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

Not yet recruiting

• Conditions: Fear Anxiety; Wisdom Tooth Removal; Heart Rate

• Registration Number: NCT06688877
• Lead Sponsor: Sigmund Freud PrivatUniversitat

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

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14
• Study Start: 2024-11-18
• Primary Completion: 2025-06-29
• Study Completion: 2025-06-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Result of the questionnaire	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 Outcome Measures

Name	Time	Method
Measurement of the heart rate	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.

Trial Locations

Locations (1)

Zahnklinik der SFU Wien / Dental clinic of the Sigmund Freud private univeristy Vienna; 🇦🇹 Vienna, Austria