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

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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The Effect of Olive Oil and Honey Combination on Episiotomy Wound Healing and Pain Relief: A Randomized Clinical Trial

Current Women s Health Reviews ◽

10.2174/1573404816666200123111718 ◽

2020 ◽

Vol 16 (2) ◽

pp. 145-151

Author(s):

Arezoo Shayan ◽

Hadis Sourinezhad ◽

Fariba Barzegar ◽

Hassan Ahmadinia ◽

Zahra Masoumi ◽

...

Keyword(s):

Clinical Trial ◽

Wound Healing ◽

Pain Relief ◽

Pain Intensity ◽

Olive Oil ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Perineal Pain ◽

Control Group ◽

Primiparous Women

Background: Episiotomy is one of the most common surgical procedures in the world that is associated with perineal pain and can be exposed to infection, or might be healed with delay. Objective: The aim of this study was to investigate the effects of honey-olive oil combination on episiotomy wound healing and pain relief in primiparous women. Methods: This single-blind, parallel randomized clinical trial (IRCT20120215009014N208) was conducted on 80 primiparous women. They were allocated randomly to each of the groups through random allocation rule: 40 in honey-olive oil group and 40 in the control group. Every 12 hours and for 14 days, the treatment group used about 1 inch of the cream on the wound area. Pain intensity and wound healing were measured by REEDA Scale and Visual Analogue Scale on days 7, 10, and 14 in both groups. The statistical analyst was not informed about the allocation of the groups. A significant level of 0.05 was considered. Results: There was a significant difference between healing score and pain intensity between the two groups on 7th, 10th and 14th postpartum days (p <0.05). Wound healing occurred much faster (Scores on days 7,10, and 14 were 11.25±2.13, 7.47±1.96 and 4.95±1.53 in the control group and 4.45±1.25, 2.32±.69 and 10±.30 in the intervention group, p <0.05). Moreover, pain intensity was significantly relieved in those who used Honey and olive oil cream (the scores were 5.6750±1.43, 3.3500±1.52, 2.2250±1.34 in the control group and 1.9750±1.52, .2250±.57, .0250±.15 in the intervention group, p<0.05). Conclusion: Using honey and olive oil combination improves episiotomy wound healing and also relieves its’ associated pain.

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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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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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Effectiveness of Olea Herbal Ointment on Episiotomy Wound Healing Among Primiparous Women: A Randomized Clinical Trial

Jundishapur Journal of Natural Pharmaceutical Products ◽

10.5812/jjnpp.104570 ◽

2021 ◽

Vol In Press (In Press) ◽

Author(s):

Shokoufeh Torkashvand ◽

Fatemeh Jafarzadeh-Kenarsari ◽

Yalda Donyaei-Mobarrez ◽

Bahare Gholami Chaboki

Keyword(s):

Clinical Trial ◽

Wound Healing ◽

Intervention Group ◽

Repeated Measure ◽

Control Group ◽

Controlled Clinical Trial ◽

Exact Test ◽

Significant Difference ◽

Perineal Region ◽

Primiparous Women

Background: Episiotomy is a surgical incision in the perineal region to increase the vaginal diameter during delivery. Since the perineal region is not well visible to the mothers and there is a possibility of infection for the episiotomy wound by vaginal and rectal bacteria, such a cut is associated with infection and delay in wound healing. Objectives: This study aimed to detect the effect of Olea ointment on episiotomy wound healing among primiparous women. Methods: This randomized controlled clinical trial included 73 women referring to the Al-Zahra educational, research, and remedial center in Rasht, Iran, during 2017 - 18. Women were randomly assigned into two groups: Intervention group (n = 39) and control group (n = 34). Episiotomy wound healing was assessed using the REEDA scale prior to the intervention, 2 and 24 hours following the first intervention, and 5 and 10 days after delivery. Statistical analysis was performed using Fisher’s exact test, Mann-Whitney U test, independent t-test, repeated-measure test, Friedman test, and chi-square. Results: The mean baseline scores of REEDA was 2.72 ± 0.46 in the Olea ointment group and 2.71 ± 0.46 in the control group; however, there no statistically significant difference between the two groups. On the other hand, the episiotomy healing scores in the Olea ointment group were significantly lower than those of the control group at four intervals in the follow-up assessments: -0.34 (95% CI: -0.56 to -0.12) two hours after intervention, -0.63(95% CI: -0.89 to -0.37) 24 hours after intervention, -0.30 (95% CI: -0.48 to -0.12) on Day 5 postpartum, and -0.29 (95% CI: -0.46 to -0.13) on Day 10 postpartum. Conclusions: The present findings suggested that the Olea ointment facilitated wound healing episiotomy; however, further studies are suggested to support these data.

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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

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v31i330303 ◽

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.

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

10.21203/rs.3.rs-103718/v1 ◽

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.

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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.

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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

Global Pediatric Health ◽

10.1177/2333794x211022238 ◽

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.

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The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

International Electronic Journal of Medicine ◽

10.31661/iejm805 ◽

2018 ◽

Vol 7 ◽

Author(s):

Azita Kamjoo

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Active Phase ◽

Labor Pain ◽

Control Group ◽

Singleton Pregnancy ◽

Group Data ◽

Significant Difference ◽

Labor Length ◽

Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

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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.

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