Randomized Clinical Trial Study Research Articles

The effect of the simulated intrauterine sound on behavioral and physiological indices of pain during capillary blood sampling for screening preterm infants: a randomized clinical trial study

IntroductionDue to medical procedures, preterm infants are at high risk for side effects of pain. In this regard, heel lancing for capillary blood sampling is a common painful procedure. The present study was conducted to assess the effectiveness of a simulated intrauterine sound on behavioral and physiological indices of pain due to heel-prick blood sampling in preterm infants.MethodsA double‑blind randomized clinical trial (RCT) was conducted. The data were collected from September 23 to December 22, 2019. We measured the effect of a simulated intrauterine sound on changes in the behavioral and physiological parameters of pain (heart rate, SPO2) caused by heel lance that was measured 5 min before the intervention, during the sampling, and 5 min after the procedure. We measured behavioral pain by video recording the infants’ faces and then the scoring neonatal infant pain scale (NIPS). Heart rate and SPO2 were measured using a pulse oximeter device. The data were analyzed using analysis of variance (ANOVA) and independent t‑test in SPSS software version 20.0.ResultsEighty infants were randomized (40 in each group). Mean scores NIPS during and after intervention were in the intervention group (3.55 ± 0.84, 95% CI: 3.30–3.80(, and (1.15 ± 0.84, 95%: 0.95–1.35) and in the control group (5.57 ± 0.95, 95% CI:5.30–5.85) and (3.00 ± 0.98) respectively. There were significant differences in scores of NIPS between the two study groups during (p < 0.001) and five min after heel lancing (p < 0.001). Mean scores of heart rate in the three phases of before, during, and five min after the intervention were respectively in the intervention group (127.57 ± 4.45, 95% CI:126.27-128.99), (131.07 ± 6.54, 95% CI:129.20-133.22), (128.45 ± 5.15, 95% CI:127.02-130.07) and in the control group (128.67 ± 4.57, 95% CI:127.32-130.07), (136.07 ± 7.24, 95% CI:133.90-138.37), and (132.42 ± 6.47, 95% CI:130.37-134.49). There were significant differences in heart rate between the intervention and the control group during (p = 0.002) and five min after the heel lance (p = 0.003). Mean scores of SPO2 in the three phases of baseline, during, and five min after the intervention were respectively in the intervention group (96.72 ± 0.93, 95% CI:96.42-97.00), (91.47 ± 1.46, 95% CI:91.05–91.92), (94.17 ± 1.03, 95% CI:93.22-94.00) and in the control group (96.6 ± 0.84, 95% CI:96.35–96.85), (91.5 ± 1.24, 95% CI:91.12–91.87), and (93.60 ± 1.27, 95% CI:93.85–94.50).ConclusionThis study showed that the simulated intrauterine sound reduces the behavioral pain and heart rate in the intervention group during and after heel lance. These results suggest using the method during the painful heel lancing to reduce pain parameters in preterm infants.

Clinical Simulation in Palliative Care for Undergraduate Nursing Students: A Randomized Clinical Trial and Complementary Qualitative Study.

a lack of adequate training in palliative care leads to a greater emotional burden on nurses. to assess the effect of a simulation using standardized patients on self-efficacy in palliative care, ability to cope with death, and emotional intelligence among nursing students. a randomized clinical trial and qualitative study. A total of 264 nursing students in a palliative care module completed the Bugen, trait meta-mood, and self-efficacy in palliative care scales after active participation in the simulation (n = 51), watching the simulation (n = 113), and the control group (n = 100). An ANOVA with a multi-comparative analysis and McNemar's tests for paired samples were calculated. Active participants were interviewed, and a thematic analysis was conducted. there was an improvement after the assessment in all three groups assessed for coping with death (p < 0.01), emotional intelligence (p < 0.01), and self-efficacy (p < 0.01). In addition, the active group improved more than the observer group and the control group in coping with death, attention, and repair. The students in the interviews identified sadness and an emotional lack of control. the simulation improved nursing students' self-efficacy in palliative care. This effect was partially stronger in the active group.

Impact of circadian misalignment based on mediating role of chronotype on impulsivity, depression, anxiety, stress, addiction potential, and boredom: a randomized clinical trial and fMRI study

Impact of circadian misalignment based on mediating role of chronotype on impulsivity, depression, anxiety, stress, addiction potential, and boredom: a randomized clinical trial and fMRI study

Effect of a supportive-educational program, based on COPE model, on quality of life and caregiver burden of family caregivers of heart failure patients: a randomized clinical trial study

BackgroundHeart failure (HF) is one of the most common and spreading diseases worldwide. As HF symptoms progress, it is affected the quality of life and the caregiver burden of the family. The present study aimed to determine the effectiveness of the supportive-educational program, based on the COPE (creativity, optimism, planning and expert advice) care model, on the quality of life and caregiver burden of family caregivers of HF patients.MethodThis clinical trial was conducted on 90 caregivers of HF patients admitted to Isfahan in 2021. The samples were divided into experimental (n = 45 people) and control (n = 45 people) groups based on random allocation (card method). The experimental group received problem-solving skills based on the four components of the COPE model in six sessions during one month. to collect data, the 36-Item Short Form Survey (SF-36) and the Zarit Burden Interview (ZBI) were used in two groups before, after and three months after the intervention.ResultsThere was a significant difference between the experimental and control groups regarding gender, but This confounding factor had no significant effect on the two components of quality of life and caregiver burden. There was a significant difference between the two groups in terms of the mean score of quality of life immediately(75.99),and three months after the intervention (78.78) (P < 0.05) and the mean score of care burden, immediately (16.60) and three months after the intervention (12.73) (P < 0.05).ConclusionsOne of the important duties of nurses is to implement educational-supportive programs for patients after the discharge of patients, These programs are family-oriented remotely for their caregivers.Trial registrationThis study was registered by the Iranian Registry of Clinical Trials with decree code: IRCT20211128053202N1on 2022–02-20.

Cognitive-Motor Training Improves Reading-Related Executive Functions: A Randomized Clinical Trial Study in Dyslexia.

Children with developmental dyslexia (DD) often struggle with executive function difficulties which can continue into adulthood if not addressed. This double-blinded randomized clinical trial study evaluated the short-term effects of the Verbal Working Memory-Balance (VWM-B) program on reading-related executive functions, reading skills, and reading comprehension in Persian children with DD. The active control group [12 children with DD with a mean age of 9 years (SD = 0.90)] received training using the single-task VWM program, while the experiment group [15 children with DD with a mean age of 8 years (SD = 0.74)] received training with the dual-task VWM-B program. Both groups received fifteen training sessions, and assessments were conducted before and after the intervention. The groups were homogenized for possible confounders of age, gender, IQ level, and attention level. The study employed separate mixed ANOVA analyses to estimate the impact of training programs on various measured functions. Significant improvements were observed in the outcome measures of backward digit span, text comprehension, verbal fluency, Stroop color-word test and interference, and the reading subtests. Additionally, significant correlations were found between reading skills and backward digit span, text comprehension, verbal fluency, and Stroop variables. In conclusion, the dual-task VWM-B program was found to be more effective than the single-task VWM program in improving selective attention, cognitive inhibition, verbal working memory capacity, information processing speed, naming ability, and lexical access speed. These enhanced executive functions were associated with improved reading skills in children with DD.

The effect of using a sports application on the quality of sleep in patients with heart failure: a randomized clinical trial study

BackgroundPatients with heart failure often suffer from sleep disorders. Due to the side effects of medications used to treat this disorder, non-pharmacological methods may be used to improve these patients’ sleep quality. This study aimed to determine the effect of a sports application on sleep quality in patients with heart failure.MethodsIn this single-blinded randomized clinical trial, 60 patients aged 30–70 referred to Shafa Hospital in Kerman were randomly assigned to control (n = 30) and intervention (n = 30) groups based on convenience sampling. The intervention group used the sports application for eight consecutive weeks. Data was collected using a demographic questionnaire and the Pittsburgh Sleep Quality Index (PSQI). An independent t-test and a Mann-Whitney U test were used for comparisons between groups and paired t-tests and Wilcoxon tests were used for comparisons within groups.ResultsThe data analysis revealed a significant difference in sleep quality scores between the two groups after the intervention, meaning that the intervention group had better sleep quality than the control group (P < 0.05).ConclusionsAs a result of the study, it was found that the sport application improved the quality of sleep in patients with heart failure. Our recommendation is for healthcare providers to use this sports application to present educational content related to physical activity and improve the sleep quality of patients.Trial registrationIranian Registry of Clinical Trials: IRCT. 2019123045475N1.” Registered 16 December 2019.

The Effect of Three Forms of Local Corticosteroids on Sinonasal Polyposis.

Since sinonasal polyposis (SNP) has a high recurrence rate after surgery, various studies have investigated the effect of corticosteroid medications to prevent disease recurrence. The present study was designed to compare the effect of three forms of local corticosteroids on preventing SNP recurrence post-operatively. This double-blind, randomized clinical trial study was conducted on 108 patients with SNP who underwent functional endoscopic sinus surgery (FESS). Permuted Block Randomization randomly assigned patients into three groups of 36 people: budesonide spray, betamethasone drop, and budesonide nebulizing suspension groups. One and six months after surgery, the patients were evaluated for recurrence of SNP by nasal endoscopy. SNOT 22 questionnaire was used to assess patients' subjective improvement rate pre- and post-operatively. According to the scores obtained in the Modified Lund-Kennedy Scoring, budesonide nebulizing suspension showed better effects on preventing the recurrence of sino-nasal polyps after FESS compared with betamethasone nasal drops. The score was significantly lower in the budesonide nebulizing suspension group compared to the betamethasone drop group (P=0.043). There was no statistically significant difference in the scores between the budesonide nebulizing suspension group and the betamethasone spray group (P=0.178). Also, we observed significant improvement in facial fullness in patients who received Budesonide nebulizing suspension. Budesonide nebulizing suspension, compared to betamethasone nasal drops, showed better effects on preventing the recurrence of SNP after FESS.

Treinamento em cuidados infantis e técnicas de auriculoterapia a mães de recém-nascidos prematuros: ensaio clínico duplo-cego

Abstract Objectives: this study aimed to investigate the effect of education and auriculotherapy on stress, anxiety, and depression, and coping responses in mothers with premature infants. Methods: this is a randomized clinical trial study at Bahar Hospital carried out with 90 mothers with premature infants admitted to the neonatal intensive care unit. Those eligible for hospitalization were included in the study and distributed into three groups before intervention: (30 ones in the control, training, and auriculotherapy groups, respectively). The mean stress, anxiety, depression, and coping responses in mothers were measured both at the beginning of the study and before neonatal discharge. Results: there was no statistically significant difference in terms of anxiety, stress, and depression scores between the three groups before the intervention. However, after the intervention, there was a significant statistical difference between these three groups, which was among the mean scores of anxiety, stress, and depression. In terms of coping responses, the mean emotional and problem-oriented score in all three groups before and after the intervention is statistically significant. Conclusions: educating mothers and auriculotherapy pressure therapy are simple and practical methods in reducing anxiety, stress, depression, and increase coping responses; consequently, they can be used in neonatal intensive care.

Effect of Intranasal Remifentanil versus Lidocaine on Facilitation of Laryngeal Mask Airway Insertion and Cardiovascular Response: A Double-blind Clinical Trial Study.

This study aimed to assess and compare the effects of intranasal administration of lidocaine and remifentanil on the condition of LMA insertion and cardiovascular response. From March 2019 to March 2020, this double-blind randomized clinical trial study was conducted on 60 patients, who underwent general anesthesia with LMA insertion at Faiz Hospital, Isfahan, Iran. After induction of anesthesia and before placing the laryngeal mask, the first group received remifentanil 1 μg/Kg, the second group received lidocaine 2% 1 mg/Kg, and the third group received normal saline with the same volume intranasally. The conditions of LMA insertion and hemodynamic changes that occurred during its insertion were investigated. In terms of demographics characteristics (p>0.05), success in placing the LMA on the first try (p=0.73), number of attempts to insert LMA (p=0.61), performance of LMA (p=0.73), need for additional propofol (p=0.53), frequency of gagging (p=0.53), cough (p=0.15) p), and laryngospasm (p=0.99) did not differ significantly. In the remifentanil group, the cardiovascular response to LMA injection was less than that of the lidocaine group. Moreover, both groups were lower than the saline group, but no significant difference was observed. In facilitating LMA insertion, the effect of intranasal remifentanil was comparable to intranasal lidocaine. Intranasal remifentanil was somewhat more effective than intranasal lidocaine in weakening the cardiovascular response to LMA insertion, but it did not outperform lidocaine.

Comparing Effectiveness and Safety of Intravenous Atropine with Topical Tetracaine in Preventing and Relieving Oculocardiac Reflex in Patients Undergoing Strabismus Surgery: A Randomized Clinical Trial

Abstract Background: Oculocardiac reflex (OCR) is one of the serious complications following surgical therapeutic procedures for strabismus. Various medications have been tested to prevent or mitigate this complication. We aimed to compare the effect of intravenous atropine and topical tetracaine on the incidence and severity of OCR in strabismus surgery. Materials and Methods: In this triple-blind randomized clinical trial study, 120 patients who were candidates for strabismus surgery were randomly assigned to receive intravenous atropine, topical tetracaine, or artificial tears as the control. The incidence of OCR and its severity along with the changes in hemodynamic conditions were compared across the groups. Results: The incidence rate of OCR in the groups receiving atropine, tetracaine, and the control was found to be 17.5%, 25.0%, and 32.5% in the releasing phase without any difference, respectively (P = 0.303); however, it was 2.5%, 7.5%, and 25.0%, respectively, in the cutting phase, indicating a lower rate in the group receiving tetracaine (P = 0.004). Similarly, there was no difference in the severity of OCR across the three study groups in the releasing phase (P = 0.666); however, in the cutting phase, OCR was revealed to be milder in the group receiving atropine as compared to other groups (P = 0.033). Prescribing atropine led to higher mean systolic blood pressure and mean arterial pressure during surgery. Conclusion: The injection of atropine can effectively reduce the incidence of OCR during strabismus surgery and reduce its severity if this reflex occurs.

The Effect of Rivaroxaban in the Complementary Therapy of Sudden Sensorineural Hearing Loss

Abstract Background: Due to the importance of sudden sensorineural hearing loss (SSNHL) and the possible role of blood coagulation in its mechanism and the likely therapeutic effect of anticoagulants and also the lack of studies in this field, this study aimed to evaluate the effect of rivaroxaban (RXA) in the treatment of this disease. Materials and Methods: The present double-blind randomized clinical trial study was performed on 34 patients with SSNHL. Patients were randomly divided into two groups. In the first group, in addition to corticosteroid therapy (CST), RXA 10 mg tablets were used daily for 10 days (RXA group), and in the second group, only CST (CST group) treatment was prescribed. Hearing recovery was then assessed and recorded according to the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) criteria. Results: This study showed that the grade of hearing recovery in the RXA group (58.8%) was higher than the CST group (47.1%), but this difference was not significant (P value &gt;0.05). Also, RXA treatment increased the odds of hearing recovery, and this difference was not statistically significant (odd ratio (95% confidence interval)(OR (95% CI): 2.327 (0.180–18.082); P value = 0.518). In contrast, delay to treatment, more increased PTA (pure tone average (PTA)), and having vertigo reduced the odds of hearing recovery by 0.138-, 0.019-, and 0.069-fold, respectively (P value &lt;0.05). Conclusion: According to the results of this study, although the percentage of hearing recovery was higher in the RXA group, in general, the results of the two treatments were not significantly different.

Comparative Study Between Intramedullary Nail and Minimally Invasive Plate Osteosynthesis in Tibial Shaft Fracture

Background: Casting, open plate fixation, minimally invasive plate osteosynthesis, intramedullary nailing, and external fixation are some treatment options for tibial fractures. The aim of treatment is anatomical alignment with sufficient stability to permit early motion. The least invasive and most popular techniques are intramedullary nailing, external fixation, and minimally invasive plate osteosynthesis. Aim of Study: To compare the clinical and functional outcome between Intramedullary nailing and external fixation and minimally invasive plate osteosynthesis in treating tibial shaft fracture. Patients and Methods: A randomized clinical trial study was conducted at Al-Yarmouk Teaching Hospital and other private hospitals in Baghdad, Iraq, during a period of 17 months from September 2020 to January 2022, including a period of one year for follow-up. Patients were selected according to certain inclusion criteria and divided into two groups, each with 20 patients. IMN was treated by intramedullary nailing, and the MIPO group was treated by minimally invasive plate osteosynthesis. Patients were followed up radiologically and clinically using the JETTS Lower Extremity Trauma Scale score. Result: The difference was significant (P&lt; 0.05) regarding partial and full weight bearing, union time, and return to work. Ankle stiffness, implant irritation, and knee pain revealed significant differences. Conclusion: Intramedullary nailing and external fixation and minimally invasive plate osteosynthesis are effective methods for the treatment of extra-articular tibial shaft fracture. They provided rigid fixation, preventing major complications and good functional and anatomical outcomes.

Meta-Analysis of Data from Four Clinical Trials in the Ivory Coast Assessing the Efficacy of Two Artemisinin-Based Combination Therapies (Artesunate-Amodiaquine and Artemether-Lumefantrine) between 2009 and 2016.

The combinations of artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ) are used as first-line treatments for uncomplicated malaria in the Ivory Coast. Different studies document the efficacy of two artemisinin-based combination therapies (ACTs) (AL and ASAQ) in the Ivory Coast. However, there is no meta-analysis examining the data set of these studies. The purpose of this work was to determine the prevalence of malaria treatment failure cases in randomized control trials with two artemisinin-based combination therapies (AL versus ASAQ) in the Ivory Coast between 2009 to 2016. This study is a meta-analysis of data from the results of four previous multicenter, open-label, randomized clinical trial studies evaluating the clinical and parasitological efficacy of artemether-lumefantrine and artesunate-amodiaquine conducted between 2009 and 2016 following World Health Organization (WHO) protocol at sentinel sites in the Ivory Coast. These drug efficacy data collected between 2009 and 2016 were analyzed. During these studies, to distinguish between recrudescence and new infection, molecular genotyping of genes encoding merozoite surface protein 1 and 2 was carried out using nested polymerase chain reaction (PCR). A total of 1575 patients enrolled in the four studies, including 768 in the AL arm and 762 in the ASAQ arm, which were fully followed either for 28 days or 42 days according to WHO protocol. The adequate clinical and parasitological response (ACPR) was higher than 95% in the two groups (intention to treat (ITT): AL = 96.59% and ASAQ = 96.81; Per Protocol (PP): AL = 99.48% and ASAQ = 99.61%) after PCR correction at day 28. Aggregate data analysis (2009-2016) showed that at day 28, the proportions of patients with recurrent infection was higher in the AL group (ITT: 3.79%, PP: 3.9%) than in the ASAQ group (ITT: 2.17%, PP: 2.23%). After PCR correction, most treatment failures were classified as new infections (AL group (ITT: 0.13%, PP: 0.13%); ASAQ group (ITT: 0.39%, PP: 0.39%). The recrudescent infections rate was high, at 0.39% compared to 0.13% for ASAQ and AL, respectively, for both ITT and PP, no significant difference. However, the Kaplan-Meier curve of cumulative treatment success showed a significant difference between the two groups after PCR from 2012-2013 (p = 0.032). Overall, ASAQ and AL have been shown to be effective drugs for the treatment of uncomplicated P. falciparum malaria in the study areas, 14 years after deployment of these drugs.

A systematic review of the efficacy, safety and satisfaction of regenerative medicine treatments, including platelet-rich plasma, stromal vascular fraction and stem cell-conditioned medium for hypertrophic scars and keloids.

The primary objective of this study is to examine the efficiency of various regenerative medicine approaches, such as platelet-rich plasma, cell therapy, stromal vascular fraction, exosomes and stem cell-conditioned medium, in the process of healing hypertrophic and keloid scars. Major databases including PubMed, Scopus and Web of Science were systematically searched, and based on the content of the articles and the inclusion and exclusion criteria, eight articles were selected. Out of these eight articles, there were two non-randomized clinical trial studies (25%), one randomized, single-blinded comparative study (12.5%), one retrospective clinical observational study (12.5%) and four randomized clinical trial studies (50%). We employed EndNote X8 and Google Sheets to conduct article reviews and extract relevant data. Following the review phase, the studies underwent analysis and categorization. In all eight reviewed studies, the effectiveness of regenerative medicine in treating hypertrophic scars and keloids has been proven. Out of these studies, five (62.5%) focused on the effectiveness of platelet-rich plasma, two study (25%) examined the effectiveness of stromal vascular fraction and one study (12.5%) explored the efficacy of stem cell-conditioned medium. In two studies (25%), the treatment methods were added to standard treatment, while in six studies (75%), regenerative medicine was used as the sole treatment method and compared with standard treatment. The use of these treatment methods did not result in any serious side effects for the patients. Regenerative medicine is an effective method with minimal side effects for the treatment of hypertrophic scars and keloids. It can be used as a monotherapy or in combination with other treatment methods. However, further studies are needed to thoroughly evaluate the effectiveness of all sub-branches of this method.

Comparison of two methods of complementary medicine on postoperative pain and anxiety: A randomized clinical trial.

Postoperative pain and anxiety are unpleasant situations that are often experienced by women undergoing cesarean section. Since the routine methods of pain relief after surgery is still inadequate, the need for complementary treatments is felt. Foot Reflexology (FR) and Auricular Acupressure (AA) are two of the most popular and safe procedures of complementary and alternative medicine therapies. So, this study aimed to determine and compare the effectiveness of reflexology and AA on postoperative pain and anxiety. This three-group randomized clinical trial study was performed on 101 pregnant women, admitted to Mashhad Omolbanin hospital, for a cesarean section, in 2015. In the intervention groups, 2-3 h after the operation, AA or FR was performed for 20 min. Routine care was provided for the control group. Pain and anxiety were evaluated by VAS and Spielberger anxiety questionnaire before and 1 and 2 h after the intervention. The results showed that immediately after the intervention, pain intensity was significantly lower in both AA and FR groups (P < 0.001) compared with the control group. In addition, 2 h after the interventions, pain intensity was significantly lower in the AA group compared with the control group (P = 0.006). However, no significant differences were observed between the FR and the control groups (P = 0.095). In addition, 1 and 2 h after the intervention, anxiety was significantly different between the three groups (P = 0.033 and P = 0.018), respectively. The results of the Tukey test showed that this difference was only between FR and control groups (P = 0.025 and P = 0.017), respectively. AA is more effective in reducing post-cesarean pain while FR effectively reduces post-cesarean anxiety. Therefore, these complementary medicine treatments as easy and noninvasive methods are recommended to be used during labor for improving maternal outcomes.

Combined treatment with Minocycline and methylprednisolone in acute traumatic spinal cord Injury: A pilot study

ObjectiveThis randomized clinical trial (RCT) aimed to compare the neurologic outcomes of spinal cord injury (SCI) patients treated with Minocycline plus methylprednisolone (MCMP) versus MP (Methylprednisolone) alone. MethodsThis double-blind, single-center parallel RCT study was conducted in a community-based setting from 2022 to 2023 on consecutive patients with acute SCI within 12 h of injury. The intervention group (MPMC) received a bolus infusion of MP 30 mg/kg in 15 min intravenously, followed by a 5.4 mg/kg infusion of MP for 24–48 h and 50 mg Minocycline orally every 12 h for one week. The control group received the same amount of MP alone. Neurologic exam according to the Frankel Grading System compared two groups. ResultsA total of 54 patients completed the 6-month follow-up with a mean age of 42.5 and 41.5 in the MP (n = 27) and MPMC (n = 27) groups, respectively. The Baseline Frankel score was similar between the two groups (P = 0.92).During the follow-up period, 7.4 % and 22.2 % of the MP and MPMC groups improved to the Frankel score of D and E in the three months but insignificant between the groups (OR: 1.34, 95 % CI: 0.997–1.813, P = 0.052). At the 6-month follow-up, 33.3 % and 48.1 % of patients in MP and MPMC groups improved to Frankel scores D and E, respectively, which was significant in the mixed-effect analysis (OR: 1.45, 95 % CI: 1.074–1.952, P = 0.015). ConclusionCombination therapy with Minocycline and MP might be more effective in improving neurological recovery and reducing inflammation and tissue damage in SCI patients in the short term.

Supra- and sub-gingival instrumentation of periodontitis with the adjunctive treatment of a chloramine – a one-year randomized clinical trial study

Periodontitis is a bacterial-induced disease and for this reason controlling the microbiota is a necessity. Therapy includes self-performed daily oral hygiene in combination with supra- and sub-gingival instrumentation. An adjunctive antimicrobial agent may improve the outcome. Aims To assess whether a chloramine (Perisolv®) has an adjunctive effect to non-surgical periodontal therapy and whether non-surgical periodontal therapy affects quality of life. Material and Methods Thirty-eight patients were randomized to a test or a control group. Clinical indices were performed at baseline and at three and twelve months. In the test group, Perisolv® was applied initially and after the sub-gingival instrumentation in pathological pockets. Oral health-related quality of life was measured with the Oral Health Impact Profile (OHIP) instrument at baseline and twelve months. Results In both groups, an initial probing pocket depth (PPD) of > 4 mm and bleeding on probing (BOP) were statistically reduced (p < 0.002 and p < 0.002 respectively) at twelve months and after adjustment for Bonferroni. There were no significant differences between the test and the control group in terms of the number of PPD, BOP or plaque index, or in the mean OHIP score. Conclusions Chloramine did not have an adjunctive effect, but the overall therapy was significantly efficacious both clinically and in terms of quality of life. Trial registration Registered at www.clinicaltrials.gov: NCT05757921.

The effects of atomoxetine and trazodone combination on obstructive sleep apnea and sleep microstructure: A double-blind randomized clinical trial study

Study objectiveswe aimed to compare the effects of atomoxetine and trazodone (A-T) in combination with placebo in patients with obstructive sleep apnea (OSA). MethodsThis randomized, placebo-controlled, double-blind, crossover trial study was conducted in adults with OSA referred to a Sleep Clinic. Participants with eligibility criteria were recruited. Patients were studied on two separate nights with one-week intervals, once treated with trazodone (50 mg) and atomoxetine (80 mg) combination and then with a placebo and the following polysomnography tests. ResultsA total of 18 patients with OSA completed the study protocol, 9(50%) were male, the mean age was 47.5 years (SD = 9.8) and the mean Body mass index of participants was 28.4 kg/m2 (SD = 3.4). Compared with the placebo, the A-T combination resulted in significant differences in AHI (28.3(A-T) vs. 42.7 (placebo), p = 0.025), duration of the REM stage (1.3%TST (A-T) vs. 13.1%TST (placebo), p = 0.001), and the number of REM cycles (0.8 (A-T) vs. 4.7 (placebo), p = 0.001), number of apneas (38.3 (A-T) vs. 79.3 (placebo), p = 0.011), number of obstructive apneas (37.2 (A-T) vs. 75.2 (placebo), p = 0.011), oxygen desaturation index (29.5 (A-T) vs. 42.3 (placebo), p = 0.022) and number of respiratory arousals (43.2 (A-T) vs. 68.5 (placebo), p = 0.048). This decrement effect did not change among those with a low-arousal phenotype of OSA. ConclusionsThe A-T combination significantly improved respiratory events’ indices compared with placebo in patients with OSA. This combination is recommended to be assessed in a large trial. It could be an alternative for those who do not adhere to the standard available treatments for OSA.

Success rates of endotracheal intubation using the standard method versus the modified-ramped position.

The sniffing position used in intubation has disadvantages, including suboptimal glottic view, respiratory problems, increased risk of aspiration, and pain. In this regard, we have proposed new conditions to facilitate intubation and tube placement in patients with a Mallampati score higher than 2, by introducing a new position called the modified rapid airway management positioner (RAMP) position. The authors compared various parameters to improve intubation conditions between these two positions. This intervention is a randomized clinical trial study, with a random sampling method that divides the patients into two groups: a control group placed in the standard position (S) and an intervention group placed in the modified (M) RAMP position. An anesthesiologist performed intubation. In group (S), patients were placed in the supine position as usual, and a pillow with a height of 10cm was placed under their heads. In group (M), the patients were placed in the supine position on a modified RAMP with a triangular shape, 15cm in height, and 80cm in length, at a 30° angle. The pillow had lengths of 20 and 80cm. In the present study, 112 patients were investigated, consisting of 58 women (51.8%) and 54 men (48.2%). The intubation time in the intervention group using the modified RAMP roll technique was significantly shorter (51.25s) compared to the control group using the standard method (88.39s) (P=0.019). The results of the study showed that the modified RAMP roll improved the general conditions of intubation and led to a better view of the glottis in direct laryngoscopy. This is a very important aspect of intubation, and with a better view of the pharynx and glottis, the intubation procedure can be performed with higher quality, reducing the number of intubation attempts and the duration of the procedure.

Evidence-Supported Interventions for Reducing Secondary Stroke Risk in Sub-Saharan Africa: A Systematic Review.

The study set out to perform a systematic literature review of evidence-based interventions that target the reduction of secondary stroke risk in Africa. The review analyzed longitudinal intervention studies conducted in Sub-Saharan Africa, focusing on adult participants who had suffered a prior stroke. It encompassed publications and peer-reviewed papers sourced from reputable databases, including PubMed, Ovid, Cochrane, and Web of Science. Three randomized clinical trial (RCT) studies were included with sample sizes ranging from 16 to 400 participants, mean age ranged between 50 and 66 years, with 64.5% male participants. All studies applied multidisciplinary team interventions of enhanced patient follow-up involving care givers, nurse educators, physicians, and social workers. Interventions ranged from comprehensive patient education, tracking of medication adherence and enforcing healthy lifestyle behaviors (regular exercise, regular BP checks, and dietary changes). We found a decrease in Systolic Blood Pressure over time in 2 of 3 treatment groups, an improvement in medical adherence in all treatment groups, and a decrease in cholesterol levels in 1 treatment group. Evidence-based interventions involving multidisciplinary teams and comprehensive patient education were found to demonstrate promising results in reducing secondary stroke risk in Africa, leading to significant improvements in medical adherence and reductions in systolic blood pressure in the majority of treatment groups. However, more research is required to confirm the influence of these interventions on cholesterol levels and to establish their lasting advantages in preventing strokes among African communities.