Clinical trial 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
Official title: Einfluss Der Kombination Von Musik Und Noise Cancelling Als nichtmedikamentöse Unterstützung Bei Angst Und Unwohlsein während Der Weisheitszahnentfernung
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fear Anxiety
Wisdom Tooth Removal
Heart Rate
Keywords: fear level
wisdom teeth removal
noise reduction by music and noise cancelling
Lead sponsor: Sigmund Freud PrivatUniversitat
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People who have to get their wisdom tooth removed at the dental clinic of the Sigmund Freud Private University of Vienna, aged minimum 18 years old, no hearing impairment, want to take part in the clinical trial.

Brief summary: 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).

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* younger than 18 years old
* hearing impairment

Primary outcomes:
measure: Result of the questionnaire
timeFrame: Answering the first questionnaire to answering the second questionnaire happens both on the same day, right before and right after the surgery.
Secondary outcomes:
measure: Measurement of the heart rate
timeFrame: All three measurements happen on the same day. Before, during and after the surgery, no follow up.
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Zahnklinik der SFU Wien / Dental clinic of the Sigmund Freud private univeristy Vienna
Study officials:
References: