scholarly journals Smartphone application for celiac patients: assessing its effect on gastrointestinal symptoms in a randomized controlled clinical trial

2020 ◽  
Author(s):  
Zeinab Nikniaz ◽  
Masood Shirmohammadi ◽  
Elham Masserat ◽  
Zahra Akbari Namvar
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Gastrointestinal Symptoms ◽  
Smartphone Application ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Trial Registry ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Mean

Abstract Background: We aimed to study the effectiveness of a “celiac” smartphone application on gastrointestinal symptoms in celiac patients. Methods: In the present randomized controlled clinical trial, 60 celiac patients were randomly assigned to receive education through a smartphone application (n=30) or conventional clinical education (n=30). We assessed the gastrointestinal symptoms using the gastrointestinal symptom rating scale (GSRS) questionnaire at baseline and three months after interventions. The GSRS total score, celiac disease GSRS (CD-GSRS) score, abdominal pain, reflux, diarrhea, constipation, and indigestion scores were calculated. Results: Out of 60 randomized patients, 58 patients completed the study. In comparison to baseline, the mean score of GSRS total score (p=0.04), CD-GSRS score (p=0.001), and indigestion subscore (p<0.001) were significantly decreased in the intervention group. In the control group, compared to baseline, the mean scores of CD-GSRS score (p=0.03) and abdominal pain subscore (p=0.04) were significantly reduced; and the mean score of reflux (p=0.01) subscore was significantly increased. The results of the between-group comparisons showed that although the mean GSRS and CD-GSRS total scores were lower in the intervention group compared with the control group, the differences were not statistically significant. In terms of GSRS subscores, there was a significant difference between the two groups only in the mean score of indigestion (P=0.01).Conclusion: According to the results, smartphone application had a significantly positive effect on indigestion symptoms compared with routine clinic education. However, more large studies with longer duration of the follow-up period are needed to assure this approach Trial registration: The protocol of the study was registered in the Iranian registry of clinical trials (IRCT code: IRCT20170117032004N2). trial registry webpage: : https://www.irct.ir/user/trial/40187/view. Trial registry date: 2019.6.26

scholarly journals Smartphone application for celiac patients: assessing its effect on gastrointestinal symptoms in a randomized controlled clinical trial

2020 ◽  
Author(s):  
Zeinab Nikniaz ◽  
Masood Shirmohammadi ◽  
Elham Maserrat ◽  
Zahra Akbari Namvar
Keyword(s):  
Clinical Trial ◽  
Celiac Disease ◽  
Intervention Group ◽  
Gastrointestinal Symptoms ◽  
Smartphone Application ◽  
Controlled Clinical Trial ◽  
Trial Registry ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Mean

Abstract Background: We aimed to study the effectiveness of information provided via smartphone application on gastrointestinal symptoms in patients with celiac disease (CD).Methods: In the present randomized controlled clinical trial, 60 patients with CD were randomly assigned to receive education through a smartphone application (n=30) or conventional clinical education (n=30). The patients were asked to use it for obtaining the required information for three months. We assessed gastrointestinal symptoms using the gastrointestinal symptom rating scale (GSRS) questionnaire at baseline and three months after interventions. The GSRS total score, celiac disease GSRS (CD-GSRS) score, abdominal pain, reflux, diarrhea, constipation, and indigestion scores were calculated.Results: Out of 60 randomized patients, 58 patients completed the study. The mean age of the participants was 37.49±9.32 years, and the mean disease duration was 4.57±3.36 years. There were no significant differences between the two groups regarding the baseline values. In comparison to baseline, the mean CD-GSRS score (p=0.001) and indigestion subscore score (p<0.001) were significantly decreased in the intervention group. The results of the between-group comparisons showed that although the mean GSRS and CD-GSRS total scores were lower in the intervention group than in the standard care group, the differences were not statistically significant. In terms of GSRS subscores, there was a significant difference between the two groups only in the mean score of indigestion (P=0.002).Conclusion: According to the results, using smartphone application for providing information to patients with celiac disease had only a significant positive effect on indigestion symptoms compared with routine clinic education, and we did not observe any significant differences in GSRS and CD-GSRS scores between the two groups.Trial registration: The protocol of the study was registered in the Iranian registry of clinical trials (IRCT code: IRCT20170117032004N2). trial registry webpage: https://www.irct.ir/user/trial/40187/view. Trial registry date: 2019.6.26

scholarly journals The Effect of Rhythmic Breathing on the Severity of Sternotomy Pain after Coronary Artery Bypass Graft Surgery: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Hassan Babamohamadi ◽  
Masoumeh Karkeabadi ◽  
Abbasali Ebrahimian
Keyword(s):  
Clinical Trial ◽  
Pain Control ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Artery Bypass Graft ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Mean

Background. Moderate-to-severe pain is reported in up to 75% of the patients in the first 48 hours after cardiac surgery. Evidence suggests that distraction is an effective nursing intervention for controlling short-term and transient pain. Distraction can be achieved by various techniques, including progressive muscle relaxation, meditation, and rhythmic breathing (RB). The present research aimed at evaluating the impacts of RB on the severity of sternotomy pain after Coronary Artery Bypass Graft (CABG). Methods. This randomized, controlled clinical trial was conducted on 60 patients after CABG surgery at the open-heart surgery Intensive Care Unit (ICU) of Kowsar Hospital, affiliated to Semnan University of Medical Sciences in Semnan, Iran. The patients were selected through convenience sampling and randomly assigned to two groups, including (1) intervention or RB and (2) control groups. RB was performed in the intervention group every 12 hours (9 a.m. and 9 p.m.) for three consecutive days after the surgery. The control group received only routine care for pain control (opioid analgesics) with no additional interventions. The severity of pain was measured every day in both groups of patients before and after the interventions using the Visual Analog Scale (VAS). Results. The mean postintervention pain scores were significantly different from the mean preintervention scores in the intervention group ( p  < 0.05). The changes in the mean pain score in the intervention group were also significantly different from the corresponding changes in the controls ( p  < 0.05). Conclusion. Based on the results, the severity of pain after the intervention was significantly lower in the RB group compared to the control. RB was found to be an effective technique for reducing the patients’ pain and is therefore recommended as a post-CABG pain control technique. Iranian Registry of Clinical Trials: this trial is clinically registered with IRCT20120109008665N7, registered 3 September 2018.

scholarly journals Multidisciplinary Nutrition Management Based on Enhanced Recovery after Surgery Protocols in Patients Undergoing Percutaneous Endoscopic Interlaminar Discectomy: A Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Jiali Chen ◽  
Xinyu Zhang ◽  
Ning Ning ◽  
Peifang Li ◽  
Yueer Zhang
Keyword(s):  
Clinical Trial ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Intervention Group ◽  
Postoperative Recovery ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Nutrition Management ◽  
Randomized Controlled

Abstract Background Few studies reported the impact of nutrition management based on Enhanced Recovery after Surgery (ERAS) protocols in spinal surgery. The aim of this study was to examine the association of multidisciplinary nutrition management in percutaneous endoscopic interlaminar discectomy (PEID) with patients’ subjective feelings and postoperative recovery.Methods A randomized controlled clinical trial was conducted from August to November in 2017. A total of 101 patients undergoing PEID were randomized into two groups: a control group (50 patients experiencing traditional nutrition management) and an intervention group (51 patients experiencing multidisciplinary nutrition management). Fasting time, subjective feelings, satisfaction and postoperative recovery were evaluated in all patients.Results In all, 96 patients completed the study: 48 in each group. Our findings revealed that patients in intervention group had weaker preoperative hunger (p＝0.036), preoperative thirst (p＜0.001) and postoperative thirst (p＝0.006), higher satisfaction about nutrition management (p＝0.001), shorter pre and post-operative fasting liquids and solids time, and shorter first passage of flatus (p＝0.005) than those of patients in control group.Conclusion Multidisciplinary nutrition management can promote patients’ subjective feelings and postoperative gastric recovery.Trial registration: Current Controlled Trials ChiCTR-IOQ-17011742, June/22/2017.

Comparision of two fluoride varnishes for controlling white spot lesions. Randomized clinical trial

2017 ◽  
Vol 16 (1) ◽  
Author(s):  
Jesús Alberto Luengo - Fereira
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
White Spot ◽  
Controlled Clinical Trial ◽  
White Spot Lesions ◽  
Randomized Controlled Clinical Trial ◽  
Chi Square ◽  
Randomized Controlled ◽  
Anterior Teeth ◽  
The Mean

Objective: To compare two fluorinated varnishes for the control of white spot lesions.Material and Methods: A randomized controlled clinical trial was conducted. A total of 103 active whitespot lesions on permanent upper anterior teeth from 24 patients, aged 7 to 9 years were randomly assigned totwo groups, G1: Duraphat® (n=52) and G2: DuraShield® (n=51). Weekly applications were perform for fourconsecutive weeks. Fifth week the dimension, regression and activity of the lesions were evaluated. Student’sT test, Wilcoxon Ranks and Chi square were used at 5% significance. Results: At the end of the study, the lesion reduction was observed in 69.7%, finding significant differences(p<0.05) in the mean of the initial and final dimensions in general (2.74 mm to 1.91 mm) and in each group, G1(2.84 mm to 2.03 mm), G2 (2.64 mm to 1.78 mm). In the activity of the lesions, it was found in the G1, 12 active and6 inactive lesions; while in G2, there were 14 active and 29 inactive; these differences were significant (p<0.05). Conclusions: The two evaluated products showed similar clinical efficacy in the remineralization of activewhite spot lesions after 4 weeks of therapy.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

A Randomized, Controlled Clinical Trial of Four Anti-Dandruff Shampoos

1981 ◽  
Vol 9 (2) ◽  
pp. 152-156 ◽  
Author(s):  
Marvin Rapaport
Keyword(s):  
Clinical Trial ◽  
Test Preparation ◽  
The Other ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Mean ◽  
Rate Of Improvement

A total of 199 patients were selected for a comparison of the anti-dandruff efficacy of four shampoos. After a 2-week lead-in (all patients used only Johnson's Baby Shampoo twice weekly) the patients were randomly assigned to Selsun Blue®, Head & Shoulders®, Flex®, or Tegrin®. The test preparation, which was unknown to the observer, was used twice weekly for 4 weeks. Loose and adherent dandruff were each rated on a scale of 0 to 20 (absent to severe) at the end of the lead-in (when a total score of 15 was required), and each week of study. The mean total pre-study score for all subjects was 19.5. At the end of the study the mean improvement scores were: 162 (Selsun Blue), 14.6 (Head & Shoulders), 13.5 (Flex), and 13.1 (Tegrin). The improvement was significantly greater (p < 0.05) on Selsun Blue than on any of the other shampoos. At the end of the study significantly (p < 0.05) more patients had total scores of zero on Selsun Blue (15) than on Tegrin or Head & Shoulders. In addition, the rate of improvement was significantly (p < 0.05) faster with Selsun Blue than with any of the other test preparations.

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

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.

scholarly journals The Effect of Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial

2015 ◽  
Vol 4 (1) ◽  
pp. 26-32
Author(s):  
Sara Azima ◽  
Hajar Rajaei Bakhshayesh ◽  
Keramatollah Abbasnia ◽  
Maasumeh Kaviani ◽  
Mehrab Sayadi
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pharmacological Method

Background: Primary dysmenorrhea is the most common cyclic pelvic pain and is also the most common gynecological problem worldwide and affects quality of life. The present study aimed to investigate the effect of isometric exercises on intensity and duration of pain and level of anxiety in the students with primary dysmenorrhea.Materials and Methods: In this randomized controlled clinical trial, 68 students living in dormitories of Shiraz University with primary dysmenorrhea  were randomly assigned to isometric exercises and control groups. The intervention group performed isometric exercises since the third day of the menstrual cycle for 8 weeks. Pain intensity was measured using Visual Analog Scale (VAS). In addition, the anxiety level was assessed using Spielberger questionnaire. The data were analyzed using independent t-test, repeated measures ANOVA, and Bonferroni Post hoc test at the end of the second and third months of the study. Besides, P<0.05 was considered as statistically significant.Results: Pain intensity and duration of pain was significantly reduced in exercises group (p<0.001). However, no significant difference was found between the two groups concerning the mean anxiety levels.Conclusion: Primary dysmenorrhea is a common complaint among young women. Isometric exercises seem to be an easy, non-pharmacological method for reducing primary dysmenorrheal.

scholarly journals A randomized clinical trial to stimulate the cholinergic anti-inflammatory pathway in patients with moderate COVID-19-pneumonia using a slow-paced breathing technique

2021 ◽  
Author(s):  
Elisabeth Maria Balint ◽  
Beate Grüner ◽  
Sophia Haase ◽  
Mandakini Kaw-Geppert ◽  
Julian Thayer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Interleukin 6 ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Single Center ◽  
Paced Breathing ◽  
Randomized Controlled ◽  
Lr Test ◽  
Practice Time

AbstractImportanceVagus nerve stimulation via slow-paced breathing could serve as adjuvant therapeutic approach to reduce excessive inflammation in coronavirus disease 2019 (COVID-19) pneumonia.ObjectiveDoes a slow-paced breathing technique increasing vagal activity reduce Interleukin-6 (IL-6) in patients hospitalized with moderate COVID-19 pneumonia compared to standard care?DesignSingle-center randomized controlled clinical trial with enrolment from February 23rd 2021 through June 17th 2021 and follow-up until July 22nd 2021.SettingWard for infectious diseases and temporary COVID-19 ward, Ulm University Hospital, GermanyParticipantsConsecutive sample of patients hospitalized with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (primary diagnosis). Of 131 patients screened, 48 patients were randomized and 46 patients analyzed (N=23 per group).InterventionsSlow-paced 20-minute breathing exercise three times a day with six breaths per minute (inhale-to-exhale ratio 4:6).Main outcomes and measuresDifferences between intervention and control group in IL-6 calculated using multilevel mixed-effect linear regression models with random slope including the covariates relevant comorbidities, COVID-19 medication, and age.ResultsMean age 57 years±13 years, N= 28 (60%) male, N=30 (65%) with relevant comorbidities. The model including group by time interaction revealed a significantly lower trajectory of IL-6 in the intervention group compared to the control group (effect size Cohens f2=0.11, LR-test p=.040) in the intention-to-treat sample, confirmed by treatment-per-protocol analysis (f2=0.15, LR-test p=.022).Exploratory analysis using the median split of practice time to predict IL-6 of the next morning indicated a dose-response relationship with beneficial effects of practice time above 45 minutes a day.Three patients in each group were admitted at ICU, one died. Oxygen saturation increased during slow-paced breathing (from 95.1%±2.1% to 95.4%±1.6%, p=0.006).Conclusion and relevancePatients practicing slow-paced breathing had significantly lower IL-6 values than controls without relevant side effects. Further trials should evaluate clinical outcomes as well as an earlier start of the intervention, i.e., at symptom onset. This would offer an access to a therapy option not only for high-income, but also for low- and middle-income countries.Trial registrationGerman register of clinical trials (ID: DRKS00023971) https://www.drks.de, Universal Trial Number (UTN) U1111-1263-8658;Key pointsQuestionCan slow-paced breathing reduce Interleukin-6 (IL-6) in hospitalized patients with moderate coronavirus disease 2019 (COVID-19) pneumonia?FindingsSingle-center randomized controlled clinical trial including 46 patients hospitalized with moderate COVID-19 pneumonia. Compared to controls, IL-6 values were significantly lower (small-to-medium effect sizes) in patients who were instructed to practice six breaths per minute for 20 minutes three times a day. More minutes of slow-paced breathing were significantly correlated with lower IL-6 values the next morning.MeaningSlow-paced breathing could be a safe and feasible adjuvant therapeutic approach in moderate COVID-19 pneumonia.

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