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.

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.

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

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.

scholarly journals DISTRACTION TECHNIQUES: TELLING STORIES TO DECREASE PAIN FOR PRESCHOOL CHILDREN DURING INFUSION

2019 ◽  
Vol 22 (1) ◽  
pp. 23-30
Author(s):  
Lina Dewi Anggraeni ◽  
Widiyanti Widiyanti
Keyword(s):  
Demographic Data ◽  
Intervention Group ◽  
Pain Scale ◽  
Control Group ◽  
P Value ◽  
Pediatric Nurses ◽  
Control Groups ◽  
Analysis Technique ◽  
Quasi Experimental ◽  
And Control

Hospital procedures, such as infusions, are often associated with pain. Preschool-aged children who are hospitalized for infusions will often exhibit a strong fearful response because their concept of body integrity has not fully developed. One way to reduce the fear of infusion pain is by using stories as a distraction technique. The purpose of this study was to identify differences in the scale of pain between members of an intervention group, to which the distraction technique was applied, and a control group, to which it was not applied. The study used quasi-experimental methods, with intervention and control groups. The study was conducted on 46 preschool aged respondents (3-6 years old), divided into a 34 member intervention group and a 12 member control group and ran from September to December 2017 in one of the private hospitals in the East Bekasi. The research employed a questionnaire to collect demographic data and used the Wong-Baker Faces Pain Scale to assess pain levels. The data analysis technique used was the independent t-test. The results showed there was a difference of pain response between the intervention and control groups with P value < 0.05. Pediatric nurses are advised to use storytelling therapy as an option for providing atraumatic care intervention.  Keywords: Distraction Technique, Infusion installation, Pain, Stories, Preschool Abstrak Teknik Distraksi: Bercerita Menurunkan Nyeri Pada Anak Usia Pra Sekolah Selama Penggunaan Infus. Rasa sakit seringkali dikaitkan dengan salah satu prosedur rumah sakit yakni pemasangan infus. Reaksi anak prasekolah yang dipasang infus menunjukkan ketakutan yang luar biasa, hal itu disebabkan karena konsep integritas tubuhnya belum berkembang dengan baik. Salah satu cara untuk mengurangi ketakutan akibat nyeri pemasangan infus pada prasekolah adalah teknik distraksi bercerita. Tujuan penelitian ini untuk mengidentifikasi perbedaan skala nyeri antara kelompok intervensi dan kelompok kontrol. Penelitian ini merupakan penelitian kuantitatif dengan metode quasy eksperimen, yang menggunakan kelompok intervensi dan kelompok kontrol. Penelitian dilakukan terhadap 46 responden usia prasekolah (3-6 tahun) yang terdiri dari 34 kelompok intervensi dan 12 kelompok kontrol dari bulan September-Desember 2017 di salah satu Rumah Sakit Swasta di wilayah Bekasi Timur. Instrumen penelitian menggunakan kuisioner data demografi dan lembar observasi skala nyeri Wong Baker Faces Pain. Teknik analisis data menggunakan Uji Independent T test.Hasil penelitian menunjukkan terdapat perbedaan respon nyeri antara kelompok intervensi dan kelompok kontrol dengan nilai p= 0,012 (< 0.05). Perawat anak sebaiknya menggunakan metode bercerita sebagai sarana asuhan keperawatan atraumatik.  Kata kunci: Cerita, Nyeri, Pemasangan infus, Prasekolah, Teknik distraksi

scholarly journals The effect of delivery ball and warm shower on the childbirth experience of nulliparous women: A randomized controlled clinical trial

2021 ◽  
Author(s):  
parvaneh sharifipour ◽  
Masoomeh Kheirkhah ◽  
Mojgan Rajati ◽  
hamid haghani
Keyword(s):  
Clinical Trial ◽  
Pregnant Women ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Childbirth Experience ◽  
Nulliparous Women ◽  
Significant Difference ◽  
The Mean ◽  
And Control

Abstract Background Childbirth is a unique experience that affects women’s life. Therefore, this study was performed to determine the effect of delivery ball and warm shower on the childbirth experience of primiparous women. Methods This study is a clinical trial that was carried out on primiparous pregnant women referred to Motazedi Hospital in Kermanshah, Iran. Sampling was done by continuous method and pregnant women were divided into three groups of delivery ball-warm shower (n = 33), delivery ball (n = 33) and control (n = 33). Exercise with ball at the dilation of 4 cm was similar in the two groups of delivery ball-warm shower and delivery ball, but the first group also used warm shower at the dilatation of 7 cm. The control group only received the routine delivery care. Demographic information form consisting of pregnancy history and information about the mother and infant were completed and the childbirth experience questionnaire (CEQ) were completed by the women two hours after the childbirth. Results There was a statistically significant difference in the mean score of childbirth experience after the intervention between the two groups of delivery ball-warm shower and control (P = 0.001), and also between the delivery ball and control groups (P = 0.001). There was a statistically significant difference in the mean scores of professional support between the two groups of delivery ball-warm shower and control (P = 0.02) and also between the delivery ball and control groups (p = 0.02). There was a statistically significant difference in the mean scores of participation between the two groups of delivery ball-warm shower and control (P = 0.003) and also between the delivery ball and control groups (P = 0.01). There was also a statistically significant difference in the mean scores of sense of security between the two groups of delivery ball-warm shower and control (P = 0.01). Conclusion Delivery ball and warm shower were effective interventions to create a positive childbirth experience. This method was more effective than using delivery ball alone in childbirth experience. To achieve a positive experience of childbirth in mothers, the use of both intervention (delivery ball and warm shower) is recommended.

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 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.

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

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.

scholarly journals The Effect of Distraction Techniques on Pain and Stress during Labor: A Randomized Controlled Clinical Trial

2019 ◽  
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 .

scholarly journals Comparing the Effect of Aromatherapy with Peppermint and Lavender Essential Oils on Fatigue of Cardiac Patients: A Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Somayeh Mahdavikian ◽  
Masoud Fallahi ◽  
Alireza Khatony
Keyword(s):  
Essential Oil ◽  
Essential Oils ◽  
Intervention Group ◽  
Cardiac Patients ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Randomized Controlled ◽  
Significant Difference ◽  
And Control

Background and Objectives. There is limited and contradictory evidence about the effect of aromatherapy with peppermint and lavender essential oils on the fatigue of cardiac patients. Therefore, the present study was aimed to compare the effect of aromatherapy with peppermint and lavender essential oils on fatigue in cardiac patients. Methods. This randomized controlled clinical trial was conducted on 105 cardiac patients. They were randomly divided into three groups: peppermint essential oil (n = 35), lavender essential oil (n = 35), and control (n = 35). Fatigue Severity Scale (FSS) was used to collect data. The intervention was performed for 7 nights. Before and after the intervention, the questionnaire was completed by all patients. In each intervention group, patients inhaled 3 drops of lavender or peppermint essential oils. In the control group, patients inhaled 3 drops of aromatic placebo. Results. The results showed the average fatigue decreased in the study groups. There was no statistically significant difference between the two groups of lavender and peppermint in terms of mean fatigue after the intervention. However, there was a statistically significant difference between lavender and control groups ( P < 0.001 ), as well as peppermint and control groups ( P < 0.001 ). Conclusion. Aromatherapy with peppermint and lavender essential oils can reduce the fatigue of cardiac patients, so the use of these fragrances is recommended.

scholarly journals A Preliminary Study on the Safety, Efficacy and Acceptability of the Community Preparation of Siling Labuyo (Capsicum frutescens) Liniment in the Management of Knee Osteoarthritis in a Six-Week, Active-Controlled Community-Based Clinical Trial

2019 ◽  
Vol 53 (4) ◽  
Author(s):  
Elizabeth R. Paterno ◽  
Clarisse A. Pangilinan ◽  
Erna C. Arollado ◽  
Rachael Marie B. Rosario
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Control Agent ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Double Blind ◽  
The Difference ◽  
And Control ◽  
Experimental Group

Objective. The study determined the safety, efficacy and acceptability of a Philippine community preparation of Siling Labuyo liniment in the management of knee osteoarthritis. Methods. A 6-week randomized, double-blind, active-controlled clinical trial was conducted in three municipalities of Cavite from 2017-2018. The municipalities were randomly assigned to either the control or experimental group, using a commercially available Diclofenac 1% gel as the control agent. Knee Injury and Osteoarthritis Outcome Score (KOOS) and Pain Visual Analogue Scale (VAS) were used to measure the outcomes. Results. Forty-seven participants completed the study. Statistically significant improvement (p<0.05) in pain relief, reduction of symptoms and increase in knee functionality was reported by participants in both the experimental and control groups. Across the dimensions measured, at least 30% improvement in scores was reported by the experimental group, and at least 40% by the control group. The difference was statistically not significant (p>0.05). Itching (13%), burning sensation (11%) and reddening of the skin (15%) were experienced in both the experimental and the active control groups. Conclusion. Use of the liniment led to a modest therapeutic effect and was well-tolerated by the participants.

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