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
Einfluss Der Kombination Von Musik Und Noise Cancelling Als nichtmedikamentöse Unterstützung Bei Angst Und Unwohlsein während Der Weisheitszahnentfernung
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).
Study Overview
Status
Conditions
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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sophia Felicitas Pfister, BSc
- Phone Number: 0049 157 514 50343
- Email: sophia_pfister@yahoo.com
Study Contact Backup
- Name: Markus Hof, Univ.-Prof. Dr. med. dent., PhD, MSc
- Email: markus.hof@med.sfu.ac.at
Study Locations
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Vienna, Austria, 1020
- Zahnklinik der SFU Wien / Dental clinic of the Sigmund Freud private univeristy Vienna
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Contact:
- Markus Hof, Univ.-Prof. Dr. med. dent., PhD, MSc
- Email: markus.hof@med.sfu.ac.at
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Contact:
- Wolfgang Manschiebel, DDr.
- Phone Number: +43 1 720 19 66
- Email: zahnklinik@sfu.ac.at
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Principal Investigator:
- Sophia Felicitas Pfister, BSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- willing to participate in the clinical trial, understood and signed the information sheet
Exclusion Criteria:
- younger than 18 years old
- hearing impairment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Controlgroup: No headphones, no music, no noise cancelling (no additional treatment)
Experimental group 1: headphones with activated noise cancelling
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three times (before, during and after surgery)
two times (before and after surgery)
|
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Experimental group 2: headphones with activated noise cancelling and soft 60 bpm music
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three times (before, during and after surgery)
two times (before and after surgery)
noise cancelling is new
|
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Experimental group 1: headphones with activated noise cancelling
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three times (before, during and after surgery)
two times (before and after surgery)
noise cancelling is new
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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.
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Answering the first questionnaire to answering the second questionnaire happens both on the same day, right before and right after the surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of the heart rate
Time Frame: All three measurements happen on the same day. Before, during and after the surgery, no follow up.
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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.
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All three measurements happen on the same day. Before, during and after the surgery, no follow up.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 834-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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