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

NCT ID: NCT06688877

Last Updated: 2024-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-18

Study Completion Date

2025-06-29

Brief Summary

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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).

Detailed Description

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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

Conditions

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Fear Anxiety Wisdom Tooth Removal Heart Rate

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Controlgroup: No headphones, no music, no noise cancelling (no additional treatment)

Experimental group 1: headphones with activated noise cancelling

heart rate measurement

Intervention Type DEVICE

three times (before, during and after surgery)

Questionnaire

Intervention Type OTHER

two times (before and after surgery)

Experimental group 2: headphones with activated noise cancelling and soft 60 bpm music

headphones with activated noise cancelling and soft 60 bpm musc

Intervention Type DEVICE

noise cancelling is new

heart rate measurement

Intervention Type DEVICE

three times (before, during and after surgery)

Questionnaire

Intervention Type OTHER

two times (before and after surgery)

Experimental group 1: headphones with activated noise cancelling

headphones with activated noise cancelling

Intervention Type DEVICE

noise cancelling is new

heart rate measurement

Intervention Type DEVICE

three times (before, during and after surgery)

Questionnaire

Intervention Type OTHER

two times (before and after surgery)

Interventions

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headphones with activated noise cancelling

noise cancelling is new

Intervention Type DEVICE

headphones with activated noise cancelling and soft 60 bpm musc

noise cancelling is new

Intervention Type DEVICE

heart rate measurement

three times (before, during and after surgery)

Intervention Type DEVICE

Questionnaire

two times (before and after surgery)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* younger than 18 years old
* hearing impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sigmund Freud PrivatUniversitat

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zahnklinik der SFU Wien / Dental clinic of the Sigmund Freud private univeristy Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Central Contacts

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Sophia Felicitas Pfister, BSc

Role: CONTACT

0049 157 514 50343

Markus Hof, Univ.-Prof. Dr. med. dent., PhD, MSc

Role: CONTACT

Facility Contacts

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Wolfgang Manschiebel, DDr.

Role: primary

+43 1 720 19 66

Markus Hof, Univ.-Prof. Dr. med. dent., PhD, MSc

Role: backup

Other Identifiers

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834-2023

Identifier Type: -

Identifier Source: org_study_id

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