NCT06688877

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 156 (estimated)
• Sponsor: Sigmund Freud PrivatUniversitat · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Fear Anxiety
• Wisdom Tooth Removal
• Heart Rate

Interventions

Type	Name	Description
DEVICE	headphones with activated noise cancelling	noise cancelling is new
DEVICE	headphones with activated noise cancelling and soft 60 bpm musc	noise cancelling is new
DEVICE	heart rate measurement	three times (before, during and after surgery)
OTHER	Questionnaire	two times (before and after surgery)

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-06-29
• Completion: 2025-06-29
• First posted: 2024-11-14
• Last updated: 2024-11-14

Locations

1 site across 1 country: Austria