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

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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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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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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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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Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

Journal of Telemedicine and Telecare ◽

10.1177/1357633x211009640 ◽

2021 ◽

pp. 1357633X2110096

Author(s):

Maria KEF Feijó ◽

Karen Brasil Ruschel ◽

Daniela Bernardes ◽

Eduarda B Ferro ◽

Luis E Rohde ◽

...

Keyword(s):

Clinical Trial ◽

Emergency Department ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Heart Association ◽

Functional Class ◽

Emergency Department Visits ◽

Control Group ◽

Point Change ◽

Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

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Evaluation of Methods to Minimize Pain in Newborns during Capillary Blood Sampling for Screening: A Randomized Clinical Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph19020870 ◽

2022 ◽

Vol 19 (2) ◽

pp. 870

Author(s):

Magdalena Napiórkowska-Orkisz ◽

Aleksandra Gutysz-Wojnicka ◽

Mariola Tanajewska ◽

Iwona Sadowska-Krawczenko

Keyword(s):

Clinical Trial ◽

Heart Rate ◽

Heart Rate Variability ◽

Pain Management ◽

Pain Relief ◽

Pain Intensity ◽

Randomized Clinical Trial ◽

Capillary Blood ◽

Pain Outcome ◽

Capillary Blood Sampling

Aim: The aim of the study was to assess the severity of pain experienced by a newborn during a heel puncture for screening using the Newborn Pain Scale (NIPS), measure the heart rate and compare the effectiveness of non-pharmacological methods of pain control. Design: Randomized clinical trial. No experimental factors. The test was performed during routine screening. Surroundings: Provincial Specialist Hospital in Olsztyn. Patients/Participants: Pain was assessed in 90 full-term newborns. The newborns were rooming in with their mothers in the hospital. Interventions: Newborns were divided into three groups. Three different methods of pain relief were used: breastfeeding, 20% glucose administered orally and non-nutritional sucking. Main Outcome Measures: The primary pain outcome was measured using the NIPS and the secondary pain outcome measures (heart rate, oxygen saturation) were measured using a pulse oximeter. Results: During capillary blood sampling from the heel, most newborns, n = 56 (62.2%), experienced no pain or mild discomfort, severe pain occurred in n = 23 (25.6%) and moderate pain occurred in n = 11 (12.2%). No significant statistical differences were found between the degree of pain intensity and the intervention used to minimize the pain p = 0.24. Statistically significant relationships were demonstrated between heart rate variability and the degree of pain intensity (p = 0. 01). There were no statistically significant differences between the newborn’s pain intensity and the mother’s opinion on the effectiveness of breastfeeding in minimizing pain. Conclusions: This study did not answer the question of which pain management method used during the heel prick was statistically more effective in reducing pain. However, the results indicate that each of the non-pharmacological interventions (breastfeeding, oral glucose dosing and non-nutritive sucking) applied during heel puncture resulted in effective pain management in most of the newborns enrolled in the study. The relationship between heart rate variability and the severity of pain was confirmed. Mothers of newborns in the breastfeeding group were satisfied with the pain relief methods used in the child and the opportunity to console their newborn during painful procedures in a technologically invasive environment.

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The Effect of Subcutaneous and Intraperitoneal Instillation of Local Anesthetics on Postoperative Pain after Laparoscopic Varicocelectomy: A Randomized Controlled Trial

Children ◽

10.3390/children8111051 ◽

2021 ◽

Vol 8 (11) ◽

pp. 1051

Author(s):

Zenon Pogorelić ◽

Tea Gaberc ◽

Miro Jukić ◽

Goran Tintor ◽

Ana Nevešćanin Biliškov ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Pain Intensity ◽

Randomized Clinical Trial ◽

Local Anesthetic ◽

Local Anesthetics ◽

Control Group ◽

Number Of Patients ◽

Intraperitoneal Instillation ◽

Time Point

Background: The main goal of the present randomized clinical trial was to investigate the effects of subcutaneous administration of two different local anesthetics at trocar incision sites at the abdominal wall in combination with intraoperative intraperitoneal instillation of local anesthetics, on the character of postoperative pain, in adolescents who underwent laparoscopic varicocelectomy. Methods: A total of 60 patients with a median age of 16 years, who received laparoscopic varicocele repair, were included in this randomized clinical trial. The patients were randomly assigned to three study groups receiving 2% lidocaine, 0.5% levobupivacaine, or the control group. The Visual Analogue Scale (VAS) was used by a blinded nurse at four different time points (2, 6, 12 and 24 h after the surgery) to measure pain intensity. Results: The significant effect of time on the pain intensity (p = 0.001) was found. Additionally, the interaction between time and different local analgesics (p < 0.001) was observed. In patients in whom 0.5% levobupivacaine has been used, significantly lower VAS pain scores were recorded at each time point assessed, in comparison with the patients who received 2% lidocaine or the patients from the control group in whom no local anesthetic was applied (p < 0.001). Furthermore, in patients in whom 2% lidocaine was administrated, significantly lower pain levels according to VAS were reported than in those from the control group, except for the time point at 24 h after surgery when pain levels were comparable. Concerning the postoperative pain control, the number of patients who requested oral analgesics postoperatively was significantly lower in the group of patients in whom local anesthetic was administrated intraoperatively (2% lidocaine – n = 4, 20%; 0.5% levobupivacaine – n = 1, 5%) compared to the patients who did not receive any local anesthetic during the surgery (n = 13; 65%) (p < 0.001). Conclusion: A significant reduction in postoperative pain intensity and analgesics consumption in patients undergoing laparoscopic varicocelectomy who received intraoperative local anesthetic was observed. The best effect on postoperative pain intensity, according to the VAS score, was achieved by 0.5% levobupivacaine.

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Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2017-0085 ◽

2018 ◽

Vol 15 (3) ◽

Author(s):

Mansoor Keshavarz ◽

Maryam Kashanian ◽

Soodabeh Bioos ◽

Yasaman Vazani

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Active Phase ◽

Obstetric Outcomes ◽

Control Group ◽

Control Groups ◽

Persian Medicine ◽

Traditional Persian Medicine ◽

And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

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The Effect of Support Surfaces on the Incidence of Pressure Injuries in Critically Ill Patients: A Randomized Clinical Trial

Critical Care Research and Practice ◽

10.1155/2018/3712067 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Wesley Henrique Bueno de Camargo ◽

Rita de Cassia Pereira ◽

Marcos T. Tanita ◽

Lidiane Heko ◽

Isadora C Grion ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Critically Ill ◽

Critically Ill Patients ◽

Intervention Group ◽

Control Group ◽

Support Surface ◽

Intention To Treat ◽

Support Surfaces ◽

Effect Of Support

Purpose. To analyze whether a viscoelastic mattress support surface can reduce the incidence of stage 2 pressure injuries compared to a standard hospital mattress with pyramidal overlay in critically ill patients. Method. A randomized clinical trial with intention-to-treat analysis was carried out recruiting patients with Braden scale ≤14 on intensive care unit admission from April 2016 to April 2017. Patients were allocated into two groups: intervention group (viscoelastic mattress) and control group (standard mattress with pyramidal overlay). The level of significance adopted was 5%. Results. A total of 62 patients were included in the study. There was a predominance of males (53%) and the mean age was 67.9 (SD 18.8) years. There were no differences in clinical or severity characteristics between the patients in the control group and the intervention group. Pressure injuries occurred in 35 patients, with a median time of 7 days (ITQ 4–10) from admission. The frequency of pressure injuries was higher in the control group (80.6%) compared to the intervention group (32.2%; p<0.001). Conclusions. Viscoelastic support surfaces reduced the incidence of pressure injuries in moderate or higher risk critically ill patients when compared to pyramidal support surfaces.

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Effect of an early mobilisation programme on pain intensity after laparoscopic surgery: a randomised clinical trial

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2020-002618 ◽

2020 ◽

pp. bmjspcare-2020-002618

Author(s):

Azam Dehghani ◽

Ali Hajibagheri ◽

Ismail Azizi-Fini ◽

Fatemeh Atoof ◽

Noushin Mousavi

Keyword(s):

Clinical Trial ◽

Laparoscopic Surgery ◽

Pain Intensity ◽

Repeated Measures ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Early Mobilisation ◽

Repeated Measures Analysis ◽

The Mean

BackgroundPain is a common complication after laparoscopic surgery. This study aimed to examine the effect of an early mobilisation programme on postoperative pain intensity after laparoscopic surgery.MethodsA randomised controlled clinical trial was conducted on 80 patients who underwent laparoscopic surgery in Shahid Beheshti Hospital in Kashan, Iran. The patients were randomly allocated to intervention (n=40) and a control (n=40) group. In the intervention group, an early mobilisation programme was implemented in two rounds. The patient’s perceived pain was assessed using a Visual Analogue Scale 15 min before and 30 min after each round of early mobilisation. Data were analysed through the independent samples t, χ2 and Fisher’s exact tests and the repeated measures analysis.ResultsThe repeated measures analysis showed that the mean pain scores have been decreased over time (F=98.88, p<0.001). Considering the observed interaction between time and the intervention, the t test was used for pairwise comparisons and showed that the mean pain score was not significantly different between the two groups in 15 min before the first round of early mobilisation (p=0.95). However, the mean pain in the intervention group was significantly less than the control group in all subsequent measurements (p<0.05).ConclusionEarly mobilisation programmes such as the one implemented in the current study are easy and inexpensive and can be implemented safely for the reduction of pain after laparoscopic surgeries.

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Effect of Mindfulness Sessions on Chronic Fatigue Syndrome and Job Satisfaction of Nurses: A Randomized Clinical Trial

10.21203/rs.3.rs-567623/v1 ◽

2021 ◽

Author(s):

Nasrin Bonakdari ◽

Nadereh Mohammadi ◽

Mohammad Reza Taghvizadeh Yazdi ◽

Reza Norouzadeh ◽

Mohammad Abbasinia ◽

...

Keyword(s):

Job Satisfaction ◽

Clinical Trial ◽

Chronic Fatigue Syndrome ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Clinical Trial Design ◽

Well Being ◽

Chronic Fatigue ◽

Control Group ◽

Fatigue Syndrome

Abstract Background: Nursing is considered a stressful profession, so nurses are at higher risk of physical and mental illness. Mindfulness is an important concept for nursing with practical implications for nurse well-being, development, and quality nursing care sustainability.Objectives: This study identified mindfulness sessions' effect on nurses' chronic fatigue syndrome(CFS) and job satisfaction )JS.(Methods: A randomized clinical trial design was conducted on 80 nurses to intervention and control groups. The intervention in the intervention group was eight mindfulness sessions training, and the control group had no intervention. Nurses' CFS and JS were assessed using the Minnesota Satisfaction Questionnaire and The Multidimensional Fatigue Inventory.Results: After implementing a mindfulness-based stress reduction program, the intervention group nurses reported lower CFS and higher JS than the control group(p<0.005). Conclusion: The findings of this study indicate the effectiveness of mindfulness programs on improving nurses' chronic fatigue and JS. Since CFS and job dissatisfaction are two disturbing elements for nurses' optimal performance in professional and personal life, this study can recommend the implementation of mindfulness exercises as a routine, operational and uncomplicated program in nurses.

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