Effects of flower essences on nursing students’ stress symptoms: a randomized clinical trial

Abstract Objective: To analyze the effects of flower essence bouquets on the signs and symptoms of stress in nursing students. Method: Randomized clinical trial, triple blind, with two groups, flower essence group and placebo group, carried out with 101 nursing students. The groups used the formula for 60 days at a dosage of 4 drops 4 times a day. The outcome was evaluated using the Baccaro Test and the Perceived Stress Scale applied at the beginning and at the end of the intervention. The outcome analysis was performed using the mixed effects model, with 〈 = 5% and the effect size verified by the Cohen’s d test. Results: There was no significant difference between the groups in stress reduction (p > 0.05). Both groups showed a reduction in scale scores (p < 0.001) with large effect size. There was an influence of the COVID-19 pandemic in the reduction of Baccaro Test scores. Conclusion: The intervention with flower essence therapy was not more effective than placebo in reducing stress signs and symptoms. Brazilian Registry of Clinical Trials: UTN U1111–1257-5715.

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Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽

10.1186/s12885-021-08197-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Safa Najafi ◽

Maryam Ansari ◽

Vahid Kaveh ◽

Shahpar Haghighat

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Single Dose ◽

Side Effects ◽

Randomized Clinical Trial ◽

Cancer Patients ◽

Injection Site Reaction ◽

Study Groups ◽

Breast Cancer Patients ◽

Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

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Complications and surgical results of stone-directed antegrade pyelography compared to the retrograde pyelographic access method in percutaneous nephrolithotomy using ‘bull’s eye’ technique: A randomized clinical trial

Journal of Clinical Urology ◽

10.1177/2051415821993729 ◽

2021 ◽

pp. 205141582199372

Author(s):

Dariush Irani ◽

Abdolreza Haghpanah ◽

Mohammad Mehdi Hosseini ◽

Leila Malekmakan ◽

Mohammad Ali Ashraf ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Percutaneous Nephrolithotomy ◽

Renal Stones ◽

Surgical Results ◽

Retrograde Pyelography ◽

Antegrade Approach ◽

Antegrade Pyelography ◽

Significant Difference ◽

Bull's Eye

Objectives: This study aimed to evaluate the differences in outcomes and complications in stone-directed antegrade pyelography using the ‘bull’s eye’ technique in patients with renal stones versus the conventional method of percutaneous nephrolithotomy (PCNL). Although conventional PCNL access using retrograde pyelography is useful, it is time-consuming and may cause postoperative discomfort. Herein, we report our experience in the application of this new technique. Methods: Between January 2017 and June 2018, 100 patients participated in this randomized clinical trial. Stone-directed antegrade pyelography using the ‘bull’s eye’ technique under fluoroscopic guidance was used for percutaneous access in the intervention group. The second group, consisting of those who had undergone conventional PCNL using retrograde pyelography and ‘bull’s eye’ technique in the same period, were considered as the controls. Pre- and postoperative laboratory examinations, surgical results and complications were recorded and compared between the two groups. Results: A single calyceal puncture in partial staghorn and staghorn stone patients was sufficient in 72.2% of the antegrade group and in 78.9% of the retrograde group ( p=0.69). The double-puncture technique was necessary for 71.9% of renal pelvis stones in the antegrade group and for 9.4% in the retrograde group ( p<0.001). The antegrade approach reduced the mean operative time and analgesic requirement significantly ( p<0.001). No statistically significant difference, however, was found between the two groups regarding stone migration to the ureter, radiation time and postoperative complications. Conclusions: The stone-directed antegrade approach using the ‘bull’s eye’ technique is a safe and accurate method in PCNL access in patients with radiopaque and semi-opaque renal stones.

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Topical Low Dose Preservative-Free Hydrocortisone Reduces Signs and Symptoms in Patients with Chronic Dry Eye: A Randomized Clinical Trial

Advances in Therapy ◽

10.1007/s12325-019-01137-8 ◽

2019 ◽

Vol 37 (1) ◽

pp. 329-341 ◽

Cited By ~ 4

Author(s):

Martin Kallab ◽

Stephan Szegedi ◽

Nikolaus Hommer ◽

Hannes Stegmann ◽

Semira Kaya ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Dry Eye ◽

Low Dose ◽

Signs And Symptoms ◽

Preservative Free

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Dance Rhythms Improve Motor Symptoms in Individuals with Parkinson’s Disease: A Randomized Clinical Trial

Journal of Dance Medicine & Science ◽

10.12678/1089-313x.031522a ◽

2021 ◽

Author(s):

Jéssica A. Moratelli ◽

Kettlyn H. Alexandre ◽

Leonessa Boing ◽

Alessandra Swarowsky ◽

Clynton L. Corrêa ◽

...

Keyword(s):

Parkinson’S Disease ◽

Clinical Trial ◽

Parkinson's Disease ◽

Randomized Clinical Trial ◽

Rating Scale ◽

Freezing Of Gait ◽

Motor Symptoms ◽

Score Change ◽

Significant Difference ◽

Binary Group

Background: Evidence-based practices involving dance modalities found in binary (two-beat rhythm) or quaternary (four-beat rhythm) show that dance positively influences the motor aspects of disease.Aim: This randomized clinical trial aimed to analyze the effect of two dance rhythm (binary and quaternary) on the balance, gait, and mobility in individuals with Parkinson’s disease (PD). Methods: Thirty-one individuals with PD were randomized into the binary group (n = 18) and the quaternary group (n = 13). Both groups participated in different dance rhythms lasting 12 weeks, twice a week, for 45 minutes. Results: The binary group showed a significant difference in balance (p = 0.003), freezing of gait (p = 0.007), as well as in the motor aspects of MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), with emphasis on the total values with a score change of 3.23. In the quaternary group, significant differences were found in balance (p = 0.021) with a score change of -2.54 and in the motor aspects of the MDS-UPDRS Part III where the total values stood out with a change of 3.54. Discussion: When comparing the possible effects of binary and quaternary rhythms on the motor symptoms of individuals with PD, it was demonstrated that binary rhythm improved balance, freezing gait, and UPDRSIII. As for the quaternary rhythm, the benefits were in balance and the UPDRSIII. Conclusion: The binary and the quaternary rhythm dance protocols positively influenced the motor symptoms of individuals with PD after 12 weeks of intervention.

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Efficacy of auriculotherapy for the reduction of stress in nursing students: a randomized clinical trial

Revista Latino-Americana de Enfermagem ◽

10.1590/s0104-11692012000400013 ◽

2012 ◽

Vol 20 (4) ◽

pp. 727-735 ◽

Cited By ~ 7

Author(s):

Juliana Miyuki do Prado ◽

Leonice Fumiko Sato Kurebayashi ◽

Maria Júlia Paes da Silva

Keyword(s):

Clinical Trial ◽

Nursing Students ◽

Sham Group ◽

School Of Nursing ◽

The Third ◽

Stress Symptoms ◽

Single Blind ◽

Very High ◽

Single Blind Trial

This study is a randomized single-blind trial, which aimed to evaluate the efficacy of true auriculotherapy and placebo auriculotherapy in reducing the stress levels of mid-level Nursing students of the School of Nursing of the Beneficência Portuguesa Hospital. Seventy-one students with average, high and very high scores, according to Vasconcellos' List of Stress Symptoms, were divided into three groups: Control (25), Auriculotherapy (24), and Placebo/Sham (22). They were evaluated at the baseline, 8th and 12th sessions and at the follow-up (15 days) and received Shen Men and Brainstem points (Auriculotherapy Group) and Wrist and Outer Ear points (Placebo/Sham Group). The analysis of variance (ANOVA) showed statistically significant differences between the Control/Auriculotherapy groups from the 8th session, which was maintained in the third and fourth evaluations (p=0.000) and between the Control/Placebo groups (p<0.05) at the three evaluations. It was concluded that the true auriculotherapy obtained better responses (45.39%) than the placebo (34.18%) in the reduction of the stress, but further studies are recommended for the re-evaluation of the sham points for stress. ClinicalTrials.gov Identifier: NCT01420848.

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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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Effect of Acupressure on Stress and Anxiety of Patients with Multiple Sclerosis: A Sham-controlled Randomized Clinical Trial

Complementary Medicine Journal ◽

10.32598/cmja.10.3.1020.1 ◽

2020 ◽

Vol 10 (3) ◽

pp. 270-283

Author(s):

Mohammad Ali Nahayati ◽

◽

Seyed Abolfazl Vaghar Seyyedin ◽

Hamid Reza Bahrami-Taghanki ◽

Zahra Rezaee ◽

...

Keyword(s):

Multiple Sclerosis ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Test Scores ◽

Sham Group ◽

Applied Pressure ◽

Intervention Group ◽

T Test ◽

Significant Difference ◽

The Mean

Objective: Stress and anxiety are common in patients with Multiple Sclerosis (MS). These complications exacerbate the symptoms of MS. This study aims to evaluate the effect of acupressure on stress and anxiety of MS patients. Methods: In this randomized clinical trial, participants were 106 MS Patients referred to Multiple Sclerosis Society in Mashhad, Iran. After signing an informed consent form, they completed a demographic form and stress, and the Depression Anxiety Stress Scale - 42 items (DASS-42). Then, they were randomly assigned into intervention and sham groups by tossing a coin. Participants in the intervention group were asked apply a pressure on the Shenmen and Yin Tang acupoints for one month (once per day for 15 minutes), while the sham group applied pressure 2.5 cm below the Shenmen acupoint and 3 cm above the Yin Tang acupoint. Participants in each group were then completed the DASS-42 again one hour after the final session. Data were analyzed using chi-square test, Kolmogorov-Smirnov test, independent t-test, and Paired t-test. Results: In the intervention and sham groups, there was no statistically significant difference between the mean pre-test scores of stress (34.73±5.80 vs. 33.06±6.42) and anxiety (27.09±6.99 vs. 25.31±6.88), and neither between the mean post-test scores of stress (29.20±6.21 vs. 33.73±9.44) and anxiety (22.79±5.68 vs. 25.21±6.72) (P>0.05). However, comparison of DASS-42 scores between groups showed that the mean scores of stress and anxiety in the intervention group were significantly lower than in the sham group (P< 0.05). Conclusion: It seems that acupressure can be used along with other therapeutic and pharmacological interventions to reduce stress and anxiety in patients with MS.

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Shear Bond Strength of Brackets Bonded with Self-Etching Primers Compared to Conventional Acid-Etch Technique: A Randomized Clinical Trial

Frontiers in Dentistry ◽

10.18502/fid.v14i4.2083 ◽

2019 ◽

Author(s):

Nasrin Farhadian ◽

Amirfarhang Miresmaeili ◽

Vahid Shahidi Zandi

Keyword(s):

Clinical Trial ◽

Bond Strength ◽

Randomized Clinical Trial ◽

Shear Bond Strength ◽

Allocation Concealment ◽

Wilcoxon Test ◽

Adhesive Remnant Index ◽

Significant Difference ◽

Acid Etch ◽

Registration Number

Objectives: The purpose of this randomized clinical trial (RCT) was to compare the shear bond strength (SBS) of orthodontic brackets bonded to enamel with conventional acid-etch (AE) technique and self-etching primers (SEP). Materials and Methods: Twenty-two patients, requiring extraction of two bicuspids for orthodontic reasons, were recruited. In each individual, following blinding and allocation concealment, one intact premolar received conventional AE, whereas the contralateral premolar received SEP with a split-mouth design. Bonded brackets remained in the oral cavity for two months. Afterward, the teeth were extracted without debonding the brackets. SBS and adhesive remnant index (ARI) were measured using a Universal Instron machine and a stereomicroscope, respectively. Results: The mean SBS of the conventional AE and SEP groups was 9.53 and 9.20 MPa, respectively. Paired t-test showed no statistically significant difference between the two groups (P=0.096). Comparison of ARI between the two groups, using Wilcoxon test, indicated that significantly less adhesive remained on enamel with brackets bonded with SEP compared to brackets bonded with conventional AE (P<0.001) although the SBS was higher in the AE group. Conclusion: The present study indicated that although there is no significant difference in SBS between SEP and conventional AE for bonding orthodontic metal brackets, the amount of residual adhesive on the enamel surface is significantly less with SEP than with conventional AE. (IRCT registration number: IRCT201705099086N3).

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O12 OPEN PREPERITONEAL INGUINAL HERNIA REPAIR, TREPP VERSUS TIPP IN A RANDOMIZED CLINICAL TRIAL

British Journal of Surgery ◽

10.1093/bjs/znab396.011 ◽

2021 ◽

Vol 108 (Supplement_8) ◽

Author(s):

Willem Bökkerink ◽

Giel Koning ◽

Patrick Vriens ◽

Roland Mollen ◽

Willem Akkersdijk ◽

...

Keyword(s):

Clinical Trial ◽

Inguinal Hernia ◽

Hernia Repair ◽

Learning Curve ◽

Randomized Clinical Trial ◽

Inguinal Hernia Repair ◽

Recurrence Rates ◽

Significant Difference ◽

Related Quality

Abstract Aim The preperitoneal mesh position for inguinal hernia repair showed beneficial results regarding Chronic Postoperative Inguinal Pain (CPIP) with low recurrence rates. Two open preperitoneal techniques, the TransREctus Sheath PrePeritoneal (TREPP) and the TransInguinal PrePeritoneal (TIPP) technique, were compared in a randomized clinical trial with the hypothesis of less patients with CPIP after TREPP due to complete avoidance of nerve contact. Materials and Methods Adult patients with a primary unilateral inguinal hernia were randomized to either TREPP or TIPP in four hospitals. Prior to the trial’s start the study protocol was ethically approved and published. Outcomes included CPIP after 1 year (primary outcome) and recurrence rates, adverse events and Health related Quality of Life (secondary outcomes). Follow-up was performed at 2 weeks, 6 months and 1 year. Results Baseline characteristics were comparable in both groups. Pain was less often present after TREPP at 2 weeks and 6 months, but the CPIP at rest at 1 year was comparable 1.9% after TREPP vs 1.4% after TIPP, p = 0.535). The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, p = 0.022). Corrected for a learning curve for TREPP, no significant difference could be assessed (TREPP 5.7% and TIPP 4.8%, p = 0.591). Conclusions both the TREPP and TIPP technique resulted in a low incidence of CPIP after 1 year follow-up. The TREPP method can be considered a solid method for inguinal hernia repair if expertise is present. The learning curve of the TREPP techniques needs further evaluation.

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Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

10.31487/j.jicoa.2021.04.01.sup ◽

2021 ◽

Author(s):

Maj Siercke ◽

Sanne Pagh Moller ◽

Lau Caspar Thygesen ◽

Henrik Sillesen ◽

Dorthe Overgaard

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Clinical Trial ◽

Mixed Methods ◽

Usual Care ◽

Randomized Clinical Trial ◽

Intermittent Claudication ◽

Walking Distance ◽

Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

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