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临床试验/NCT04909736
NCT04909736已完成不适用

Sequential Allocation Study of Music Duration

Tufts Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年6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
已完成
入组人数
40
试验地点
2
主要终点
Change in anxiety through a questionnaire rating anxiety levels on a scale of 0-10

研究概览

简要总结

The investigators are interested in studying the effects of varying lengths of musical exposure on patient anxiety and stress levels.

详细描述

In prior studies, anxiety and musical exposure was investigated, but yielded results showing both a decrease in anxiety and increase in anxiety. As such, it is possible that there is a "dose" of musical exposure that would achieve optimal anti-anxiety effects, with decreasing efficacy when undershot or overshot. In previous studies, it has been demonstrated that specific selections of Mozart Sonata's, composed with specific rhythms and modes have helped improve patient anxiety through patient mechanisms. As such, this study will continue to use music described in Conrad's previous studies not only as a control mechanism for exposure, but also utilizing already established principals and groundwork.

Once the subject is recruited, patient demographic data and baseline vital signs (including anxiety levels) will be recorded from the patient charts that have been filled out by the patient's provider. Anxiety assessment will be on a scale of 0-10 and the patient will simply be asked to rate their anxiety on that scale, with 0 being absolutely no anxiety and a 10 being the most anxious they have ever felt.

In the exposure group, an investigator will come in with a stereo music player with external speakers that will have the musical pieces pre-loaded. The investigator will be in charge of setting up the music player and starting the music. The patients will then proceed with their predetermined listening time of music. Upon completion, vital signs (including anxiety levels) will once again be collected by the patient's providers and recorded by the investigator. The investigator will also ask a few questions that assess the patient's experience throughout the study and their experience with listening to and playing musical instruments.

In the control group, an investigator will proceed with a predetermined time of no music. Participants and supporting staff would be asked not to play music in the room during the observed time. Upon completion, vital signs (including anxiety levels) will once again be collected by the patient's providers and recorded by the investigator. The investigator will also ask a few questions that assess the patient's experience throughout the study and their experience with listening to and playing musical instruments.

This study will be performing an Up-Down sequential allocation study using Dixon's method to estimate the minimum dose, which provides a 50% chance of reducing anxiety. Specifically, the investigators will start at a musical exposure of 15 minutes for the first study participant. Upon collecting the first participant's anxiety score post-music exposure, the differences in pre-exposure and post-exposure anxiety scores will be calculated. The second study participant will have their exposure time "stepped up" or increased, by 5 minutes if the first study subject results in a failure, defined as either no change or an increase in their post-exposure anxiety. If there was a decrease in anxiety post-exposure, or a "success", then the second subject will have their exposure time reduced by 5 minutes, or "stepped down". From there, the third participant's exposure time will be adjusted based on the outcomes of the second participant. This method and pattern will be applied for all subsequent participants in order to find the lowest duration of music exposure to achieve an effective dose.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Age 18-50
  • •Elective scheduled cesarean delivery
  • •Able to provide informed consent

排除标准

  • •Patient refusal
  • •Impaired hearing
  • •Patient taking at least one anti-anxiolytic medication on a daily basis at baseline
  • •No anxiety (a score of 0, on a scale of 0-10 of pre-music exposure anxiety) after consent is given.

研究组 & 干预措施

Music Exposure

Experimental

Patient will listen to a specified duration of music.

干预措施: Music Exposure (Other)

No-Music Exposure

No Intervention

Patient will not listen to music to for specified duration of time.

结局指标

主要结局

Change in anxiety through a questionnaire rating anxiety levels on a scale of 0-10

时间窗: baseline and up to 60 minutes after exposure.

Investigators will measure the patient's anxiety pre exposure on a scale of 0-10, with 0 being no anxiety and 10 being extreme anxiety. Anxiety will be assessed again on the same scale post musical exposure.

次要结局

  • Change in Heart Rate between baseline and at end of exposure(baseline and up to 60 minutes after exposure.)
  • Change in Blood Pressure between baseline and at the end of exposure(baseline and up to 60 minutes after exposure.)
  • General Musical Experience(Up to 60 minutes after musical exposure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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