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

NCT06688877 | Not Yet Recruiting

• 1 other identifier: 834-2023
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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).

Conditions

Fear Anxiety; Wisdom Tooth Removal; Heart Rate

Keywords

fear level; wisdom teeth removal; noise reduction by music and noise cancelling

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Measurement of the heart rate

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

Study Arms (3)

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

Experimental group 1: headphones with activated noise cancelling

Device: heart rate measurement; Other: Questionnaire

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

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

Experimental group 1: headphones with activated noise cancelling

Device: headphones with activated noise cancelling; Device: heart rate measurement; Other: Questionnaire

Interventions

headphones with activated noise cancelling DEVICE

noise cancelling is new

Experimental group 1: headphones with activated noise cancelling

headphones with activated noise cancelling and soft 60 bpm musc DEVICE

noise cancelling is new

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

heart rate measurement DEVICE

three times (before, during and after surgery)

Controlgroup: No headphones, no music, no noise cancelling (no additional treatment); Experimental group 1: headphones with activated noise cancelling; Experimental group 2: headphones with activated noise cancelling and soft 60 bpm music

Questionnaire OTHER

two times (before and after surgery)

Controlgroup: No headphones, no music, no noise cancelling (no additional treatment); Experimental group 1: headphones with activated noise cancelling; Experimental group 2: headphones with activated noise cancelling and soft 60 bpm music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• younger than 18 years old
• hearing impairment

Sponsors & Collaborators

• Sigmund Freud PrivatUniversitat: lead

Study Sites (1)

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

Vienna, 1020, Austria

Location

MeSH Terms

Interventions

Heart Rate; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Sophia Felicitas Pfister, BSc

CONTACT

0049 157 514 50343; sophia_pfister@yahoo.com

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

CONTACT

markus.hof@med.sfu.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: November 18, 2024
• Primary Completion: June 29, 2025
• Study Completion: June 29, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)