scholarly journals 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

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.

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

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.

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

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]

scholarly journals The Effect of Capsella bursa-pastoris Extract on Heavy Menstrual Bleeding and Quality of Life in Patients with Uterine Leiomyoma: A Double-blind Randomized Clinical Trial

2019 ◽  
pp. 1-10
Author(s):  
Atieh Sadat Danesh ◽  
Faraz Mojab ◽  
Abolfazl Mohammadbeigi ◽  
Soodabeh Bioos ◽  
Zahra Siaghati ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Uterine Leiomyoma ◽  
Intervention Group ◽  
Menstrual Bleeding ◽  
Control Group ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean

Objectives: Heavy Menstrual Bleeding (HMB) is the most important problems of Uterine Leiomyoma (UL). This study aimed to assess the effect of the extract of the Capsella bursa-pastoris (CBP) on the control of HMB and quality of life in patients with uterine leiomyoma. Design: In a double-blind randomized, clinical trial 54 women with uterine leiomyoma were randomly assigned to the intervention/control groups by block randomization. Setting: Gynecology outpatient clinics. Intervention: The intervention group received 350 mg of alcoholic extract of Capsella bursa-pastoris and the control group received placebo twice daily for three months. Main Outcome Measures: Amount of bleeding by Pictorial blood loss assessment chart (PBAC), quality of life by menstrual quality of life questionnaires (MQ) and bleeding duration by calendar were evaluated. Results: The mean of PBAC decreased from 464.00± 283.61 at baseline to 323.82±207.66 in the intervention group and decreased from 445.92±362.64 to 214.36±137.68 in control group in the third month. The improvement trend was significant in the two groups, but there was no significant difference between groups. The mean of bleeding duration and menstrual quality of life showed improvement in patients of two groups without significant difference between the two groups. Conclusion: Despite the effectiveness of CBP in the intervention group in decreasing of PBAC score and menstrual bleeding duration and improvement of menstrual quality of life in patients who suffered from UL, it did not show a significant effect compared to the control group. Future studies with a larger sample size in one specific type of UL suggested.

scholarly journals Resilience and Coping Strategy after Abortion due to Fetal Malformation: A Web-Based Randomized Controlled Intervention

2020 ◽  
Author(s):  
Maryam Zarei ◽  
Masoomeh Kheirkhah ◽  
Nemam Ali Azadi ◽  
Mahdi Saberi ◽  
Nazanin Esmaeeli
Keyword(s):  
Clinical Trial ◽  
Coping Strategies ◽  
Intervention Group ◽  
Control Group ◽  
Fetal Malformation ◽  
Network Education ◽  
Significant Difference ◽  
The Mean ◽  
And Coping ◽  
Experimental Group

Abstract Background: Today, due to the development of advanced fetal screening techniques, termination for fetal abnormalities has increased, and has caused significant grief for women which can lead to long-term mental disorders. Self-help intervention with web guide may help provide appropriate education and counseling to women. Therefore, this study was conducted to determine the effect of social network education on resilience and coping strategies of women abortion due to fetal malformation.Methods: This clinical trial studied two groups of 100 qualified pregnant women with abnormal fetuses who referred to Tehran Forensic Medicine Center. Randomly assigned into a randomized blocks list as two intervention group and routine group. Sampling was done by random allocation method by Excel software and blinding in the statistical analysis stage and was done as single-blind. The intervention in the experimental group was done as education through mobile social software (Soroush) and for 6 weeks and three times a week. The control group received routine care and after the second test, the content of the network education was also given to them. Resilience and coping strategies were evaluated before, immediately and three months after the intervention using the Persian version of Connor-Davidson Resilience Scale (CD-RISC-2003) and coping strategies (COPE-1989), respectively. Analysis of variance with repeated measures of ANOVA was used for statistical analysis.Results: The mean resilience score in both control and test groups increased significantly (P<0.001) which can indicate the effect of time, but the study of the effect of group over time indicated that in the resilience variable there was a significant difference between the two groups (P<0.001). The simultaneous effect and group on the resilience variable was significant (p<0.001) and the mean variation of resilience score in the intervention group was significantly higher than the control group (p<0.001). The mean score of problem-focused coping strategies in the experimental group increased significantly during 12 weeks (p<0.001) but no significant difference was observed in the control group (p=0.218). Regarding the emotion-focused strategy, a significant decrease was observed in the experimental group (p<0.001) but in the control group there was a significant increase (P=0.001). There was a significant decrease in the avoidance strategy in the experimental group (p<0.001); there was no significant changes in the control group (p=0.066) and the simultaneous effect of group and time in all coping strategies was significant (P<0.001).Conclusion: Social network education leads to enhanced resilience and greater use of problem-focused coping strategies in women after abortion due to fetal malformation and is effective on improving women’s health by reducing emotion-focused and avoidance-focused coping strategies. Low cost and fast access to virtual mobile networks allow women to access educational content after abortion due to fetal malformation.Registration in clinical trial: it is registered in the Thai Clinical Trial Registry (TCTR) under the number TCTR20200519001.CONSORT : This study follows the CONSORT guidelines.

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

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.

scholarly journals The effect of combined education on the knowledge and care and supportive performance of parents with children with cleft lip and palate: A clinical trial study

2021 ◽  
Vol 8 ◽  
pp. 2333794X2110222
Author(s):  
Ashrafalsadat Hakim ◽  
Zahra Zakizadeh ◽  
Nader Saki ◽  
Mohammad Hossein Haghighizadeh
Keyword(s):  
Clinical Trial ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Intervention Group ◽  
Parental Knowledge ◽  
Control Group ◽  
Demographic Information ◽  
Significant Difference ◽  
The Mean ◽  
And Performance

Cleft lip and palate is a major problem that disrupts the child’s family life. The present study aimed to investigate the effect of combined education on the knowledge and care and supportive performance of parents with children with cleft lip and palate. This is a clinical trial study was conducted on 40 parents referring to hospitals. The data were collected using the demographic information questionnaire, the questionnaire of parental knowledge and care supportive performance questionnaire and analyzed using descriptive and analytical tests. After education the intervention group, the mean score of parents’ care and supportive knowledge significantly increased in the intervention group as compared to the control group. There was also a significant difference in the mean score of parents’ care-supportive performance between the two groups ( P < 0.001). It is recommended to use the combined education as an effective method to increase knowledge and performance in parents of children with cleft lip and palate.

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

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
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.

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.

Effects of Relationship Enrichment Training on Improving Marital Satisfaction of Infertile Couples: A Randomized Control Trial

2021 ◽  
Vol 17 ◽  
Author(s):  
Seyedeh Zahra Masoumi ◽  
Khodayar Oshvandi ◽  
Masoumeh Rostami-Moez ◽  
Arezoo Shayan ◽  
Farideh Kazemi
Keyword(s):  
Marital Satisfaction ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Chi Square ◽  
Significance Level ◽  
Significant Difference ◽  
The Mean ◽  
Infertile Couples ◽  
Relationship Enrichment

Background: Infertility can cause low marital satisfaction. Marital satisfaction has an important effect on infertile couples’ health. Objective: This study aimed to assess the effect of relationship enrichment training on improving the marital satisfaction of infertile couples. Methods: This randomized clinical trial was conducted on 50 infertile couples in the infertility center of Fatemieh Hospital in Hamadan, Iran in 2018. Participants were matched for demographic characteristics and randomly assigned to intervention and control groups (each group had 25 couples). Informed consent was obtained from all participants. The Enrich Marital Satisfaction questionnaire and demographic information were used to collect data before the study and two months after the intervention. Two trained midwifery students taught only the intervention group the relationship enrichment topics in seven sessions (each session = 90 minutes). The data were analyzed by SPSS Statistics version 21 using analysis of covariance, independent t-test, chi-square, and Mann–Whitney. The significance level was set at p ≤ 0.05. Results: There was no significant difference in demographic and obstetric information between the two groups (p >0.05). The mean of marital satisfaction in the intervention group significantly increased among women and men from 151.00 ±28.61 to 154.88 ±22.62 and from 152.56 ±27.33 to 159.24 ±22.14, respectively, (p <0.001). Conversely, the mean of marital satisfaction decreased among women and men from 158.13 ±13.86 to 146.25 ±19.53 and from 164.25 ±17.00 to 153.17 ±27.50 in the control group (p=0.02). Conclusion: Relationship enrichment training can be effective in promoting the marital satisfaction of infertile couples. Registration number: The National Center for Strategic Research in medical education, No. 960185.

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.

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