The Study is About the influence of the Combination of Music and Noise Cancelling as a Non-pharmacological Aid in Reducing Anxiety and Discomfort During Wisdom Tooth Removal. The Level of Fear is Measured by a Questionnaire Which the Patients Answer Twice and a Measurement of the Heartbeat

Официальное название

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

Обзор

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).

Подробное описание

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

Вмешательства

• Устройство headphones with activated noise cancelling
  noise cancelling is new
• Устройство headphones with activated noise cancelling and soft 60 bpm musc
  noise cancelling is new
• Устройство heart rate measurement
  three times (before, during and after surgery)
• Другое Questionnaire
  two times (before and after surgery)

Первичные конечные точки

• Result of the questionnaire [Срок оценки: Answering the first questionnaire to answering the second questionnaire happens both on the same day, right before and right after the surgery.]

Вторичные конечные точки (1)

• Measurement of the heart rate [Срок оценки: All three measurements happen on the same day. Before, during and after the surgery, no follow up.]

Критерии участия

Критерии включения

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

Критерии исключения

• younger than 18 years old
• hearing impairment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Австрия · 1 центр

• Zahnklinik der SFU Wien / Dental clinic of the Sigmund Freud private univeristy Vienna — Vienna

Идентификаторы

NCT: NCT06688877 · 834-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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