Preoperative AnxietyNCT05533112
Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia
A study testing Binaural Beat Stimulation in people with Preoperative Anxiety and Perioperative Complication, run by Technical University of Munich at 1 site in Germany.
Trial summary
We plan to evaluate the potential of binaural beat stimulation as a cost-effective tool to improve perioperative patient outcome. Preoperative anxiety and postoperative neurocognitive disorders are two major issues patients have to deal with in the perioperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety, Perioperative Complication
- What is being tested?
- Binaural Beat Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 10 Nov 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Fluent in German (Munich) or Portuguese (Porto)
- Scheduled for elective minor or intermediate risk procedure
Who cannot join
- ASA status 4
- History of drug abuse
- Pre-existing neurocognitive or psychiatric disorders
- Auditory Impairments, vision diseases or other diagnosed cognitive impairments
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Technische Universität München
München, München (Stadt), 80686
Julian Ostertag, MSc, +4941408681, julian.ostertag@tum.de
Stephan Kratzer, Dr.
About this study
Official title: Binaural Beat Stimulation as a Cost-effective Tool to Reduce Preoperative Anxiety and Improve Postoperative Outcome After General Anesthesia
We plan to evaluate the potential of binaural beat stimulation as a cost-effective tool to improve perioperative patient outcome. Preoperative anxiety and postoperative neurocognitive disorders are two major issues patients have to deal with in the perioperative period. In this context, preoperative stress and anxiety are independent risk factors for postoperative neurocognitive disorders. The primary goal of our proposed study therefore is to reduce preoperative anxiety by stimulating patients with binaural beats. As binaural beats might also entrain brainwaves, the secondary goal of the study is to investigate whether binaural beats can induce alpha oscillatory activity during emergence from anesthesia. This type of oscillation has been demonstrated to be protective for postoperative neurocognitive disorders and might therefore complement the effects of preoperative anxiety reduction.
- Conditions
- Preoperative Anxiety, Perioperative Complication
- Being tested
- Binaural Beat Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural Beat StimulationOther
During binaural beats stimulation both ears receive a tone which varies slightly in its frequency. If the left ear is stimulated with a sinusoidal wave of 98 Hz and the right ear with a sinusoidal wave of 108 Hz, the brain will perceive this stimulation as a single tone at the mean frequency of 103 Hz. The amplitude of the perceived tone will fluctuate with a frequency that is equal to the difference of the two initial tones, i.e., 10 Hz
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control Group, no Intervention received |
| Preop Stimulation | Experimental | Binaural Beat Stimulation preoperatively Receives: Other: Binaural Beat Stimulation |
| Postop Stimulation | Experimental | Binaural Beat Stimulation postoperatively Receives: Other: Binaural Beat Stimulation |
| Pre- & Postop Stimulation | Experimental | Binaural Beat Stimulation pre- and postoperatively Receives: Other: Binaural Beat Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of preoperative anxiety
Binaural beat stimulation before surgery can reduce preoperative anxiety
Measured: Assessments will take place one day before surgery as well as before administration of the intervention
Secondary outcomes (2)
Increase of EEG alpha-band power during anesthesia emergence
Binaural beat stimulation during anesthesia emergence can increase or stabilize EEG alpha-band power.
Measured: Analysis will include the last 20 minutes of surgical procedure until patients are responsive again
Lower incidence of perioperative neurocognitive disorders
- Reduced preoperative anxiety and/or increased or stabilized alpha oscillations during anesthesia emergence are correlated with a lower incidence of perioperative neurocognitive disorders.
Measured: Incidence of perioperative neurocognitive disorders will be assessed during the patients stay in the PACU as well as one day post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start10 Nov 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Kratzer, Dr., Principal investigator, Klinik für Anästhesiologie und IntensivmedizinGerhard Schneider, Prof., Study chair, Klinik für Anästhesiologie und IntensivmedizinMatthias Kreuzer, Dr., Principal investigator, Klinik für Anästhesiologie und Intensivmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533112
- Sponsor's protocol ID
- 2022-332-S-NP
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All recorded data may be shared with collaborating researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binaural Beat Stimulation as a Cost-effective Tool to Reduce Preoperative Anxiety and Improve Postoperative Outcome After General Anesthesia
- ClinicalTrials.gov ID
- NCT05533112
- Acronym / sponsor ID
- 2022-332-S-NP
- Conditions
- Preoperative Anxiety, Perioperative Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 8 Sep 2022 (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.
We plan to evaluate the potential of binaural beat stimulation as a cost-effective tool to improve perioperative patient outcome. Preoperative anxiety and postoperative neurocognitive disorders are two major issues patients have to deal with in the perioperative period. In this context, preoperative stress and anxiety are independent risk factors for postoperative neurocognitive disorders. The primary goal of our proposed study therefore is to reduce preoperative anxiety by stimulating patients with binaural beats. As binaural beats might also entrain brainwaves, the secondary goal of the study is to investigate whether binaural beats can induce alpha oscillatory activity during emergence from anesthesia. This type of oscillation has been demonstrated to be protective for postoperative neurocognitive disorders and might therefore complement the effects of preoperative anxiety reduction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control Group, no Intervention received |
| Preop Stimulation | Experimental | Other: Binaural Beat StimulationBinaural Beat Stimulation preoperatively |
| Postop Stimulation | Experimental | Other: Binaural Beat StimulationBinaural Beat Stimulation postoperatively |
| Pre- & Postop Stimulation | Experimental | Other: Binaural Beat StimulationBinaural Beat Stimulation pre- and postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fluent in German (Munich) or Portuguese (Porto)
- Scheduled for elective minor or intermediate risk procedure
Key exclusion criteria (4 listed)
- ASA status 4
- History of drug abuse
- Pre-existing neurocognitive or psychiatric disorders
- Auditory Impairments, vision diseases or other diagnosed cognitive impairments
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 |
|---|---|---|
| Binaural Beat StimulationDuring binaural beats stimulation both ears receive a tone which varies slightly in its frequency. If the left ear is stimulated with a sinusoidal wave of 98 Hz and the right ear with a sinusoidal wave of 108 Hz, the brain will perceive this stimulation as a single tone at the mean frequency of 103 Hz. The amplitude of the perceived tone will fluctuate with a frequency that is equal to the difference of the two initial tones, i.e., 10 Hz | Other | Postop Stimulation, Pre- & Postop Stimulation, Preop Stimulation |
Primary outcome
Reduction of preoperative anxiety
Time frame: Assessments will take place one day before surgery as well as before administration of the intervention
Binaural beat stimulation before surgery can reduce preoperative anxiety
2 secondary outcomes
Increase of EEG alpha-band power during anesthesia emergence
Time frame: Analysis will include the last 20 minutes of surgical procedure until patients are responsive again
Lower incidence of perioperative neurocognitive disorders
Time frame: Incidence of perioperative neurocognitive disorders will be assessed during the patients stay in the PACU as well as one day post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: Yes. All recorded data may be shared with collaborating researchers
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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. This study is not recruiting at the moment.
Stephan Kratzer, Dr. principal investigator
Klinik für Anästhesiologie und Intensivmedizin
Gerhard Schneider, Prof. study chair
Klinik für Anästhesiologie und Intensivmedizin
Matthias Kreuzer, Dr. principal investigator
Klinik für Anästhesiologie und Intensivmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural Beat Stimulation in people with Preoperative Anxiety and Perioperative Complication, run by Technical University of Munich at 1 site in Germany.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Dec 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian Ostertag, MSc (+4941408681, julian.ostertag@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of preoperative anxiety (time frame: Assessments will take place one day before surgery as well as before administration of the intervention). 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 22 Dec 2023.