scholarly journals Effect of Autologous Platelet–Rich Plasma on Cesarean Section Scar; A Randomized, Double-Blinded Pilot Study

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Shahla Chaichian ◽  
Shahla Mirgaloybayat ◽  
Kobra Tahermanesh ◽  
Mohammad Hossein Mohammadi ◽  
Reza Saadat Mostafavi ◽  
...  
Keyword(s):  
Cesarean Section ◽  
Platelet Rich Plasma ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Incision Site ◽  
Duration Of Surgery ◽  
Double Blinded ◽  
And Control

Background: One of the complications of cesarean section (C/S) is related to the incision site. Considering the effectiveness of platelet–rich plasma (PRP) on healing of wounds and management of scars, the present study aimed to inquire the effect of PRP on the thickness and completeness of the uterine scar. Methods: In a randomized double-blinded, placebo-controlled clinical trial, the women who underwent C/S from November 2019 to 2020 were included and randomized into two studied groups, including the control (n = 15) and intervention (n = 15) groups. In the intervention group, PRP, extracted from patients’ blood samples, was injected to the incision site (between decidua and myometrium), while the control group did not receive this treatment. The scar thickness of C/S as the primary outcome and postpartum hemorrhage as the secondary outcome were compared between the groups. Both groups were followed for 12 weeks. Results: The two groups (intervention and control) were not significantly different in terms of weight, height, BMI, age, parity, gravidity, duration of surgery, and blood hemoglobin (HB) level (P > 0.05). Comparison of scar characteristics showed the creation of a niche in the PRP group, which was almost one-fourth of that of the control group; a difference that was statistically significant (P = 0.002). The thickness of adjoining myometrium was comparable between the two groups. Mean uterine niche height in the intervention group was lower than in the control group, which was statistically significant (P = 0.048). The mean of residual myometrium thickness (RMT) in the intervention and control groups were 7.62 ± 0.95 and 5.6 ± 3.5 mm, respectively, a difference that was statistically significant (P < 0.001). Conclusions: Local injection of PRP is an effective and viable measure for reducing the uterine niche; therefore, it is suggested to be included in the routine wound care of CS. Future studies are needed to confirm PRP efficacy in different settings.

scholarly journals Efficacy of customized insoles in the improvement of plantar pressure in patients with diabetic neuropathy: Protocol of a randomized and controlled clinical trial

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Gabriel Farhat ◽  
Camila Marinelli Martins ◽  
Ricardo Zanetti Gomes ◽  
Letícia Carollyne Galvão ◽  
Rodolfo Martins Kravutschke ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Plantar Pressure ◽  
Randomized Clinical Trials ◽  
Demographic Data ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
And Control

OBJECTIVE: To evaluate the influence of customized insoles in the plantar pressure of diabetes patients with neuropathy in comparison to the sham group. METHODS:  The work method, duly registered at the Registro Brasileiro de Ensaios Clínicos – REBEC (Clinical Trial Brazilian Register) (http://www.ensaiosclinicos.gov.br/) RBR-5NQK4K, includes a randomized, controlled, prospective, double-blinded clinical trial, with a sample of 46 volunteers that will be randomly randomized in a 1: 1 ratio to be referred to intervention and control groups. The intervention group will receive customized insoles, with a retrocapital bar and an ethyl vinyl acetate plaque (EVA) in the same shape as the retrocapital bar, in order to reduce the pressure on the forefoot. In the control group, flat insoles will be prepared without any therapeutic objective. This project was developed according to the standard protocol for randomized clinical trials (SPIRIT). Along with the clinical evaluation, demographic data of the sample will be collected to identify and confirm the presence of peripheral neuropathy, next, the pedobarographic will be evaluated, and finally, the patients will answer the FAAM questionnaire to assess foot functionality. The primary outcome will be analyzing pressure points in KiloPascal (kPa) in the patients’ feet through pedobarographic of the patients in the intervention and control groups. The secondary outcome will be the foot functionality in activities of daily living through the FAAM (Foot and Ankle Ability Measure), considering the volunteers in the initial evaluation, third and sixth months.  FINAL CONSIDERATIONS: Mainly, results of this study will show whether there is a structural alteration in the analysis of the plantar pressure due to the continuous use of insoles and present the evaluation of whether the use of therapeutic insoles improves the foot functionality of the same users when compared to sham insoles.

Effect of aromatherapy massage with orange essential oil on postoperative pain after cesarean section: a randomized controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Seyedmohammad Mirhosseini ◽  
Ali Abbasi ◽  
Nastaran Norouzi ◽  
Fatemeh Mobaraki ◽  
Mohammad Hasan Basirinezhad ◽  
...  
Keyword(s):  
Side Effects ◽  
Essential Oil ◽  
Cesarean Section ◽  
Statistical Tests ◽  
Intervention Group ◽  
Nursing Intervention ◽  
Anxiety Score ◽  
Control Group ◽  
And Control ◽  
Orange Essential Oil

Abstract Objectives Many women in recent years have been willing to undergo puncture surgery for childbirth, which, like other surgeries, has physical and psychological side effects such as incision, infertility, chronic pain, and anxiety. Therefore, it is important to reduce and improve these side effects. The aim of this study was to determine the effect of foot massage with orange essential oil on pain and anxiety in women undergoing cesarean section. Methods This randomized clinical trial study was conducted in 2019 on 80 women referred to Bahar Shahroud Hospital after cesarean section surgery. The samples were divided into two groups by intervention (foot massage with orange essential oil) and control (foot massage without orange essential oil). The Spielberger scale was used to determine anxiety scores after cesarean section. In the intervention group, the feet were massaged with orange essential oil, and in the control group, the orange essential oil massage was performed without oil. Anxiety before, immediately after, and 60 min after the intervention was measured and evaluated in both groups. Data analysis was performed using descriptive and inferential statistics. Significant levels were considered for all statistical tests (p<0.05). Results The anxiety score before the intervention in the two groups of intervention and control was 57.12 ± 3.12 and 57.07 ± 3.54, respectively, which were not significantly different, but immediately after the intervention, the anxiety scores in both groups decreased significantly so that there was a further decrease in the intervention group (52.10 ± 4.75 and 56.02 ± 3.77), 1 h after the intervention, the anxiety score in the intervention group decreased compared to the previous stage and increased in the control group (50.40 ± 3.74 and 56.85 ± 4.27). Conclusions Foot massage with orange essential oil can probably be effective as a proper nursing intervention in reducing anxiety after cesarean section surgery.

The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

2021 ◽  
pp. 1-8
Author(s):  
Sevde Aksu ◽  
Pelin Palas Karaca
Keyword(s):  
Pilot Study ◽  
Cesarean Section ◽  
Intervention Group ◽  
Control Group ◽  
Breast Pain ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Right ◽  
Documentation Tool ◽  
And Control

<b><i>Aim:</i></b> The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). <b><i>Methods:</i></b> A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (<i>n</i> = 30) and control groups (<i>n</i> = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. <b><i>Results:</i></b> Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (<i>p</i> &#x3c; 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (<i>p</i> &#x3e; 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (<i>p</i> &#x3c; 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (<i>p</i> &#x3c; 0.05). <b><i>Conclusions:</i></b> In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

scholarly journals Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 929
Author(s):  
Nouran Hesham El-Sherazy ◽  
Naglaa Samir Bazan ◽  
Sara Mahmoud Shaheen ◽  
Nagwa A. Sabri
Keyword(s):  
Ascorbic Acid ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Statistical Significance ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Control Groups ◽  
The Absolute ◽  
And Control

Background Antioxidants show nephroprotective effect against vancomycin associated nephrotoxicity (VAN) in animals. This study aimed to assess the ascorbic acid nephro-protective role against VAN clinically. Methods Forty-one critically ill patients were randomly assigned to one of two groups: intervention group (vancomycin IV plus ascorbic acid, n=21) or control group (vancomycin IV only, n=20). Primary outcomes were the incidence of VAN and the absolute change in creatinine parameters, while mortality rate was the secondary outcome. Nephrotoxicity was defined as an increase in serum creatinine (S.cr) by at least 0.5 mg/dL or 50% of baseline for at least two successive measurements. This study is registered at Clinicaltrials.gov (NCT03921099), April 2019. Results Mean absolute S.cr increase was significant when compared between both groups, P-value = 0.036, where S.cr increased by 0.05(0.12) and 0.34(0.55) mg/dL in the intervention and control groups, respectively. Mean absolute Cr.cl decline was significant when compared between both groups, P-value = 0.04, where Cr.cl was decreased by 5.9(17.8) and 22.3(30.4) ml/min in the intervention and control groups, respectively. Incidence of VAN was 1/21(4.7%) versus 5/20(25%) in the intervention and control groups, respectively (RR: 0.19; CI: 0.024–1.49; P-value = 0.093). Mortality was higher in the control group; however, it was not statistically significant, P-value = 0.141. Conclusion Co-administration of ascorbic acid with vancomycin preserved renal function and reduced the absolute risk of VAN by 20.3%, however, the reduction in VAN incidence didn’t reach statistical significance level. Further large multicenter prospective trials are recommended.

scholarly journals Cold spray for reducing venopuncture pain in hemodialysis patients; a randomized double-blinded controlled trial

2019 ◽  
Vol 9 (1) ◽  
pp. e01-e01
Author(s):  
Zahra Shafii ◽  
Neshiman Abdi Bastami ◽  
Amir Ahmad Nasiri
Keyword(s):  
Cold Spray ◽  
Controlled Trial ◽  
Intervention Group ◽  
Needle Insertion ◽  
Hemodialysis Patients ◽  
Chronic Hemodialysis ◽  
Pain Severity ◽  
Control Group ◽  
Double Blinded ◽  
And Control

Introduction: The pain due to cannulation and needle insertion into blood vessels becomes problematic among patients suffering hemodialysis. Objectives: The present study aimed to assess the pain relieving effects of cooling sprays among patients undergoing hemodialysis. Patients and Methods: Eighty patients aged higher than 18 years who were on chronic hemodialysis were randomly assigned into two groups including the group received cooling spray for relieving pain (n = 40) and the group received stilled water as placebo (n = 40). In the intervention group and in a hemodialysis session, 2 puffs of the Cramer Cold Spray were sprayed 30 seconds before the cannulation. The pain severity was assessed by the visual analogue scale (VAS) method. Results: The mean of pain severity score was not different between the intervention and control group before intervention, however after intervention, the patients in the intervention group experienced milder pain due to cannulation as compared to control group (3.28 ± 1.13 versus 5.30 ± 1.76; P < 0.001). Interviewing with the patients receiving cooling spray showed willingness to the use of spray in 87.5% of cases. The local complication due to the use of cold spray was revealed only in 5% of patients. Conclusion: The use of cooling spray in hemodialysis patients can reduce the pain caused by needle insertion. This method can be routinely used as a non-pharmacological pain relief method to reduce pain in hemodialysis patients

scholarly journals The effect of prenatal counseling on breastfeeding self-efficacy and frequency of breastfeeding problems in mothers with previous unsuccessful breastfeeding: A randomized controlled clinical trial

2020 ◽  
Author(s):  
fahimeh sehhatie shafaei ◽  
mojgan mirghafourvand ◽  
shiva havizari
Keyword(s):  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Prenatal Counseling ◽  
Control Groups ◽  
Randomized Controlled ◽  
Breastfeeding Problems ◽  
And Control

Abstract Background: Breastfeeding is one of the most important interfering factors in infants’ health. Monitoring mothers’ performance and providing them with the feedback helps to increase their self-efficacy, interest in learning, and level of performance. The present research evaluates the effect of prenatal counseling on the breastfeeding self-efficacy and frequency of breastfeeding problems in mothers with previous unsuccessful breastfeeding.Methods: This randomized controlled clinical trial was conducted on 108 pregnant women with unsuccessful breastfeeding in Tabriz health centers during 2017-2018. The participants were randomly assigned to intervention and control groups. The intervention group had four prenatal counseling sessions and the controls only received routine care. Then, the mothers who gave birth to their children received a counseling session up to 4 months after the delivery. The Breastfeeding Self-Efficacy (BSES) questionnaire and the frequency of breast feeding problems checklist on the 15th day, and 2nd and 4th month were completed both by the intervention and control groups.Results: The mean (SD) of breastfeeding self-efficacy was 119.3 (10.5), 128.3 (8.3) and 133.8 (10.3) in the intervention group and 105.3 (16.1), 105.7 (19.7) and 109.4 (24.7) in the control group on the 15th day, 2nd and 4th month after the delivery, respectively. There was a significant difference in terms of breastfeeding self-efficacy between intervention and control group on the 15th day (p<0.001), and 2nd (p<0.001) and 4th (p<0.001) month after the delivery. The frequency of breastfeeding problems on the 15th (p=0.008), 2nd (p<0.001) and 4th (p<0.001) after the delivery was significantly different in most cases of the intervention group when compared to the controls.Conclusion: The results indicated that prenatal counseling can increase mothers’ breastfeeding self-efficacy and solves most breastfeeding problems during postpartum period.Trial registration: IRCT20100109003027N19

scholarly journals Effect of a Short-Time Probiotic Supplementation on the Abundance of the Main Constituents of the Gut Microbiota of Term Newborns Delivered by Cesarean Section—A Randomized, Prospective, Controlled Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3128
Author(s):  
Joanna Hurkala ◽  
Ryszard Lauterbach ◽  
Renata Radziszewska ◽  
Magdalena Strus ◽  
Piotr Heczko
Keyword(s):  
Lactic Acid ◽  
Lactic Acid Bacteria ◽  
Cesarean Section ◽  
Gut Microbiota ◽  
Mode Of Delivery ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Bacterial Strains ◽  
Gut Colonization

The gut microbiota plays a pivotal role in the maintenance of human health. Numerous factors, including the mode of delivery, impact early gut colonization in newborns. Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS). The objective of this study was to determine whether a probiotic supplement given to newborns delivered by CS during their stay in the maternity ward alters the pattern of early gut colonization by lactic acid bacteria versus potential pathogens. A prospective, randomized trial was conducted. In total, 150 newborns, born at 38–40 weeks gestational age and delivered by CS, were included in the study. They were randomized into the intervention group, supplemented orally with a probiotic containing Bifidobacterium breve PB04 and Lactobacillus rhamnosus KL53A, and the control group. Stool samples were obtained on days 5 and 6 of life and after one month of life and were analyzed for the presence and abundance of the main groups of bacteria. An application of two probiotic bacteria during the first days of life after CS resulted in quick and abundant colonization by days 5 and 6, with high populations of L. rhamnosus and B. breve. The applied bacterial strains were present in the majority of neonates one month after. The supplementation of term neonates delivered by cesarean section immediately after birth with a mixture of L. rhamnosus and B. breve enriched the gut microbiota composition with lactic acid bacteria.

scholarly journals Eremostachys laciniata as effective as rectal diclofenac suppository in cesarean section pain relief: A triple-blind controlled clinical trial

2020 ◽  
Vol 12 (1) ◽  
pp. 26-34
Author(s):  
Shabnam Mohammad Pour ◽  
Sevil Hakimi ◽  
Abbas Delazar ◽  
Yousef Javad Zadeh ◽  
Fatemeh Mallah
Keyword(s):  
Clinical Trial ◽  
Cesarean Section ◽  
Intervention Group ◽  
Massive Hemorrhage ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Total Extract ◽  
Significant Difference ◽  
Healing Score ◽  
Distress Scale

Background: Pain and distress are two common complications of cesarean section. Among complementary therapies, Eremostachys was introduced as a pain mitigator. This study aimed at investigating the effect of Eremostachys laciniata on cesarean section pain and distress. Materials and methods: This randomized clinical trial was conducted on 86 women who gave childbirth by cesarean section. The control group received 50 mg rectal diclofenac suppository every 8 h for 3 days, and the intervention group received 35 mg E. laciniata total extract suppository every 8 h up to three doses. Pain was measured with the Visual Analogue Scale at 8, 16, and 24 h after cesarean section. The Symptom Distress Scale was completed at 8 and 24 h after cesarean section. The Redness, Edema, Ecchymosis, Discharge, Approximation scale was completed 5 days after cesarean section. Findings: Pain score at 8, 16, and 24 h after surgery (15 min after intervention) was not significantly different between the intervention and control groups. The distress score 24 h after cesarean section showed a significant difference in favor of the control group according to Friedman’s test. There was a significant difference between the two groups in wound healing score, which indicated better efficacy of rectal diclofenac suppository than E. laciniata suppository. We assessed nausea, vomiting, headache, massive hemorrhage, and any type of anaphylactic reaction. No side events were observed in two groups. Conclusion: Rectal E. laciniata suppository could be introduced as a low-complication, appropriate, and effective medication in controlling pain and distress after cesarean section; more studies should be conducted on this matter.

scholarly journals Randomised, prospective clinical trial of platelet-rich plasma injection in the management of severe dry eye

2018 ◽  
Vol 103 (5) ◽  
pp. 648-653 ◽  
Author(s):  
Marcel Y Avila ◽  
Angela M Igua ◽  
Amparo M Mora
Keyword(s):  
Hyaluronic Acid ◽  
Outcome Measures ◽  
Dry Eye ◽  
Primary Outcome ◽  
Platelet Rich Plasma ◽  
Intervention Group ◽  
Treatment Compliance ◽  
Secondary Outcome ◽  
Control Group ◽  
Corneal Staining

BackgroundTo evaluate the effectiveness of platelet-rich plasma (PRP) injections in the treatment of severe dry eye.MethodsThis prospective, intervention study included patients with severe dry eye who had been diagnosed with Sjogren syndrome. Patients were divided into two groups. The intervention group received PRP (n=15) injections on days 0, 30, 60 and 90, as well as hyaluronic acid five times per day. The comparison group received hyaluronic acid (n=15) five times per day. Subjects were measured at baseline and at 30, 60 and 90 days. The primary outcome measures were changes in corneal staining according to the Oxford classification, results of the Schirmer test and tear break-up time (TBUT). The secondary outcome measures were changes in the Ocular Surface Disease Index (OSDI) and treatment compliance.ResultsAll subjects completed the study. The intervention group showed improvements in all primary outcome measures when compared with the control group, including a reduction in corneal staining (p<0.001), increase in the mean Schirmer value from 5.6±0.7 to 9.0±1.1 mm, and an increase in TBUT from 4.0±0.4 to 6.4±0.4 s at day 90. An improvement in subjective OSDI values was also found.ConclusionPRP injection is safe and effective in improving tear parameters as well as subjective parameters, and was found to be superior to hyaluronic acid alone in the management of patients with severe dry eye. This represent a novel alternative treatment for severe dry eye.Trial registration numberNCT02257957.

scholarly journals The effect of distraction techniques on pain and stress during labor: a randomized controlled clinical trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Paria Amiri ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Mahin Kamalifard ◽  
Reyhaneh Ivanbagha
Keyword(s):  
Intervention Group ◽  
Active Phase ◽  
Labor Pain ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Fear Of Childbirth ◽  
Control Groups ◽  
Significant Difference ◽  
The Mean ◽  
And Control

Abstract Background Pain control and the stress associated with labor and delivery are among the most important issues of health care system. Use of distraction techniques during childbirth is reported to reduce pain and stress of labor. However, there is a limited publication that looked on the effect of distraction techniques on labor pain and stress. Thus, the aim of this study was to determine the effect of distraction techniques on labor pain and stress (primary outcomes), fear of childbirth, length of delivery stages, first minute Apgar score and oxytocin consumption (secondary outcomes). Methods A randomized controlled clinical trial was conducted on 68 pregnant women. Participants were allocated into two groups (intervention and control groups) by blocked randomization. Participants in the intervention group received distraction techniques in four sessions. Questionnaires of Fear of Childbirth (W-DEQ version A) and PSS once were completed before intervention and again at the 36th week for the W-DEQ and in the active phase for the PSS through interviews. The pain was assessed through VAS during active phase per hour. The length of delivery stages was recorded in the partograph chart. Data were analyzed by independent t-test and ANCOVA. Results The mean of perceived stress during labor in the intervention group was significantly less than that of the control group (AMD: -3.2; 95% CI: − 0.8 to − 6.0; P = 0.01). The mean (SD) of pain intensity during labor was less than in the intervention and control groups compare to the control group (6.2 vs 7.5; P < 0.001). There was no significant difference between the two groups in terms of fear of childbirth score (AMD: 5.3; 95% CI: 13.0 to − 6.0; P = − 2.3). Moreover, there was no statistically significant difference between the two groups in terms of the active phase of labor (P = 0.504), second stage of delivery (P = 0.928), total length of delivery (P = 0.520), Apgar score (P = 1.000) and frequency of oxytocin consumption (P = 0.622). Conclusion According to the results, distraction techniques can reduce the pain and stress of labor, but further studies by using the distraction techniques are needed to reach a decisive conclusion. Trial registration IRCT2017042910324N39; Name of registry: Iranian Registry of Clinical Trials; Registered 11 September 2017. URL of registry: https://fa.irct.ir/user/trial/10814/view. Date of enrolment of the first participant to the trial: September 2017.

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