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The Effect of Music Therapy on Perceived Pain, Mental Health, Vital Signs, and Medication Usage of Burn Patients Hospitalized in the Intensive Care Unit: A Randomized Controlled Feasibility Study Protocol

ABSTRACT: Background: Burn patients experience major physiological and psychological stressors during treatment and rehabilitation, including elevated levels of pain, anxiety, stress, or depression. Music interventions inclusive of music therapy (MT) have been shown to improve such symptoms, but rigorous clinical trials investigating specific music therapy methods in adult burn patients are scarce. Methods: This is a single center Randomized Controlled Trial (RCT) protocol with two parallel arms. Participants are 81 adult burn patients admitted to the Intensive Care Unit (ICU) of the University Hospital Fundación Santa Fe de Bogotá in Colombia. The intervention consists of a Music Assisted Relaxation (MAR) protocol, a music therapy technique composed of entrained live music combined with a guided relaxation and/or the use of imagery. The effects of the MAR will be compared to a control group (treatment as usual) over a period of maximum 2 weeks or six interventions. The primary outcome measure is perceived background pain, as measured with a Visual Analog Scale (VAS) before and after each intervention. Secondary outcomes are anxiety and depression levels; vital signs; and the use of pain medication. Additionally, some patients in the intervention group will be invited to participate in electroencephalography, electromyography, and electrocardiography recordings during the MAR. Discussion: This study protocol follows the SPIRIT guidelines for defining items of clinical trials and is the first study in Colombia to evaluate the effects of music therapy for adult burn patients. With this RCT it is hoped to gather new knowledge about the potential of music therapy to help critical care patients cope and recover from their injuries during the hospitalization in the ICU. Trial registration:www.clinicaltrials.gov, Identifier: NCT04571255. Protocol version: V1.0, May 24th 2021

SUBMITTER: Ettenberger M

PROVIDER: S-EPMC8558489 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Continuous monitoring of vital signs by using wearable wireless devices may allow for timely detection of clinical deterioration in patients in general wards in comparison to detection by standard intermittent vital signs measurements. A large number of studies on many different wearable devices have been reported in recent years, but a systematic review is not yet available to date. OBJECTIVE:The aim of this study was to provide a systematic review for health care professionals regarding the current evidence about the validation, feasibility, clinical outcomes, and costs of wearable wireless devices for continuous monitoring of vital signs. METHODS:A systematic and comprehensive search was performed using PubMed/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from January 2009 to September 2019 for studies that evaluated wearable wireless devices for continuous monitoring of vital signs in adults. Outcomes were structured by validation, feasibility, clinical outcomes, and costs. Risk of bias was determined by using the Mixed Methods Appraisal Tool, quality assessment of diagnostic accuracy studies 2nd edition, or quality of health economic studies tool. RESULTS:In this review, 27 studies evaluating 13 different wearable wireless devices were included. These studies predominantly evaluated the validation or the feasibility outcomes of these devices. Only a few studies reported the clinical outcomes with these devices and they did not report a significantly better clinical outcome than the standard tools used for measuring vital signs. Cost outcomes were not reported in any study. The quality of the included studies was predominantly rated as low or moderate. CONCLUSIONS:Wearable wireless continuous monitoring devices are mostly still in the clinical validation and feasibility testing phases. To date, there are no high quality large well-controlled studies of wearable wireless devices available that show a significant clinical benefit or cost-effectiveness. Such studies are needed to help health care professionals and administrators in their decision making regarding implementation of these devices on a large scale in clinical practice or in-home monitoring.

Project description:Introduction: Hospitalized pediatric hematology-oncology and post-hematopoietic cell transplant (HCT) patients have frequent deterioration requiring Pediatric Intensive Care Unit (PICU) care. Critical deterioration (CD), defined as unplanned PICU transfer requiring life-sustaining interventions within 12 h, is a pragmatic metric to evaluate emergency response systems (ERS) in pediatrics, however, it has not been investigated in these patients. The goal of this study was to evaluate if CD is an appropriate metric to assess effectiveness of ERS in pediatric hematology-oncology and post-HCT patients and if it is preceded by an actionable period of vital sign changes. Methods: A retrospective review of all unplanned PICU transfers and floor cardiopulmonary arrests in a dedicated pediatric hematology-oncology hospital between August 2014 and July 2016. Vital signs and physical exam findings 48 h prior to events were converted to Pediatric Early Warning System-Like Scores (PEWS-LS) using cardiovascular, respiratory, and neurologic criteria. Results: There were 220 deterioration events, with 107 (48.6%) meeting criteria for CD, representing a rate of 2.98 per 1,000-inpatient-days. Using the first event per hospitalization (n = 184), patients with CD had higher mortality (17.4 vs. 7.6%, p = 0.045), fewer median ICU-free-days (21 vs. 24, p = 0.011), ventilator-free-days (25 vs. 28, p < 0.001), and vasoactive-free-days (27 vs. 28, p < 0.001). Using vital sign data 48 h prior to deterioration events, those with CD had higher PEWS-LS on PICU admission (p < 0.001), spent more time with elevated PEWS-LS prior to PICU transfer (p = 0.008 to 0.023) and had a longer time from first abnormal PEWS-LS (p = 0.007 to 0.043). Significant difference between the two groups was observed as early as 4 h prior to the event (p = 0.047). Conclusion: Hospitalized pediatric hematology-oncology and post-HCT patients have frequent deterioration resulting in a high mortality. In these patients, CD is over 13 times more common than floor cardiopulmonary arrests and associated with higher mortality and fewer event-free days, making it a useful metric in these patients. CD is preceded by a long duration of abnormal vital signs, making it potentially preventable through earlier recognition.

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The Effect of Music Therapy on Perceived Pain, Mental Health, Vital Signs, and Medication Usage of Burn Patients Hospitalized in the Intensive Care Unit: A Randomized Controlled Feasibility Study Protocol

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