a gratitude journaling control group (36 days total; total n = 22; depressed at baseline n = 13). The self-report PHQ-9 was used to assess depression levels in both groups at three time points: baseline, study week one, and study week six. Depression severity improved over time, with a significantly greater reduction in the psychosocial training program group (−82.7%) vs. the control group (−23%), p = 0.02 for baseline vs. week six. The effect size for this reduction in depression symptoms was large for the intervention group (d = −1.3; 95% CI, −2.07, −0.45; p < 0.001) and small for the control group (d = −0.3; 95% CI, −0.68, 0.03; p = 0.22). Seventy-nine percent (11/14) of depressed participants in the intervention condition were in remission (PHQ-9 ≤ 4) by week one and 100% (14/14) were in remission at week six. Secondary measures of anxiety, stress, loneliness, and well-being also improved by 15–80% in the intervention group (vs. 0–34% in the control group), ps < 0.05. Overall, this brief, immersive psychosocial training program rapidly and substantially improved depression levels and several related secondary outcomes, suggesting that immersive interventions may be useful for reducing depressive symptoms and enhancing well-being.

Investigating the Effect of the 10° Reverse Trendelenburg Position on Spinal Block Characteristics and Hemodynamic Parameters in Lower Limb Surgeries.

Introduction: The primary goal of spinal anesthesia in lower limb surgeries is to achieve a successful sensory and motor block. Adequate level of spinal block for lower limb orthopedic surgery is T10. Due to multiple factors affecting the level of spinal anesthesia, it is not always easy to control the level of spinal anesthesia.We proposed that maintaining patients in a 10° reverse Trendelenburg position after spinal anesthesia can significantly control the height of the sensory block, resulting in stable hemodynamics.Materials and methods: This study is a single centric, prospective, single-blinded randomized clinical trial (CTRI/2018/08/015455) conducted in a tertiary care center in Sub-Himalayan region in India from July 2018 to June 2019. Total 60 patients fulfilling our inclusion and exclusion criteria were recruited in the study and were divided into two groups. In the supine group, patients were positioned in the supine position, and in the Trendelenburg group, patients were positioned in a 10° reverse Trendelenburg position after administering spinal anesthesia with 12.5 mg bupivacaine heavy. The two groups were compared in terms of sensory block, motor block, and analgesia duration. Heart rate, blood pressure, mean arterial pressure, and hypotension were also compared between the two groups.Results: Duration of sensory block, motor block, and analgesia were significantly higher in patients of the reverse Trendelenburg group (group T) compared to the supine group (group S). In group T, 26.6% had a sensory block level above T8, whereas in group S, 86.6% of patients had a sensory block level above T8. No hypotension was observed in the Trendelenburg group, which was present in 33% of patients in the supine group (group S).Conclusion: Ten-degree reverse Trendelenburg position immediately after giving spinal anesthesia significantly limits the level of sensory block and provides better hemodynamic stability, and can be more beneficial, especially in geriatric patients and other high-risk patients for lower limb surgeries.

Comparing the Influence of Conventional and Rotary Instrumentation Techniques on the Behavior of the Children: A Randomized Clinical Trial.

BackgroundPulpectomy has gained popularity in the pediatric dental practice for preserving the primary teeth in its position until exfoliation. There has been a paradigm shift from using manual instrumentation to rotary instrumentation for canal preparation in primary teeth. While studies show that there is a reduction in the instrumentation time with the use of rotary instruments which in turn influences the behavior of the child, its direct effect on the behavior of the children has not been evaluated.AimTo compare the behavior of the children during manual and rotary instrumentation for pulpectomy in the primary molars.Materials and methodsA single-blinded randomized clinical trial was conducted in 88 children in any one of the mandibular primary molars indicated for pulpectomy. The canal preparation was done using manual K files and rotary ProTaper (44 children in each group). The influence of these instrumentation techniques on the children was assessed with three different scales- Frankl Behavior Rating Scale; Venham Interval Rating Scale; Wong Baker FACES Pain Scale for evaluating the behavior, anxiety, and the pain experienced by the children, respectively during canal preparation.ResultsA total of 88 participants, comprising 50 females and 38 males, participated in the study. An equal distribution of the participants with respect to age (p = 0.064), gender (p = 0.389), and teeth (p = 0.877) was observed between the groups. More cooperative behavior (p < 0.001); lesser anxiety levels (p < 0.001); lower intensity of pain (p < 0.001) were recorded in the children instrumented using Rotary files.ConclusionThe present study concludes that it is preferable to use rotary instrumentation for primary canal preparation in pediatric practice as it has a more positive influence on the behavior of the children, which eventually determines the success of the treatment.Clinical significanceWith rise in the use of rotary files for pulpectomy in primary teeth, the present paper demonstrates the influence of rotary instrumentation technique for canal preparation during pulpectomy on the behavior of the children in a dental chair. This paper throws light for the pedodontists to effectively perform pulpectomy in children with ease without leaving a psychological impact on the children.How to cite this articleGovindaraju L, Subramanian EMG, Jeevanandan G. Comparing the Influence of Conventional and Rotary Instrumentation Techniques on the Behavior of the Children: A Randomized Clinical Trial. Int J Clin Pediatr Dent 2021;14(S-2):S179–S185.