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

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.

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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.

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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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Compare the effect of aromatherapy using lavender and Damask rose essential oils on the level of anxiety and severity of pain following C-section: A double-blinded randomized clinical trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2019-0141 ◽

2020 ◽

Vol 17 (3) ◽

Author(s):

Ali Abbasijahromi ◽

Hamed Hojati ◽

Saeid Nikooei ◽

Hossein Kargar Jahromi ◽

Hamid Reza Dowlatkhah ◽

...

Keyword(s):

Clinical Trial ◽

Essential Oil ◽

Essential Oils ◽

Randomized Clinical Trial ◽

Control Group ◽

Content Type ◽

Gate Control Theory ◽

Significant Difference ◽

The Mean ◽

Damask Rose

AbstractBackgroundAnxiety is the most common psychological reaction in women during labor. Similar to numerous other surgeries, postoperative pain is also reported following cesarean section (C-section). According to the (Gate) Control Theory, there is a relationship between pain and psychological problems such as anxiety. Accordingly, the present study aimed to compare the effect of aromatherapy using lavender and Damask rose essential oils on the level of anxiety and severity of pain following C-section.MethodsThis triple-group randomized clinical trial was performed on 90 mothers who visited Motahari Hospital of Jahrom, Iran, for C-section in 2017. The incidence and severity of pain and anxiety were measured and recorded for all three groups prior to intervention. The intervention groups underwent aromatherapy with lavender and Damask rose essential oils. Patients were asked to inhale cotton balls, separately stained with three drops of each essential oil at a distance of 10 cm for 30 mins. The severity of pain and anxiety was measured using the visual analogue scale (VAS) and the Spielberger State-Trait Anxiety Inventory (STAI) 5 min after the specified process, respectively. The control group underwent aromatherapy in a similar fashion with normal saline. Finally, data were analyzed using descriptive statistical indices and ANOVA and Kruskal–Wallis tests in SPSS 21.ResultsThere was no significant difference between the three groups in the mean severity of pain and anxiety before the intervention (p>0.05). The mean severity of pain and overt anxiety in the lavender and Damask rose aromatherapy groups was significantly different than the control group after the intervention (p<0.001). In addition, no significant difference was observed between the overt and overall anxiety levels of the two intervention groups after the intervention (p>0.05).ConclusionsThe findings suggested that inhalation aromatherapy can reduce the severity of overt anxiety and pain after C-section, with Damask rose essential oil showing a larger effect than lavender.

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

Anesthesiology and Pain Medicine ◽

10.5812/aapm.115576 ◽

2021 ◽

Vol 11 (4) ◽

Author(s):

Reza Shariat Moharari ◽

Shervin Shahinpour ◽

Negin Saeedi ◽

Elaheh Sahraei ◽

Atabak Najafi ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Randomized Clinical Trial ◽

Spine Surgery ◽

Intervention Group ◽

Morphine Consumption ◽

Control Group ◽

Scoliosis Surgery ◽

Canal Stenosis ◽

Significant Difference

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.

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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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Comparison of the Effect of Two Methods of Breastfeeding and Oral Glucose 10% on the Severity of Venipuncture-Induced Pain and Physiological Indicators in Hospitalized Infants: A Randomized Clinical Trial Study

10.21203/rs.3.rs-25615/v1 ◽

2020 ◽

Author(s):

Mozhgan Saeid nejad ◽

monirsadat Nematollahi ◽

Farokh Abazari ◽

Abdoali Mortazavi

Keyword(s):

Clinical Trial ◽

Intervention Group ◽

Normal Growth ◽

Control Group ◽

Oral Glucose ◽

Physiological Indicators ◽

Significant Difference ◽

Infant Pain ◽

The Mean ◽

Neonatal Ward

Abstract Background: The incidence of pain in ill infants hospitalized in the neonatal ward is unavoidable.. The aim of the present study was to compare the effects of two methods of breastfeeding and oral glucose 10% on the severity of venipuncture-induced pain and physiological indicators in infants hospitalized in the neonatal ward of Seyyed Al-Shohada Hospital in Kerman in 2019.Methods: The present study is a clinical trial study with three groups and with a pre-test and a post-test. It was conducted on 120 neonates who met the inclusion criteria. Infants were selected by a convenient sampling method, and they were randomly divided into three groups. The study instruments included a neonatal demographic questionnaire, and neonatal infant pain scale and a checklist for recording physiological indicators. Then, the data were analyzed using SPSS25 software.Results: The results of the study showed that the mean score of pain severity before the intervention was the same and zero in the three groups (P > 0.05), but during venipuncture and after that, a statistically significant difference was observed among three groups (P < 0.05). The highest mean pain during venipuncture was observed in the control group (86.95) and the lowest mean pain was observed in the breastfeeding intervention group (35.91). After venipuncture, the lowest mean pain was observed in the breastfeeding intervention group (40.40). Also, there was no significant difference between the mean physiological indicators (temperature and heart rate) in different stages of the venipuncture (before, during, and after) in three groups (P > 0.05).Conclusion: Based on the results of the study, breastfeeding is more effective than oral glucose 10% in reducing the severity of infant pain during venipuncture. Breastfeeding is an easy and inexpensive and available method that can be easily implemented with proper training for the mother and it can be used as a method of reducing infant pain by nurses in neonatal intensive care units to ensure the normal growth and development of the infant and prevent the physical effects and discomfort of infants.

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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.

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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.

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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.

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The Effects of Transcutaneous Electrical Nerve Stimulation on Post-Episiotomy Pain Severity in Primiparous Women: A Randomized, Controlled, Placebo Clinical Trial

10.31661/gmj.v8i0.1404 ◽

2019 ◽

Vol 8 ◽

pp. 1404

Author(s):

Seyedeh Soma Zakariaee ◽

Roonak Shahoei ◽

Leila Hashemi Nosab ◽

Ghobad Moradi ◽

Mina Farshbaf

Keyword(s):

Clinical Trial ◽

Pain Relief ◽

Transcutaneous Electrical Nerve Stimulation ◽

Intervention Group ◽

Pain Severity ◽

Control Group ◽

Electrical Nerve Stimulation ◽

Significant Difference ◽

The Mean ◽

Primiparous Women

Background: Episiotomy or cutting the perineum is the most common operation in obstetrics. Perineal pain is the main complication of episiotomy that affects the quality of life and mental health of the mother. Reducing the pain and side effects of the chemical drugs prescribed for pain relief has attracted the attention of both physicians and scientists. This study was conducted to determine the effects of transcutaneous electrical nerve stimulation (TENS), as an alternative method, on post-episiotomy pain severity. Materials and Methods: This randomized clinical trial was performed on 120 primiparous women who had referred to Sanandaj Besat Hospital in 2018. The patients were divided randomly into three groups, including the intervention group (TENS-On), the placebo group (TENS-Off), and the control group. TENS electrodes were placed near the episiotomy site in genitofemoral and pudendal nerves. The pain was measured after episiotomy in lying, sitting, and activity positions. The pain severity was measured using a pain measurement instrument (numeral rating score) at four-time points, i.e., before the intervention as well as 30, 60, and 120 minutes after the TENS intervention. For data analysis, Pearson correlation, student’s t-test, Kruskal-Wallis test, ANOVA test, and Mann-Whitney U tests were used. Results: Intragroup evaluation results for placebo and control groups demonstrated no significant difference in the pain score (P>0.05). A significant difference was observed between the mean pain severity of the intervention group and that of the group with walking activities (P=0.04). In terms of the intergroup evaluation, there was a significant difference observed between the mean pain severity of the lying position and that of the control group (P=0.008). Regarding the sitting position, no significant difference was observed between its mean pain severity and that of the other two groups (P=0.04). Conclusion: TENS is an effective and safe method for post-episiotomy pain relief and a routine method used in the obstetrics and gynecology ward. [GMJ.2019;8:e1404]

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