FAST Performance in a Stationary versus In-Motion Military Ambulance Utilizing Handheld Ultrasound: A Randomized Controlled Study

2020 ◽  
Vol 35 (6) ◽  
pp. 632-637
Author(s):  
Cecil J. Simmons ◽  
Lisa D. Mack ◽  
Aaron J. Cronin ◽  
Jonathan D. Monti ◽  
Michael D. Perreault ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Sensitivity And Specificity ◽  
Completion Time ◽  
Image Acquisition ◽  
Controlled Trial ◽  
Physician Assistants ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Fast Training ◽  
Significant Difference

AbstractObjective:On-scene prehospital conditions and patient instability may warrant a during-transport ultrasound (US) exam. The objective of this study was to assess the effect of ambulance turbulence on the performance of the Focused Assessment with Sonography in Trauma (FAST) with a handheld US device.Methods:This was a randomized controlled trial in which participants were randomized to perform a FAST in either a stationary or an in-motion military ambulance. Participants were physicians and physician assistants (PAs) with previous FAST training. All exams were performed on an US phantom model. The primary outcome was FAST completion time, reported as a mean, in seconds. Secondary outcomes included image acquisition score (range of 0-24, reported as a mean), diagnostic accuracy (reported as sensitivity and specificity), and a post-participation survey with five-item Likert-type scales.Results:Twenty-seven participants performed 27 FASTs, 14 in the stationary ambulance and 13 in the in-motion ambulance. All participants obtained the four requisite views of the FAST. A significant difference was detected in image acquisition scores in favor of the stationary ambulance group (19.4 versus 16.7 [95% CI for difference, 0.9-4.4]; P <.01). Significant differences in survey items between groups were related to obtaining and maintaining US images and the exam conditions. There was not a difference in FAST completion time between groups (98.5 seconds versus 78.7 seconds [95% CI for difference, -13.5 seconds to 53.1 seconds]; P = .23). Sensitivity and specificity of FAST in the stationary ambulance was 85.7% (95% CI, 67.3%-96.0%) and 96.4% (95% CI, 81.7%-99.9%) versus 96.2% (95% CI, 80.4%-99.9%) and 100.0% (95% CI, 86.8%-100.0%) in the in-motion ambulance group (P = .21).Conclusion:Vehicular motion did not affect FAST completion time and diagnostic accuracy; however, it did reduce FAST image acquisition scores. The results suggest timely and diagnostically accurate FASTs may be completed by experienced sonographers during moderate levels of ambulance turbulence. Further investigation assessing the utility and limitations of newer handheld US devices in various prehospital conditions is warranted.

scholarly journals LO22: Does point-of-care ultrasonography improve diagnostic accuracy in emergency department patients with undifferentiated hypotension? An international randomized controlled trial from the SHoC-ED investigators

CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S15
Author(s):  
P. Atkinson ◽  
M. Peach ◽  
S. Hunter ◽  
A. Kanji ◽  
L. Taylor ◽  
...  
Keyword(s):  
Cardiogenic Shock ◽  
Diagnostic Accuracy ◽  
Diagnostic Performance ◽  
Primary Outcome ◽  
Point Of Care ◽  
Statistical Tests ◽  
Controlled Study ◽  
Point Of Care Ultrasound ◽  
Randomized Controlled ◽  
Significant Difference

Introduction: Point of care ultrasound has been reported to improve diagnosis in non-traumatic hypotensive ED patients. We compared diagnostic performance of physicians with and without PoCUS in undifferentiated hypotensive patients as part of an international prospective randomized controlled study. The primary outcome was diagnostic performance of PoCUS for cardiogenic vs. non-cardiogenic shock. Methods: SHoC-ED recruited hypotensive patients (SBP &lt; 100 mmHg or shock index &gt; 1) in 6 centres in Canada and South Africa. We describe previously unreported secondary outcomes relating to diagnostic accuracy. Patients were randomized to standard clinical assessment (No PoCUS) or PoCUS groups. PoCUS-trained physicians performed scans after initial assessment. Demographics, clinical details and findings were collected prospectively. Initial and secondary diagnoses including shock category were recorded at 0 and 60 minutes. Final diagnosis was determined by independent blinded chart review. Standard statistical tests were employed. Sample size was powered at 0.80 (α:0.05) for a moderate difference. Results: 273 patients were enrolled with follow-up for primary outcome completed for 270. Baseline demographics and perceived category of shock were similar between groups. 11% of patients were determined to have cardiogenic shock. PoCUS had a sensitivity of 80.0% (95% CI 54.8 to 93.0%), specificity 95.5% (90.0 to 98.1%), LR+ve 17.9 (7.34 to 43.8), LR-ve 0.21 (0.08 to 0.58), Diagnostic OR 85.6 (18.2 to 403.6) and accuracy 93.7% (88.0 to 97.2%) for cardiogenic shock. Standard assessment without PoCUS had a sensitivity of 91.7% (64.6 to 98.5%), specificity 93.8% (87.8 to 97.0%), LR+ve 14.8 (7.1 to 30.9), LR- of 0.09 (0.01 to 0.58), Diagnostic OR 166.6 (18.7 to 1481) and accuracy of 93.6% (87.8 to 97.2%). There was no significant difference in sensitivity (-11.7% (-37.8 to 18.3%)) or specificity (1.73% (-4.67 to 8.29%)). Diagnostic performance was also similar between other shock subcategories. Conclusion: As reported in other studies, PoCUS based assessment performed well diagnostically in undifferentiated hypotensive patients, especially as a rule-in test. However performance was similar to standard (non-PoCUS) assessment, which was excellent in this study.

scholarly journals Modulation of the human immune status by spinal thermal massage: a non-randomized controlled study

2021 ◽  
Keyword(s):  
Quality Of Life ◽  
Nk Cells ◽  
Nk Cell ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Experimental Group

Thermal and massage therapies have long been used to control pain. Although spinal thermal massage (STM) has been used worldwide, its effectiveness has not been proven in a controlled clinical study. We here conducted a non-randomized controlled trial to assess the pain-relieving and immunomodulatory effects of STM in old-aged patients experiencing pain or disability. The experimental group was treated with STM five times a week for 8 weeks and rehabilitative regular care (RRC). The control group was treated with only RRC. Pain and immunological parameters were tested before treatment and after 4 and 8 weeks of treatment. The scores of three pain parameters were lowered by STM, and the differences between the groups were statistically significant at the two time points (p < 0.01). Quality of life determined using the 3-level EuroQol five-dimensional questionnaire scores was significantly higher in patients in the experimental group than those in the control group. Effect sizes (ES) were in the range of medium to large in the pain-related measures (0.54–1.22). The total leukocyte counts and the proportions of lymphocytes and subsets were not significantly different between the groups, whereas the proportions of monocytes and natural killer (NK) cells were higher in the experimental group than in the control group after 8 weeks (p < 0.05). The production of interleukin (IL)-4 and interferon γ in T cells was not significantly different between the groups, whereas the production of IL-2 was high in the control group. However, there was a significant increase in IFN-γ production by NK cells in the experimental group (at 4 weeks, p < 0.05). ES were medium in the immunological measures (0.53–0.68). No significant difference was observed in the production of proinflammatory cytokines, IL-1β, tumor necrosis factor α, or IL-6 between the groups. In conclusion, STM treatment has a positive effect on subjective pain and quality of life. It also enhanced NK cell proportion and activity, suggesting that STM may be beneficial in the prevention of viral diseases and cancer in old-aged people.

scholarly journals The midline approach for endotracheal intubation using GlideScope video laryngoscopy could provide better glottis exposure in adults： A randomized controlled trial

2019 ◽  
Author(s):  
Lianxiang Jiang ◽  
Shulin Qiu ◽  
Peng Zhang ◽  
Weidong Yao ◽  
Yan Chang ◽  
...  
Keyword(s):  
Tracheal Intubation ◽  
Endotracheal Intubation ◽  
Elective Surgery ◽  
Controlled Trial ◽  
Video Laryngoscopy ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Midline Approach ◽  
Approach Group

Abstract Background: Previous studies have demonstrated that the common laryngoscopic approach (right-sided) and midline approach are both used for endotracheal intubation by direct laryngoscopy. Although the midline approach is commonly recommended for video laryngoscopy (VL) in the clinic, there is a lack of published evidences to support this practice. This study aimed to evaluate the effects of different video laryngoscopic approaches on intubation. Methods: Two hundred sixty-two patients aged 18 years who underwent elective surgery under general anaesthesia and required endotracheal intubation were included in the present prospective, randomized, controlled study. The participants were randomly and equally allocated to the right approach (Group R) or midline approach (Group M). All the intubations were conducted by experienced anaesthetists using GlideScope video laryngoscopy. The primary outcomes were Cormack-Lehane laryngoscopic views (CLVs) and first-pass success (FPS) rates. The secondary outcomes were the time to glottis exposure, time to tracheal intubation, haemodynamic responses and other adverse events. Comparative analysis was performed between the groups. Results: Finally, 262 patients completed the study, and all the tracheas were successfully intubated. No significant differences were observed in the patient characteristics and airway assessments ( P >0.05). Compared with Group R, Group M had a better CLV ( χ2 =14.706, P =0.001) and shorter times to glottis exposure (8.82±2.04 vs 12.38±1.81; t =14.94; P <0.001) and tracheal intubation (37.19±5.01 vs 45.23±4.81; t =13.25; P <0.001), but no difference was found in the FPS rate (70.2% vs 71.8%; χ2 =0.074; P =0.446) and intubation procedure time (29.86±2.56 vs 30.46±2.97, t =1.75, P =0.081). Between the groups, the rates of hoarseness or sore throat, minor injury, hypoxemia and changes in SBP and HR showed no significant difference ( P >0.05). Conclusion: Although the FPS rate did not differ based on the laryngoscopic approach, the midline approach could provide better glottis exposure and shorter times to glottis exposure and intubation. The midline approach should be recommended for teaching in VL-assisted endotracheal intubation. Trial registration: The study was registered in the Chinese Clinical Trial Registry ( ChiCTR-RNC-1900023252 ).

scholarly journals Effect of Xiangbin Prescription in Gastrointestinal Function After Gynecological Abdominal Surgery: a Randomized Controlled Trial

2021 ◽  
Author(s):  
Yuyan Wu ◽  
Jinxuan Lin ◽  
Haiping Zeng ◽  
Yi Chen ◽  
Zhiqiang Chen ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Abdominal Surgery ◽  
Controlled Trial ◽  
Controlled Study ◽  
Chewing Gum ◽  
Control Group ◽  
Gastrointestinal Function ◽  
Blank Control Group ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background: Recovery of gastrointestinal function after gynecological abdominal surgery is a major clinical problem. An effective intervention to promote the rapid recovery of gastrointestinal function postoperatively is lacking. This randomized trial investigated whether Xiangbin prescription (XBP) was feasible in terms of efficacy and safety on gastrointestinal function recovery in patients after gynecological abdominal surgery. Methods: A randomized controlled study was conducted, in which 190 patients with gynecological abdominal surgery who met the inclusion and exclusion criteria were enrolled. They were assigned randomly to XBP group, chewing gum group or blank control group, and respectively received the following treatments: took the XBP twice a day, chewed a piece of gum for about 15 minutes each 4 hours, or received conventional western basic treatment, starting on postoperative day 1 until defecation. Three groups were compared in terms of primary outcomes including the time of the first defecation and the time of the first flatus and secondary outcomes including the level of Ghrelin (GHRL) and the incidence of postoperative complications. Meanwhile, the safety of this trial was evaluated. Results: There was no statistical difference in baseline characteristics among the three groups. For the time of the first flatus, XBP group (22.33 ± 6.68 h) showed less time compared with the chewing gum group (23.06 ± 7.37 h), while it was shorter than that in the blank control group (25.86 ± 7.93 h) with significant difference (P < 0.05). As for the time of the first defecation, XBP group (38.65 ± 12.96 h) showed shorter time significantly compared with both the chewing gum group (47.29 ± 14.50 h) and the blank control group (54.01 ± 20.32 h) (P < 0.05). For the postoperative GHRL levels, XBP group was higher than that in the chewing gum group with no significant difference and had more significant improvement of the GHRL levels at postoperative day 3 compared with the blank control group (P < 0.05). For postoperative complications, XBP group had lower incidence than the other two groups but with no significant difference. For safety evaluations, no serious adverse events occurred in the three groups. Conclusions: XBP could promote the recovery of gastrointestinal function after gynecological abdominal surgery and it is overall safe. Trial registration: This trial was retrospectively registered by Chinese Clinical Trial Registry with the identifier number, ChiCTR1900026327, at September 30, 2019. http://www.chictr.org.cn/.

scholarly journals A controlled study on the diagnostic accuracy of panoramic and peri-apical radiography for detecting furcation involvement

2020 ◽  
Author(s):  
Gijsbrecht Jan Berghuis ◽  
Jan Cosyn ◽  
Hugo De Bruyn ◽  
Geert Hommez ◽  
Melissa Dierens ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Sensitivity And Specificity ◽  
Clinical Experience ◽  
High Sensitivity ◽  
High Specificity ◽  
Weighted Kappa ◽  
Time Frame ◽  
Controlled Study ◽  
Significant Difference ◽  
Furcation Involvement

Abstract Background: The aim of this study was to determine diagnostic accuracy, sensitivity and specificity of panoramic and peri-apical radiography for detecting furcation involvement (1) and to evaluate the possible impact of clinical experience on these diagnostic parameters (2).Methods: Periodontitis patients in need of an implant were retrospectively selected. Inclusion criteria were the presence of a CBCT, panoramic and peri-apical radiograph of the site of interest within a one-year time frame. All furcation sites were classified on the basis of CBCT using Hamp’s index (1975). These data were considered gold standard. Ten experienced examiners and 10 trainees were asked to assess furcation involvement for the same defects on the basis of corresponding panoramic and peri-apical radiographs. Absolute agreement, Cohen’s weighted kappa, sensitivity and specificity were calculated. In addition, ROC-curves were constructed.Results: The study sample included 60 furcation sites in 29 multi-rooted teeth from 17 patients (10 females; mean age 62). On average 20/60 furcations were correctly classified on the basis of panoramic radiography, corresponding to weighted kappa of 0.209 indicative of slight agreement. Respective data for peri-apical radiography were 19/60 and 0.221. When recategorizing FI Grades into ‘no to limited FI’ (FI Grade 0 and I) and ‘advanced FI’ (FI Grade II and III), panoramic and peri-apical radiography showed low sensitivity (0.558 and 0.441, respectively), yet high specificity (0.791 and 0.790, respectively) for identifying advanced FI. Both showed diagnostic value given the area under the ROC-curve amounting to 0.79 and 0.69 for panoramic and peri-apical radiography, respectively. There was no significant difference between experienced periodontists and trainees (P = 0.257 versus P = 0.880).Conclusion: Panoramic and peri-apical radiography are relevant in the diagnosis of FI given high specificity. These are best combined with furcation probing showing high sensitivity. Clinical experience does not seem to improve the accuracy of a radiological diagnosis of furcation sites.Trial Registration: Patients were retrospectively registered.

scholarly journals In Vivo Randomized Controlled Study of the Bone Response of All-Suture Anchors and Biocomposite Anchors

2020 ◽  
Vol 8 (4) ◽  
pp. 232596712091496
Author(s):  
Christopher M.B. Stewart ◽  
Haseem Raja ◽  
Emma Torrance ◽  
Lennard Funk
Keyword(s):  
Interrater Reliability ◽  
Suture Anchor ◽  
Controlled Trial ◽  
Intraclass Correlation ◽  
Controlled Study ◽  
Suture Anchors ◽  
Randomized Controlled ◽  
Bone Response ◽  
Significant Difference

Background: Suture anchors are widely used for labral reconstruction surgery. However, there has been some concern over the development of osteolysis around the anchor. This has been reported for both biocomposite and all-suture anchors, but they have not been compared directly in vivo. Purpose: To compare the bone response to 2 common suture anchors: a traditional biocomposite push-fit anchor and an all-suture anchor. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Included in this study were 17 patients with a total of 37 unique suture anchors. Magnetic resonance imaging scans were performed at 3 weeks and 6 months postoperatively. A total of 38 senior radiologists and shoulder surgeons evaluated the images using a previously validated system for grading the bone response around suture anchors. The mean difference in grading at 3 weeks and 6 months was calculated using unpaired t tests, and the interrater reliability was evaluated with an intraclass correlation coefficient (ICC). Results: At 3 weeks, there was no statistically significant difference in the degree of osteolysis surrounding each suture anchor type ( P = .258), with little bone response. However, on the 6-month scans, there was a significantly lower level of osteolysis seen in the all-suture anchors compared with the biocomposite anchors ( P = .040). Interrater reliability was excellent, with an ICC value of 0.975 (95% CI, 0.962-0.985). Conclusion: All-suture anchors cause significantly less osteolysis in glenoid bone at 6 months compared with biocomposite anchors.

scholarly journals Percutaneous Epidural Adhesiolysis Using Inflatable Balloon Catheter and Balloon-less Catheter in Central Lumbar Spinal Stenosis with Neurogenic Claudication: A Randomized Controlled Trial

2018 ◽  
Vol 1 (21;1) ◽  
pp. 593-605
Author(s):  
Seong-Soo Choi
Keyword(s):  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Controlled Trial ◽  
Balloon Catheter ◽  
Controlled Study ◽  
Neurogenic Claudication ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Lumbar Spinal

Background: When conventional interventional procedures fail, percutaneous epidural adhesiolysis (PEA), which has moderate evidence for successful treatment of lumbar spinal stenosis (LSS), has been recommended over surgical treatments. In a previous study, we demonstrated the efficacy of a newly developed inflatable balloon catheter for overcoming the access limitations of pre-existing catheters for patients with severe stenosis or adhesions. Objectives: This study compared the treatment response of combined PEA with balloon decompression and PEA only in patients with central LSS over 6 months of follow-up. Study Design: This study used a randomized, single-blinded, active-controlled trial design. Setting: This study took place in a single-center, academic, outpatient interventional pain management clinic. Methods: This randomized controlled study included 60 patients with refractory central LSS who suffered from chronic lower back pain and/or lumbar radicular pain. Patients failed to maintain improvement for > 1 month with epidural steroid injection or PEA using a balloon-less catheter. Patients were randomly assigned to one of 2 interventions: balloon-less (n = 30) and inflatable balloon catheter (n = 30). The Numeric Rating Scale (NRS-11), Oswestry Disability Index (ODI), Global Perceived Effect of Satisfaction (GPES), and Medication Quantification Scale III were each measured at 1, 3, and 6 months after PEA. Results: There was a significant difference between groups in NRS-11 reduction ≥ 50% (or 4 points), ODI reduction ≥ 30% (or 10 points), GPES ≥ 6 and ≥ 4 points at 6 months, and NRS11 reduction ≥ 50% (or 4 points) at 3 months after PEA (P < .03). The proportion of successful responders was higher in the balloon group than in the balloon-less group throughout the total follow-up period. Furthermore, there was a statistically significant difference between groups at 6 months after PEA (P = .035). Limitations: The results may vary according to the definition of successful response. Follow-up loss in the present study seemed to be high. Conclusion: PEA using the inflatable balloon catheter leads to significant pain reduction and functional improvement compared to PEA using the balloon-less catheter in patients with central LSS. The study protocol was approved by our institutional review board (2012-0235), and written informed consent was obtained from all patients. The trial was registered with the Clinical Research Information Service (KCT 0002093). Key words: Balloon decompression, central, chronic pain, epidural adhesiolysis, lumbar, percutaneous, radiculopathy, spinal stenosis

scholarly journals Clinical Effectiveness of Intravenous Peramivir Compared with Oseltamivir in Patients with Severe Influenza A with Primary Viral Pneumonia: A Randomized Controlled Study

2020 ◽  
Author(s):  
Hong-dou Chen ◽  
Xu Wang ◽  
Shu-le Yu ◽  
Yue-hui Ding ◽  
Meng-lei Wang ◽  
...  
Keyword(s):  
Influenza A ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Viral Pneumonia ◽  
Controlled Study ◽  
Once Daily ◽  
Randomized Controlled ◽  
Severe Influenza ◽  
Significant Difference

Abstract Background High-quality evidence confirm the clinical efficacy of peramivir in severe influenza patients with primary viral pneumonia is lacking. To optimize clinical medication, we evaluate the different efficacy between peramivir and oseltamivir in the treatment of severe influenza A with primary viral pneumonia. Methods A single-center, randomized, controlled trial was conducted during the Chinese influenza season from December 2018 to April 2019 in patients with severe influenza A with primary viral pneumonia. A total of 40 inpatients were enrolled and treated with either intravenous peramivir (300 mg, once daily for 5 days) or oral oseltamivir (75 mg, twice daily for 5 days). Results The durations of influenza virus nucleic acid positivity in the oseltamivir group and the peramivir group were 2.95 days and 2.80 days, respectively. The remission times of clinical symptoms in the oseltamivir group and the peramivir group were 3.90 days and 3.25 days, respectively. In addition, the remission time of cough symptoms in the peramivir group (63.89 hours) was shorter than that in the oseltamivir group (75.53 hours). There was no significant difference between these values (P&gt;0.05). The remission time of fever symptoms in the oseltamivir group was 23.67 hours, which was significantly longer than that in the peramivir group (12.32 hours) (P=0.034). Conclusions Peramivir is no less effective than oseltamivir in the treatment of severe influenza A with primary viral pneumonia, and patients treated with peramivir had significantly shorter remission times of fever symptoms than those treated with oseltamivir.

scholarly journals Comparison between GlideRite® rigid stylet and Parker Flex-It™ stylet to facilitate GlideScope intubation in simulated difficult intubation: a randomized controlled study

2021 ◽  
Author(s):  
Ji Won Bak ◽  
Yeonji Noh ◽  
Juyoun Kim ◽  
Byeongmun Hwang ◽  
Seongsik Kang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Acute Angle ◽  
Controlled Study ◽  
Analog Scale ◽  
Randomized Controlled ◽  
Glottic View ◽  
Significant Difference ◽  
Rigid Stylet ◽  
Intubation Success Rate ◽  
Difficult Airways

Background: The GlideScope® videolaryngoscope (GVL) is widely used in patients with difficult airways and provides a good glottic view. However, the acute angle of the blade can make insertion and advancement of an endotracheal tube (ETT) more difficult than direct laryngoscopy, and the use of a stylet is recommended. This randomized controlled trial compared Parker Flex-It™ stylet (PFS) with GlideRite® rigid stylet (GRS) to facilitate intubation with the GVL in simulated difficult intubations. Methods: Fifty-four patients were randomly allocated to undergo GVL intubation using either GRS (GRS group) or PFS (PFS group). The total intubation time (TIT), 100-mm visual analog scale (VAS) for ease of intubation, success rate at the first attempt, use of laryngeal manipulation, tube advancement rate by assistant, and complications were recorded. Results: There was no significant difference between the GRS and PFS groups regarding TIT (50.3 ± 12.0 s in the GRS group and 57.8 ± 18.8 s in the PFS group, P = 0.108). However, intubation was more difficult in the PFS group than in the GRS group according to VAS score (P = 0.011). Cases in which the ETT was advanced from the stylet by an assistant, were more frequent in the GRS group than in the PFS group (P = 0.002). The overall incidence of possible complications was not significantly different. Conclusions: In patients with a simulated difficult airway, there was no difference in TIT using either the PFS or GRS. However, endotracheal intubation with PFS is more difficult to perform than GRS.

scholarly journals Effects of daily mindfulness practice on fatigue, kinesiophobia, and quality of life in patients with acute myocardial infarction: a randomized controlled trial

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
C Karadas ◽  
M Oksul ◽  
N Ozer ◽  
L Ozdemir
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Mindfulness Practice ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Quality Of Life Scale ◽  
Tampa Scale For Kinesiophobia

Abstract Funding Acknowledgements Type of funding sources: None. Background and Aim Mindfulness meditation (MM) leads to controlled blood pressure and positive improvements in other symptoms which may trigger acute coronary diseases. The present randomized controlled study was aimed to investigate the effect of the MM on fatigue, kinesiophobia, and the quality of life (QoL) in patients with acute MI. Method The study was carried out with 56 MI patients. Participants were randomly assigned to meditation group (MG; n = 28) or control group (CG; n = 28).  The MG patients received a 15 min MM session comprising sitting and breathing for a total of eight weeks, while the CG patients received only a single-time attention-matched education. Piper Fatigue Intervention, Tampa Scale for Kinesiophobia-Heart and MacNew Quality of Life scales were utilized for data collection. Results After completion of the 8-week MM, any significant difference was not found in the fatigue scores of the patients (p &gt; 0.05). On the other hand, kinesiophobia scores in the MG were significantly lower in the 4th, 8th and 12th weeks (p &lt; 0.05). Similarly, the QoL scores were significantly higher in the MG in 8th week (p &lt; 0.05). Significant change in the emotional function sub-dimension of QoL continued in the follow-up assessment at 12th week (p &lt; 0.05). Conclusion The MM can significantly improve the QoL and decrease kinesiophobia in patients with MI. Beneficial effect of MM is maintained particularly in the emotional aspect. Based on the results of the study, MM may be recommended as a mind-body based complementary approaches within the scope of secondary protection after MI. Comparison of the study groupsGroupBaseline(Mean ± SD)4th week(Mean ± SD)8th week(Mean ± SD)12th week(Mean ± SD)PFSMM2.08 ± 1.870.90 ± 0.990.47 ± 0.780.44 ± 0.76CG1.56 ± 2.011.12 ± 1.590.98 ± 1.520.76 ± 1.33tp1.004 0.32-0.6210.54-1.5840.12-1.0850.28TSK-HMM40.25 ± 5.0436.18 ± 4.4934.39 ± 4.6134.96 ± 4.71CG41.71 ± 7.2841.89 ± 6.7441.82 ± 5.8441.00 ± 5.54tp-0.8750.39-3.7340.001-5.279 0.000-4.3900.00MacNewMM5.04 ± 0.715.53 ± 0.455.76 ± 0.475.77 ± 0.47CG5.17 ± 0.855.32 ± 0.605.37 ± 0.525.53 ± 0.46t; p-0.640; 0.531.436; 0.162.933; 0.0051.964; 0.06(Mean ± SD): Mean ± Standard Deviation; PFS: Piper Fatigue Scores; TSK-H: Tampa Scale for Kinesiophobia-Heart; MacNew: MacNew Quality of life Scale; EFS: emotional functioning sub-dimension; PFS: physical functioning sub-dimension; SFS: social functioning sub-dimension; t= Student T Test value; p&lt; 0.05

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