Single-blind Randomized Clinical Trial Research Articles

USAGE OF CHLORHEXIDINE AS A FINAL IRRIGANT IN ONE-VISIT ROOT CANAL TREATMENT IN COMPARISON WITH CONVENTIONAL TWO-VISIT ROOT CANAL TREATMENT IN MANDIBULAR MOLARS: A RANDOMIZED CLINICAL TRIAL

The effectiveness of 1-visit root canal treatment (RCT), especially for teeth with large periapical lesions, are still being debated. Although, the use of chlorhexidine (CHX) as a final irrigant have been recommended to provide an optimized approach in 1-visit RCT, there is limited knowledge about the outcome of 1-visit RCT using CHX as the final irrigant. The aim of this randomized clinical trial was to evaluate the healing of mandibular molar teeth with large periapical lesions after RCT that was completed in 1 visit using 2% CHX as a final irrigant, comparing the results with a conventional 2-visit RCT as a control group. This study is a prospective, parallel-designed, and single-blinded randomized clinical trial. One-hundred asymptomatic mandibular molar teeth with large periapical lesions were randomly assigned to 2 groups. All teeth were instrumented with Reciproc files with 2.5% sodium hypochloride (NaOCl) and 5% ethylenediaminetetraacetic acid (EDTA) as irrigants. In the intervention group, half of the teeth were treated in 1 visit, receiving an additional final rinse with 2% CHX before obturation; the other half of the teeth, however, were treated in 2 visits with calcium hydroxide (CH) dressings, in the control group. All root canals were obturated with Reciproc gutta-percha cones and AH Plus root canal sealer. All patients were recalled and investigated clinically and radiographically for 48 months. Periapical healing was evaluated statistically using the Mann-Whitney U test, followed by the Friedman and the Wilcoxon tests (α = 0.05). During the 48-month follow-up process, 86 teeth (44 in 1-visit and 42 in 2-visit group) were examined. There were no significant differences between the 2 groups regarding the radiographic healing rates (1-visit group 91% and 2-visit group 88%) (P > .05). In this study, 1-visit RCT using 2% CHX as final irrigant in asymptomatic mandibular molars with large periapical lesions produced favorable healing results, similar to 2-visit root canal treatment with calcium hydroxide.

The effect of repeated flexion-based exercises versus extension-based exercises on the clinical outcomes of patients with lumbar disk herniation surgery: a randomized clinical trial

ABSTRACT Background Valuable impact of postoperative exercises on the clinical outcomes of patients with lumbar discectomy has been demonstrated. However, there is a lack of consensus on the best kind of postoperative exercises. This study aimed to evaluate the impact of the early postoperative flexion-based and extension-based exercises on the clinical outcomes of patients with lumbar discectomy. Methods In this single-blind randomized clinical trial (RCT), 90 subjects with lumbar discectomy were randomly assigned to three groups. The flexion-based and extension-based exercises were planned for the first and the second groups, respectively. The third group was considered as the control group. Subjects in the experimental groups started their exercise program at the end of the 6th postoperative week and continued exercises for 8 weeks. We used Visual analogue scale (VAS), Oswestry Disability Index (ODI), modified Biering-Sorensen test (mBST), and Trunk Flexion Endurance Test (TFET) to evaluate back pain, disability, back and abdominal muscle endurance, respectively. The outcomes were investigated before starting the exercises program as well as at the end of the study. Moreover, return to work was evaluated at the end of the study. Data were analyzed using descriptive and inferential statistics by SPSS-24 software. Results Our results showed that the VAS pain diminished in all the groups. However, this reduction was most in the McKenzie group (P < 0.001). Moreover, extension-based exercises reduced ODI more than other groups (P < 0.001). We found that extension-based and flexion-based exercises had more efficacy in increasing the back and trunk flexion endurance, respectively (P < 0.001). There was not a significant difference between the three groups in the term of returning to work (P = 0.06). Conclusions Both flexion-based and extension-based exercises could reduce postoperative back pain and disability. However, the impact of the extension-based program was more dominant. Moreover, these exercises could increase back and abdominal muscle endurance. Therefore, prescribing such low-cost home-based exercises could be very helpful for patients with lumbar discectomy.

Handgrip Strength Exercises Modulate Shoulder Pain, Function, and Strength of Rotator Cuff Muscles of Patients with Primary Subacromial Impingement Syndrome.

Background Impingement syndrome was shown to be associated with shoulder pain in 44–70% of patients worldwide. It usually occurs due to imbalance and insufficient activation of the rotator cuff (RC) muscles. Aim This study explores the relative effects of handgrip-strengthening exercises on shoulder function, pain, strength, and active range of motion as part of the treatment program for the patients with primary subacromial impingement syndrome. Materials and Methods A total of 58 patients aged 18-50 years with primary subacromial impingement syndrome were randomly enrolled to participate in this single-blind randomized clinical trial. Out of them, only forty patients have eligibly matched the inclusion criteria and randomly assigned to one of two groups to undergo a standardized therapeutic program consisting of two sessions a week for 8 weeks. The control group prescribed ultrasound therapy, ice, and stretching exercises, while the experimental group followed the same program with the addition of handgrip-strengthening exercises (HGSE). Both patients of conventional therapy (control) and handgrip-strengthening exercises (experimental group) were advised to adhere also to stretching and HGSE exercises once a day at home for eight weeks. The outcomes were the shoulder function, pain intensity, muscle strength, and active range of motion of the shoulder joint. Results Patients treated with conventional interventions plus handgrip-strengthening exercises showed the significant improvement over time in shoulder pain and function, strength of rotator cuff muscles, and pain-free range of motion forward flexion, abduction, and external and internal rotation through eight weeks in the experimental group compared to control patient group treated with conventional interventions. In addition, patients of both control and experimental groups showed no significant difference in the adherence to respective home-based stretching and HGSE exercises once a day at home for eight weeks. Conclusions Adding handgrip-strengthening exercises to conventional intervention increases the efficacy of treatment for patients with primary subacromial impingement syndrome in terms of shoulder function, pain, muscle strength, and active range of motion.

The Effect of Auriculotherapy on Anxiety and Physiological Parameters of Male Coronary Angiography Patients: A Single-blind Randomized Clinical Trial

PurposeTo determine the effect of auriculotherapy on anxiety and physiological parameters of male patients undergoing coronary angiography. DesignA single-blind randomized clinical trial was performed in 2019 with 94 subjects selected by convenience sampling. MethodsThe subjects were divided into 2 groups via random allocation. Two hours before angiography, all patients completed the Depression, Anxiety, and Stress Scale-21 items (DASS-21) and their physiological parameters (blood pressure, pulse rate, and respiratory rate) were measured 60 minutes before angiography. Auriculotherapy was performed on ear acupoints of patients in the experimental group for 4 minutes. In the control group, patients were given auricular acupressure in sham points. The anxiety and physiological parameters were re-measured 10 minutes after the intervention. FindingsPatients' anxiety was clinically lower in the experimental group (2.55 ± 0.27) compared to the control group (3.02 ± 0.33) (effect size = -1.42) after the intervention. There was no significant difference between 2 groups regarding physiological parameters after the intervention. However, the respiratory rates of patients were lower in the experimental group than in the control group (P < .001). After the intervention, physiological parameters significantly decreased in the experimental group compared to before the intervention (P < .001). ConclusionsAuriculotherapy reduces patient anxiety; therefore, it can be used as a complementary method before angiography.

Comparing the effects of vaginal and oral evening primrose oil on cervical ripening and labor progress among primiparous women

Background &amp; Aim: Evening primrose is a medicinal plant with potential effects on labor. This study aimed to compare the effects of vaginal and oral evening primrose oil on cervical ripening and labor progress among primiparous women.&#x0D; Methods &amp; Materials: This single-blind randomized clinical trial was conducted in 2020. Participants were 126 pregnant women with a gestational age of 39 weeks purposively selected from the obstetrics and gynecology ward of Valiasr hospital, Bafgh, Iran, and randomly allocated to vaginal evening primrose oil, oral evening primrose oil, and a control group. Participants in the vaginal evening primrose oil and the oral evening primrose oil groups received one 1000-mg evening primrose oil capsule per twelve hours for one whole week through the vaginal and the oral routes, respectively. The Bishop score and pregnancy outcomes were measured when participants referred to the study setting with labor pains.&#x0D; Results: After the intervention, the Bishop score in both intervention groups was significantly greater than the control group (P= 0.001). The length of the second stage of labor in the vaginal evening primrose oil group was significantly shorter than the control group (P= 0.009). There were no significant differences among the groups respecting the time interval between hospital admission and delivery (P= 0.21), 1 and 5-minute Apgar scores (P= 0.83), and (P= 0.37), need for induction (P= 0.26), and type of delivery (P= 0.26).&#x0D; Conclusion: Vaginal and oral evening primrose oil administrations significantly positively affect cervical ripening. The Bishop score and vaginal evening primrose oil significantly positively affect the length of the second stage of labor.

Evaluation of the Efficacy and Complications of Uterine Artery Embolization in Comparison with Laparotomy-Myomectomy in the Treatment of Uterine Myomas: A Randomized Clinical Trial.

Background: Due to the high prevalence of uterine fibroids or leiomyomas in women of reproductive age and the many treatment options for myomas, finding the best treatment is a challenge for surgeons. Therefore, this study aimed at evaluating the efficacy and safety of 2 treatment options surgical interventions and uterine artery embolization (UAE) in patients with uterine myoma. Methods: The present study was a single-blind randomized clinical trial. The study population included all women with uterine myoma. Hence, 80 patients were divided into 2 groups of 40. The first group underwent laparotomy-myomectomy and the second underwent UAE. These patients were evaluated for clinical symptoms, menstrual disorders, estimated blood loss per menstrual cycle, and pain and complication on the 10th day, and at 2, 6, and 12 months after the intervention. The data were analyzed with SPSS software (Version 25) using an independent samples t test, a repeated measure analysis, and a chi-square test. Results: Ten days, 2, 6, and 12 months after the intervention, there was no significant difference between the 2 approaches in terms of their decreasing effects on per menstrual cycle blood loss (p > 0.05), respectively. After 10 days and 2 months, the pain intensity in the embolization group was higher than laparotomy group (p = 0.045, 0.060), respectively. The pain intensity was also not significantly different between the 2 groups after 6 months and 1 year (p > 0.05), respectively. Also, the frequency of fever was higher in the embolization group (p = 0.745). However, the documented post-procedural complications indicated that hemoglobin level declined post-operation (p > 0.050). Conclusion: The results showed no significant difference between the 2 groups in terms of post-procedural mensuration blood loss or pain intensity and the incidence of menstrual disorders within 1 year. It seems that there is no significant difference between the 2 groups and it may be possible to use the UAE depending on the patient's condition.

Comparison of Thoracic Manipulation and MET (Muscle Energy Technique) on Chronic Mechanical Neck ache: A Randomized Control Trail

Chronic mechanical neck ache is one of the most disabling conditions in general population which affects individuals’ Activities of Daily Living (ADLs). Objective: To compare the effectiveness of thoracic manipulation and MET on chronic mechanical neck ache. Methods: It was a single blind randomized clinical trial registered at ClivicalTrial.gov under trial registry no# NCT05138199. Non-probability simple random sampling was used to recruit over 30 patients. This study was conducted at Rawal General and Dental Hospital, Islamabad and at the Physiotherapy Clinic Rawalpindi. Two groups were made, group “A” was termed as control group and received MET (2 sessions/week) and group “B” was termed as experimental group and received thoracic manipulation (1 session/week), for six weeks each. Effect of these interventions were evaluated on frequency of pain, duration of pain and Numeric Pain Rating Scale (NPRS). As data were not normally distributed, we employed Wilcoxon Rank test for intra-group analysis and Man Whitney U test for inter-group analysis. Results: Both groups mean +SD of age, gender, and marital status was 26.27+8.55 and 1.60+0.49, 1.20+0.40, respectively. Wilcoxon Rank test showed marked difference within both groups as p-value was &lt;0.05 and “r value &gt;0.05” showed larger effect of interventions. Man-Whitney U test showed no significant difference between groups as p-vale was &gt;0.05. Conclusion: Both manipulation and MET are effective for management of chronic mechanical neck ache and both have same impact on NPS.

Adequacy of an Altitude Fitness Program (Living and Training) plus Intermittent Exposure to Hypoxia for Improving Hematological Biomarkers and Sports Performance of Elite Athletes: A Single-Blind Randomized Clinical Trial.

Athletes incorporate altitude training programs into their conventional training to improve their performance. The purpose of this study was to determine the effects of an 8-week altitude training program that was supplemented with intermittent hypoxic training (IHE) on the blood biomarkers, sports performance, and safety profiles of elite athletes. In a single-blind randomized clinical trial that followed the CONSORT recommendations, 24 male athletes were randomized to an IHE group (HA, n = 12) or an intermittent normoxia group (NA, n = 12). The IHE consisted of 5-min cycles of hypoxia–normoxia with an FIO2 of between 10–13% for 90 min every day for 8 weeks. Hematological (red blood cells, hemoglobin, hematocrit, hematocrit, reticulated hemoglobin, reticulocytes, and erythropoietin), immunological (leukocytes, monocytes, and lymphocytes), and renal (urea, creatinine, glomerular filtrate, and total protein) biomarkers were assessed at the baseline (T1), day 28 (T2), and day 56 (T3). Sports performance was evaluated at T1 and T3 by measuring quadriceps strength and using three-time trials over the distances of 60, 400, and 1000 m on an athletics track. Statistically significant increases (p < 0.05) in erythropoietin, reticulocytes, hemoglobin, and reticulocyte hemoglobin were observed in the HA group at T3 with respect to T1 and the NA group. In addition, statistically significant improvements (p < 0.05) were achieved in all performance tests. No variations were observed in the immunological or renal biomarkers. The athletes who were living and training at 1065 m and were supplemented with IHE produced significant improvements in their hematological behavior and sports performance with optimal safety profiles.

Horizontal instability after acromioclavicular joint reduction using the two-hole technique is preferred over the loop technique: a single-blind randomized clinical trial.

BackgroundMost acromioclavicular joint (ACJ) injuries are caused by direct trauma to the shoulders, and various methods and techniques are used to treat them; however, none of the options can be considered the gold standard. This study examines the horizontal stability of the ACJ after a complete dislocation was repaired using one of two Ethibond suture techniques, the loop technique and the two holes in the clavicle technique.MethodsIn this single-blind, randomized clinical trial, 104 patients diagnosed with complete ACJ dislocation type V were treated using Ethibond sutures with either the loop technique or the two holes in the clavicle technique. Horizontal changes in the ACJ were radiographically assessed in the lateral axial view, and shoulder function was evaluated by the Constant (CS) and Taft (TS) scores at intervals of 3, 6, and 12 months after surgery. ResultsThe horizontal stability of the ACJ was better with the two-hole technique than the loop technique at all measurement times. CS and TS changes showed a significant upward trend over time with both techniques. The mean CS and TS at the final visit were 95.2 and 11.6 with the loop technique and 94.0 and 11.9 with the two-hole technique, respectively. The incidence of superficial infections caused by the subcutaneous pins was the same in the two groups.ConclusionsDue to the improved ACJ stability with the two-hole technique, it appears to be a more suitable option than the loop technique for AC joint reduction.

Effect of Telenursing on Caregiver Burden of Care and Incidence of some Complications in Patients with Acute Stroke Discharged from Neurological Wards: A Randomized Control Trial

Background: Brain stroke is the main cause of death and disability worldwide. This disease can cause major complications in patients and place a great burden of care on caregivers. Therefore, this study was conducted to determine the effect of telenursing on the burden of care in caregivers and the rate of complications in patients with acute brain stroke discharged from neurological wards. Methods: This two-arm parallel-group single-blind randomized clinical trial study was carried out on 72 patients with acute brain stroke discharged from neurological wards in Qom, Iran, in 2019. The patients and their caregivers were divided to control and intervention groups using random block allocation. In addition to the usual training of the ward, the intervention group received training and counseling based on their needs through phone calls for 4 weeks. However, the control group received only the usual ward training. Immediately after discharge from the hospital and 1 month later, the average care load in caregivers and urinary problems, bedsores, and the number of falls in patients were measured. A demographic questionnaire, Caregiver Burden Inventory, Braden Scale, Morse Scale, and a urinary problem checklist were used for data collection. The data were analyzed using the chi-square test, Mann-Whitney U test, independent t-test, and paired t-test by SPSS software (version 24). Results: After the intervention, the mean scores of the caregiver’s burden of care in the control and counseling groups were 35.22 ± 17.215 and 8.00 ± 7.556, respectively (P &lt; 0.001). In addition, the counseling group experienced remarkably fewer urinary problems (P &lt; 0.001) and falling (P = 0.011). Conclusions: This study showed that telenursing reduced the burden of care in caregivers and decreased urinary tract infections and the number of falls in patients with acute stroke. Therefore, nurses and healthcare providers can use this program to improve the lifestyle of patients with acute brain stroke and their caregivers.

Effects of a supervised exercise program in addition to electrical stimulation or kinesio taping in low back pain: a randomized controlled trial

Chronic low back pain it is one of the most common health problems worldwide. Usually is accompanied by a complex set of symptoms and generates significant direct and indirect socioeconomic and health costs. From a therapeutic point of view, there are a wide variety of methods to address the treatment of this pathology, however, these therapies have not been shown definitive efficacy. To investigate the effect of a mixed treatment with exercise and electrical stimulation versus exercise and kinesio taping in patients with non-specific chronic low back pain. A total of 58 patients participated in this single-blinded randomised clinical trial. Participants were assigned to the exercises- kinesio taping group, or exercises- analgesic current group, both received 12 treatment sessions. Disability, fear of movement, anxiety, depression, sleeps quality, pain, lower limb mechanosensitivity and pressure-pain thresholds were recorded at baseline and after 4 weeks of treatment. The 2 × 2 mixed analysis of covariance test showed statistically significant differences between groups for pain (P = 0.046). Pair-wise comparisons with baseline demonstrated significant differences for both groups in pain (P ≤ 0.001), disability (P ≤ 0.001), pressure-pain thresholds (P ≤ 0.044), lower limb mechanosensitivity, (P ≤ 0.047), anxiety (P ≤ 0.001), depression (P ≤ 0.001) and sleep quality (P ≤ 0.010). Patients with chronic low back pain who received a combined treatment of exercises and kinesio taping or analgesic current showed an improvement in pain, disability, anxiety, depression and sleep pattern. Moreover, exercises combined with electrotherapy produces greater improvements over these variables.Trial registration: NCT02812459.

A prospective single-blind randomised clinical trial comparing two treatment tables for the initial management of mild decompression sickness.

Limited evidence suggests that shorter recompression schedules may be as efficacious as the US Navy Treatment Table 6 (USN TT6) for treatment of milder presentations of decompression sickness (DCS). This study aimed to determine if divers with mild DCS could be effectively treated with a shorter chamber treatment table. All patients presenting to the Fremantle Hospital Hyperbaric Medicine Unit with suspected DCS were assessed for inclusion. Participants with mild DCS were randomly allocated to receive recompression in a monoplace chamber via either a modified USN TT6 (TT6m) or a shorter, custom treatment table (FH01). The primary outcome was the number of treatments required until resolution or no further improvement (plateau). Forty-one DCS cases were included, 21 TT6m and 20 FH01. Two patients allocated to FH01 were moved to TT6m mid-treatment due to failure to significantly improve (as per protocol), and two TT6m required extensions. The median total number of treatments till symptom resolution was 1 (IQR 1-1) for FH01 and 2 (IQR 1-2) for TT6m (P = 0.01). More patients in the FH01 arm (17/20, 85%) showed complete symptom resolution after the initial treatment, versus 8/21 (38%) for TT6m (P = 0.003). Both FH01 and TT6m had similar overall outcomes, with 19/20 and 20/21 respectively asymptomatic at the completion of their final treatment (P = 0.97). In all cases where two-week follow-up contact was made, (n = 14 FH01 and n = 12 TT6m), patients reported maintaining full symptom resolution. The median total number of treatments till symptom resolution was meaningfully fewer with FH01 and the shorter treatment more frequently resulted in complete symptom resolution after the initial treatment. There were similar patient outcomes at treatment completion, and at follow-up. We conclude that FH01 appears superior to TT6m for the treatment of mild decompression sickness.

Effect of sterile tetracycline ophthalmic ointment as an adjuvant to mechanical debridement on the treatment of peri-implantitis: A randomized controlled clinical trial.

Background Peri-implantitis is an infectious disease that affects the tissues around dental implants, with clinical signs of inflammation and irreversible loss of supporting bone. This study aimed to compare the effect of sterile topical tetracycline ophthalmic ointment as an adjuvant to mechanical debridement with mechanical debridement alone in the treatment of peri-implantitis. Methods In this single-blind randomized clinical trial, 32 patients (16 patients in each group) with peri-implantitis were treated topically using sterile tetracycline ophthalmic ointment. Four clinical parameters, including modified bleeding index (mBI), modified plaque index (mPI), probing depth (PD), and clinical attachment level (CAL), were measured at baseline and at 3- and 6-month follow-up intervals. Results PD reduction was statistically significant after 3 and 6 months in the test and control groups (P=0.001). Also, mPI and mBI reduction rates were significant in the test and control groups (P=0.001) after 3 and 6 months. However, in all the samples in the two groups, the mean of CAL before and after treatment was constant, with no significant difference (P>0.05). Conclusion Using sterile ocular tetracycline ointment could be an adjunctive treatment in improving and enhancing the therapeutic effects of mechanical debridement in the treatment of peri-implantitis. (IRCT20210909052418N1)

Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair

Urinary catheters are commonly placed during laparoscopic inguinal hernia repair as a presumed protection against postoperative urinary retention (PUR), one of the most common complications following this operation. Data from randomized clinical trials evaluating the effect of catheters on PUR are lacking. To investigate the effect of intraoperative catheters on PUR after laparoscopic inguinal hernia repair. This 2-arm registry-based single-blinded randomized clinical trial was conducted at 6 academic and community hospitals in the US from March 2019 to March 2021 with a 30-day follow-up period following surgery. All patients who presented with inguinal hernias were assessed for eligibility, 534 in total. Inclusion criteria were adult patients undergoing laparoscopic, elective, unilateral, or bilateral inguinal hernia repair. Exclusion criteria were inability to tolerate general anesthesia and failure to understand and sign the written consent form. A total of 43 patients were excluded prior to intervention. Patients in the treatment arm had placement of a urinary catheter after induction of general anesthesia and removal at the end of procedure. Those in the control arm had no urinary catheter placement. PUR rate. Of the 491 patients enrolled, 241 were randomized to catheter placement, and 250 were randomized to no catheter placement. The median (IQR) age was 61 (51-68) years, and 465 participants (94.7%) were male. Overall, 44 patients (9.1%) developed PUR. There was no difference in the rate of PUR between the catheter and no-catheter groups (23 patients [9.6%] vs 21 patients [8.5%], respectively; P = .79). There were no intraoperative bladder injuries. In the catheter group, there was 1 incident of postoperative urethral trauma in a patient who presented to the emergency department with PUR leading to a suprapubic catheter placement. Intraoperative urinary catheters did not reduce the risk of PUR after laparoscopic inguinal hernia repair. While their use did not appear to be associated with a high rate of iatrogenic complications, there may be a low rate of catastrophic complications. In patients who voided urine preoperatively, catheter placement did not appear to confer any advantage and thus their use may be reconsidered. ClinicalTrials.gov Identifier: NCT03835351.

Lavender aromatherapy on anxiety and depression in patients with Acute Coronary Syndrome: a single-blind randomized clinical trial

Abstract Objective In cardiovascular disease, a patient's anxiety and depression can increase cardiac rehabilitation duration and recovery. Lavender aromatherapy as a non-pharmacological intervention effective in other contexts may be an efficient intervention to alleviating anxiety and depression in patients with Acute Coronary Syndrome (ACS). Methods In this study, 110 ACS patients were randomly assigned to two intervention and control groups. Inhalation of the lavender fragrance was prescribed for the intervention group and the drop of aromatic almond for the control group for 3 days. Results The first-day anxiety and depression were significantly different in the two groups at 1 h and 9 h after the intervention. The ’morning's difference before the intervention was not significant, but it was substantial 1 h after the intervention. On the third morning of the intervention, this difference was confirmed. Conclusions This study confirmed the effectiveness of lavender aromatherapy in reducing anxiety and depression in ACS patients. This ‘study's results enable intensive care nurses to use aromatherapy with lavender oil as a non-pharmacological and cost-effective intervention to reduce their psychological tensions and increase patient satisfaction during hospitalization in the cardiac care units (CCU).

The effectiveness of “Women’s Postpartum Sexual Health Program (WPSHP)” on Iranian women’s postpartum sexual health: A randomized clinical trial

In this study, we examined the effectiveness of Women’s Postpartum Sexual Health Program (WPSHP) on Iranian women’s sexual health in the postpartum period. A single-blinded randomized clinical trial was conducted in 2016 on 80 postnatal women in Iran. We used the Female Sexual Function Index, Sexual Quality of Life - Female questionnaire and Female Sexual Distress Scale. The intervention group received counseling based on WPSHP. After 28 weeks, the mean score of the Female Sexual Function Index and Female Sexual Quality of Life significantly increased in the WPSH group (p < 0.001, p < 0.001), while the mean score of the Female Sexual Distress significantly decreased in the WPSH group (p < 0.001). We concluded that Women’s Postpartum Sexual Health Program could promote postnatal women’s sexual function and female sexual quality of life and reduces female sexual distress in women suffering from sexual problems in the postpartum period.

Effect of Supine vs Prone Breast Radiotherapy on Acute Toxic Effects of the Skin Among Women With Large Breast Size

Women with large breast size treated with adjuvant breast radiotherapy (RT) have a high rate of acute toxic effects of the skin. Breast RT in the prone position is one strategy that may decrease these toxic effects. To determine if breast RT in the prone position reduces acute toxic effects of the skin when compared with treatment in the supine position. This phase 3, multicenter, single-blind randomized clinical trial accrued patients from 5 centers across Canada from April 2013 to March 2018 to compare acute toxic effects of breast RT for women with large breast size (bra band ≥40 in and/or ≥D cup) in the prone vs supine positions. A total of 378 patients were referred for adjuvant RT and underwent randomization. Seven patients randomized to supine position were excluded (5 declined treatment and 2 withdrew consent), and 14 patients randomized to prone position were excluded (4 declined treatment, 3 had unacceptable cardiac dose, and 7 were unable to tolerate being prone). Data were analyzed from April 2019 through September 2020. Patients were randomized to RT in the supine or prone position. From April 2013 until June 2016, all patients (n = 167) received 50 Gy in 25 fractions (extended fractionation) with or without boost (range, 10-16 Gy). After trial amendment in June 2016, the majority of patients (177 of 190 [93.2%]) received the hypofractionation regimen of 42.5 Gy in 16 fractions. Main outcome was moist desquamation (desquamation). Of the 357 women (mean [SD] age, 61 [9.9] years) included in the analysis, 182 (51.0%) were treated in the supine position and 175 (49.0%) in prone. There was statistically significantly more desquamation in patients treated in the supine position compared with prone (72 of 182 [39.6%] patients vs 47 of 175 [26.9%] patients; OR, 1.78; 95% CI, 1.24-2.56; P = .002), which was confirmed on multivariable analysis (OR, 1.99; 95% CI, 1.48-2.66; P < .001), along with other independent factors: use of boost (OR, 2.71; 95% CI, 1.95-3.77; P < .001), extended fractionation (OR, 2.85; 95% CI, 1.41-5.79; P = .004), and bra size (OR, 2.56; 95% CI, 1.50-4.37; P < .001). This randomized clinical trial confirms that treatment in the prone position decreases desquamation in women with large breast size receiving adjuvant RT. It also shows increased toxic effects using an RT boost and conventional fractionation. ClinicalTrials.gov Identifier: NCT01815476.

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.