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Effect of Benson's relaxation technique versus music intervention on physiological parameters and stress of children with thalassemia during blood transfusions: A randomized controlled trial
Badr, E. A., Ibrahim, H., Saleh, S. E.
Journal of pediatric nursing. 2023
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Editor's Choice
Abstract
BACKGROUND Children with thalassemia are generally dependent on blood transfusions and face a lot of stress and alteration in their physiological parameters through the procedure. AIM: This study aimed to investigate the effect of Benson's relaxation technique versus music intervention on physiological parameters and stress of children with thalassemia during blood transfusions. DESIGN A randomized, controlled trial with three parallel groups. METHODS One hundred and twenty preschool-age children with thalassemia who underwent blood transfusions were randomly assigned to three groups. Children of the control group received only routine hospital care through blood transfusions. Music intervention group children listened to recorded Mozart's music and children of Benson's relaxation group received relaxation intervention before and during the blood transfusions. Outcome measures were physiological parameters and behavioral distress levels. SETTING Hematology outpatient clinic of the Children's University Hospital at El-Shatby in Alexandria from October 2022 to February 2023. RESULTS The mean total score of children's behavioral responses to stress before the blood transfusions procedure was 19.32 ± 4.08, 14.20 ± 0.93, and 16.92 ± 4.74 in the control, music, and Benson groups, respectively. Beyond that, there was a decline in their physiological parameters and behavioral stress response during and after procedure among groups of study (P = 0.005 & <0.001, respectively). CONCLUSION Music and Benson's relaxation interventions had a helpful effect on stabilizing the physiological parameters and reducing behavioral distress levels in children with thalassemia undergoing blood transfusions. PRACTICE IMPLICATIONS This study directs paediatric nurses to apply Benson's relaxation and music interventions for children with thalassemia to enhance their responses.
PICO Summary
Population
Preschool-age children with thalassemia who underwent blood transfusions (n= 120).
Intervention
Benson’s relaxation technique intervention (n= 40).
Comparison
Mozart's music intervention (n= 40); routine hospital care (n= 40).
Outcome
The mean total score of children's behavioral responses to stress before the blood transfusions procedure was 19.32 ± 4.08, 14.20 ± 0.93, and 16.92 ± 4.74 in the control, music, and Benson groups, respectively. Beyond that, there was a decline in their physiological parameters and behavioral stress response during and after procedure among groups of study.
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Weekly epistaxis duration as an indicator of epistaxis severity in hereditary hemorrhagic telangiectasia-Preliminary results from a randomized controlled trial
Wu V, Lee JM, Vozoris NT, Faughnan ME
Laryngoscope investigative otolaryngology. 2021;6(3):370-375
Abstract
OBJECTIVES There is great interest in developing and studying novel therapies for epistaxis in hereditary hemorrhagic telangiectasia (HHT) given its associated morbidity and impact on patients' quality of life. Several recent randomized controlled trials (RCTs) have been negative, likely attributed to poorly characterized outcome measures. This study reported on and evaluated an epistaxis outcome measure, weekly epistaxis duration (WED) in an ongoing RCT, with the aim of better characterizing the measurement of epistaxis for clinical trials. MATERIALS AND METHODS Patients were recruited to an ongoing phase II, double-blind, cross-over RCTs of oral doxycycline for HHT-associated epistaxis. Patients were included for the epistaxis measures analysis if they had already completed the initial 3-month run-in period, and had received treatment of either study drug doxycycline or placebo for a minimum of 6 months. The primary measure of interest was patient-reported outcome (PRO)-WED, captured from prospective daily diaries. Epistaxis severity score (ESS) was collected as a secondary outcome. RESULTS Seven patients were included for analysis, with 98% completion of the daily diary. The average PRO-WED across all patients was 85.0 minutes, SD 93.2 at baseline, and 65.6 minutes, SD 59.5 during treatment/placebo. Coefficient of variance for PRO-WED at baseline and during treatment/placebo was 0.49, SD 0.1 and 0.58, SD 0.2, respectively. Statistically significant changes in the mean PRO-WED from baseline to treatment/placebo was noted in six patients (86%). Only two patients (29%) had a significant change in ESS, with both reporting decreased (improved) scores after treatment/placebo as compared to baseline. CONCLUSIONS PRO-WED was a feasible clinical trials measure, was reasonably stable during baseline measurement, and appeared to be variable with treatment state, suggesting it may provide a sensitive clinical trials PRO in HHT.
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Clinical Pharmacist-Provided Services In Iron-Overloaded Beta-Thalassaemia Major Children: A New Insight Into Patient Care
Bahnasawy SM, El Wakeel LM, Beblawy NE, El-Hamamsy M
Basic & Clinical Pharmacology & Toxicology. 2017;120(4):354-359
Abstract
Iron-overloaded β-thalassaemia major (BTM) children have high risk of delayed sexual/physical maturation, liver/heart diseases and reduced life expectancy. The lifelong need to use iron chelators, their unpleasant administration, side effects and lack of awareness regarding iron overload risks all hamper BTM patient compliance to iron chelators. This study evaluated the impact of clinical pharmacist-provided services on the outcome of iron-overloaded BTM children. Forty-eight BTM children were randomly assigned to either control group, who received standard medical care, or intervention group, who received standard medical care plus clinical pharmacist-provided services. Services included detection of drug-related problems (DRPs) and their management, patient education regarding disease nature and iron chelators, as well as providing patient-tailored medication charts. After six months of study implementation, there was a highly significant difference between the control and intervention groups in serum ferritin (SF) (mean: 3871 versus 2362, μg/l, p = 0.0042), patient healthcare satisfaction (median: 24.47 versus 90.29, p < 0.0001) and quality of life (QoL) (median: 49.84 versus 63.51, p = 0.0049). The intervention group showed a decline from baseline to the end of study in DRPs (64-4), the number of non-compliant patients (24-3) and mean SF levels (3949-2362 μg/l, p < 0.0001). Clinical pharmacist-provided services can positively impact the outcome of BTM children.
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Intra-patient variability of thromboelastographic parameters following in vivo and ex vivo administration of recombinant activated factor VII in haemophilia patients. A multi-centre, randomised trial
Kenet G, Stenmo CB, Blemings A, Wegert W, Goudemand J, Krause M, Schramm W, Kirchmaier C, Martinowitz U
Thrombosis and Haemostasis. 2010;103((2):):351-9.
Abstract
Thromboelastography methods have been used to predict or monitor treatment of haemophilia patients with recombinant activated factor VII (rFVIIa). However, neither of the two thromboelastographic methods (ROTEM and TEG) has as yet been validated. This multi-centre, randomised trial compared both methods in terms of intra- and inter- patient variability following in vivo and ex vivo rFVIIa administration to haemophilia A and B patients with and without inhibitors. Patients ((3)16 years old) received the same intravenous rFVIIa dose (45, 90 or 180 microg/kg) twice, 1-12 weeks apart. Blood samples were collected pre-dose and 15, 60, 120 and 240 minutes post-dose for ROTEM and TEG analysis. Pre-dose samples were also spiked ex vivo with rFVIIa (0. 6, 1. 2 or 2. 4 microg/ml), to correspond to the three in vivo doses. Twenty-six haemophilia A and four haemophilia B patients were enrolled. A significant treatment effect was observed with in vivo rFVIIa (p<0. 05) with more pronounced effects in inhibitor (n=14) versus non-inhibitor (n=16) patients. There was a strong positive correlation between ROTEM and TEG parameters. Intra- and inter-patient variation was large for all thromboelastography parameters at all time points and rFVIIa doses. Intra-patient variation was generally lower for non-inhibitor than inhibitor patients, and lower following ex vivo spiking versus in vivo rFVIIa administration. In conclusion, there was a clear effect of rFVIIa on all thromboelastography parameters, but the large intra- and inter-patient variability following in vivo rFVIIa administration renders the use of our method unsuitable for dose-response prediction for haemophilia patients in the clinical setting.
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Factor concentrate tracking in haemophilia home therapy: a randomized trial (RCT)
Heddle N
Vox Sanguinis. 2004;87((Suppl 3):):11. Abstract No. Tu08.06.
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6.
Effect of blood transfusion on in vivo levels of plasma fibronectin
Snyder EL, Mosher DF, Hezzey A, Golenwsky G
Journal of Laboratory & Clinical Medicine. 1981;98((3):):336-41.
Abstract
Fibronectin, an opsonic glycoprotein, is known to bind fibrinogen and fibrin. Microaggregate debris contained in stored bank blood is composed of degenerating platelets, leukocytes, and fibrin strands. The debris ranges in size from 10 to 160 micrometers. This study examined the effect of transfusion of 2 units of stored red blood cells, containing varying amounts of macroaggregate debris, on in vivo levels of fibronectin. Anemic outpatients were selected at random to receive blood transfusion through either a 170 micrometer standard blood filter or one of four microaggregate filters. A sixth group received saline-washed red blood cells. Results showed that the greatest drop in posttransfusion levels of fibronectin (39 microgram/ml) were found in the group that received blood through a 170 micrometer standard filter and thus received the greatest amount of microaggregate debris (p less than 0.05; N = 50). The patients who received the least microaggregate debris, those receiving washed red cells, showed the smallest decrease in posttransfusion levels of fibronectin (9 microgram/ml); this decrease was not significant (p greater than 0.05; N = 50). Patients receiving blood through 20 to 25 micrometer microaggregate blood filters showed a fall in posttransfusion levels of fibronectin (10 to 15 microgram/ml) intermediate between that found for the two groups described above; this decrease was not significant (p greater than 0.05; N = 35). The decrease in posttransfusion levels of fibronectin found after administration of blood through a 40 micrometer microaggregate screen filter (31 microgram/ml) was significantly different from pretransfusion levels (p less than 0.05; N = 20). Data obtained from this study suggest that transfusion of the microaggregate debris contained in 2 units of stored bank blood can lower in vivo levels of fibronectin. We conclude that if maintaining high levels of fibronectin is shown to be of value in the treatment of critically ill patients, removal of microaggregate debris from any blood transfusions required by these patients would be warranted.