scholarly journals Perioperative booklet for orthognathic patients: A randomized controlled clinical trial

2018 ◽  
Vol 8 (12) ◽  
pp. 90 ◽  
Author(s):  
Cristina Silva Sousa ◽  
Vanessa de Brito Poveda ◽  
Ruth Natalia Teresa Turrini
Keyword(s):  
Clinical Trial ◽  
Mixed Models ◽  
Pain Treatment ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Bodyweight Loss ◽  
Single Blind ◽  
Scale Data

Objective: This study compared the effectiveness of an informational booklet on postoperative self-care, knowledge, anxiety and symptoms related to orthognathic surgery.Methods: This study is a randomized, single-blind, controlled clinical trial. This study was carried out from August 2013 to August 2015 and included 40 participants (20/group). The intervention group had routine postoperative surgeon guidance, and received a self-care booklet. Booklet information was explained by a nurse. The control group received only routine surgeon guidance. Knowledge and anxiety were compared pre- and postoperatively. Postoperative outcomes included self-care (oral hygiene, mobility and sensitivity, hydration of the lips, edema, and sleeping and breathing conditions), nutrition (eating ability and change in bodyweight), and pain (treatment required and a visual analog scale). Data were analyzed by general linear mixed models and mixed-effects models.Results: Knowledge was higher in intervention group compared to control group (p < .001). Anxiety assessment displayed no difference between groups. The intervention group had more halitosis (p = .003) and greater bodyweight loss (p = .002).Conclusions: The booklet increased knowledge of postoperative self-care, but did not lower anxiety. Halitosis and weight loss were higher in the intervention group, however, most outcomes were similar between groups.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals The Effect of Health Literacy Counselling on Self-Care in Women after Mastectomy: a Randomized Clinical Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 39-45
Author(s):  
Masoume Rastegar ◽  
Zohreh Mahmoodi ◽  
Sara Esmaelzadeh Saeieh ◽  
Nasibeh Sharifi ◽  
Kourosh Kabir
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Health Literacy ◽  
Intervention Group ◽  
Self Care ◽  
Essential Element ◽  
World Health ◽  
Control Group ◽  
Fars Province ◽  
The Mean

Introduction: Breast cancer has a high prevalence, constituting a major cause of mortality in women around the world. Health literacy has a vital role in the self-care of chronic diseases such as cancer and is an essential element in the ability of each person to engage with health promotion. The aim of this study was to determine effect of health literacy counselling on selfcare in women after mastectomy. Methods: This study is a randomized, controlled, clinical trial carried out on 72 women with breast cancer after mastectomy in Fars province. The eligible women entered the study using convenience sampling and were then divided into an intervention and a control group through randomized blocks of four. Health literacy questionnaire and self-care questionnaire were distributed among the participants before, immediately after and three weeks following the intervention. Data analysis was performed in SPSS ver.13. Results: The results showed no significant differences between the two groups in terms of their health literacy and self-care scores before the intervention (P=0.299 and 0.059). A comparison of the mean values showed a greater increase in the mean score of health literacy and score of selfcare immediately and three weeks after the intervention in the intervention group compared to the control group. Also, the mean score of the dimensions of self-care in chemotherapy increased over time in the intervention group. Conclusion: The findings of this study confirm the higher effectiveness of counseling with a health literacy approach on overall self-care in chemotherapy and all its dimensions.

scholarly journals Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

2019 ◽  
Vol 53 ◽  
Author(s):  
Luciana Regina Ferreira da Mata ◽  
Cissa Azevedo ◽  
Mariana Ferreira Vaz Gontijo Bernardes ◽  
Tânia Couto Machado Chianca ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Home Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Teaching Program ◽  
Significant Difference ◽  
The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

scholarly journals Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Yu-yang Pang ◽  
Yan Li ◽  
Gang Kui ◽  
Yong Tang ◽  
Ming-juan Liao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Myeloproliferative Neoplasms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Complete Healing ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Leg Ulcers ◽  
Open Label ◽  
Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

Effect of an early mobilisation programme on pain intensity after laparoscopic surgery: a randomised clinical trial

2020 ◽  
pp. bmjspcare-2020-002618
Author(s):  
Azam Dehghani ◽  
Ali Hajibagheri ◽  
Ismail Azizi-Fini ◽  
Fatemeh Atoof ◽  
Noushin Mousavi
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Surgery ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Early Mobilisation ◽  
Repeated Measures Analysis ◽  
The Mean

BackgroundPain is a common complication after laparoscopic surgery. This study aimed to examine the effect of an early mobilisation programme on postoperative pain intensity after laparoscopic surgery.MethodsA randomised controlled clinical trial was conducted on 80 patients who underwent laparoscopic surgery in Shahid Beheshti Hospital in Kashan, Iran. The patients were randomly allocated to intervention (n=40) and a control (n=40) group. In the intervention group, an early mobilisation programme was implemented in two rounds. The patient’s perceived pain was assessed using a Visual Analogue Scale 15 min before and 30 min after each round of early mobilisation. Data were analysed through the independent samples t, χ2 and Fisher’s exact tests and the repeated measures analysis.ResultsThe repeated measures analysis showed that the mean pain scores have been decreased over time (F=98.88, p<0.001). Considering the observed interaction between time and the intervention, the t test was used for pairwise comparisons and showed that the mean pain score was not significantly different between the two groups in 15 min before the first round of early mobilisation (p=0.95). However, the mean pain in the intervention group was significantly less than the control group in all subsequent measurements (p<0.05).ConclusionEarly mobilisation programmes such as the one implemented in the current study are easy and inexpensive and can be implemented safely for the reduction of pain after laparoscopic surgeries.

scholarly journals Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients: Study Protocol for a Single Blind, Randomized, Sham-Controlled Clinical Trial

2021 ◽  
Author(s):  
Linda LD Zhong ◽  
Chi-Fung CHOY ◽  
Hung-Wai CHO ◽  
Yi-Ping WONG ◽  
Alan Yat-Lun WONG ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Sham Acupuncture ◽  
Olfactory Dysfunction ◽  
Secondary Outcome ◽  
Control Group ◽  
Common Symptom ◽  
Real Acupuncture ◽  
Single Blind

Abstract Background: Olfactory dysfunction (OD) was recognized as one of common symptom of COVID-19. OD, defined as the reduced or distorted ability to smell during sniffing (orthonasal olfaction) and may represent one of early symptoms in the clinical course of COVID-19 infection. A large online questionnaire-based survey found that some of post COVID-19 patients showed no improvement at one month after they were discharged from hospital. Therefore, this clinical trial is designed to explore the efficacy of acupuncture for OD in infected COVID-19 patients and to determine whether acupuncture could have benefits than sham acupuncture for OD in post- COVID-19 patients.Methods: This is a single blind, randomized controlled, cross over trial. We plan to recruit forty post-COVID-19 patients who are presenting with smell loss or smell distortions more than one month. Qualified patients will be randomly allocated into the intervention group (real acupuncture) or the control group (sham acupuncture) in a 1:1 ratio. Each patient will receive 8 sessions of treatment over 4 week (Cycle 1), and 2-week follow-up. After the follow-up, the control group will be conducted with real acupuncture for another 4 weeks (Cycle 2), and the real acupuncture group will be conducted with the 4-week sham acupuncture. The primary outcomes are the scores change on the questionnaire of olfactory functioning and olfaction related quality of life at weeks 6, 8, 12 and 14 from the baseline. Secondary outcome is the change on the Olfactory Test score at the week 6 and 12 from the baseline measured by using the Traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC).Discussion: The results of this trial will help to determine the effectiveness of acupuncture for OD in post-COVID-19 Patients. This may provide a new treatment option for patients.Trial registration: ClinicalTrials.gov, NCT04959747, Registered on July 13, 2021.

scholarly journals Yoga Effects on Anthropometric Indices and Polycystic Ovary Syndrome Symptoms in Women Undergoing Infertility Treatment: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Maryam Mohseni ◽  
Mohammad Eghbali ◽  
Homa Bahrami ◽  
Farzaneh Dastaran ◽  
Leila Amini
Keyword(s):  
Clinical Trial ◽  
Polycystic Ovary ◽  
Intervention Group ◽  
Clinical Signs ◽  
Infertility Treatment ◽  
Abdominal Circumference ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Hip Circumference ◽  
Anthropometric Parameter

The aim of this study was to investigate the effects of yoga exercises on anthropometric parameter and clinical sign of PCOS among women undergoing infertility treatment. This clinical trial study was performed on 61 women with PCOS who have undergone infertility treatment at Sarem Hospital in Tehran, Iran. The patients were first selecting based on purposeful and then randomly assigning to the intervention and control groups. In the intervention group, yoga exercises were performed for 6 weeks and the patients in the control group only received routine care. Anthropometric parameters and clinical signs were performed and recorded. After the intervention, here was a significant reduction in hirsutism, abdominal circumference, and hip circumference scores in the intervention group compared to the control group ( P < 0.05 ). Given the effects of yoga exercises on the improvement of hirsutism, abdominal circumference, and hip circumference, it is suggested to use yoga as a treatment strategy in women with PCOS.

scholarly journals The Effect of Combined Herbal Capsule on Glycemic Indices and Lipid Profile in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Rezvan Ghafarzadegan ◽  
Javad Javaheri ◽  
Mina Asgari ◽  
Mohammad Golitaleb ◽  
Fatemeh Maraki ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Type 2 Diabetes Mellitus ◽  
Lipid Profile ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Glycemic Indices

Objectives: The present study aimed to investigate the potential effects of the combined herbal capsule (CHC), as a nutritional supplement, on glycemic indices (GIs) and lipid profile (LP) of patients with type 2 diabetes mellitus (T2DM). Methods: Following a randomized, single-blind, placebo-controlled clinical trial, the current study was conducted on 80 cases with T2DM who were randomly assigned into two groups of treatment (CHCs; n = 40) and control (placebo; n = 40). Both groups received the intervention (500 mg capsules) twice a day for three months, without changes in the previous dose of oral anti-hyperglycemic drugs. The GI and LP levels were measured before the intervention and three months later to investigate the potential efficacy of the interventions. Results: For those in the intervention group, the mean GI [i.e., fasting blood sugar, two hours postprandial (2hpp), and HbA1c] was significantly different after 3 months (P < 0.05). The GI- and LP-related outcomes (TG, LDL-C except for TC) were improved after 3-month of receiving the intervention compared to the control group; however, the observed improvement was no statistically significant (P > 0.05). The HDL-C level was also significantly improved in the intervention group compared to the control group (P < 0.05). Conclusions: This study demonstrated that receiving CHCs could improve GI and LP levels (TG, LDL-C, and HDL-C, except for TC), which indicates its potential to control T2DM. Moreover, no significant side effect was observed in the intervention group. It can be argued that the use of CHCs, as adjuvant therapy, in combination with conventional hypoglycemic and lipid-lowering drugs, as well as following a modified lifestyle, not only can significantly enhance glycemic control but also may prevent T2DM complications.

scholarly journals Telephone intervention to promote maternal breastfeeding self-efficacy: randomized clinical trial

2021 ◽  
Vol 55 ◽  
Author(s):  
Hilana Dayana Dodou ◽  
Raylla Araújo Bezerra ◽  
Anne Fayma Lopes Chaves ◽  
Camila Teixeira Moreira Vasconcelos ◽  
Lorena Pinheiro Barbosa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Educational Intervention ◽  
Self Efficacy ◽  
Short Form ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Telephone Intervention ◽  
Clinical Trial Registry

ABSTRACT Objective: To analyze the effects of an educational intervention via telephone on maternal breastfeeding self-efficacy. Method: Randomized controlled clinical trial including 240 puerperae from a secondary care hospital randomized into two groups: control and intervention. The educational intervention took place at seven, 30, 90, and 150 days postpartum and centered on self-efficacy and motivational interviewing principles. Self-efficacy was measured by the Breastfeeding Self-Efficacy Scale – Short Form. The data followed the abnormal distribution, so non-parametric tests were used. Results: The intervention group obtained higher median breastfeeding self-efficacy scores across the three outcome measures when compared to the control group (p < 0,001). Furthermore, the intervention group showed increased self-efficacy scores at all monitoring moments, which shows that the educational intervention was able to raise and maintain women’s confidence in breastfeeding their child over time. Conclusion: The use of a telephone-based intervention focused on self-efficacy principles and delivered by trained nurses effectively promoted maternal confidence in breastfeeding. Brazilian Clinical Trial Registry: RBR-7m7vc8.

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