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

ConditionsFear Anxiety Wisdom Tooth Removal Heart Rate

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSigmund Freud PrivatUniversitat

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

younger than 18 years old

hearing impairment

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

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 intervention
two times (before and after surgery)

Treatment groups

156 Participants

are divided into 3 treatment groups

Group A: Controlgroup: No headphones, no music, no noise cancelling (no additional treatment)2 interventions

Group B: Experimental group 2: headphones with activated noise cancelling and soft 60 bpm music3 interventions

Group C: Experimental group 1: headphones with activated noise cancelling3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Answering the first questionnaire to answering the second questionnaire happens both on the same day, right before and right after the surgery.

Secondary outcomes

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sigmund Freud PrivatUniversitat

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: