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临床试验/NCT03069677
NCT03069677已完成3 期

Music vs Midazolam During Preoperative Nerve Block Placement: A Prospective, Randomized Controlled Study

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年4月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
160
试验地点
1
主要终点
Anxiety Levels

研究概览

简要总结

The purpose of this study is to determine if there are differences in anxiety scores, heart rate, blood pressure, and oxygen status when using sedation medication versus music while undergoing a peripheral nerve block before your surgery.

详细描述

The general flow of the study will be conducted as follows:

  1. Research coordinator will call or approach patients who are scheduled for a surgical procedure that is planning for a peripheral nerve block either for the primary anesthetic or for postoperative pain control to be placed in the preoperative bay in the ambulatory surgical center.
  2. Research coordinator will discuss the purpose of our study and explain the study in detail for the patient. If a patient agrees to participate, then we will have the patient sign the informed consent for the study. If patient is on the phone and decides to participate, the patient will sign the informed consent upon arriving to Penn Medicine University City (PMUC).
  3. Once the patient signs the informed consent for the peripheral nerve block by anesthesia team. The patient randomized will be revealed to either music or IV midazolam. The pre-procedure anxiety score will then be obtained using the STAI-6 validated tool.
  4. The golden moment will be conducted between the patient, provider, and nursing staff. Once this golden moment is completed, the anxiolytic intervention will start (music or IV midazolam)*
  5. The preoperative nerve block will be conducted by the regional anesthesia block team.
  6. Once the nerve block is complete, we will obtain the post-procedure anxiety score using the STAI-6 validated tool.
  7. Once the post-procedure anxiety score has been obtained, we will also obtain the patient satisfaction score, the provider satisfaction score, and the evaluation of any difficulties in communication between the provider and patient. After these questions have been obtained, the study is complete.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients who are >18 years of age, who will give informed consent in receiving a peripheral nerve block in the preoperative bay for their primary anesthetic and/or for their postoperative pain control.

排除标准

  • significant psychiatric disorder such as generalized anxiety disorder, panic disorder, depression, psychosis, bipolar disorder; individuals who were incompetent to give informed consent; pregnant and/or breast feeding patients; any underlying coagulopathy, infection or other factors which would be a contraindication to receiving a peripheral nerve block; hypersensitivity to midazolam; and history of renal impairment. Patients who were extremely anxious (scores 50 and greater on the State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.

研究组 & 干预措施

Music group

Active Comparator

research-selected music

干预措施: music (Other)

Midazolam group

Active Comparator

IV midazolam (1mg to 2mg max)

干预措施: Midazolam (Drug)

结局指标

主要结局

Anxiety Levels

时间窗: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)

Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.

Change in STAI-6 Scores From Post to Pre.

时间窗: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)

Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.

次要结局

  • Provider Satisfaction Scores of the Experience During Procedure(immediately after nerve block placement (less than 1 minute after))
  • Block Times(immediately after nerve block placement (less than 1 minute after))
  • Patient Satisfaction Scores of the Experience During Procedure(immediately after nerve block placement (less than 1 minute after))
  • Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider(immediately after nerve block placement (less than 1 minute after))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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