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临床试验/NCT06688877
NCT06688877尚未招募不适用

Einfluss Der Kombination Von Musik Und Noise Cancelling Als nichtmedikamentöse Unterstützung Bei Angst Und Unwohlsein während Der Weisheitszahnentfernung

Sigmund Freud PrivatUniversitat1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
156
试验地点
1
主要终点
Result of the questionnaire

研究概览

简要总结

The goal of this clinical trial is to learn if the reduction of the noises (through head phones with music and noise cancelling) that occur during wisdom teeth removal, leads to a significant reduction in fear levels in patients compared to patients who do not have any noise reduction. The main questions it aims to answer are:

Do music and noise cancelling help patients to have less fear during wisdom teeth removal surgery by reducing the sounds of the surgery? Is there a difference between just the noise cancelling function or is it better to combine noise cancelling and music together?

Participants will:

Just come to their regular appointment (wisdom teeth removal) to our clinic, no follow ups needed. All participants will answer one questionnaire before and one after the surgery. All of them will have their rate of heartbeat measured for three times (before, during and after surgery, measured by a puls oximeter on the finger). They will be allocated to one of the three study groups (no headphones, headphones with noise cancelling or headphones with noise cancelling and music).

详细描述

The headphones that will be used are Sennheiser Overear Headphones with modern noise cancelling function.

Pulse Oximeter is by BRAUN and CE-certified.

Observational Study Model: Randomised controlled, unblinded clinical trial, parallel group design

Sampling method: randomisation by a online randomizer tool

研究设计

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

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

  • willing to participate in the clinical trial, understood and signed the information sheet

排除标准

  • younger than 18 years old
  • hearing impairment

结局指标

主要结局

Result of the questionnaire

时间窗: Answering the first questionnaire to answering the second questionnaire happens both on the same day, right before and right after the surgery.

The primary outcome measure is the result of the questionnaire, which the probands answer two times, before and after the surgery. The score of these two will be summarized for a final result of each patient.

次要结局

  • Measurement of the heart rate(All three measurements happen on the same day. Before, during and after the surgery, no follow up.)

研究者

发起方
Sigmund Freud PrivatUniversitat
申办方类型
Other
责任方
Sponsor

研究点 (1)

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