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临床试验/NCT06235996
NCT06235996进行中(未招募)不适用

Effects of Musical Intervention on Patient Pain and Anxiety for Office-based Procedures

Lake Erie College of Osteopathic Medicine3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
3
主要终点
VAS score

研究概览

简要总结

The purpose of this study is to determine if the use of musical intervention reduces patient anxiety and provides a less painful experience during office-based procedures in a pain management clinic setting.

详细描述

100 patients who are scheduled for interventional procedures will be randomly assigned to either a music intervention group or a no-music group. Such interventional procedures include sacroiliac joint (SI) steroidal injections, SI radiofrequency ablations, peripheral nerve stimulator implantations, caudal and laminar epidural steroidal injections, lumbar medial branch blocks, lumbar medial branch nerve radiofrequency ablations, spinal cord implantation of electro stimulators. These procedures are fluoroscopically guided. Each group will consist of 50 participants. Participants in the music intervention group will listen to their preferred genre of music during their procedure. The study participants in the music intervention group will listen to music via external speakers played in the procedure room. The music will not be loud enough to disrupt the physician's communication with the patient. The no-music group will receive the same treatment throughout the procedure; however, this group will not listen to music at any time during the procedure. To ensure acute pain and anxiety control, participants in both groups will receive standard analgesic treatment in the beginning of their scheduled interventional procedure. Such treatment includes injection and topical application of lidocaine to induce local anesthesia. The patients in both groups will complete a questionnaire that contains VAS and STAI scoring metrics to measure pain and anxiety levels, respectively. This questionnaire will be completed before and immediately after the procedure. Furthermore, we will use salivary cortisol as a non-subjective biomarker of psychological stress in study subjects not undergoing corticosteroid injections. The saliva samples from the study participants will be collected before and after their scheduled office-based procedures. Upon collection of saliva samples from the study participants, the samples will be picked up by the LabCorp, which then will perform salivary cortisol testing; the results will be reported to the study team.

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

  • Scheduled office-based procedure
  • Informed consent is signed by a subject

排除标准

  • Major hearing impairment
  • Sensitivity to music

研究组 & 干预措施

Control

Other

A patient is scheduled for an office-based procedure such as a nerve block, epidural steroid injection, etc. No music intervention is assigned to this group. No music at any time during the procedure. To ensure acute pain and anxiety control, participants will receive standard analgesic treatment in the beginning of their scheduled interventional procedure. Such treatment includes injection and topical application of lidocaine to induce local anesthesia. Standard of care is applied.

干预措施: Office-based procedure indicated for chronic pain without music (Procedure)

Music Intervention

Experimental

A patient is scheduled for an office-based procedure such as a nerve block, epidural steroid injection, etc. Music-of-choice during the office-based procedure intervention is assigned to this group. Music via external speakers played in the procedure room. To ensure acute pain and anxiety control, participants will receive standard analgesic treatment in the beginning of their scheduled interventional procedure. Such treatment includes injection and topical application of lidocaine to induce local anesthesia. Standard of care is applied.

干预措施: Office-based procedure indicated for chronic pain with music (Procedure)

结局指标

主要结局

VAS score

时间窗: Immediately before and after an office-based procedure

Visual Analogue Scale (VAS) score

Blood pressure

时间窗: Immediately before and after an office-based procedure

Systolic and diastolic blood pressure

Biochemical marker of stress

时间窗: Immediately before and after an office-based procedure

Salivary cortisol levels

STAI score

时间窗: Immediately before and after an office-based procedure

State-Trait Anxiety Inventory (STAI) score

Heart rate

时间窗: Immediately before and after an office-based procedure

Heart rate

次要结局

未报告次要终点

研究者

发起方
Lake Erie College of Osteopathic Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Steiner, Ph.D.

Principal Investigator

Lake Erie College of Osteopathic Medicine

研究点 (3)

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