A cluster-controlled clinical trial of two prophylactic silicone sacral dressings to prevent sacral pressure injuries in critically ill patients

2019 ◽  
pp. 21-26 ◽  
Author(s):  
Monica Stankiewicz ◽  
Jodie Gordon ◽  
Joel Dulhunty ◽  
Wendy Brown ◽  
Hamish Pollock ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intensive Care ◽  
Similar Efficacy ◽  
Care Patient ◽  
Controlled Clinical Trial ◽  
Cost Difference ◽  
Increased Risk ◽  
Pressure Injury ◽  
Risk Patients ◽  
The Mean

Objective Patients in the intensive care unit (ICU) have increased risk of pressure injury (PI) development due to critical illness. This study compared two silicone dressings used in the Australian ICU setting for sacral PI prevention. Design A cluster-controlled clinical trial of two sacral dressings with four alternating periods of three months' duration. Setting A 10-bed general adult ICU in outer-metropolitan Brisbane, Queensland, Australia. Participants Adult participants who did not have a sacral PI present on ICU admission and were able to have a dressing applied for more than 24 hours without repeated dislodgement or soiling in a 24-hour period (>3 times). Interventions Dressing 1 (Allevyn Gentle Border Sacrum™, Smith & Nephew) and Dressing 2 (Mepilex Border Sacrum™, Mölnlycke). Main outcomes measures The primary outcome was the incidence of a new sacral PI (stage 1 or greater) per 100 dressing days in the ICU. Secondary outcomes were the mean number of dressings per patient, the cost difference of dressings to prevent a sacral PI and product integrity. Results There was no difference in the incidence of a new sacral PI (0.44 per 100 dressing days for both products, p = 1.00), the mean number of dressings per patient per day (0.50 for both products, p = 0.51) and product integrity (85% for Dressing 1 and 84% for Dressing 2, p = 0.69). There was a dressing cost difference per patient (A$10.29 for Dressing 1 and A$28.84 for Dressing 2, p < 0.001). Conclusions Similar efficacy, product use and product integrity, but differential cost, were observed for two prophylactic silicone dressings in the prevention of PIs in the intensive care patient. We recommend the use of sacral prophylactic dressings for at-risk patients, with the choice of product based on ease of application, clinician preference and overall cost-effectiveness of the dressing.

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 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.

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 Noninvasive ventilation versus conventional oxygen therapy after extubation failure in high-risk patients in an intensive care unit: a pragmatic clinical trial

2021 ◽  
Vol 33 (3) ◽  
Author(s):  
Alberto Belenguer-Muncharaz ◽  
Maria-Lidón Mateu-Campos ◽  
Bárbara Vidal-Tegedor ◽  
María- Desamparados Ferrándiz-Sellés ◽  
Maria-Luisa Micó-Gómez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
High Risk ◽  
Noninvasive Ventilation ◽  
Oxygen Therapy ◽  
Extubation Failure ◽  
Pragmatic Clinical Trial ◽  
High Risk Patients ◽  
Risk Patients

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 Comparison of Complications and Safety of Hemorrhoidectomy with Ligasureand Hemorrhoidectomy with Ferguson: A Randomized Controlled Clinical Trial Study

2021 ◽  
pp. 50-56
Keyword(s):  
Clinical Trial ◽  
Surgical Techniques ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Exact Test ◽  
Randomized Controlled ◽  
Surgical Methods ◽  
The Mean ◽  
And Control

Introduction: Hemorrhoid is one of the most common anorectal diseases which affects 5% of the general population. Complications and pain are inevitable after all surgeries with different intensities and degrees.Management and control of these complications is one of the most important aspects of postoperative care. There are surgical techniques and interventions for the treatment and control of pain after hemorrhoid. According to the contradictory results of the studies on surgical methods, the present study aimed to compare the effectiveness, complications, and safety of hemorrhoidectomy with Ligasureand Ferguson hemorrhoidectomy. Methods: The study sample in this randomized controlled clinical trial studyincluded54 patientswhowere randomly divided into two groupsofLigasureandFerguson surgery. Prior to the surgery, patients were educated abouttheVisual Analogue Scale(VAS).Patients underwent general anesthesia and the same surgeon performed the surgery in both groups. Immediately after the surgery (oncethe patient regainedconsciousness and understoodthe environment), 6, 12, and 24 hours after the surgery, patients’ pain and complications were assessed.The collected data were analyzed using SPSS software (version 18)through independent t-test, Mann-Whitney, Friedman, Chi-square and Fisher’s exact test at a significance level of α=0.05. Results: The mean bleeding during the surgery was significantly lower in the Ligasuregroupthan the Ferguson group. The mean pain at 0, 6, 12, and 24 hafterthe surgery was not significantly different between the two groups.Postoperative complications were significantly higher in the Ligasuregroup than the Ferguson group. Conclusion: Ligasurehemorrhoidectomy is not superior to the Ferguson method in terms of analgesia up to 24 h after the surgery; however, this method of surgeryis preferable to the Ferguson method in terms of bleeding during the surgery.

scholarly journals Probing Pocket Depth and Clinical Attachment Level between Non-Surgical and Surgical Periodontal Therapy in Chronic Periodontitis Patients: A Randomised Controlled Clinical Trial

2018 ◽  
Vol 2 (2) ◽  
pp. 40-44
Author(s):  
Harish Kumar Shah ◽  
Shivalal Sharma ◽  
Khushboo Goel ◽  
Sajeev Shrestha ◽  
Surya Raj Niraula
Keyword(s):  
Clinical Trial ◽  
Surgical Therapy ◽  
Chronic Periodontitis ◽  
Controlled Clinical Trial ◽  
Pocket Depth ◽  
Clinical Attachment Level ◽  
Probing Pocket Depth ◽  
The Mean ◽  
The Difference ◽  
Attachment Level

Background: : Chronic periodontitis is one of the most common form of periodontal diseases which either require non-surgical periodontal therapy or open flap debridement-surgical therapy or both. To date, it is unclear as of how much changes occur after NSPT or OFD and which therapy provides the best outcome in chronic periodontitis having probing pocket depth ≥ 5-7 mm. Aim: The aim of this randomized controlled clinical trial was to evaluate the Probing Pocket Depth and Clinical Attachment Level between NSPT and OFD in chronic periodontitis patients. Materials and Methods: A total of 52 healthy patients with PPD ≥ 5-7 mm were included in the present study. Half of the patients assigned for the NSPT and half in the OFD group. The PPD and CAL were measured at baseline, three and six months. Independent sample t-test was used to compare the change in mean PPD and CAL between NSPT and OFD group at three and six months, respectively. Results: The difference in the mean decrease of PPD between NSPT and OFD group at three and six months were 0.15 mm (P<0.05) and 0.19 mm (P<0.05), respectively. The difference in the mean gain of CAL between NSPT and OFD group at three and six months were 0.03 mm (p>0.05) and 0.12 mm (P<0.05), respectively. Conclusion: Substantial improvement in periodontal status occurred with both the therapies, however, significantly higher decrease in PPD and gain in CAL were seen with surgical therapy.

A controlled clinical trial of the addition of transdermal scopolamine to a standard metoclopramide and dexamethasone antiemetic regimen.

1987 ◽  
Vol 5 (12) ◽  
pp. 1994-1997 ◽  
Author(s):  
B R Meyer ◽  
V O'Mara ◽  
M M Reidenberg
Keyword(s):  
Clinical Trial ◽  
Statistical Significance ◽  
Prospective Clinical Trial ◽  
Controlled Clinical Trial ◽  
Combination Regimen ◽  
Potential Utility ◽  
Standard Regimen ◽  
Antiemetic Regimen ◽  
The Mean ◽  
To Receive

A randomized prospective clinical trial was conducted to evaluate the potential utility of adding transdermal scopolamine to a standard regimen of metoclopramide and dexamethasone for the prevention of cisplatin-induced emesis. Thirty-one patients who were about to receive their first cycle of chemotherapy, using a combination regimen including cisplatin at a dose greater than or equal to 60 mg/m2 were randomized to receive an antiemetic regimen of either metoclopramide and dexamethasone alone, or these two drugs plus transdermal scopolamine patches. The mean number of episodes of emesis was .63 +/- 1.31 in the 16 scopolamine-treated patients, and 2.27 +/- 2.66 in the 15 patients who did not receive scopolamine (P less than .01). The scopolamine appeared to inhibit extrapyramidal reactions to the metoclopramide, but the number of cases was too small for statistical significance. We conclude that the addition of transdermal scopolamine to a standard metoclopramide and dexamethasone antiemetic regimen provides additive benefit in the control of cisplatin-induced emesis.

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