Evaluation the effect of Silybum marianum ointment on episiotomy wound healing and pain intensity in primiparous women: a randomized triple blind clinical trial

Abstract Background Episiotomy is the most commonn surgical procedure in midwifery which as any other wounds can cause infection or delay in healing. The current study aimed to determine effect of Silybum marianum ointment on pain severity and healing of episiotomy wound in primiparous women referring to Shahid Nourani Hospital at 2019. Methods This research was done as a randomized, triple-blind clinical trial on 87 priiparous women (44 indivdiuals in Silybum marianum ointment group and 43 indivdiuals in placebo group) referred to Shahid Nourani Hospital in Talesh (Guilan Province), Iran at September 2019. After labor and performing episiotomy, twice a day for 10 days as a fingertip size of the ointment was prescribed to be topically used on the episiotomy incision for both groups (Silybum marianum ointment or placebo ointment). Data gathering was done using demographic and midwifery information questionnaire, Episiotomy healing assessment: Redness, Edema, Ecchymosis, Discharge, Approximation)REEDA Scale (REEDA Scale: Redness(R); Edema (E), Ecchymosis(E), Discharge from the wound(D); Approximation of the perineal tissues(A))(scale, and visual analogue scale of pain. Examination of healing status of the perinea incision was performed during first 12 h, fifth day and tenth day after labor.Kolmogrov-Smirnov test was used in order to investiagte nomrality of data distribution of quantitative data, and two- independent samples t test, Chi square, repeated measures two factorial analysis of variance and Fischer’s exact test were used. SPSS software version 23 was used to analyze data and 0.05 was considered as signifcance level. Results Both groups of Silybum marianum and placebo groups did not differ regarding demographic and midwifery characteristics, hygiene status prior to intervention (P > 0.05). Mean difference of pain severity and REEDA scale in Silybum marianum ointment group in 12 h after labor, at fifth day and tenth day after labor was significant comparing to control group which indicates decline in episiotomy pain severity and faster wound healing (P < 0.001). Conclusions Silybum marianum ointment ointment accelerates episiotomy wound healing rate due to its healing properties and decreases pain severity. Trial registration This study was registered in Iranian Registry of Clinical Trials in 10/08/2019 with the IRCT ID: IRCT201811100411603N1.

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

Complementary Medicine Journal ◽

10.32598/cmja.10.3.1019.1 ◽

2020 ◽

Vol 10 (3) ◽

pp. 258-269

Author(s):

Fatemeh Imani ◽

◽

Ebrahim Nasiri ◽

Houshang Akbari ◽

Mohammad Reza Safdari ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Randomized Clinical Trial ◽

Repeated Measures ◽

Intervention Group ◽

Control Group ◽

Control Groups ◽

Chi Square ◽

Chi Square Test ◽

And Control

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

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Educational intervention with serial album about pregnant women positioning for spinal anesthesia: randomized clinical trial

Revista Brasileira de Enfermagem ◽

10.1590/0034-7167-2019-0878 ◽

2020 ◽

Vol 73 (suppl 4) ◽

Author(s):

Sarah de Lima Pinto ◽

Larissa Alves Sampaio ◽

Nelson Miguel Galindo Neto ◽

Paulo César de Almeida ◽

Mirna Fontenele de Oliveira ◽

...

Keyword(s):

Clinical Trial ◽

Pregnant Women ◽

Spinal Anesthesia ◽

Randomized Clinical Trial ◽

Educational Intervention ◽

Intervention Group ◽

Maternity Hospital ◽

Control Group ◽

Chi Square ◽

Exact Test

ABSTRACT Objective: To evaluate effectiveness of using educational intervention serial album to positioning pregnant women for spinal anesthesia. Method: Randomized clinical trial with 90 women casually assigned to control (CG) and intervention group (IG), in a maternity hospital located in Northeast region of Brazil. The primary endpoint was “achieve correct positioning to perform spinal anesthesia”; and secondary, “how number of spinal cord puncture attempts”. Effectiveness was verified using the chi-square test, Fisher’s exact test and likelihood ratio. Results: The positioning was correct in 37 women in each group. There was an association between women in control group remaining still, relaxing shoulders and flexing the spine; and women in intervention group should remain still and relax the shoulders; furthermore there was a statistical association achieved by correct positioning and the number of attempts to access the lumbar puncture. Conclusion: Educational intervention with serial album was effective and contributed to immobility and positioning of pregnant women. Brazilian Registry of Clinical Trials (RBR-3Z7SRD).

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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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Effect of chamomile oil on cesarean section pain in primiparous women: a randomized clinical trial

Current Clinical Pharmacology ◽

10.2174/1574884715666200331133157 ◽

2020 ◽

Vol 15 ◽

Author(s):

Roghayeh Zardosht ◽

Ameneh Basir ◽

Amirhossein Sahebkar ◽

Seyed Ahmad Emami

Keyword(s):

Clinical Trial ◽

Cesarean Section ◽

Pain Intensity ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Chi Square ◽

Double Blind ◽

The Difference ◽

Primiparous Women

Background: Pain after cesarean section can turn the pleasant event of childbirth into an unpleasant experience for the mother. Pain relief through non-pharmaceutical methods, such as aromatherapy, could potentially be a useful intervention. In this study, the analgesic effect of chamomile oil was studied. Purpose: The current research was conducted to study the effect of chamomile oil on cesarean section pain in primiparous women. Materials and methods: This was a randomized double blind clinical trial wherein 128 primiparous pregnant women (who willingly selected cesarean section) took part. In the aromatherapy group, the subjects inhaled one drop of 5% chamomile oil, and in the control group the subjects inhaled one placebo drop. In both groups the subjects inhaled for 15-20 minutes at a distance of 5 cm from the nose at 4, 8, and 12 hours after surgery, and pain intensity was measured before and after half an hour after inhalation using the visual analog scale (VAS). For data analysis, the software SPSS (version 25) and descriptive statistics (frequency, frequency percentage, mean, and standard deviation) were used. In order to determine the significance, inferential statistics (Mann-Whitney, Wilcoxon, independent t-test, and Chi-square) were used. Findings: Data indicated that the intervention and placebo groups were homogeneous in terms of demographic variables. The average weights and heights of women in the intervention group were 86/5± 5/9 and 163/7 ±5/1, respectively. Corresponding values women in the control group were 84/5± 5/7 kg and 163/4± 5/8 cm. The finding of the current research indicates that the intervention and placebo groups showed no significant statistical difference in terms of baseline pain before intervention (p=0.08), while the difference between the two groups was significant in terms of pain 4, 8, and 12 hours after intervention (p<0.01). Therefore, inhalation of chamomile oil reduced pain intensity significantly compared to post-intervention. Conclusion: According to the results of the present study, inhalation of chamomile oil following caesarean section in primiparous women reduced pain and also the need for analgesics. Therefore, the use of aromatherapy with chamomile oil as a simple way without any side effects for the reduction of pain in mothers after cesarean section is recommended.

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Effectiveness of Spiritual Therapy on Depression, Anxiety, and Stress in Hemodialysis Patients

Modern Care Journal ◽

10.5812/modernc.108879 ◽

2020 ◽

Vol 17 (4) ◽

Author(s):

Vihan Moodi ◽

Anahita Arian ◽

Jalil Reza Moodi ◽

Reza Dastjerdi

Keyword(s):

Repeated Measures ◽

Hemodialysis Patients ◽

Psychological Problems ◽

Control Group ◽

Chi Square ◽

Significance Level ◽

Exact Test ◽

Spiritual Therapy ◽

Spiritual Intervention ◽

And Control

Background: The most important psychological problems of dialysis patients are anxiety, depression, and stress. These psychological problems cause different consequences for the patients. ‎Therefore, it seems necessary to use strategies to reduce the psychological problems in hemodialysis ‎patients. Objectives: This study was conducted to evaluate the effectiveness of spiritual therapy on depression, anxiety, and stress in hemodialysis patients referred to the dialysis ward of special diseases center of Birjand in 2019 - 2020. Methods: In this semi-experimental study, 70 patients with chronic kidney disease (CKD) under hemodialysis referred to the dialysis ward of special diseases center of Birjand in 2019 - 2020 were selected by available sampling method and randomized into two experimental groups (35 patients) and control (35 patients). The patients in the experimental group received eight sessions of 60-minute (one session per week) of spiritual intervention therapy, and the control group received no spiritual intervention. Data collection tools were a form of demographic profile and Lovibond SH and Lovibond PF (1995) questionnaire. Data were analyzed using SPSS 26 statistical software, and Fisher’s exact test, chi-square test, independent t-test, repeated measures ANOVA, Bonferroni post hoc test at a significance level of P < 0.05. Results: In this study, 68 patients were ‎examined in two experimental (33 patients) and control (35 patients) groups.‎ The mean score of depression, anxiety, and stress before the intervention in patients in the ‎experimental and control groups was not significantly different ‎(‎P‎ =‎ 0.61‎)‎, but immediately and three ‎months after the intervention in patients in the experiment group was significantly lower than the ‎control group (P < 0.001).‎ Conclusions: Based on the results of the present study, it can be said that spiritual therapy is considered an effective solution for reducing depression, anxiety, and stress in hemodialysis patients.

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PREEMPTIVE ANALGESIA WITH AMITRIPTYLINE IN WOMEN UNDERGOING ABDOMINAL HYSTERECTOMY: A RANDOMIZED CLINICAL TRIAL

10.36106/gjra/4508238 ◽

2020 ◽

pp. 2-5

Author(s):

Antônio Henriques De França Neto ◽

Alexandre Magno Nóbrega Marinho ◽

Eveline Pereira De Arruda Agra ◽

Priscilla Guimarães Alves ◽

Josikwylkson Costa Brito ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Pressure Pain Threshold ◽

Abdominal Hysterectomy ◽

Tricyclic Antidepressant ◽

Preemptive Analgesia ◽

Chi Square ◽

Double Blind ◽

Exact Test ◽

Student’S T

The concept of preemptive analgesia, albeit long-standing, has reemerged. Consequently, recent research has focused on testing a variety of drugs preoperatively to prevent the occurrence of postoperative pain, a major factor of morbidity. Amitriptyline is a tricyclic antidepressant used to treat chronic pain. Because amitriptyline acts on pain transmission pathways, it could theoretically be used as an agent for the prevention of postoperative pain. This study evaluated the effectiveness of amitriptyline in preventing pain in patients submitted to hysterectomy, the most commonly performed gynecological surgery. A randomized, double-blind clinical trial was conducted with 145 patients, 72 of these receiving amitriptyline and 73 placebo. All patients were evaluated at 6, 12, 24 and 48 hours after surgery using a visual analog scale (VAS) for pain and algometry to determine the pressure-pain threshold. Statistical analysis was conducted using the chi-square test of association, Student's t-test, and the Mann-Whitney test, with Fisher's exact test being used whenever appropriate. No statistically signicant difference was found between the two groups with respect to pain at any of the time points evaluated, leading to the conclusion that at a dose of 25 mg, amitriptyline is ineffective in preventing postoperative pain in patients submitted to abdominal hysterectomy

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Success Rate of Obturation of Root Canals by Different Techniques in Primary Molars: A Comparative Clinical Study

Current Dentistry ◽

10.2174/2542579x02999200503032916 ◽

2020 ◽

Vol 2 (1) ◽

pp. 36-44

Author(s):

Satyawan G. Damle ◽

Ritika Bansal ◽

Dhanashree D. Sakhare

Keyword(s):

Success Rate ◽

Study Groups ◽

Primary Molars ◽

Control Group ◽

Second Primary ◽

Chi Square ◽

Exact Test ◽

Root Canals ◽

Significant Difference ◽

Comparative Clinical Study

Objective: To compare the success rate of different obturation procedures in primary mandibular second molars clinically and also by digital radiovisiography. Methods: A total of 40 children aged between 4-8 years with deeply carious mandibular second primary molars indicated for single session pulpectomy were selected. Canals were obturated with Metapex. The 3 study groups (Endodontic plugger, Handheld lentulospiral, Navi Tip syringe) were compared with the control group (reamer) both clinically and radiovisiographically. The data collected were statistically analyzed using Pearson’s Chi-square and Fisher’s exact test. Results: The use of Navi tip syringe led to the least number of voids followed by Endodontic plugger and Reamer and the highest number of voids was reported with Lentulospiral. Navitip presented maximum number of optimally filled cases followed by Endodontic plugger and Lentulospiral and least number of optimally filled cases with reamer. However, there was no statistically significant difference (p>0.05) in any of the groups with clinical (pain and tenderness to percussion) and radiographic parameters (presence or absence of voids and length of obturation). Conclusion: Within the limitations of the present study, though the clinical outcome was statistically insignificant, Navitip syringe exhibited encouraging results and is a promising option for obturation in primary teeth.

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The Effect of the Mobile ‘Blood Pressure Management Application’ on Hypertension Self-Management Enhancement: A Randomised Controlled Trial

10.21203/rs.2.1820/v2 ◽

2019 ◽

Author(s):

Ali Bozorgi ◽

Hamed Hosseini ◽

Hassan Eftekhar ◽

Reza Majdzadeh ◽

Ali Yoonessi ◽

...

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Clinical Trial ◽

Repeated Measures ◽

Patient Adherence ◽

Intervention Group ◽

Public Hospitals ◽

Self Management ◽

Control Group ◽

Management Application

Abstract Background : Self-management of blood pressure is of great significance given the increasing incidence of hypertension and associated disabilities. With the increased use of mobile health in medicine, the present study evaluated the effect of the self-management application on patient adherence to hypertension treatment. Methods : This clinical trial was performed on 120 hypertensive patients who were provided with a mobile intervention for 8 weeks and followed-up to 24 th weeks. Data on the primary outcome (adherence to treatment) and secondary outcomes (adherence to the DASH diet, regular monitoring of blood pressure, and physical activity) were collected using a questionnaire and a mobile application, respectively. The inter-group change difference over time was analyzed using repeated measures ANOVA (General Linear Model). Results : The treatment adherence score increased by an average of 5.9 (95%CI: 5.0-6.7) in the intervention group compared to the control group. Scores of adherence to the low-fat and low-salt diet plans were 1.7 (95%CI: 1.3-2.1) and 1.5 (95%CI: 1.2-1.9), respectively. Moreover, moderate physical activity increased to 100.0 minutes (95%CI: 61.7-138.3) per week in the intervention group. Conclusion: The treatment and control of blood pressure require a multifaceted approach given its complexity and multifactorial nature. Considering the widespread use of smartphones , mhealth interventions can be effective in self-management and better patient adherence to treatments. Our results showed that this application can be used as a successful tool for hypertension self-management in patients attending public hospitals in developing countries. Trial registration: This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

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