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

Sigmund Freud PrivatUniversitat

Status: Not yet enrolling

Conditions: Fear Anxiety; Heart Rate; Wisdom Tooth Removal

Treatments: Device: heart rate measurement; Device: headphones with activated noise cancelling; Other: Questionnaire; Device: headphones with activated noise cancelling and soft 60 bpm musc

Study type: Observational

Funder types: Other

Identifiers

NCT06688877

834-2023

Details and patient eligibility

About

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).

Full 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

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• younger than 18 years old
• hearing impairment

Trial design

156 participants in 3 patient groups

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

Description:

Experimental group 1: headphones with activated noise cancelling

Treatment:

Other: Questionnaire

Device: heart rate measurement

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

Treatment:

Device: headphones with activated noise cancelling and soft 60 bpm musc

Other: Questionnaire

Device: heart rate measurement

Experimental group 1: headphones with activated noise cancelling

Treatment:

Other: Questionnaire

Device: headphones with activated noise cancelling

Device: heart rate measurement