Comparison of Intraoperative Infusion of Remifentanil versus Fentanyl on Pain Management in Patients Undergoing Spine Surgery: A Double Blinded Randomized Clinical Trial

Background: Remifentanil is an ultra-short-acting opioid which facilitates hemodynamic management. However, there are concerns about postoperative Remifentanil hyperalgesia because of its potent fast onset and offset. Objectives: The aim of this study was to determine visual analog scale (VAS), postoperative pain, and morphine used in two groups after spine surgery. Methods: In this randomized clinical trial study, 60 patients aged 18 - 60 years old, according to the American Society of Anesthesiology (ASA) I - II, who underwent spinal canal stenosis or scoliosis surgery, were divided into two groups. In the control group, patients received 0.07 - 0.1 µg/kg/h intraoperative Fentanyl infusion, and in the intervention group 0.1 - 0.2 µg/kg/min remifentanil was infused during the surgery. Both groups received 15 mg/kg intravenous Acetaminophen 20 minutes before the end of the surgery. Postoperative pain score and morphine consumption were measured 6, 12, 24, and 48 hours after discharge from the post-anesthesia care unit (PACU). Results: During the first 12 hours, VAS and morphine consumption were significantly higher in remifentanil group (P < 0.001). However, no significant difference was found between the two groups in morphine consumption 12 - 48 hours after surgery. Conclusions: These findings suggest that Remifentanil infusion during surgery may increase postoperative pain. Also, VAS and morphine consumption were higher during the first 12 hours.

Download Full-text

Effect of Foot Reflexology on Postoperative Pain in Patients Undergoing Tibia Plating Surgery: A Randomized Clinical Trial

Complementary Medicine Journal ◽

10.32598/cmja.10.3.1019.1 ◽

2020 ◽

Vol 10 (3) ◽

pp. 258-269

Author(s):

Fatemeh Imani ◽

◽

Ebrahim Nasiri ◽

Houshang Akbari ◽

Mohammad Reza Safdari ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Randomized Clinical Trial ◽

Repeated Measures ◽

Intervention Group ◽

Control Group ◽

Control Groups ◽

Chi Square ◽

Chi Square Test ◽

And Control

Objective: One of the major problems of patients after orthopedic surgeries is acute pain. The present study aims to evaluate the effect of foot reflexology massage on postoperative pain in patients undergoing plating surgery for tibia fracture. Methods: This study is a randomized clinical trial conducted on 96 patients who were candidates for tibia plating surgery referred to Imam Ali Hospital in Bojnourd, Iran, randomly divided into intervention and control groups. Foot reflexology massage in the intervention group was performed on patients’ healthy feet for 10 minutes, one hour before surgery. In the control group, the foot sole was touched for one minute without any pressure. Pain intensity was measured using the standard Visual Analog Scale before and immediately after the intervention and 2, 4, 6, 12 and 24 hours after surgery. Data were analyzed using chi-square test, t-test, repeated measures ANOVA, Mann-Whitney U and Friedman tests. Results: The baseline pain scores in the intervention and control groups were reported 8.1±0.9 and 8.4±0.9, respectively. After the intervention, the pain score in these groups was reduced to 6.9±1.1 and 8.1±1.0, respectively (P<0.001). At other times, up to 24 hours after surgery, the pain reduction was higher in the intervention group (P<0.05). Conclusion: Foot reflexology massage reduces postoperative pain of patients undergoing tibia plating surgery. Therefore, this method can be used to reduce pain and anxiety in orthopedic surgery patients.

Download Full-text

Effectiveness of Counseling for Infertile Couples on Women's Emotional Disturbance: A Randomized Clinical Trial

Revista Brasileira de Ginecologia e Obstetrícia / RBGO Gynecology and Obstetrics ◽

10.1055/s-0041-1736305 ◽

2021 ◽

Vol 43 (11) ◽

pp. 826-833

Author(s):

Tayebeh Mokhtari Sorkhani ◽

Atefeh Ahmadi ◽

Moghaddameh Mirzaee ◽

Victoria Habibzadeh ◽

Katayoun Alidousti

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Emotional Disturbance ◽

Intervention Group ◽

T Test ◽

Control Group ◽

Infertile Women ◽

Primary Infertility ◽

Significant Difference ◽

The Mean

Abstract Objective The psychosocial burden of infertility among couples can be one of the most important reasons for women's emotional disturbance. The goal of the present study was to investigate the effect of counseling on different emotional aspects of infertile women. Methods The present randomized clinical trial was performed on 60 couples with primary infertility who were referred for treatment for the first time and did not receive psychiatric or psychological treatment. Samples were allocated to an intervention group (30 couples) and a control group (30 couples) by simple randomization. The intervention group received infertility counseling for 6 45-minute sessions twice a week, and the control group received routine care. The Screening on Distress in Fertility Treatment (SCREENIVF) questionnaire was completed before and after the intervention. Samples were collected from November to December 2016 for 3 months. For the data analysis, we used the Statistical Package for the Social Sciences (IBM SPSS Statistics for Windows, IBM Corp., Armonk, NY, United States) software, version 19.0, and the paired t-test, the independent t-test, the Mann-Whitney test, the Wilcoxon test, and the Chi-squared test. Results The mean age of the participants was 33.39 ± 5.67 years. All studied couples had primary infertility and no children. The mean duration of the couples' infertility was 3 years. There was a significant difference regarding depression (1.55 ± 1.92; p < 0.0001), social support (15.73 ± 3.41; p < 0.0001), and cognitions regarding domains of fertility problems (26.48 ± 3.05; p = 0.001) between the 2 groups after the intervention, but there was no significant difference regarding anxiety (25.03 ± 3.09; p = 0.35). Conclusion The findings showed that infertility counseling did not affect the total score of infertile women' emotional status, but improved the domains of it except, anxiety.

Download Full-text

Effect of Ear Acupressure on Anxiety and Cortisol Levels in Women Receiving Premastectomy Radiotherapy: A Randomized Clinical Trial

10.30699/acadpub.ijbd.12.3.8 ◽

2019 ◽

Vol 12 (3) ◽

pp. 8-16

Author(s):

Reza Eghdam-Zamiri ◽

Abbasali Dorosti

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Serum Cortisol Level ◽

Control Group ◽

P Value ◽

Breast Cancer Patients ◽

Significant Difference ◽

Cortisol Levels ◽

Manifest Anxiety

Introduction: Radiation therapy before mastectomy increases the severity of stress and cortisol hormone. Because of the preference of patients and physicians for nonpharmacologic stress management methods, we conducted the present study with the aim of evaluating the effect of ear acupressure on anxiety and cortisol hormone levels in women receiving premastectomy radiotherapy. Methods: This randomized clinical trial was carried out on 66 patients (based on sample size formula) at Imam Reza Hospital in Tabriz during the years 2018-19. The intervention group was given acupressure, twice a day (8 minutes on each ear), for three days before surgery. Serum cortisol level and latent and manifest anxiety (the Spielberger State-Trait Anxiety Inventory) were measured before and after the intervention. Data were analyzed using SPSS 20 software. A P value less than 0.05 were considered significant. Results: There was no significant difference in latent anxiety, manifest anxiety, or cortisol levels between the groups at baseline. Ear acupressure caused a significant decrease in latent anxiety (from 43.22 ± 6.41 to 33.09 ± 4.91), explicit anxiety (from 49.50 ± 5.52 to 32.18 ± 5.01), and plasma cortisol levels (from 156.15 ± 18.95 to 115.59 ± 17.80) (P < 0.005), while no significant changes were observed in the control group (P > 0.05). Conclusion: Ear acupressure can reduce anxiety and stress (cortisol) levels in breast cancer patients undergoing radiotherapy before mastectomy.

Download Full-text

Low-laser light therapy in venous ulcer healing: a randomized clinical trial

Revista Brasileira de Enfermagem ◽

10.1590/0034-7167-2021-0396 ◽

2022 ◽

Vol 75 (3) ◽

Author(s):

Taline Bavaresco ◽

Amália de Fátima Lucena

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Ulcer Healing ◽

Laser Light ◽

Intervention Group ◽

Light Therapy ◽

Venous Ulcer ◽

Control Group ◽

Nursing Outcomes ◽

Significant Difference

ABSTRACT Objectives: to compare the effect of adjuvant low-laser light therapy versus conventional treatment alone on venous ulcer healing. Methods: this is a randomized clinical trial with 40 patients randomized equally to a control group (topical and compressive treatment) and intervention group (adjuvant low-laser light therapy). Outcomes of interest were Wound Healing: Secondary Intention and Tissue Integrity: Skin & Mucous Membranes, as described in the Classification of Nursing Outcomes/NOC. Results: groups with similar sociodemographic and clinical characteristics. Eighty-two ulcers were assessed, with an average duration of 1 to 5 years, in 1,066 nursing consultations, with a statistically significant difference in the time and number of healed ulcers (intervention group). There was a significant improvement in the nursing outcomes under study and in eight clinical indicators. Conclusions: low-laser light therapy improves and reduces tissue regeneration time, contributing to advances in wound treatment.

Download Full-text

The herbal combination of Sugarcane, Black Myrobalan, and mastic as a supplementary treatment for COVID-19: a randomized clinical trial

10.1101/2021.04.27.21256221 ◽

2021 ◽

Author(s):

Alireza Hashemi Shiri ◽

Esmaeil Raiatdoost ◽

Hamid Afkhami ◽

Ruhollah Ravanshad ◽

Seyed Ehsan Hosseini ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Treatment Protocol ◽

Vital Signs ◽

Control Group ◽

Event Analysis ◽

Herbal Supplement ◽

Significant Difference ◽

And Control

AbstractBackgroundGiven the COVID-19 pandemic’s, researchers are beseeched for effective treatments. Herbal medicine is also queried for potential supplementary treatments for COVID-19. We aimed to evaluate the effects of Sugarcane, Black Myrobalan, and Mastic herbal medications for COVID-19 patients.MethodsThis was a double-blinded randomized clinical trial study conducted over three months from May to July 2020 in patients admitted with a diagnosis of COVID-19 in Peymaniyeh Hospital in Jahrom, Iran. The intervention group received the treatment protocol approved by the Ministry of Health of Iran during the period of hospitalization and the herbal supplement obtained from the combination of black myrobalan and mastic and sugarcane, twice a day (3g of herbal supplements). All patients were compared in terms of demographic variables, vital signs, clinical and laboratory variables.Results72 patients with COVID-19, divided into intervention (n=37) and control (n=35) groups. intervention and control groups had not any significant difference in terms of baseline characteristics. The time-to-event analysis revealed a significant difference in 4 symptoms of cough, fever, dyspnea, and myalgia (P<0.05). The Control group had a significantly lower decrease in C-reactive protein during 7 days (P<0.05). Patients in the herbal supplement group were hospitalized for 4.12 days and in the control group were hospitalized for 8.37 days (P=0.001). ICU admission and death only happened in 3 (8.6%) patients of the control group.ConclusionWhile advanced studies with more sample size are needed; the proposed combination seems to be effective in the symptom treatment and reducing the length of hospitalization.

Download Full-text

Effect of Progressive Muscle Relaxation on Sleep Quality and Side Effects of Chemotherapy in Children with Cancer: Randomized Clinical Trial

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2021.5774 ◽

2021 ◽

Vol 9 (T4) ◽

pp. 300-308

Author(s):

Erna Sulistyawati ◽

Allenidekania Allenidekania ◽

Dewi Gayatri

Keyword(s):

Clinical Trial ◽

Side Effects ◽

Sleep Quality ◽

Randomized Clinical Trial ◽

Muscle Relaxation ◽

Intervention Group ◽

Progressive Muscle Relaxation ◽

Control Group ◽

Children With Cancer ◽

Significant Difference

BACKGROUND: Sleep disturbance affects quality of life in children receiving chemotherapy. AIM: The aim of this study was to identify the effect of progressive muscle relaxation on the sleep quality and side effects of chemotherapy in children with cancer. METHODS: This study used randomized clinical trial with single blind method, where 30 children were allocated randomly to the control group and intervention group. The intervention group received progressive muscle relaxation twice a day, in the morning and evening, 15 minutes each session for 7 days. Control group received routine nursing care. RESULTS: The study concluded there was no significant difference in the two groups on fatigue and pain. However, progressive muscle relaxation had significant relation to decreased sleep quality score. CONCLUSION: Relaxation therapy, particularly progressive muscle relaxation, may be one of the nursing cares to improve sleep quality and reduce the side effects of chemotherapy in children with cancer.

Download Full-text

Impact of Mild Hypothermia on Final Outcome of Patients with Acute Stroke: A Randomized Clinical Trial

Indian Journal of Neurotrauma ◽

10.1055/s-0040-1713462 ◽

2020 ◽

Vol 17 (01) ◽

pp. 17-23

Author(s):

Abbas Rouzbahani ◽

Esmail Khodadadi ◽

Marjaneh Fooladi

Keyword(s):

Clinical Trial ◽

Acute Stroke ◽

Randomized Clinical Trial ◽

Mild Hypothermia ◽

Intervention Group ◽

Final Outcome ◽

Control Group ◽

Risk Of Death ◽

Significant Difference ◽

The Mean

Abstract Background and Aim Stroke is a sudden neurological disorder caused by disturbances in the brain blood flow and loss of normal brain function. Stroke is also the second leading cause of death worldwide. In the last two decades, among the various treatment options for stroke, hypothermia has shown the promise of improving the final outcome. This study aimed to investigate the effect of noninvasive hypothermia on the final outcome of patients with an acute stroke in Iran. Methods In a randomized clinical trial, 60 Iranian patients diagnosed with acute stroke were enrolled in 2018. Patients were selected by convenience sampling method and then randomized in two groups as experimental (n = 30) and control (n = 30). Mild hypothermia was applied using a cooling device for 72 hours on the patients’ heads and intervention results were compared with the control group. Data were collected by using Acute Physiology and Chronic Health Evaluation III (APACHE III), Full Outline of Un-Responsiveness (FOUR), and National Institutes of Health Stroke Scale (NIHSS), and later analyzed by Statistical Package for the Social Sciences (SPSS) software version 22. Results No significant difference was found in the mean scores of all three scales before and after the intervention in control group (p > 0.05) but statistically significant difference was found in the mean scores of all three scales for the intervention group (p < 0.05). The intervention group had an increased mean score in FOUR, while APACHE and NIHSS values dropped. Researchers found statistically significant difference between the mean scores after the intervention in the experimental group compared with the control group in all three scales (p < 0.05). Conclusion The findings of this study indicate that hypothermia has a significant statistical and clinical effect on the acute stroke outcome and it can be argued that hypothermia therapy can increase the level of consciousness and reduce the risk of death in stroke patients.

Download Full-text

The Effect of Pretreatment Conditioning by Mothers on Dental Behavior of Children: A Randomized Clinical Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.102453 ◽

2021 ◽

Vol In Press (In Press) ◽

Author(s):

Nahid Ramazani ◽

Hedyeh Mohsenzadeh

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Control Group ◽

Behavior Rating Scale ◽

Dental Practitioners ◽

Mandibular Molar ◽

Significant Difference ◽

Mother’S Age ◽

Parents Education

Background: Behavior management techniques are an integral component of pediatrics dental visits. Objectives: This study aimed to evaluate the effect of child pretreatment conditioning by mothers on the dental behavior of children during dental treatment. Methods: Following a randomized clinical trial design, this study was conducted on 72 child-mother dyads, attending the pediatric dental department of Zahedan University of Medical Sciences (southeast of Iran). The children were 3 to 6 years old and required pulpotomy of one asymptomatic carious primary mandibular molar under inferior alveolar nerve block anesthesia. The dyads were randomly divided into control and intervention groups. Data on age and gender of children, mother’s age, and parents’ education were collected. Mothers in the intervention group received a brochure, containing information on how to prepare the child at home to better cope with the dental procedure. Those in the control group received no intervention. A one-month interval was set between the randomization and treatment. For both groups, an experienced pedodontist performed pulpotomy and stainless steel crown placement in a single session. The dental behavior of children during the operation was scored by a blind instructed and calibrated observer, using the Franckle behavior rating scale. Data were analyzed using the chi-square test, Fisher’s exact test, and Mann-Whitney U test in SPSS version 20 at a significance level of 0.05. Results: The child dental behavior in the intervention group was more frequently acceptable than their counterparts, and a significant difference was found between the groups (P = 0.047). The intervention was successful, regardless of the child's gender and age, mother’s age, and parents’ education (P > 0.05). Conclusions: Based on the results, dental practitioners can promote child behavior by engaging mothers to prepare their children before dental procedures.

Download Full-text

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

Download Full-text

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

BMC Endocrine Disorders ◽

10.1186/s12902-021-00731-8 ◽

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.

Download Full-text