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Showing 16 results for Type of Study: randomized clinical trial

A Haji, Q Karimi,
Volume 17, Issue 3 (9-2015)
Abstract

Background & objectives: Epilepsy is a prevalent neurological disorder that puts trouble for many people worldwide. The impact of epilepsy on the self-efficacy and quality of life of patients is greater than the limitations imposed by the seizures alone. Worry, uncertainty and stigma associated with epilepsy may affect the self-efficacy and quality of life. The present study aimed to identify the relationship of worry, uncertainty and stigma with the self-efficacy and quality of life in the patients with epilepsy.

Methods: A descriptive-correlational design was used to conduct the study. Through the convenience sampling method, 60 patients with epilepsy admitted to the neurology unit of Alavi hospital affiliated to Ardabil University of Medical Sciences were involved in the study during 2014. Data were collected by administering the Penn State Worry Questionnaire, Intolerance of Uncertainty Scale, Epilepsy Stigma Scale, Epilepsy Self-Efficacy and Epilepsy Quality of Life Scale. Data were analyzed using Pearson&rsquos correlation coefficient and multivariate regression analysis in SPSS v.20.

Results: Findings indicated that quality of life of patients with epilepsy negatively correlated with reported worry, uncertainty and stigma (p=0.000), also self-efficacy negatively correlated with the social stigma (p=0.008). Regression analysis also showed that 44 percent of the variance in quality of life and 21% of the variance of self-efficacy in these patients is predicted by uncertainty, fear and social stigma.

Conclusions: According to the findings, patients with epilepsy suffer from stigma, uncertainty and worry and consequently the sense of self-efficacy is decreased among them so they need support from the community and family.


Z Ghazavi , Z Mardany, S Pahlavanzadeh,
Volume 19, Issue 3 (11-2017)
Abstract

Background and aim: Increasing the happiness of nurses can reduce stress and promote health, quality of life, self-esteem and job performance. The aim of this study was to determine the effect of Fordyce Happiness Training Program on nurses' happiness.
Methods: This study was a randomized clinical trial conducted in different parts of Seyedol Shohada hospital in Isfahan in 2014. 52 nurses working in different parts of the study were randomly assigned into two experimental and control groups. Fordyce Happiness Training Program was held at 6 sessions each week and a Oxford Happiness Questionnaire was completed before, immediately and one month after the intervention in both groups.. Data were analyzed by Chi-square and independent t-test and ANOVA through SPSS 18.
Results: The mean score of happiness before intervention was not significant in the two groups (p=0.94). While the happiness score in the experimental group, immediately (p=0.003) and one month after intervention (p=0.001) significantly increased compared to control group.
Conclusion: According to the results, happiness educational program of Fordyce can increase nurses’ happiness, so psychiatric nurses, psychologist and consultants can use this method to make happy nurses.
M Mohammad Alipour , Sh Jafari Zare, M Sohrabi, , S Ejder Apay , T Sakar,
Volume 20, Issue 2 (7-2018)
Abstract

Background & aim: Stimulation of labor pain is one of the most common and necessary procedures in midwifery. Delivery is induced to accelerate the delivery process in more than 15% of pregnancies. In this study, two labor induction methods, including Foley catheter insertion and hot water shower, were compared with natural vaginal delivery.
Methods: A clinical trial study was conducted on 150 nulliparous pregnants at gestational weeks of 40-41. Patients were divided into three groups randomly. Groups 1, 2, and 3 were performed using catheterization, warm shower, and routine delivery, respectively. All patients went under Induction using oxytocin after the performance. Descriptive-analytical tests were used to assess the progress of labor using SPSS/v16.
Results: The mean age in the three groups were 24.70±11.43, 24.19±10.23 and 23.92±10.30 years, respectively (p=0.728). The slow progression of labor in the first and second groups and the post-date delivery in the third group were the most common causes of induction. There were no significant differences in the pain intensity of uterine contractions between groups before intervention (p<0.169). After the intervention, the pain intensity was increased in all groups significantly (p<0.001). The highest and lowest increases in pain were seen in induction (2.08) and hot water shower (0.03) groups, respectively. The shortest time between contraction and complete dilation of the cervix was revealed in the first group (p<0.001). Normal deliveries leading to the Cesarean operation had the highest rate in the third group (p=0.266).
Conclusion: It seems that Foley's catheter insertion has a positive effect on the process of delivery as well as the warm shower bath reduces the pain of patients during the delivery process.
 
V Atashi, A Yazdannik, H Mahjobipoor, H Yousefi, R Bekhradi,
Volume 20, Issue 3 (9-2018)
Abstract

Background & aim: Oral care is one of the main aspects of nursing care in intensive care units which not only helps the patient to feel comfortable but also prevents serious complications such as ventilator-dependent pneumonia. The aim of this study was to determine the effect of a systematic oral care program on oral health in patients of intensive care unit.
Methods: This study was a randomized clinical trial performed on 76 patients in intensive care units in 2017. They were randomly assigned to the control and intervention group. In addition to routine oral care, a 5-day systematic oral care program including brushing, chlorhexidine solution, mouth moisturizing gel, and Vaseline was performed for the intervention group. Oral health evaluated in both groups during five days of study. Data were collected using a demographic and Beck Oral Assessment Scale and then analyzed using SPSS ver16.
Results: There was no significant difference between the intervention and control groups in Beck Oral Assessment Scale in the first to third days, but after the third day, the oral health status of the intervention group was significantly better than the control group (p<0.05).
Conclusion: According to the findings, oral care program is effective in improving oral health. The application of the proposed program in the current study is simple and guarantees minimal oral care for ICU patients.
M Rahnavardi, S Heydarifard, M Mohammadi,
Volume 20, Issue 3 (9-2018)
Abstract

Background & aim: The usage of complementary medicine in pregnancy and childbirth is increasing. Chamomile consumption reduces anxiety and makes calmness. In this study, the effect of aromatic herbal use on chamomile essential oil was studied on anxiety and some of the delivery consequences in primiparous women.
Methods: The study was a randomized clinical trial performed on 130 primiparous women (65 in the intervention group and 65 in control group) referred to Emdadi hospital, Abhar in 2014. The anxiety state and its trait were measured at the time of entering the study by State-Trait Anxiety Inventory (STAI). Two drops of chamomile essential oil or distilled water dipped into gas were inhaled by the intervention and control groups respectively from a distance of 7-10 cm. After the intervention, anxiety was measured at cervical dilations of 4-3 and 10-8 cm. At the end of the intervention, the delivery outcomes were recorded and compared in the two groups. Data were analyzed by SPSS software version 22 using the independent t-test, Mann-Whitney, and Chi-square.
Results: The results showed that the anxiety scores in the intervention group at dilations of 3-4 and 8-10 cm were significantly lower than the control group (p<0.0001). Chamomile odor did not affect the normal delivery outcome, newborn hospitalization in ICU, and newborns Apgar scores at first and fifth minutes after delivery.
Conclusion: The findings of the present study showed that the aromatherapy of chamomile essential oil decreases the women anxiety without changing the delivery outcomes. So, chamomile essential oil is recommended to reduce childbirth anxiety.
T Ramezani , Z Gharlipour , G Sharifirad , S Mohebi ,
Volume 20, Issue 4 (1-2019)
Abstract

Background & objectives: Skin problems and incidence of infection in the vascular access sites are two common problems in hemodialysis patients. Increasing the self-efficacy of patients can improve self-care behaviors. Considering the importance of patients training about skin and fistula care, the current study was performed with aiming of determining the effect of education based on the self-efficacy theory on the skin and fistula care in hemodialysis patients.
Methods: This interventional study was performed on 70 hemodialysis patients, in two groups of 35 persons, in Qom city, 2016. Data collection tools consisted of demographic characteristics form, researcher-made questionnaires of skin and fistula care, and self-efficacy standard questionnaire (SUPPH). Questionnaires were completed before and 3 months after the intervention in the sort of education based on the self-efficacy theory in 4 sessions of 15-20 minutes. Data were analyzed by Chi-square, independent T-test, Paired T-test, and Mann-Whitney test using SPSS 16. 
Results: The difference between the two groups in terms of mean scores of self-efficacy and skin and fistula care was no significant before the intervention but it was significant after the intervention (p<0.001). Mean scores of self-efficacy and skin and fistula care of patients showed significant difference before and after the intervention (p<0.001).
Conclusion: According to the results of this research, implementation of proper education program using the self-efficacy theory can promote the self-efficacy of hemodialysis patients in the field of skin and fistula care.
R Motavalli , T Mousazadeh ,
Volume 21, Issue 1 (3-2019)
Abstract

Background & objectives: Primary dysmenorrhea is one of the common problems of women in reproductive age, disrupting the quality of life young women, especially when accompanied with symptoms such as headache, fatigue, nausea, vomiting, diarrhea and impatience. The present study aimed to investigate the effect of Fennel on reduction of symptoms associated with pain in primary dysmenorrhea.
Methods: This clinical trial study was conducted on 105 dormitory students of Ardabil Islamic Azad University with primary dysmenorrhea who consented to the study. Among them, 72 qualified individual with grade 3 primary dysmenorrhea were selected and then randomly divided into two experimental (Fennel) and control (placebo) groups. In experimental group and at the first 3 days of the menstrual cycle, 3-5 drops of fennel, in tea or water, was administered for three consecutive cycles. The control group received distilled water-containing capsule (placebo) 4 times a day for three consecutive cycles. The data were collected by five-part questionnaire and analyzed with descriptive statistics and chi-square test in SPSS version 17.
Results: The results of this study showed that there was no significant difference in the symptoms associated with pain during menstruation cycle between experimental and control groups.
Conclusion: The study found that Fennel was not able to reduce the symptoms associated with pain in the primary dysmenorrhea, including headaches, fatigue, diarrhea, nausea, and vomiting. It seems that this herbal cannot be used as remedy for systemic symptoms in dysmenorrhea.
Z Khodaveisi , Sr Borzou , Y Mohammadi , A Azizi ,
Volume 21, Issue 2 (5-2019)
Abstract

Background & objectives: Nausea, retching and vomiting are common complications after surgery. Despite the medical treatment, patients still suffer from these complications. The use of non-pharmacological methods can reduce these complications. Therefore, the aim of this study was to determine the effect of inhalation of ginger extract on postoperative nausea, retching and vomiting after laparoscopic cholecystectomy.
Methods: This clinical trial study was performed on 70 patients undergone laparoscopic cholecystectomy in Besat hospital of Hamadan. The samples were selected by convenience sampling and then were assigned to two groups of 35 individuals, including ginger extract and placebo groups, by simple random assignment. In ginger group, 6 drops of ginger extract and 1cc of distilled water were poured on a 2×2 gas and placed in a zipper bag and patients were asked to inhale it 3 times/minute during 20 minutes. The intervention in placebo group was similar; with the difference that normal saline serum was used. The severity of nausea in two groups was determined and compared before intervention as well as after 0.5 and 1 hour, with visual analog scale. The frequency of vomiting and retching was evaluated based on the number of incidence in the 4 first hours after intervention. Data were analyzed by independent T-test and analysis of variance of repeated measures.
Results: The results showed a significant reduction in the severity of nausea (p=0.003), the number of retching (p=0.036), and vomiting (p=0.007) times in ginger group compared to placebo group.
Conclusions: Inhalation aromatherapy with ginger extract can be used to reduce the postoperative nausea severity and the frequency of retching and vomiting in laparoscopic cholecystectomy.
 
P Lak , M Noroozi , S Ehsanpoor,
Volume 21, Issue 4 (12-2019)
Abstract

Background & aim: Children are among the most vulnerable groups in society who are always threatened by the danger of being abused by various people. Mothers are the most important reliable source of information for children. The aim of this study was to compare the effect of two methods of group education and education by multimedia compact disk (CD) on mothers’ knowledge and attitude about child sexual abuse.
Methods: In this clinical trial, 100 mothers of children under 18 who had a medical record at health centers of Isfahan province were selected. Participants were allocated into two groups of group education and education with multimedia CD and trained about the definition, prevalence, diagnosis, prevention and management of child sexual abuse. Data were collected by a researcher-made questionnaire which completed before and after the intervention. Data were analyzed using descriptive and inferential statistics in SPSS19 software.
Results: The mean score of knowledge and attitude of mothers about child sexual abuse had a statistically significant increase after the intervention in group education and also in the multimedia CD group compared to before the intervention (p<0.001). No significant difference was observed between two groups in the mean scores of knowledge and attitude of mothers about child sexual abuse after intervention.
Conclusion: Group education and education with multimedia CD were effective in improving the knowledge and attitude of mothers about child sexual abuse. Therefore, considering the benefits of educating with multimedia CD including its affordability and the possibility of using at any time, it is recommended to be used for mothers’ education programs.
N Semnani , H Hojjati , G Akhoundzadeh ,
Volume 22, Issue 2 (8-2020)
Abstract

Background & aim: Premature infants, due to incomplete physical development, are exposed to various painful procedures during care and treatment. One of the painful procedures is gavage feeding due to lack of coordination in swallowing premature infants. This study has been performed to evaluate the effect of Yakson touch on pain control of nasogastric intubation in premature infants.
Methods: This clinical trial study was performed on 64 premature infants referred to Taleghani Gonbad Hospital in Golestan province in 2019. The samples that met the inclusion criteria were divided into experimental and control groups by random sampling method. Infants in the intervention group received the Yakson Touch once a day for 15 minutes and 5 consecutive days. Infants in the control group received only routine care. Data were collected using a demographic questionnaire and pain assessment in infants was evaluated by a neonatal-infant pain assessment tool. Data analysis was performed by descriptive and inferential statistical methods and SPSS-16 software.
Results: Mean and standard deviation of pain on the first day of hospitalization was 5.24±0.71 in the control group and 5.24±0.72 in the experimental group. These values in the fifth day of hospitalization were 4.27±0.44 in control group and 3.9±0.53 in the experimental group. The results of this study with repeated measures analysis of variance showed that pain decreased over time in both groups independently. However, this reduction in pain did not show a significant difference between two groups (p=0.96).
Conclusion: The findings of the present study, which was performed to determine the effect of Yakson touch on the pain of premature infants admitted to the intensive care unit, showed that the pain intensity score did not show a significant difference between the experimental and control groups. Due to the difference between the results of this study and some other studies, it seems that there is a need for further studies on the effectiveness of this technique in low birth weight infants.
A Yalfani , N Bigdeli , F Gandomi ,
Volume 22, Issue 2 (8-2020)
Abstract

Background and aim: Increasing of gap between the inter-recti abdominal muscles during pregnancy and postpartum, called diastasis recti, which is the result of weakness and transverse stretching of the linea alba. In this disorder, lumbopelvic control is impaired, which is one of the causes of lumbar pain and disability after childbirth. One of the treatment methods for this disorder is rehabilitation training in the core area of ​​the trunk. This study aimed to evaluate the effect of isometric-isotonic exercises on improving the width of linea alba, lumbopelvic control, pain, and disability in women with diastasis recti after postpartum.
Methods: This study is a randomized controlled double-blind clinical trial in which 24 women with diastasis recti were participated and divided into two groups of exercise and control (n=12) with a mean age of 29.66 (4.97) and 28.25 (4.55), respectively. We used the digital caliper for the assessment of diastasis recti and lateral step down test for assessment of lumbopelvic control. Also, vas scale and Oswestry questionnaire were used for assessing pain and disability. The exercise group exercised for 8 weeks and 3 sessions per week and the control group continued their normal life routine.
Results: By comparing the mean results of the intervention and control groups after eight weeks of isometric-isotonic training, a significant difference was observed in the rate of rectus diastasis and lumbopelvic control, pain, and disability (p≤ 0.05). Also, ETA squared of the effect size of exercise showed that these exercises had a very strong effect on the transverse distance of Lina Alba (0.846), the degree of pelvic lumbar control (0.850), the degree of disability (0.720), but had a moderate effect on pain variable (0.546).
Conclusion: Isometric-isotonic exercises of core stability can improve lumbopelvic control by reducing the width of Linea Alba and thus reduce lumbopelvic pain and disability in people with diastasis recti. According to the results, the exercises presented in this study can be used to treat diastasis recti.
P Sharifian , A Khalili , F Cheraghi,
Volume 22, Issue 2 (8-2020)
Abstract

Background & objectives: Burn is one of the most common events in childhood. Pain relief in burned patients helps to stabilize the patient's hemodynamic parameters. The aim of this study was to determine the effect of auditory deviation on dressing replacement pain in children aged 6-12 years.
Methods: In this single-blind clinical trial with a control group, 80 children aged 6-12 years admitted to the burn ward of Besat Hospital in Hamadan were selected by convenience sampling method and then randomly divided into two groups of control and intervention. Data were collected using a demographic profile checklist and Oucher pain scale. From two minutes before the end of the dressing, special children's music was played for the auditory group. In both groups, pain intensity was measured and recorded 10 minutes before dressing, at intervals of two minutes during dressing and 5 minutes after dressing. Data were analyzed using SPSS-16 software and chi-square tests, one-way analysis of variance and analysis of variance with repeated measures.
Results: The results showed that no significant differences were found in the demographic characteristics of children and parents between the intervention and control groups. The mean pain intensity scores at all times of measurement were statistically significant between the intervention and control groups and in general, the pain intensity score in children in the intervention group was lower than the control group (p<0.001).
Conclusion: In general, the results showed that the method of auditory aberration is effective in reducing the severity of burn pain in children. Therefore, nurses can use this method as a cheap and accessible method that has no side effects on and interference with other therapeutic interventions to improve the pain relief of changing children's burn dressings.
F Akbarnya, M Habibian, Moosavi,
Volume 22, Issue 3 (11-2020)
Abstract

Background & aim: Nowadays, the prevalence of chronic low back pain is increasing in the world and vitamin D deficiency is associated with impaired neuromuscular function and chronic musculoskeletal pain. In addition, exercise therapy and selection of core stabilization exercise interventions have main roles in rehabilitation of these patients. The aim of this study was to investigate the effect of 8 weeks of core stabilization exercises and vitamin D intake on the pain and functional disability levels in women with chronic non-specific low back pain.
Methods: This clinical trial study was performed by pre-test and post-test design. Initially, 48 women with chronic non-specific low back pain were selected by available sampling method and then randomly divided into control, exercise, vitamin D and exercise+vitamin D (combined) groups (12 subjects in each group). The exercise and combined groups performed 8 weeks of core stabilizing exercises. The vitamin D and combined groups received 50,000 IU vitamin D/week for 8 weeks. The severity of the pain and functional disability, before and after the interventions, were determined by visual analog scale of pain and Oswestry questionnaire, respectively. Data analysis was performed using Paired T-Test and ANOVA with the significance level of less than 0.05.
Results: Eight weeks of core stabilizing exercises, vitamin D intake and the combined intervention were associated with a significant reduction (p<0.001) in pain (20.15%, 18.60% and 34.20%, respectively) and functional disability (48.35%, 44.26% and 51.81%, respectively) in women with chronic non-specific low back pain. In addition, combined intervention induced more reduction in the pain compared with two other interventions (p<0.001)
Conclusion: It seems that core stabilizing exercises, vitamin D intake, and the combination intervention can reduce the pain and improve the physical function in patients with chronic low back who have low levels of vitamin D. But combined intervention is associated with greater effectiveness in reducing the pain.
A Zarneshan, N Safaee, L Esmealy, B Esmealy,
Volume 22, Issue 4 (3-2021)
Abstract

Background & aim: Adequate oxygenation and hemodynamic stability are important goals of nursing care after coronary artery bypass graft (CABG). This study aimed to evaluate the effects of stretching combined with breathing exercise on hemodynamic and oxygenation changes in CABG patients.
Methods: In this randomized clinical trial study performed in 2020, 48 patients (35 men and 13 women) undergoing non-emergency CABG surgery at Shahid Madani Hospital of Tabriz were randomly divided into experimental (n=24) and control (n=24) groups. Evaluations of heart rate, blood pressure, and arterial blood oxygenation were performed before, immediately, and five day after exercises. Combined Stretching-breathing exercises were performed in the experimental group for five days and two times a day (morning and evening). The patients in the control group received the usual hospital care. Data were analyzed using ANCOVA at a significant level of p<0.05.
Results: After five days of combined stretching-breathing exercise, the mean oxygen pressure (F=12.90, p=0.001) and oxygen saturation (F=16.38, p<0.001) of arterial blood increased significantly, while heart rate (F=21.01, p<0.001) and mean carbon dioxide pressure (F=11.95, p=0.001) decreased significantly in the experimental group compared to the control group. Immediately after the intervention, no significant difference was observed between two groups in the research variables.
Conclusions: Based on the research findings, combined stretching-breathing exercise had a beneficial effect on improving heart rate and arterial blood oxygenation in CABG patients and this can speed patient recovery as a rehabilitation program.

M Heydari, M Keshavarzynejad,
Volume 24, Issue 4 (3-2023)
Abstract

Background & aim: Postpartum pain or painful uterine contractions are one of the most common postpartum problems. This pain is affected by various factors and has maternal and neonatal adverse consequences. Nowadays, herbal and traditional remedies have been considered for management of this pain. The aim of this study was to evaluate the effect of hydroalcoholic extract of priest sachet Capsella bursa-pastoris on postpartum pain and volume of bleeding in women referring to Damghan Hospital affiliated to Semnan University of Medical Science.
Method: In this clinical trial, 110 mothers with vaginal delivery were enrolled. Inclusion criteria were postpartum pain criteria of four and more. Patients were randomly assigned into two groups, the first group received hydroalcoholic extract of Capsella bursa-pastoris and the other received placebo. Visual scale of pain was used to assess postpartum pain. Data were analyzed by SPSS-20 software using independent t-test, Mann-Whitney, Chi-square and analysis of variance with repeated measures and linear regression at significance level less than 0.05.
Results: The mean age was 29.13±6.6 years. The two groups were matched in terms of age and other factors including cultural and economic status, parity, delivery, and abortion, history of stillbirth and curettage, anthropometric indices, administration of oxytocin during labor, labor conditions and neonatal factors. There was no significant difference between the two groups in receiving of analgesics. Analysis of variance showed that time had a significant effect on pain severity, however, pain intensity at different times in the intervention group was significantly lower than control group (p=0.026).
Conclusion: Despite the effect of time on decreasing of postpartum pain, the severity of pain at different times in the intervention group was significantly lower than control group and recommended for postpartum pain.


 
P Mohammadi, Sh Madadkar, Z Karimiankakolaki, Sh Mirzaeian,
Volume 24, Issue 4 (3-2023)
Abstract

Background & aim: One of the basic tools in changing the lifestyle and the patients’ perception of the disease is the existence of an educational program using innovative teaching methods. The present study was conducted to determine the effect of multimedia education with the Leventhal’s Model approach on the lifestyle and understanding of the disease in patients with atrial fibrillation.
Methods: In this quasi-experimental study, 60 patients with atrial fibrillation were randomly assigned into two intervention (n=30) and control (n=30) groups at Kashani Shahrekord hospital during the year of 2022. In the intervention group, two virtual training sessions were held through multimedia software (voice, video, image and animation) under the title of 4-hour training workshop for patients on the date and time coordinated with the help of Adobe Connect program. There was no intervention in the control group. After the workshop, lifestyle and disease perception were measured using Walker’s lifestyle and disease perception questionnaire. Data analysis was done using independent t and paired t-tests.
Results: There was no statistically significant difference in the average score of lifestyle and disease perception between the two intervention and control groups before the study, and the two groups were homogeneous (p=0.041). However, the average score of lifestyle and disease perception in the intervention group has increased significantly after the implementation of the intervention compared to the control group (p≤0.001).
Conclusion: Multimedia virtual education has led to the improvement of patients’ lifestyles and disease perception. It is recommended to carry out educational interventions to improve lifestyle and disease perception in patients with atrial fibrillation.

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