Impact of inhalation aromatherapy with Damask Rose (Rosa damascena) on stress, anxiety and hemodynamic parameters of patients undergoing coronary angiography: a single blind randomized clinical trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ali Bikmoradi ◽  
Ghodratollah Roshanaei ◽  
Shirin Moradkhani ◽  
Azad Fatahi
Keyword(s):  
Clinical Trial ◽  
Coronary Angiography ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Rosa Damascena ◽  
Hemodynamic Parameters ◽  
Coronary Artery Angiography ◽  
Before And After ◽  
And Control ◽  
Single Blind

Abstract Objectives Coronary arteries angiography is used commonly for diagnosing cardiovascular diseases. In spite of the low risk of coronary artery angiography method, it could lead to stress, anxiety and consequently hemodynamic changes in patients. This study aimed to assess the effects of inhalation aromatherapy with Rosa damascena on stress, anxiety, and hemodynamic parameters of patients undergoing coronary angiography. Methods A single-blind randomized clinical trial was conducted on 98 patients in Besat Educational Hospital, Hamadan, Iran. Before coronary angiography, patients at aromatherapy group inhaled five drops of 40% Rosa damascena for 20 min and in the control group, patients inhaled distilled water. Stress, anxiety, and hemodynamic parameters were measured before and after the intervention using DASS-21 questionnaire and checklist. Results Data were analysed by SPSS 16 software using descriptive and inferential statistics such as paired t-test and non-parametric tests. There were significant differences in terms of stress and anxiety severity in patients at aromatherapy group (p=0.005) and control group (p=0.001). There were significant differences in terms of hemodynamic parameters such as heart rate (p=0.001), mean arterial pressure (p=0.001), systolic (p=0.003) and diastolic blood pressure (p=0.001) and SpO2 (p=0.02). Conclusions Inhalation aromatherapy with Rosa damascena can significantly decrease stress and anxiety severity and improve hemodynamic parameters of patients undergoing coronary angiography. Registry number This study has registered with the number IRCT201702019759N8 at Iranian Registry Clinical Trial.

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

2018 ◽  
Vol 71 (3) ◽  
pp. 967-974 ◽  
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.

scholarly journals Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

2020 ◽  
Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Strong Dependence ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Control Group ◽  
Standard Of Care Treatment ◽  
And Control ◽  
To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

scholarly journals The Analgesic Effects of Bupivacaine and Magnesium Sulfate Combination, Bupivacaine, and Adrenaline Combination and Bupivacaine Alone on Post-cesarean Section Pain: A Randomized Clinical Trial

2018 ◽  
Vol 9 (4) ◽  
pp. 284-290
Author(s):  
Zinatossadat Bouzari ◽  
Seyedeh Rabeeh Rouhani ◽  
Ebrahim Alijanpour ◽  
Shahla Yazdani ◽  
Bahman Hasannasab ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cesarean Section ◽  
Magnesium Sulfate ◽  
Randomized Clinical Trial ◽  
Normal Saline ◽  
Repeated Measures ◽  
The Other ◽  
Hemodynamic Parameters ◽  
Analgesic Effects ◽  
Single Blind

Objectives: The present study was performed to compare the analgesic effects of bupivacaine and magnesium sulfate combination on post-cesarean (C) section pain. Materials and Methods: The present single-blind randomized clinical trial was conducted on 160 C-section candidates. The participants were randomly divided into four groups. When the fascia healed, the first group received 20 mL of 0.25% bupivacaine and the second group received 20 mL of 0.25% bupivacaine combined with subcutaneous adrenaline. In addition, both groups received 50 mL of intravenous normal saline. Further, the third group received subcutaneous bupivacaine and 50 mg/kg of magnesium sulfate and the fourth group received subcutaneous and intravenous normal saline as a placebo. The pain intensity was assessed 2, 6, 12, 18, and 24 hours after spinal anesthesia using the visual analogue scale (VAS) for pain. The dose of pethidine (as a standard analgesic) and hemodynamic parameters (i.e., heart rate [HR] and blood pressure [BP]) was recorded as well. The obtained data were then analyzed utilizing ANOVA, Tukey’s HSD, and repeated measures ANOVA tests. Results: The intensity of pain and the dose of pethidine decreased significantly in the combination of bupivacaine with magnesium compared to the other groups at all times (P < 0.001). However, diastolic BP significantly increased in the bupivacaine + adrenaline group in comparison with the other groups (P = 0.02). Conclusions: Overall, bupivacaine combination with magnesium sulfate is suitable for controlling post-cesarean section pain.

Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

2018 ◽  
Vol 15 (3) ◽  
Author(s):  
Mansoor Keshavarz ◽  
Maryam Kashanian ◽  
Soodabeh Bioos ◽  
Yasaman Vazani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Control Groups ◽  
Persian Medicine ◽  
Traditional Persian Medicine ◽  
And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

scholarly journals Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation

2020 ◽  
Vol 17 (13) ◽  
pp. 4882 ◽  
Author(s):  
Manuel Pabón-Carrasco ◽  
Aurora Castro-Méndez ◽  
Samuel Vilar-Palomo ◽  
Ana María Jiménez-Cebrián ◽  
Irene García-Paya ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Scientific Evidence ◽  
Control Group ◽  
Initial State ◽  
Post Intervention ◽  
Before And After ◽  
Training Post ◽  
Foot Posture ◽  
Statics And Dynamics

Background: There is little scientific evidence regarding the effectiveness of strengthening exercises on the foot’s intrinsic musculature in improving the lower limb on the statics and dynamics in healthy individuals. Method: To evaluate the effect on foot posture with regard to the reinforcement of the short foot exercise (SFE) compared to another without a recognized biomechanical action, which we called the “non-biomechanical function” (NBF) exercise. A randomized clinical trial was carried out with 85 asymptomatic participants with a bilateral Foot Posture Index (FPI) greater than 6 points. An experimental group (n = 42) did SFE training and a control group (n = 43) carried out NBF exercises. The foot posture was evaluated twice via the navicular drop (ND) test, and the FPI was assessed on the day of inclusion in the study (pre-intervention) and after four weeks of training (post-intervention). Results: Statistically significant values were not found in foot posture between the experimental and the control groups when comparing before and after the training. However, the foot posture was modified in both groups with respect to its initial state, and the ND value decreased. Conclusions: SFE could be considered a useful tool to deal with pathologies whose etiology includes excessive pronation of the foot.

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

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.

scholarly journals Manual therapy in the treatment of facial wrinkles and sagging: a quantitative-qualitative randomized clinical trial

2020 ◽  
pp. 1-4
Author(s):  
Aline de Souza Massulo Garcia ◽  
Dilane Braga da Silva ◽  
Vanessa Daniele Ferreira Gonçalves ◽  
Alessandra Couto de Camargo Ferreira
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Manual Therapy ◽  
Therapy Group ◽  
Wilcoxon Test ◽  
Average Score ◽  
Control Group ◽  
Evaluation Instrument ◽  
Before And After ◽  
Therapy Protocol

Background: Manual therapy has emerged as an option for facial rejuvenation treatment due to its effects on connective tissue. Objectives: The aim of the study was to verify the effectiveness of the manual therapy protocol in attenuating wrinkles and facial sagging. Methods: This is a quantitative-qualitative, randomized clinical trial. The study included female volunteers, aged between 40 and 50 years, distributed in 2 groups: Manual therapy group (MTG) and Control group (CG). The protocol used consisted of: lymph node decongestion, sliding massages, fast and vigorous movements, and traction on the fasciae. The evaluation instrument was through photos, in which they were analyzed by Dermato-functional specialists through a scale that graduates the wrinkles. The Shapiro-Wilk normality test was used to analyze the symmetry of the results by the Gauss curve. Pre- and post-intervention differences between the groups were determined using the non-parametric Wilcoxon test. Results: The average score obtained in the graduation of wrinkles and signs of aging in the manual therapy group showed significant differences in all regions of the face before and after treatment. And there was a decrease in the score, which shows improvement in the reduction of wrinkles and signs of aging, especially in the upper third. In contrast, in the control group, the average remained before and after the follow-up by the research, showing that there were no significant changes in this group. Conclusion: The manual therapy protocol showed significant results in reducing the signs of aging, such as fine lines and wrinkles, being another option to be applied in clinics.

scholarly journals Fluoxetine for Anterior Ischemic Optic Neuropathy (AION); a Double Blind Randomized Clinical Trial

2021 ◽  
Author(s):  
Mohammad Hossein Abbasi ◽  
Shahnaz Rimaz ◽  
Zahra Pourmousa ◽  
Leila Janani ◽  
Mostafa Soltan Sanjari
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Optic Neuropathy ◽  
Study Groups ◽  
Anterior Ischemic Optic Neuropathy ◽  
Control Group ◽  
Ischemic Optic Neuropathy ◽  
Double Blind ◽  
Clinical Prognosis ◽  
Before And After

Abstract Background: Fluoxetine enhances the levels of brain-derived neurotrophic factor (BDNF); considering its known improving effects on neurogenesis and plasticity, it seems to improve the Anterior Ischemic Optic Neuropathy (AION). This study aimed to evaluate the effect of Fluoxetine on clinical prognosis of patients with AION.Methods: In this double-blind placebo-controlled randomized clinical trial, subjects with AION who were referred to Rasool Akram Hospital were divided into two study groups; the fluoxetine group that received 20 mg Fluoxetine daily(n=50) and the control group (n=50) that received placebo for a period of six months. Patients underwent clinical and paraclinical evaluations before and after the trial. This study was a registered trial with IRCT code IRCT20181109041596N1.Results: One hundred patients were enrolled from August 2019 to December 2020 and assessed in this study. Subjects in Fluoxetine group showed significant improvement in visual acuity in comparison to the placebo group with less score in LogMAR scale (P: 0.008 and 0.002, respectively), improvement in MD parameters of perimetry (P: 0.003 and 0.002, respectively), and decrease in VEP latencies (P (in 1st minute): <0.001 and <0.001, P (in 15st minute): 0.038 and 0.011, respectively). There were no differences in color vision, Rnfl in all dimensions, PSD parameter of perimetry or VEP amplitudes following the trial of Fluoxetine therapy (Ps> 0.05).Conclusion: Fluoxetine showed promising therapeutic value for patients with AION besides its safety as an additive treatment option to corticosteroids.

Effect of Low-Pressure Drainage Suction on Pharyngocutaneous Fistula After Total Laryngectomy

2020 ◽  
Vol 130 (1) ◽  
pp. 32-37
Author(s):  
Mojtaba Maleki Delarestaghi ◽  
Aslan Ahmadi ◽  
Fatemeh Dehghani Firouzabadi ◽  
Maryam Roomiani ◽  
Mohammad Dehghani Firouzabadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Total Laryngectomy ◽  
Recovery Time ◽  
Low Pressure ◽  
Control Group ◽  
Pharyngocutaneous Fistula ◽  
Significant Difference ◽  
Drain Group ◽  
And Control

Objective: Pharyngocutaneous fistula (PCF) is one of the most severe multifactorial complications following laryngectomy. The current study aimed at determining the effect of a low-pressure vacuum drain on the incidence of PCF after total laryngectomy. Methods: The current randomized clinical trial was conducted on 35 patients undergoing total laryngectomy in Hazrat Rasoul Akram and Firoozgar hospitals in Tehran, Iran. The subjects were divided into the vacuum drain (n = 15) and control (without vacuum drain) (n = 20) groups. The incidence of PCF and the recovery time were recorded. Results: The rate of PCF formation from the stoma and wound edges was significantly lower in the low-pressure vacuum drain group than in the control group (6.7% vs 40%) ( P < .05). There was no significant difference between the groups in time to recovery from PCF. Conclusion: The low-pressure vacuum drain method is effective in reducing the incidence of PCF after total laryngectomy.

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