Single-blind Randomized Clinical Trial Research Articles

Effects of backward walking exercise using lower body positive pressure treadmill on knee symptoms and physical function in individuals with knee osteoarthritis: a protocol for RCT

ObjectivesThe primary aim is to compare the effects of backward walking exercise to forward walking exercise on knee pain, knee functions, and thigh muscle strength in individuals with mild to moderate knee osteoarthritis using lower body positive pressure, in addition to mobility functions, balance, and self-reported health status.MethodsThe study is a single blind randomized clinical trial with two independent groups. This study will enroll 26 participants with mild to moderate knee osteoarthritis. The participants will be randomized into either experimental group (backward walking exercise) or control group (forward walking exercise). Both groups will use lower body positive pressure treadmill for walking exercise. Both groups will perform regular conventional exercise and worm-up exercise before walking exercise. The treatment will be three times a week for six weeks. Walking session will be up to 30 min each session. Data collection will be collected during pre- and post- intervention including primary outcomes including numeric pain rating scale (NPRS), knee injury and osteoarthritis outcome score (KOOS), and thigh muscle strength test. The secondary outcomes include five times sit to stand test (FTSTS), 3-meter backward walk test (3MBWT), timed up and go test (TUG), four square step test (FSST), functional reach test (FRT), 10-meter walk test (10-MWT), six minute walk test (6MWT), medical outcomes study short form 12 (SF-12), patient health questionnaire -9 (PHQ-9), and rapid assessment of physical activity (RAPA). An independent t-test will be used to evaluate the effect of treatment on the outcome measures.ResultsNot applicable.ConclusionUsing lower body positive pressure may have promising results against knee osteoarthritis. Moreover, walking backward exercise using lower body positive pressure might add more benefits to individuals with knee osteoarthritis and help clinicians in decision making.Trial registration: This study was registered in ClinicalTrails.gov (ID: NCT05585099).

Effects of spinal manipulation or mobilization as an adjunct to neurodynamic mobilization for lumbar disc herniation with radiculopathy: a randomized clinical trial

ABSTRACT Objectives To determine the long-term clinical effects of spinal manipulative therapy (SMT) or mobilization (MOB) as an adjunct to neurodynamic mobilization (NM) in the management of individuals with Lumbar Disc Herniation with Radiculopathy (DHR). Design Parallel group, single-blind randomized clinical trial. Setting The study was conducted in a governmental tertiary hospital. Participants Forty (40) participants diagnosed as having a chronic DHR (≥3 months) were randomly allocated into two groups with 20 participants each in the SMT and MOB groups. Interventions Participants in the SMT group received high-velocity, low-amplitude manipulation, while those in the MOB group received Mulligans’ spinal mobilization with leg movement. Each treatment group also received NM as a co-intervention, administered immediately after the SMT and MOB treatment sessions. Each group received treatment twice a week for 12 weeks. Outcome Measures The following outcomes were measured at baseline, 6, 12, 26, and 52 weeks post-randomization; back pain, leg pain, activity limitation, sciatica bothersomeness, sciatica frequency, functional mobility, quality of life, and global effect. The primary outcomes were pain and activity limitation at 12 weeks post-randomization. Results The results indicate that the MOB group improved significantly better than the SMT group in all outcomes (p < 0.05), and at all timelines (6, 12, 26, and 52 weeks post-randomization), except for sensory deficit at 52 weeks, and reflex and motor deficits at 12 and 52 weeks. These improvements were also clinically meaningful for neurodynamic testing and sensory deficits at 12 weeks, back pain intensity at 6 weeks, and for activity limitation, functional mobility, and quality of life outcomes at 6, 12, 26, and 52 weeks of follow-ups. The risk of being improved at 12 weeks post-randomization was 40% lower (RR = 0.6, CI = 0.4 to 0.9, p = 0.007) in the SMT group compared to the MOB group. Conclusion This study found that individuals with DHR demonstrated better improvements when treated with MOB plus NM than when treated with SMT plus NM. These improvements were also clinically meaningful for activity limitation, functional mobility, and quality of life outcomes at long-term follow-up. Trial Registration Pan-African Clinical Trial Registry: PACTR201812840142310.

Comparison of the Dexmedetomidine and Sufentanil Added to Spinal Anesthesia with Bupivacaine for Hemodynamic Stability and Postoperative Analgesia in Elective Cesarean Section Surgery: A Single-Blinded Randomized Clinical Trial

Background: Hemodynamic instability, including hypotension and bradycardia, can occur due to spinal anesthesia by bupivacaine. However, it is possible to reduce the chance of hemodynamic changes by the reduction of the dose of bupivacaine and/or the addition of adjunctive agents. Objective: This study aimed to compare the effects of the addition of intrathecal dexmedetomidine and sufentanil to spinal anesthesia with bupivacaine in elective cesarean section (CS). Methods: This prospective single-blinded randomized clinical trial with parallel groups was performed on 60 pregnant women who were candidates for elective CS in Imam Reza Hospital in Kermanshah, Iran. In addition to receiving 10 mg of hyperbaric bupivacaine 0.5%, they were randomly divided into two groups to receive intrathecal sufentanil 5 μg (30 cases) or dexmedetomidine 5 μg (30 cases). Changes in blood pressure, heart rate, and occurrence of side effects (e.g., nausea, vomiting, headache, and shivering) were recorded within 1 h after the injections. Moreover, the postoperative analgesia rate and duration (using a visual analog scale [VAS]) were recorded within the first 24 h after the completion of the CS. Headache severity (using a VAS) was also measured during the first week after CS. Results: Patients declared their satisfaction with analgesia after surgery. No significant difference was found between the two groups in terms of heart rate and systolic and diastolic blood pressure changes during the first 60 min. Similarly, no significant difference was observed between the two groups in terms of the severity of incision pain in the first 24 h after CS surgery. On days 3, 4, and 5, none of the patients in the sufentanil and bupivacaine group had headaches (VAS=0), but patients in the dexmedetomidine and bupivacaine group had some degree of headache (P=0.040). Conclusions: Based on the results, intrathecal administration of bupivacaine with either sufentanil or dexmedetomidine in CS did not have significantly different effects, except for slightly more severe headaches in the dexmedetomidine group. Therefore, no superiority of one drug over the other was observed for intrathecal administration with bupivacaine in CS.

Does a New Modification of the Two-Step Injection Technique for Inferior Alveolar Nerve Block Reduce Pain Compared to the Conventional Technique? A Randomized Clinical Trial.

The ability to control pain is an essential part of dental procedures and the need for optimal pain control and reduction of discomfort is the primary concern of every dentist. This study aims to compare the pain and vital signs during inferior alveolar nerve block between conventional and a new modification of the two-step injection techniques. In this institutional single-blind randomized clinical trial, attendees of dental school at Mazandaran University of Medical Sciences from February to May 2022 were included. Inclusion criteria were 20-60 years old and healthy (ASA1) individuals who were willing to participate in this study. Individuals who were taking medications affecting their understanding of pain and patients with active infections at the injection site were excluded. These individuals were divided into two groups. First, superficial anesthesia was performed and afterward, conventional and two-step injection techniques were performed. For the two-step injection method, 6 mm of the needle was injected into the mucosa and one-third of the local anesthetic solution was released from the computer-controlled injection toolkit. Afterward, a 25 mm 30-gauge needle was reinserted into the previous hole delivering the remaining local anesthetic. The pain during injection was measured by a patient-reported numerical rating scale (NRS). Moreover, vital signs were monitored immediately before and after the injection. Kolmogorov-Smirnov test, Mann-Whitney U test, independent T-test, and Fisher's exact χ 2 test were performed for statistical analysis (α = 0.05). This study involved 32 adults aged between 20 and 50 years old with 1 : 1 female/male sex distribution. The pain score was significantly higher in the conventional injection technique compared to the two-step injection technique in all sex and age groups. There were no significant differences in vital signs between the conventional and two-step injection techniques. There was no significant difference in the mean pain scores of females and males, regardless of their injection techniques. Utilizing the two-step injection technique in patients for inferior alveolar block reduces pain during injection without altering patients' vital signs significantly. This trial is registered with IRCT20220106053646N1.

Relationship Between the Underlying Factors and the Treatment Results of Platelet-Rich Plasma (PRP) Injection in Degenerative Knee Disease; A Blinded Randomized Study

Background: To investigate the therapeutic effects of PRP injection + conservative treatment as the intervention group versus normal saline injection + conservative treatment as the control group. Objectives: This study we determined the effects of underlying factors, including age, gender, and body mass index (BMI), on the therapeutic effects of PRP. Methods: In this single-blinded randomized clinical trial, 60 patients with grade 2 knee OA with an age of 40 - 65 years were enrolled. In the intervention group, leukocyte-poor PRP with double spinning, and in the control group, normal saline was injected with a similar protocol. All patients in both groups were also provided with a conservative protocol, including oral celecoxib 100 mg BID for four weeks, modifying physical activity, and 15 sessions of physiotherapy. Results: Demographic characteristics (age, gender, and BMI) and pre-treatment scores were similar between the two groups (all P &gt; 0.05). The WOMAC score was improved from pre-treatment to first week post-treatment in both groups (from 54.89 ± 3.4 to 64.9 ± 3.7 in the intervention group and from 53.7 ± 3.1 to 63.8 ± 3.9 in the control group). It means that PRP + conservative treatment was effective, similar to normal saline + conservative treatment. After adjusting BMI as an underlying variable, it was indicated that in the patients with lower BMI, PRP + conservative provided a better outcome in comparison to saline + conservative treatment (P = 0.014 and P = 0.019, respectively). Also, the comparison of functional scores changes with age as an underlying variable, demonstrating that younger cases obtained a better response from PRP + conservative rather than normal saline + conservative (P = 0.012 and P = 0.007, respectively). Conclusions: PRP seems to be an appropriate choice for treatment of moderate osteoarthritis, especially in younger patients and those with lower BMI.

The Effects of Tracheal Suction with N-acetylcysteine on Incidence of Ventilator-associated Pneumonia

Background: Correct endotracheal tube suction is one of the effective methods to prevent ventilator-associated infection. Many studies have reported that normal saline and N-acetylcysteine (NAC) in the trachea lead the translocation of bacteria to lower levels and increase the risk of pneumonia. Objectives: The present study sought to examine the effect of tracheal suction with NAC on the incidence of ventilator-associated pneumonia (VAP). Methods: This single-blind randomized clinical trial study was conducted on 60 patients admitted to the intensive care unit (ICU) of the Khatam Al-Anbia Hospital in Zahedan, Iran, in 2020. The patients were selected using the convenience sampling method and assigned into two intervention and control groups by permutation block randomization. Before the intervention, the patients were evaluated using the Modified Clinical Pulmonary Infection Score (MCPIS), and the patients with scores &lt; 5 on this scale were included in the study. Suctioning tracheal secretions in the intervention group was performed by pouring 2 cc of NAC into the tracheal tube during suction. The same suction procedure was performed for the patients in the control group by pouring 2 cc of normal saline into the tracheal tube in a standard way. The intervention was conducted for five days. After the intervention, the MCPIS scale was administered once more for the two groups. The collected data were analyzed using the independent samples t-test and chi-square test with SPSS software (version 25). Results: The independent samples t-test showed no significant difference between the intervention and control groups regarding the incidence of pneumonia (P = 0.31). Conclusions: Despite the effect of NAC on the incidence rate of pneumonia in patients under mechanical ventilation, there was no significant difference between NAC and normal saline in reducing the incidence of pneumonia. However, since NAC leads to no specific complication in patients, it can be safely used in the suction of tracheal lobule secretions in patients under ventilators. In this regard, further studies should examine the use of NAC for suctioning during tracheal tube obstruction by secretions.

Aerobic exercise improves central blood pressure and blood pressure variability among patients with resistant hypertension: results of the EnRicH trial.

Central blood pressure (BP) and BP variability are associated with cardiovascular disease risk. However, the influence of exercise on these hemodynamic parameters is unknown among patients with resistant hypertension. The EnRicH (The Exercise Training in the Treatment of Resistant Hypertension) was a prospective, single-blinded randomized clinical trial (NCT03090529). Sixty patients were randomized to a 12-week aerobic exercise program or usual care. The outcome measures include central BP, BP variability, heart rate variability, carotid-femoral pulse wave velocity, and circulating cardiovascular disease risk biomarkers including high-sensitivity C-reactive protein, angiotensin II, superoxide dismutase, interferon gamma, nitric oxide, and endothelial progenitor cells. Central systolic BP decreased by 12.22 mm Hg (95% CI, -1.88 to -22.57, P = 0.022) as did BP variability by 2.85 mm Hg (95% CI, -4.91 to -0.78, P = 0.008), in the exercise (n = 26) compared to the control group (n = 27). Interferon gamma -4.3 pg/mL (95%CI, -7.1 to -1.5, P = 0.003), angiotensin II -157.0 pg/mL (95%CI, -288.1 to -25.9, P = 0.020), and superoxide dismutase 0.4 pg/mL (95%CI, 0.1-0.6, P = 0.009) improved in the exercise compared to the control group. Carotid-femoral pulse wave velocity, heart rate variability, high-sensitivity C-reactive protein, nitric oxide, and endothelial progenitor cells were not different between groups (P > 0.05). In conclusion, a 12-week exercise training program improved central BP and BP variability, and cardiovascular disease risk biomarkers in patients with resistant hypertension. These markers are clinically relevant as they are associated with target organ damage and increased cardiovascular disease risk and mortality.

Screening of therapeutic potentials of proprioceptive exercises and topical glucosamine sulfate on pain and functional disability in knee osteoarthritis

Purpose: To compare the effects of proprioceptive exercises and topical glucosamine sulfate on knee osteoarthritis in terms of reducing pain and functional disability.&#x0D; Methods: A single-blinded randomized clinical trial (IRCT20220115053712N1) was conducted at Muhammad Physical Therapy Clinic and Rehabilitation Center, Multan, Pakistan, from November 2021 to April 2022. Eighty-four patients enrolled and were randomized into two groups; patients in Group A were treated with proprioceptive exercises while those in Group B were treated with topical glucosamine sulfate. The Numerical Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale were used to measure pain and functional activities at baseline, 9th and 18th sessions.&#x0D; Results: The results showed that both interventions were effective, but more in Group A (p &lt; 0.05). Group A also showed highly significant improvement in relieving the pains associated with osteoarthritis when compared to Group B (p ≤ 0.001).&#x0D; Conclusion: Proprioceptive exercises are more efficient than topical glucosamine sulfate for managing knee osteoarthritis, improving functional outcomes and lowering pain intensity.

A Comparative Study of the Effect of Dexmedetomidine-Fentanyl and Midazolam-Ketamine Combination on the Level of Sedation in Children undergoing Bone Marrow Biopsy

Background: This study aimed to compare the effect of dexmedetomidine-fentanyl (DF) and midazolam-ketamine (MK) combination on the level of sedation in children undergoing bone marrow biopsy.&#x0D; Methods: This study was a single-blind randomized clinical trial. The patients were divided into two groups of 35. Five minutes before undergoing bone marrow biopsy, the first group underwent sedation with a combination of 0.1 mg/kg midazolam with 1 mg/kg ketamine, and the second group underwent sedation with a combination of 2 μg/kg dexmedetomidine with 1 μg/kg fentanyl. The mean arterial pressure (MAP), heart rate, SpO2, the level of sedation, and the incidence rates of complications were recorded in both groups and compared to each other.&#x0D; Results: There was no significant difference between the two groups in terms of age (P= 0.687), gender (P= 1.00), and weight (P= 0.839). However, there was a significant difference in the average length of stay in recovery (P= 0.015) and surgeon satisfaction (P= 0.000), with a longer recovery period in the midazolam-ketamine (MK) group. The Repeated measures ANOVA showed significant differences in heart rate (P= 0.008), sedation score (P= 0.038), and the percentage of oxygen saturation (P= 0.00) during surgery.&#x0D; Conclusion: The combination of dexmedetomidine and fentanyl (DF) compared to the combination of midazolam and ketamine (MK) can provide more patient sedation and surgeon satisfaction along with more stable hemodynamics for patients undergoing bone marrow biopsy.

Effects of probiotic and synbiotic supplementation on ponderal and linear growth in severely malnourished young infants in a randomized clinical trial

Severe acute malnutrition (SAM) is a major global public health problem. We aimed to assess the effects of probiotic and synbiotic supplementation on rate of weight gain and change in length in young SAM infants. This study was substudy of a single-blind randomized clinical trial (NCT0366657). During nutritional rehabilitation, 67 <6 months old SAM infants were enrolled and randomized to receive either probiotic (Bifidobacterium. infantis EVC001) or synbiotic (B. infantis EVC001 + Lacto-N-neotetraose [LNnT]) or placebo (Lactose) for four weeks and were followed for four more weeks after supplementation. In multivariable linear regression model, the mean rate of weight gain in the probiotic arm compared to placebo was higher by 2.03 unit (P < 0.001), and 1.13 unit (P = 0.030) in the synbiotic arm. In linear mixed-effects model, mean WAZ was higher by 0.57 unit (P = 0.018) in probiotic arm compared to placebo. Although not statistically significant, delta length for age z score (LAZ) trended to be higher among children in probiotc (β = 0.25) and synbiotic (β = 0.26) arms compared to placebo in multivariable linear regression model. Our study describes that young SAM infants had a higher rate of weight gain when supplemented with probiotic alone, compared to their counterparts with either synbiotic or placebo.

The Static and dynamic functional connectivity characteristics of the left temporoparietal junction region in schizophrenia patients with auditory verbal hallucinations during low-frequency rTMS treatment.

Auditory verbal hallucinations (AVH) are a core symptom of schizophrenia. Low-frequency (e.g., 1 Hz) repetitive transcranial magnetic stimulation (rTMS) targeting language processing regions (e.g., left TPJ) has been evident as a potential treatment for AVH. However, the underlying neural mechanisms of the rTMS treatment effect remain unclear. The present study aimed to investigate the effects of 1 Hz rTMS on functional connectivity (FC) of the temporoparietal junction area (TPJ) seed with the whole brain in schizophrenia patients with AVH. Using a single-blind placebo-controlled randomized clinical trial, 55 patients with AVH were randomly divided into active treatment group (n = 30) or placebo group (n = 25). The active treatment group receive 15-day 1 Hz rTMS stimulation to the left TPJ, whereas the placebo group received sham rTMS stimulation to the same site. Resting-state fMRI scans and clinical measures were acquired for all patients before and after treatment. The seed-based (left TPJ) static and DFC was used to assess the connectivity characteristics during rTMS treatment in patients with AVH. Overall, symptom improvement following 1 Hz rTMS treatment was found in the active treatment group, whereas no change occurred in the placebo group. Moreover, decreased static FC (SFC) of the left TPJ with the right temporal lobes, as well as increased SFC with the prefrontal cortex and subcortical structure were observed in active rTMS group. Increased dynamic FC (DFC) of the left TPJ with frontoparietal areas was also found in the active rTMS group. However, seed-based SFC and DFC were reduced to a great extent in the placebo group. In addition, these changed FC (SFC) strengths in the active rTMS group were associated with reduced severity of clinical outcomes (e.g., positive symptoms). The application of 1 Hz rTMS over the left TPJ may affect connectivity characteristics of the targeted region and contribute to clinical improvement, which shed light on the therapeutic effect of rTMS on schizophrenia with AVH.

Prevention and treatment for COVID-19 associated severe pneumonia in the Gambia (PaTS-COVID-19), a single-blinded randomized clinical trial: study protocol

Background: The coronavirus disease (COVID-19) pandemic resulted in an unprecedent global response for the development of COVID-19 vaccines. However, as viral mutations continue to occur, potentially decreasing the efficacy of currently available vaccines, and inequity of vaccine access continues, identifying safe and effective drugs to minimise severity of COVID-19 disease remains a priority. Methods: We designed an adaptive individually randomised single blinded non identical placebo-controlled trial to evaluate the safety and efficacy of repurposing licenced treatments for COVID-19 patients in an African setting. The trial has two cohorts: Cohort 1 recruits mild and moderate COVID-19 cases and their household contacts. Cases are actively followed up for 14 days, with a final visit at day 28. There are two co-primary endpoints: clinical progression to severe-pneumonia and persistence of the virus at day 14. The primary endpoint for household contacts is infection during a 14-day follow-up period. Cohort 2 recruits hospitalized patients with severe COVID-19 associated pneumonia followed up actively until discharge or death, and passively until day 90, with a final visit. The primary endpoint is clinical progression or death. Conclusions: This randomised trial will contribute African-specific data to the global response to COVID-19. Besides the efficacy of drugs on clinical progression, the trial will provide information on the dynamics of intra-household transmission. Trial registration: This study is registered with Clinical Trials.gov with registration number NCT04703608 and with Pan African clinical trials registry with registration number PACTR202101544570971.

Immediate effects of dry needling on pain sensitivity and pain modulation in patients with chronic idiopathic neck pain: a single-blinded randomized clinical trial

BackgroundDry needling is frequently used for the treatment of neck pain but knowledge about its neurophysiological central effects is scarce. ObjectivesTo compare the immediate effects of a single session of dry needling (DN) and sham needling (SN) on local and distant pressure pain thresholds and conditioned pain modulation in patients with chronic idiopathic neck pain. MethodParticipants with chronic idiopathic neck pain were randomly allocated to a DN or SN group. The primary outcome measure was the pressure pain threshold (PPT) at one peripheral location: quadriceps muscle (Q). Secondary outcome measures were local PPTs at the treated (most painful) (tUT) and non-treated upper trapezius muscle (ntUT), absolute and relative conditioned pain modulation (CPM) effects and pain during hot water immersion. Patients were assessed at baseline and immediately post intervention. Linear mixed models were used to examine interaction effects as well as between- and within-group differences. ResultsFifty-four participants were included for statistical analysis. Linear mixed model analyses showed no significant “group X time” interaction effects for any of the outcome measures. The relative CPM effect at the Q was significantly higher post-intervention, compared to baseline within the DN group (mean difference= 13.52%; 95% CI: 0.46, 26.59). ConclusionThe present study shows no superior effect of DN, compared to SN, in the immediate effect on local and distant PPTs and CPM in patients with chronic idiopathic neck pain.

Effect of localized acupressure massage on anxiety during chemotherapy in patients with breast cancer: A single-blind randomized clinical trial

Effect of localized acupressure massage on anxiety during chemotherapy in patients with breast cancer: A single-blind randomized clinical trial

A comparative study of 20% azelaic acid cream versus 5% tranexamic acid solution for the treatment of postinflammatory hyperpigmentation in patients with acne vulgaris: A single-blinded randomized clinical trial.

There is a lack of evidence on the therapeutic efficacy of topical tranexamic acid (TA) for the treatment of acne-related postinflammatory hyperpigmentation (PIH). The current study aimed to assess the efficacy of twice-daily administration of 20% azelaic acid (AZA) cream versus 5% TA solution for the treatment of PIH in patients with acne vulgaris. Patients in the present single-blinded randomized clinical trial were randomized into AZA or TA groups for 12 weeks. The rate of healing was assessed by scoring recorded photographs based on postacne hyperpigmentation index (PAHI) at baseline, 4th, 8th, and 12th weeks. The frequency of side effects was examined and recorded at each study time point. Thirty volunteers in each treatment group completed the intervention. PAHI score in both AZA and TA groups improved during the study course (Ptime < 0.001, for both groups). However, mean PAHI scores were comparable in the two groups (Pgroup = 0.05). No significant interaction was also found between time and treatments in terms of PAHI score (Ptime × group = 0.66). The frequency of treatment-related side effects was significantly higher in the AZA group compared to the TA group at week 4 of treatment (P < 0.05). However, no significant difference was observed in the frequency of reported side effects at weeks 8 and 12 of the treatment (P > 0.05). Topical administration of 20% AZA cream and 5% TA solution was comparably efficient in the treatment of acne-related PIH with a significantly better safety profile of TA in the 1st month of the treatment.

Comparison of Therapeutic Effect and Safety of Oral and Rectal Use of Acetaminophen on Patent Ductus Arteriosus in Preterm Infants: Clinical Randomized Trial.

The prevalence of patent ductus arteriosus (PDA) in preterm infants is high. There is little information about the therapeutic effect and safety of rectal acetaminophen in the treatment of PDA. We aimed to compare the therapeutic effect and safety of oral and rectal acetaminophen on PDA in preterm infants. This study was a single-blind randomized clinical trial using 40 preterm infants. The cases were hospitalized in the neonatal intensive care unit of Mohammad Kermanshahi and Imam Reza hospitals of Kermanshah. Subjects were randomly divided into 2 groups, the first group was treated with oral acetaminophen and the second group was treated with rectal acetaminophen. The presence of PDA and response to treatment was assessed based on pre- and post-treatment echocardiographic criteria. The likelihood of complications or prohibition of acetaminophen use was assessed with paraclinical tests before and after treatment. The neonates were in the age range of 30 to 35 weeks. Twenty-one cases (52.5%) were boys and 19 cases (47.5%) were girls. Two cases in the oral-acetaminophen group and 1 case in the rectal-acetaminophen group needed the second round of treatment. There was no difference between the success of treatment and the type of treatment. The study showed that there was no difference between PDA treatment of preterm infants with oral and rectal acetaminophen. Also, no side effects were observed in treatment with any of the treatments. Therefore, it could be suggested that in infants who are intolerant to oral acetaminophen, the rectal form can be used.

Comparison of the number of bacterial colonies among four types of suture threads using simple loop method following periodontal surgery in patients with periodontitis: A single-blind randomized clinical trial

Comparison of the number of bacterial colonies among four types of suture threads using simple loop method following periodontal surgery in patients with periodontitis: A single-blind randomized clinical trial

The effectiveness of mindful hypnotherapy on difficulties in emotion regulation, mindfulness, and mental health in patients with major depressive disorder.

More than 300 million people are affected by major depressive disorder, and despite advances in treatments over the past 50 years, this number is increasing worldwide. Due to the high prevalence and increasing numbers, along with problems in various aspects of the patient's life, new effective treatments are essential in this field. This study was a single-blinded randomized clinical trial. Thirty-four patients with major depressive disorder who were referred by clinical psychologists in the clinical psychology clinic of the Taleghani Hospital, Tehran, Iran, were selected by purposive sampling method and randomly assigned to the intervention and wait-list control groups. The Difficulties in Emotion Regulation Scale, the Five Facet Mindfulness Questionnaire, and the Mental Health Continuum Short Form were administered during the baseline and post treatment. Analyses of covariance and the repeated measures analysis of variance (ANOVA) procedure were performed to determine the difference between study groups. The results of the analysis of covariance and repeated measures ANOVA showed a clinically significant decrease in difficulties in emotion regulation and a significant increase in mindfulness and mental health in the intervention group (P < 0.001). The mean score (standard deviation) of the difficulties in emotion regulation scores was 123.75 (21.10) in the experimental group at baseline and significantly decreased to 76.19 (26.45) and 68.00 (22.83) after the intervention and two-month follow-up, respectively (P < 0.001). Additionally, the mean scores (standard deviation) for mindfulness and mental health were 93.06 (8.23) and 19.63 (7.92), respectively, at baseline and significantly increased to 149.43 (16.99) and 51.62 (9.78), respectively, after the intervention and to 144.18 (20.55) and 48.50 (13.52) after a two-month follow-up (P < 0.001). The results show that mindful hypnotherapy is an effective treatment for improving difficulties in emotion regulation, mindfulness, and mental health in patients with major depressive disorder.

PS-BPC09-2: EFFECTIVENESS OF OROPHARYNGEAL EXERCISES AND PRANAYAMA ON BLOOD PRESSURE, AND QUALITY OF SLEEP AMONG HYPERTENSIVE WITH MODERATE OBSTRUCTIVE SLEEP APNEA.

Introduction and Objectives: Burden of cardiovascular disease around the global is a major health concern and prevalence is high in adults with obstructive sleep apnea (OSA). Lowering blood pressure (BP) can greatly reduce cardiovascular disease risk and lifestyle modification including regular physical activity is routinely prescribed to achieve this goal. The relationship between sleep disordered breathing especially obstructive sleep apnea (OSA) and hypertension has been well investigated in both cross sectional and longitudinal studies. Many people with OSA suffer from severe fatigue and daytime sleepiness with poor exercise intolerance due to poor sleep quality and nocturnal hypoxemia. The objectives of this study was To evaluate the efficacy of a 6 week oropharyngeal exercises and Pranayama training program for reducing blood pressure and improving sleep quality in hypertensive patients with OSA . Design and method: This is a single site double blind randomized clinical trial. Total 40 patients with history of hypertension and moderate sleep apnea were selected that further divided into two groups oropharyngeal exercises and Pranayama group and control group. Patients were evaluated at study entry and at end by evaluating blood pressure pulse rate anthropometric measurements snoring frequency (range 0 to 4) and Pittsburgh sleep quality (0 to 21) questionnaires. After initial evaluation oropharyngeal exercises and Pranayama along with regular brisk walking for 30 to 40 mins 5 days in week is prescribed to experimental group. Pranayama consists of three phases: Puraka (inhalation) kumbhaka (retention) and rechaka (exhalation) that can be either fast or slow. Oropharyngeal exercises refers to 12 exercises of the 20 minutes duration involving tongue (4 exercises) soft palate (2 exercises) jaw (2 exercises) and lateral pharyngeal wall (4 exercises) to be performed twice a day for 6 weeks. The exercises were taught individually and were supplemented with a pamphlet for reinforcement. And only regular brisk walking for 30 to 40 mins 5 days in week is prescribed to control group. Results: Experimental group significantly (p &lt; 0.05) decreased systolic &amp; diastolic blood pressure snoring neck circumference and improved sleep quality. Heart rate changes were insignificant (p = 0.9). Conclusions: Oropharyngeal exercises and Pranayama are effective in reducing blood pressure and snoring in hypertensive patients with moderate OSA. Its also effective in improving in quality of sleep in these patients.

Lack of effects of four-week theta burst stimulation on white matter macro/microstructure in children and adolescents with autism

Following the published behavioral and cognitive results of this single-blind parallel sham-controlled randomized clinical trial, the current study aimed to explore the impact of intermittent theta burst stimulation (iTBS), a variant of excitatory transcranial magnetic stimulation, over the bilateral posterior superior temporal sulci (pSTS) on white matter macro/microstructure in intellectually able children and adolescents with autism. Participants were randomized and blindly received active or sham iTBS for 4 weeks (the single-blind sham-controlled phase). Then, all participants continued to receive active iTBS for another 4 weeks (the open-label phase). The clinical results were published elsewhere. Here, we present diffusion magnetic resonance imaging data on potential changes in white matter measures after iTBS. Twenty-two participants in Active-Active group and 27 participants in Sham-Active group underwent multi-shell high angular resolution diffusion imaging (64-direction for b = 2000 & 1000 s/mm2, respectively) at baseline, week 4, and week 8. With longitudinal fixel-based analysis, we found no white matter changes following iTBS from baseline to week 4 (a null treatment by time interaction and a null within-group paired comparison in the Active-Active group), nor from baseline to week 8 (null within-group paired comparisons in both Active-Active and Sham-Active groups). As for the brain-symptoms relationship, we did not find baseline white matter metrics associated with symptom changes at week 4 in either group. Our results raise the question of what the minimal cumulative stimulation dose required to induce the white matter plasticity is.