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临床试验/NCT04468048
NCT04468048撤回不适用

Music Utilization in Sedation and Induction in Colonoscopy

The Brooklyn Hospital Center1 个研究点 分布在 1 个国家开始时间: 2019年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Amount of sedation used

研究概览

简要总结

Conscious sedation (CS) if often used in the field of gastroenterology to alleviate pain and discomfort with interventional procedures. Although CS is relatively safe, there is concern for the development of cardiopulmonary complications. Music has been shown in multiple studies to decrease anxiety and improve patient satisfaction following cardiac, pulmonary, and surgical procedures. This is a prospective single-blinded randomized control trial that will examine the effects of active music participation and music listening on patients undergoing colonoscopy through propofol use (monitored anesthesia) at The Brooklyn Hospital Center. The study will enroll patients who will undergo colonoscopy from November 2018 to April 2019 and randomize them to receive music or no music starting at the initial nursing evaluation in the pre-procedure area. We hypothesize that incorporating music during colonoscopy procedures will alleviate patient discomfort, reduce narcotic/sedative usage and post-operative complications.

详细描述

Introduction Conscious sedation (CS) in the field of gastroenterology is commonly incorporated in order to alleviate pain and discomfort associated with interventional procedures. The use of CS to combat patient anxiety has been well documented [1]. Although CS is relatively safe, it is not immune to cardiopulmonary complications. Multiple studies have demonstrated a clear correlation between advancing age and procedure related complications [2-4]. It is also important to note that despite the lack of association between age and additional complications in a study conducted by Clarke et al, a third of their patients did not receive sedation/narcotic medications [5].

Obesity, which affects approximately two third of the U.S. population, has a myriad of health related risks and has been shown to contribute to the overall complications associated with endoscopic procedures [6]. Because those who are obese and overweight have higher than normal BMIs, BMI should not be ignored when assessing cardiopulmonary complications in patients undergoing endoscopic procedures. Moreover, a study by Qadeer et al. revealed that patients with high BMIs were more likely to experience hypoxic episodes [3].

A study by Sharma et al. (2007) looked at more than 300,000 patients who underwent endoscopic procedures while monitoring their risk factors for cardiopulmonary complications [4]. Older age, American Society of Anesthesia (ASA) grade value >2, inpatient procedures, and involvement of trainee with procedure were all shown to be associated with cardiopulmonary complications. In addition, another study by Bini et al.(2003) illustrated that the age of a patient, comorbid conditions, month of procedure (July and August), and midazolam dose were linked with increased negative outcomes [2]. The correlation between complication rate during procedures along with the year of the trainee conducting the procedure indirectly demonstrated the complications in the new academic year (July and August). Understanding that sedation during endoscopic procedures incurs significant risks particularly in patients who are underweight, obese or have numerous comorbidities can lead to steps aimed at better managing the aforementioned risks and reducing patient discomfort.

Music has been shown in many studies to decrease anxiety and improve patient satisfaction during and after procedures in cardiac, pulmonary and surgical procedures [7-16]. In regards to endoscopies, one hundred and eighty patients who were listening to music prior to endoscopic procedure had a significant reduction in stress compared to controls [17]. A similar type of study performed by Hayes et al. (year) revealed that music resulted in a statistically significant decrease in the State-Trait Anxiety Index (STAI) levels of patients undergoing an endoscopy [18] . In another study, music was played prior to and during procedure with no sedative/narcotic medications [19] . Patients with music experienced a decrease in blood pressure (BP) and RR compared to their counterparts who did not listen to music. A 3 point attitude scale showed that patients with music had less discomfort, illustrating that music has the potential to modulate physiological parameters. An instrumental composition from the album "Nada Himalaya" performed by S.G. Sachchidananda, was previously studied by Phanishree et al. (unpublished data), which demonstrated a decrease in the blood pressure and heart rate in patients. Furthermore, the patients were much more relaxed and calm compared to the beginning of the study. Other music genres have relaxation properties as well but we wanted to test one specific type of music to see proof of concept in colonoscopy before we introduce other genres.

Propofol is currently being used more frequently for the use of monitored anesthesia in surgical settings. Patients on propofol have a better recall that music was being played compared to general anesthesia, but they could not adequately recall the type of music [20]. Ambient room noise seems to be one of the main factors associated with increasing propofol requirements in an operation room (OR) which music seems to alleviate [21] . This has been further illustrated by the use of Bispectral index (BIS), which demonstrated increasing brain activity when OR decibels were over 50 [22]. With the initiation of music and propofol in the setting of spinal anesthesia, there was a significant decrease in propofol dose and cortisol levels intra-op demonstrating the stress relieving effect of music [23,24].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Anyone scheduled for in-patient colonoscopy
  • Must be able to speak English, Spanish, or Polish

排除标准

  • Hearing impairment
  • Mentally challenged
  • Previous resection of the colon
  • Currently using narcotics or sedative medications
  • If patient is unwilling to use headphones after consenting

结局指标

主要结局

Amount of sedation used

时间窗: Duration of procedure

Total dose of propofol will be calculated by the Anesthesiologist's team. The total dosage for each group will be compared using a t-test

次要结局

  • Anxiety levels and willingness to perform procedures(Duration of procedure)
  • Effect of music in relation to level of trainee(Duration of procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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