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      Comparison of the effectiveness of position change for patients with pain and vascular complications after transfemoral coronary angiography: a randomized clinical trial

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          Abstract

          Background

          Prolonged immobilization after transfemoral coronary angiography (TFA) may cause pain and vascular complications in patients. This study aimed to evaluate the effectiveness of a change in position to decrease pain and vascular complications for patients after TFA.

          Methods

          This randomized clinical trial was conducted in 2020. Purposive sampling of 72 eligible patients undergoing TFA were selected and randomly assigned to either an experimental or control group. Patients in the experimental group (EG) were placed in a supine position for 2 h after angiography, followed by a semi-seated position with the bed angle gradually increased to 45° over 4 h. Patients in the control group (CG) remained in the supine position for 6 h. Vital signs, groin, back and leg pain, hematoma, hemorrhage, and urinary retention were assessed in both groups before, immediately after, and over 6 h after angiography. The Visual Analogue Scale was used to measure pain, the Christensen scale to measure hematoma, counting bloody gases to measure hemorrhage, and patient self-rating to determine urinary retention.

          Results

          There was no significant difference between EG and CG on score of groin (2.69 ± 1.00 vs. 2.61 ± 1.00, P = 0.74), back (2.19 ± 0.98 vs. 2.47 ± 0.87, P = 0.21), and leg pain (2.14 ± 0.71 vs. 2.50 ± 1.08, P = 0.27) before the TFA. However, from the second hour to the sixth hour after the TFA, the pain in the EG was significantly less than the CG (P < 0.001). So that pain in the groin (1.36 ± 0.48 vs. 3.28 ± 0.81), back (1.25 ± 0.50 vs. 3.81 ± 1.06), and leg (1.44 ± 0.55 vs. 3.28 ± 0.81) for the EG patients was significantly less than the CG in the sixth hour after TFA (P < 0.001). No patients experienced hematoma. No differences were noted between groups in hemorrhage and urinary retention.

          Conclusions

          Position change to a semi-seated position in patients after TFA is effective and safe for reduction of pain without increasing vascular complications.

          Trial registration

          Iranian Registry of Clinical Trials: IRCT registration number: IRCT20200410047011N1, Registration date: 30/04/2020

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          Most cited references34

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          Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults

          Background: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between “no pain” and “worst pain.” Methods: One hundred consecutive patients aged ≥18 years who presented with a chief complaint of pain were asked to record pain scores via a paper VAS and digitally via both the laptop computer and mobile phone. Ninety-eight subjects, 51 men (age, 44 ± 16 years) and 47 women (age, 46 ± 15 years), were included. A mixed-model analysis of covariance with the Bonferroni post hoc test was used to detect differences between the paper and digital VAS scores. A Bland–Altman analysis was used to test for instrument agreement between the platforms. The minimal clinically important difference was set at 1.4 cm (14% of total scale length) for detecting clinical relevance between the three VAS platforms. A paired one-tailed Student t-test was used to determine whether differences between the digital and paper measurement platforms exceeded 14% (P < 0.05). Results: A significant difference in scores was found between the mobile phone–based (32.9% ± 0.4%) and both the laptop computer– and paper-based platforms (31.0% ± 0.4%, P < 0.01 for both). These differences were not clinically relevant (minimal clinically important difference <1.4 cm). No statistically significant difference was observed between the paper and laptop computer platforms. Measurement agreement was found between the paper- and laptop computer–based platforms (mean difference, 0.0% ± 0.5%; no proportional bias detected) but not between the paper- and mobile phone–based platforms (mean difference, 1.9% ± 0.5%; proportional bias detected). Conclusion: No clinically relevant difference exists between the traditional paper-based VAS assessment and VAS scores obtained from laptop computer– and mobile phone–based platforms.
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            Defining hematoma expansion in intracerebral hemorrhage: relationship with patient outcomes.

            Hematoma expansion (HE) is a surrogate marker in intracerebral hemorrhage (ICH) trials. However, the amount of HE necessary to produce poor outcomes in an individual is unclear; there is no agreement on a clinically meaningful definition of HE. We compared commonly used definitions of HE in their ability to predict poor outcome as defined by various cutpoints on the modified Rankin Scale (mRS). In this cohort study, we analyzed 531 patients with ICH from the Virtual International Stroke Trials Archive. Primary outcome was mRS at 90 days, dichotomized into 0-3 vs 4-6. Secondary outcomes included other mRS cutpoints and mRS "shift analysis." Sensitivity, specificity, and predictive values for commonly used HE definitions were calculated. Between 13% and 32% of patients met the commonly used HE definitions. All definitions independently predicted poor outcome; positive predictive values increased with higher growth cutoffs but at the expense of lower sensitivities. All HE definitions showed higher specificity than sensitivity. Absolute growth cutoffs were more predictive than relative cutoffs when mRS 5-6 or 6 was defined as "poor outcome." HE robustly predicts poor outcome regardless of the growth definition or the outcome definition. The highest positive predictive values are obtained when using an absolute growth definition to predict more severe outcomes. Given that only a minority of patients may have clinically relevant HE, hemostatic ICH trials may need to enroll a large number of patients, or select for a population that is more likely to have HE.
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              Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years.

              Observational (behavioral) scales of pain for children aged 3 to 18 years were systematically reviewed to identify those recommended as outcome measures in clinical trials. This review was commissioned by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (www.immpact.org). In an extensive literature search, 20 observational pain scales were identified for review including behavior checklists, behavior rating scales, and global rating scales. These scales varied in their reliance on time sampling and inclusion of physiological items, facial and postural items, as well as their inclusion of multiple dimensions of assessment (e.g., pain and distress). Each measure was evaluated based on its reported psychometric properties and clinical utility. Scales were judged to be indicated for use in specific acute pain contexts rather than for general use. Two scales were recommended for assessing pain intensity associated with medical procedures and other brief painful events. Two scales were recommended for post-operative pain assessment, one for use in hospital and the other at home. Another scale was recommended for use in critical care. Finally, two scales were recommended for assessing pain-related distress or fear. No observational measures were recommended for assessing chronic or recurrent pain because the overt behavioral signs of chronic pain tend to habituate or dissipate as time passes, making them difficult to observe reliably. In conclusion, no single observational measure is broadly recommended for pain assessment across all contexts. Directions for further research and scale development are offered.
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                Author and article information

                Contributors
                offface92@gmail.com
                z.farsi@ajaums.ac.ir , zahrafarsi@gmail.com
                Samantha.Butler@childrens.harvard.edu
                apishgooie@yahoo.com
                Journal
                BMC Cardiovasc Disord
                BMC Cardiovasc Disord
                BMC Cardiovascular Disorders
                BioMed Central (London )
                1471-2261
                25 February 2021
                25 February 2021
                2021
                : 21
                : 114
                Affiliations
                [1 ]GRID grid.411259.a, ISNI 0000 0000 9286 0323, Student Research Committee and Military Nursing Department, Faculty of Nursing, , Aja University of Medical Sciences, ; Tehran, Iran
                [2 ]GRID grid.411259.a, ISNI 0000 0000 9286 0323, Research and Community Health Department, Faculty of Nursing, , Aja University of Medical Sciences, ; Kaj St., Shariati St, Tehran, Iran
                [3 ]GRID grid.2515.3, ISNI 0000 0004 0378 8438, Department of Psychiatry, Harvard Medical School, , Children’s Hospital Boston, ; Boston, MA USA
                [4 ]GRID grid.411259.a, ISNI 0000 0000 9286 0323, Medical-Surgical Department, Faculty of Nursing, , Aja University of Medical Sciences, ; Tehran, Iran
                Author information
                http://orcid.org/0000-0003-1843-9794
                http://orcid.org/0000-0002-5154-0758
                http://orcid.org/0000-0001-8042-2657
                Article
                1922
                10.1186/s12872-021-01922-w
                7908805
                33632127
                2ec4120e-d380-4fa0-82b8-90ea49db9079
                © The Author(s) 2021

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 31 December 2020
                : 17 February 2021
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2021

                Cardiovascular Medicine
                hemorrhage,cardiac catheterization,coronary angiography,hematoma,pain
                Cardiovascular Medicine
                hemorrhage, cardiac catheterization, coronary angiography, hematoma, pain

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