Fear AnxietyNCT06688877
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
An observational study of Fear Anxiety and Wisdom Tooth Removal, run by Sigmund Freud PrivatUniversitat at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fear Anxiety, Wisdom Tooth Removal, Heart Rate
- What is being tested?
- headphones with activated noise cancelling, headphones with activated noise cancelling and soft 60 bpm musc and heart rate measurement
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 1 siteAustria
- Study dates
- 18 Nov 2024to 29 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- willing to participate in the clinical trial, understood and signed the information sheet
Who cannot join
- younger than 18 years old
- hearing impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Markus Hof, Univ.-Prof. Dr. med. dent., PhD, MSc contact
Austria1 site
Zahnklinik der SFU Wien / Dental clinic of the Sigmund Freud private univeristy Vienna
Vienna, 1020
Wolfgang Manschiebel, DDr., +43 1 720 19 66, zahnklinik@sfu.ac.at
Markus Hof, Univ.-Prof. Dr. med. dent., PhD, MSc, markus.hof@med.sfu.ac.at
About this study
Official title: Einfluss Der Kombination Von Musik Und Noise Cancelling Als nichtmedikamentöse Unterstützung Bei Angst Und Unwohlsein während Der Weisheitszahnentfernung
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?
Read more
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).
Read the 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
- Being tested
- headphones with activated noise cancelling, headphones with activated noise cancelling and soft 60 bpm musc, heart rate measurement, Questionnaire
- Keywords
- fear level, wisdom teeth removal, noise reduction by music and noise cancelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
headphones with activated noise cancellingDevice
noise cancelling is new
headphones with activated noise cancelling and soft 60 bpm muscDevice
noise cancelling is new
heart rate measurementDevice
three times (before, during and after surgery)
QuestionnaireOther
two times (before and after surgery)
| Study group | Role | What they receive |
|---|---|---|
| Controlgroup: No headphones, no music, no noise cancelling (no additional treatment) | Experimental group 1: headphones with activated noise cancelling Receives: Device: heart rate measurement; Other: Questionnaire | |
| Experimental group 2: headphones with activated noise cancelling and soft 60 bpm music | Not described Receives: 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 | Not described Receives: Device: headphones with activated noise cancelling; Device: heart rate measurement; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: All three measurements happen on the same day. Before, during and after the surgery, no follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start18 Nov 2024 (estimated)
- Primary completion29 Jun 2025 (estimated)
- Study completion29 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sigmund Freud PrivatUniversitat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688877
- Sponsor's protocol ID
- 834-2023
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einfluss Der Kombination Von Musik Und Noise Cancelling Als nichtmedikamentöse Unterstützung Bei Angst Und Unwohlsein während Der Weisheitszahnentfernung
- ClinicalTrials.gov ID
- NCT06688877
- Acronym / sponsor ID
- 834-2023
- Conditions
- Fear Anxiety, Wisdom Tooth Removal, Heart Rate
- Keywords
- fear level, wisdom teeth removal, noise reduction by music and noise cancelling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Sigmund Freud PrivatUniversitatUniversity, hospital or other
- Study start
- 18 Nov 2024 (estimated)
- Primary completion
- 29 Jun 2025 (estimated)
- Study completion
- 29 Jun 2025 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controlgroup: No headphones, no music, no noise cancelling (no additional treatment) | – | Device: heart rate measurement, Other: QuestionnaireExperimental group 1: headphones with activated noise cancelling |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- willing to participate in the clinical trial, understood and signed the information sheet
Key exclusion criteria (2 listed)
- younger than 18 years old
- hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| headphones with activated noise cancellingnoise cancelling is new | Device | Experimental group 1: headphones with activated noise cancelling |
| headphones with activated noise cancelling and soft 60 bpm muscnoise cancelling is new | Device | Experimental group 2: headphones with activated noise cancelling and soft 60 bpm music |
| heart rate measurementthree times (before, during and after surgery) | Device | 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 |
| Questionnairetwo times (before and after surgery) | Other | 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 |
Primary outcome
Result of the questionnaire
Time frame: 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.
1 secondary outcome
Measurement of the heart rate
Time frame: All three measurements happen on the same day. Before, during and after the surgery, no follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markus Hof, Univ.-Prof. Dr. med. dent., PhD, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear Anxiety and Wisdom Tooth Removal, run by Sigmund Freud PrivatUniversitat at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophia Felicitas Pfister, BSc (0049 157 514 50343, sophia_pfister@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result of the questionnaire (time frame: Answering the first questionnaire to answering the second questionnaire happens both on the same day, right before and right after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.