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NCT Number: NCT06688877

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Vienna, 1020, Austria

Location contact

Markus Hof, Univ.-Prof. Dr. med. dent., PhD, MSc

CONTACT

[email protected]

Sophia Felicitas Pfister, BSc

PRINCIPAL_INVESTIGATOR

Wolfgang Manschiebel, DDr.

CONTACT

[email protected]

+43 1 720 19 66

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • younger than 18 years old
  • hearing impairment

Treatment and study plan

headphones with activated noise cancelling

Device

noise cancelling is new

headphones with activated noise cancelling and soft 60 bpm musc

Device

noise cancelling is new

heart rate measurement

Device

three times (before, during and after surgery)

Questionnaire

Other

two times (before and after surgery)

Primary outcomes

  1. Result of the questionnaire

    Time frame: 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.

Secondary outcomes

  1. Measurement of the heart rate

    Time frame: All three measurements happen on the same day. Before, during and after the surgery, no follow up.

    The Secondary Outcome Measure is the Measurement of the heart rate. This will happen three times: right before, right after and at a set point during the surgery. The pulse oximeter is clipped on a finger of the patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Markus Hof, Univ.-Prof. Dr. med. dent., PhD, MSc

CONTACT

[email protected]

Sophia Felicitas Pfister, BSc

CONTACT

[email protected]

0049 157 514 50343

Sponsors and collaborators

Lead sponsor

Sigmund Freud PrivatUniversitat

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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