Effects of Palatal Expansion with Torque Activation using a Transpalatal Arch: A Preliminary Single-Blind Randomized Clinical Trial

Purpose. The literature regarding the treatment of posterior crossbites using a transpalatal arch (TPA) is scarce. Moreover, there is only one clinical study on the correction of unilateral crossbites using torque activation. This is an important clinical issue; therefore, this study was conducted to show the effects of an active Goshgarian TPA in correcting nonfunctional single-tooth unilateral crossbite. Methods. The present single-blind, randomized clinical trial examined 60 observations on 30 individuals with nonfunctional single-tooth unilateral crossbites in the first permanent molar area. Patients were randomly divided into two groups of “symmetric expansion” [control] and “expansion + torque activation” using Goshgarian TPAs [experimental]. The palatal arch was expanded at a rate of 2 mm/month, for 2–8 months. The average treatment durations were 157.9 and 117.1 days, respectively, for the control and experimental groups. Dentoskeletal alterations were assessed on dental records, posteroanterior frontal cephalographs, and occlusal radiographs taken before and after treatment. Changes induced by treatments in each group and differences between changes in both groups were analyzed statistically (α = 0.05). Results. The treatment duration was significantly shorter in the experimental group ( P < 0.05 ). The extent of dental displacement on the crossbite side was significant no matter what treatment was applied ( P < 0.001 ); no between-group difference was detected ( P > 0.05 ). Both treatments tilted the teeth in crossbite ( P < 0.001 ) without any between-group difference ( P > 0.05 ). The noncrossbite molar was displaced in the control group, whereas this did not occur in the experimental group (between-group P < 0.001 ). Conclusions. The Goshgarian TPA can be used with torque activation in order to deliver a more effective and faster correction of nonfunctional single-tooth unilateral crossbites with more favorable clinical results.

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Effects of a positive thinking program on hope and sleep quality in Iranian patients with thalassemia: a randomized clinical trial

BMC Psychology ◽

10.1186/s40359-021-00547-0 ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Somayeh Makaremnia ◽

Marieh Dehghan Manshadi ◽

Zahra Khademian

Keyword(s):

Clinical Trial ◽

Sleep Quality ◽

Training Program ◽

Randomized Clinical Trial ◽

Thalassemia Major ◽

Trial Registration ◽

Control Group ◽

Positive Thinking ◽

Experimental Group

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.

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Stress of nursing students in clinical simulation: a randomized clinical trial

Revista Brasileira de Enfermagem ◽

10.1590/0034-7167-2017-0187 ◽

2018 ◽

Vol 71 (3) ◽

pp. 967-974 ◽

Cited By ~ 6

Author(s):

Radamés Boostel ◽

Jorge Vinícius Cestari Felix ◽

Carina Bortolato-Major ◽

Edivane Pedrolo ◽

Stela Adami Vayego ◽

...

Keyword(s):

Clinical Trial ◽

Nursing Students ◽

Randomized Clinical Trial ◽

Interpersonal Relationships ◽

Control Group ◽

High Fidelity ◽

Clinical Simulation ◽

Skill Laboratory ◽

Before And After ◽

Experimental Group

ABSTRACT Objective: To evaluate and compare the perception of stressors by nursing students before and after a high-fidelity clinical simulation or conventional laboratory practice class. Method: This is a randomized clinical trial conducted with 52 nursing students. Both groups had theoretical classes about cardiothoracic physical examination, followed by practice class in skill laboratory. In addition, the experimental group took part in a high-fidelity simulation scenario. Stressors were evaluated before and after class, with the application of KEZKAK questionnaire. Results: The experimental group was significantly more worried about six factors related to lack of competence and to interpersonal relationships (p < 0.05), while the control group was significantly more worried about being in contact with suffering (p = 0.0315). Conclusion: The simulation affects students’ perception of stressors and promotes their self-evaluation and critical thinking regarding the responsibility that comes with their learning.

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Evaluation of the telephone intervention in the promotion of diabetes self-care: a randomized clinical trial

Revista Latino-Americana de Enfermagem ◽

10.1590/1518-8345.0632.2719 ◽

2016 ◽

Vol 24 (0) ◽

Author(s):

Bárbara Sgarbi Morgan Fernandes ◽

Ilka Afonso Reis ◽

Heloisa de Carvalho Torres

Keyword(s):

Physical Activity ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Self Care ◽

The Self ◽

Control Group ◽

Telephone Intervention ◽

Belo Horizonte ◽

Clinical Trials Registry ◽

Experimental Group

ABSTRACT Objective: to evaluate the effectiveness of the telephone intervention for promoting self-care related to physical activity and following a diet plan in users with diabetes, compared to conventional monitoring of users over a six-month period. Method: this was a randomized clinical trial, which included 210 users with diabetes, linked to eight Primary Health Units of Belo Horizonte, Minas Gerais. The experimental group (104 members) received six telephone interventions over the six-month monitoring; the control group (106 members) received conventional monitoring. To evaluate the self-care practices related to physical activity and following a healthy eating plan, in both groups, the self-care questionnaire was applied before the intervention and at three and six months after its start. Results: the mean effect of self-care scores in the experimental group was 1.03 to 1.78 higher than the control group, with progressive and significant improvement (p<0.001). Conclusion: the results indicate that the telephone intervention had a beneficial effect on diabetes self-care. The primary identifier of the clinical trials registry was: RBR-8wx7qb.

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Educational workshops about bonding with the fetus during pregnancy: a clinical trial

Revista Gaúcha de Enfermagem ◽

10.1590/1983-1447.2021.20200330 ◽

2021 ◽

Vol 42 ◽

Author(s):

Priscila Costa ◽

Paula Rosenberg de Andrade ◽

Bruna Arends Roschel Tomaz ◽

Samara Macedo Cordeiro ◽

Danielle Castro Jansen ◽

...

Keyword(s):

Clinical Trial ◽

Child Development ◽

Usual Care ◽

Pregnant Women ◽

Randomized Clinical Trial ◽

Gestational Age ◽

Health Clinic ◽

Control Group ◽

Before And After ◽

Experimental Group

ABSTRACT Objective: To verify if participation in educational workshops about bonding with the fetus influences the adoption of practices of interaction with the baby by pregnant women. Method: Randomized clinical trial conducted in a health clinic. The experimental group participated in educational workshops designed for the pregnant couple and the control group received usual care. The practices of interaction with the fetus were evaluated before and after the intervention. Results: 19 pregnant women participated in the study. There was a positive correlation between higher gestational age and the interaction with the fetus (p = 0.016), and between younger mothers and the practice of touching or poking the baby (p = 0.019). There was an increase in the interaction with the fetus in the control and experimental groups (p= 0.024). Conclusion: Educational workshops are strategies for sharing knowledge about fetuses' sensory skills and to foster bonding and child development since pregnancy.

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Impact of Mouthwashes on Antibacterial Activity of Subjects with Fixed Orthodontic Appliances: A Randomized Clinical Trial

The Journal of Contemporary Dental Practice ◽

10.5005/jp-journals-10024-2185 ◽

2017 ◽

Vol 18 (12) ◽

pp. 1112-1116

Author(s):

A Nishad ◽

NS Sreesan ◽

Joseph Joy ◽

Lakshmi Lakshmanan ◽

Joyce Thomas ◽

...

Keyword(s):

Clinical Trial ◽

Antibacterial Activity ◽

Randomized Clinical Trial ◽

Control Group ◽

Orthodontic Appliances ◽

Group I ◽

Fixed Orthodontic Appliances ◽

Significant Difference ◽

The Impact ◽

Experimental Group

ABSTRACT Aim The study aimed to assess the impact of mouthwashes on antibacterial activity of individuals with fixed orthodontic appliances. Materials and methods A total of 60 individuals were considered in the study. Sixty (20 each group) nonextraction class I individuals were randomly divided into experimental and control groups. Group I: Experimental group [chlorhexidine (CHX) mouthwash], group II: Experimental group (neem mouthwash), group III: Control group (distilled water). All the clinical examinations were done at baseline and 30th day respectively, after the start of orthodontic treatment. The mean differences between the different experimental groups were calculated using one-way analysis of variance (ANOVA) test. Results There was no statistical significance at baseline mean plaque index (PI), gingival index (GI) scores, and Streptococcus mutans (SM) colony count between groups. The PI and GI scores among CHX and neem mouthwash groups (p = 0.002, p = 0.032 respectively) were significantly reduced after intervention and also the SM colonies count was reduced in CHX and neem mouthwash groups and there was significant difference between the groups. Conclusion As both mouthwashes showed significant effectiveness on antibacterial activity in individuals with fixed orthodontic appliances, neem mouthwash can be used as an alternative to CHX. Clinical significance It is better to have a sound knowledge regarding the use of mouthwash in long term as fixed orthodontics are associated with accumulation of SM, enamel demineralization, and an increased number of carious lesions, predominantly in sites adjacent to bracket. How to cite this article Nishad A, Sreesan NS, Joy J, Lakshmanan L, Thomas J, Anjali VA. Impact of Mouthwashes on Antibacterial Activity of Subjects with Fixed Orthodontic Appliances: A Randomized Clinical Trial. J Contemp Dent Pract 2017;18(12):1112-1116.

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The Effect of Lavender Oil on Sleep Quality and Vital Signs in Palliative Care: A Randomized Clinical Trial

Complementary Medicine Research ◽

10.1159/000507319 ◽

2020 ◽

Vol 27 (5) ◽

pp. 328-335

Author(s):

Dilek Yıldırım ◽

Vildan Kocatepe ◽

Gülbeyaz Can ◽

Ebru Sulu ◽

Handan Akış ◽

...

Keyword(s):

Clinical Trial ◽

Palliative Care ◽

Sleep Quality ◽

Randomized Clinical Trial ◽

Vital Signs ◽

Control Group ◽

Lavender Oil ◽

The Awakening ◽

Falling Asleep ◽

Experimental Group

Background: This study was conducted to determine the effect of lavender oil on sleep quality and vital signs in palliative care patients. Methods: We examined 68 patients in a palliative care unit. Vital signs of all the patients were assessed, and also their sleep quality was evaluated using the Richards-Campbell Sleep Questionnaire. Lavender was applied to patients in the experimental group. During the intervention, vital signs of the patients were monitored at 4-h intervals throughout the night, and sleep quality was evaluated during the morning. The same evaluation processes were performed for the control group. Results:It was observed in the evaluation that lavender application did not affect the vital signs of the patients but it ensured a deeper sleep on the 2nd day after the intervention, facilitated their falling asleep and sleeping again when they were awakened and enhanced sleep quality (p < 0.05). Also, this application decreased the awakening frequency on the 1st and 2nd days and enhanced overall sleep quality (p < 0.05) after the intervention. Conclusions: Lavender has no effect on the vital signs of palliative care patients but is an effective and reliable approach to enhance their sleep quality.

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Effect of lavender aromatherapy on well-being among hemodialysis patients: A randomized clinical trial

Pharmaceutical and Biomedical Research ◽

10.18502/pbr.v4i2.215 ◽

2018 ◽

Author(s):

Masoumeh Bagheri Nesami ◽

Seyed Afshin Shorofi ◽

Attieh Nikkhah ◽

Hossein Roohi Moghaddam ◽

Ali Mahdavi

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Well Being ◽

Underlying Disease ◽

Hemodialysis Patients ◽

Control Group ◽

Significant Difference ◽

The Mean ◽

And Control ◽

Experimental Group

In spite of the improvement of dialysis techniques, hemodialysis patients still experience debilitation. Impaired functioning, well-being, and quality of life are among the factors that are of a great concern in these patients. The current study aimed to examine the effects of lavender essential oil on well-being among hemodialysis patients. This randomized clinical trial was conducted on 30 hemodialysis patients. For each patient in the experimental group, five cotton balls were prepared using two drops of lavender essence diluted with sweet almond oil. Lavender was used at five concentrations of 10%, 20%, 30%, 40%, and 50%, administered through pinning the soaked cotton ball on the patients' collar on the first, second, third, fourth, and fifth weeks of the intervention, respectively. The patients were asked to breathe normally for 20 min. On the other hand, the control group received only routine nursing care. The perceived sense of well-being was measured in both groups at the end of each week using a visual analog scale. The mean ages of patients were obtained as 58.9 ± 14.31 and 53.03 ± 15.84 years for the experimental and control groups, respectively. Hypertension was reported to be the most common underlying disease in both groups. The results showed a significant difference in the mean level of well-being in the experimental group in the fourth and fifth weeks of the intervention, compared to that before the intervention. Inhalation aromatherapy with 40% and 50% lavender essence had a positive effect on the perceived sense of well-being in hemodialysis patients. However, lower concentrations of 10%, 20%, and 30% did not exert a comparable effect.

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Effectiveness of Acupressure on the Taichong Acupoint in Lowering Blood Pressure in Patients with Hypertension: A Randomized Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2016/1549658 ◽

2016 ◽

Vol 2016 ◽

pp. 1-9 ◽

Cited By ~ 2

Author(s):

Gan-Hon Lin ◽

Wei-Chun Chang ◽

Kuan-Ju Chen ◽

Chen-Chen Tsai ◽

Sung-Yuan Hu ◽

...

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Care Plan ◽

Control Group ◽

Optimal Dosage ◽

Hypertensive Patients ◽

Significant Difference ◽

And Control ◽

Experimental Group

Objectives. To evaluate the effectiveness of acupressure on the Taichong acupoint in lowering systolic and diastolic blood pressure (BP) in hypertensive patients.Methods. Eighty patients with hypertension attending a cardiology outpatient department in central Taiwan were included in this randomized clinical trial. Acupressure was applied to the Taichong acupoint in the experimental group (n=40) and to the first metatarsal (sham acupoint) in the control group (n=40). Blood pressure was measured by electronic monitoring before and immediately 15 min and 30 min after acupressure.Results. The average age of the experimental and control participants was 59.3 ± 9.2 years and 62.7 ± 8.4 years, respectively. The two groups were similar for demographics and antihypertensive drug use. Mean systolic and diastolic BP in the experimental group decreased at 0, 15, and 30 min after acupressure (165.0/96.3, 150.4/92.7, 145.7/90.8, and 142.9/88.6 mmHg); no significant changes occurred in the control group. There was a significant difference in systolic and diastolic BP between the experimental and control groups immediately and 15 and 30 min after acupressure (p<0.05).Conclusion. Acupressure on the Taichong acupoint can lower BP in hypertensive patients and may be included in the nursing care plan for hypertension. However, additional studies are needed to determine the optimal dosage, frequency, and long-term effects of this therapy.

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Calcitriol Effect on Outcomes of in Vitro Fertilization in Infertile Women with Vitamin D Deficiency: A Double-Blind Randomized Clinical Trial

Zeitschrift für Geburtshilfe und Neonatologie ◽

10.1055/a-1206-1064 ◽

2020 ◽

Author(s):

Leila Doryanizadeh ◽

Bahar Morshed-Behbahani ◽

Mohammad Ebrahim Parsanezhad ◽

Mohammad Hossein Dabbaghmanesh ◽

Azam Jokar

Keyword(s):

Clinical Trial ◽

Vitamin D ◽

Vitamin D Deficiency ◽

Randomized Clinical Trial ◽

Active Form ◽

Clinical Pregnancy ◽

Control Group ◽

Case Group ◽

Infertile Women ◽

Experimental Group

Abstract Introduction Recent studies have addressed the role of micronutrients in fertilization, such as vitamin D. The present study aims to explore the effects of using calcitriol, an active form of vitamin D, on IVF results in women with vitamin D deficiency. Method This double-blinded randomized clinical trial was done on 180 infertile women, undergone IVF treatment. Out of them, 95 were found to have vitamin D deficiency (blood serum 25-dihydroxy vitamin D <30 ng/ml). Fifty one women in experimental group were treated with two 0.25 µg calcitriol pills daily during 4 weeks (discontinued 8 hours prior to the embryo transfer) and 44 subjects to the placebo group (mean vitamin D deficiency 27.5 ±1.8 in case group vs. 27.6±1.8 in control group, P>0.05). Final analysis includes outcomes of chemical and clinical pregnancy was done on 74 women (including 36 in case and 38 in control group). Results Our study showed that in the experimental group, chemical pregnancy success was significantly higher than that in the control group, 31.4 vs. 18.2% (P<0.05). However, there were no significant differences between the 2 groups in reaching the clinical pregnancy stage (25.5% in case group vs. 13.6% in control group) and continuation of pregnancy into week 20 (9.8% in case group vs. 11.6% in control group) (P>0.05). Conclusion Calcitriol administration by improving the implantation process can significantly increase the chances of successful IVF cycle results in infertile women with vitamin D deficiency.

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The Efficacy of Temozolomide Combined with Levetiracetam for Glioblastoma (GBM) After Surgery: a Study Protocol for a Double-Dlinded and Randomized Controlled Trial

10.21203/rs.3.rs-1036843/v1 ◽

2021 ◽

Author(s):

Maoyuan Sun ◽

Ning Huang ◽

Yihao Tao ◽

Rong Wen ◽

Guanjian Zhao ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Karnofsky Performance Status ◽

Controlled Trial ◽

Performance Status ◽

Objective Response ◽

Control Group ◽

Double Blind ◽

Experimental Group ◽

Temozolomide Chemotherapy

Abstract Background: Temozolomide is applied as the standard chemotherapy agent in patients with glioblastoma (GBM) after surgery. However, the benefit of this treatment for patients is limited by the invasive growth of glioma and drug resistance. There are indications from fundamental experimental and retrospective studies that levetiracetam has the potential to improve the survival rate of GBM patients. However, it has yet to be ascertained whether the combination of temozolomide and levetiracetam is more effective than temozolomide chemotherapy alone. Therefore, we designed a randomized clinical trial to investigate the therapeutic effect of the new combined regime for the treatment of GBM.Methods/design: This is a double-blind and randomized clinical trial carried out in a single center. A total of 142 patients will be recruited and screened for the inclusion and exclusion criteria. Then, eligible participants will be enrolled and randomly allocated into an Experimental group or a Control group in a 1:1 ratio. Based on the administration of radiation therapy (RT), participants in the Experimental group will be prescribed levetiracetam plus temozolomide chemotherapy for 34 weeks while participants in the Control group will be prescribed placebo tablets plus temozolomide for the same duration. All patients will be followed-up for three years after intervention. Accordingly, the primary outcome will be progression-free survival (PFS). The secondary endpoints include overall survival (OS), the Karnofsky Performance Status (KPS), the objective response rate (ORR), and the incidence of adverse events. Discussion: The results of this trial are expected to provide high-level evidence regarding the clinical benefits of the combination of levetiracetam and temozolomide in the treatment of GBM.Trial registration: www.ChiCTR.org.cn, ID: ChiCTR-2100049941. Registered on 14thAugust 2021.

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