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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlgroup: No headphones, no music, no noise cancelling (no additional treatment) | Experimental group 1: headphones with activated noise cancelling |
| |
| Experimental group 2: headphones with activated noise cancelling and soft 60 bpm music |
| ||
| Experimental group 1: headphones with activated noise cancelling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| headphones with activated noise cancelling | Device | noise cancelling is new |
|
| Measure | Description | Time Frame |
|---|---|---|
| Result of the questionnaire | 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. | Answering the first questionnaire to answering the second questionnaire happens both on the same day, right before and right after the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the heart rate | 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. | All three measurements happen on the same day. Before, during and after the surgery, no follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophia Felicitas Pfister, BSc | Contact | 0049 157 514 50343 | sophia_pfister@yahoo.com | |
| Markus Hof, Univ.-Prof. Dr. med. dent., PhD, MSc | Contact | markus.hof@med.sfu.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zahnklinik der SFU Wien / Dental clinic of the Sigmund Freud private univeristy Vienna | Vienna | 1020 | Austria |
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| 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) |
|
| ID | Term |
|---|---|
| D006339 | Heart Rate |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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