AnxietyNCT02712749
Use of Binaural Beat Premedication in Elderly Submitted to Major Orthopedic Surgery
A study testing Sound with Binaural Beats and Sound without Binaural Beats in people with Anxiety and Postoperative Pain, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
Trial summary
The Investigators verify the effectiveness of "Binaural Beats" as premedication instrument in elderly patients submitted to orthopedic surgery to reduce anxiety , post operative pain and morphine consumption Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Anxiety, Postoperative Pain, Morphine Consumption
- What is being tested?
- Sound with Binaural Beats and Sound without Binaural Beats
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2016to 28 Mar 2019
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects over 65 years aged candidated to elective major orthopedic surgery
- Stable hemodynamic and clinical conditions (ASA 1/2, Goldman Desky Class 1)
- Absence of cognitive impairment (MMSE greater than 24)
- Valid consent expression to the study participation
- No history of epilepsy and other chronic neurological diseases that may interfere with the study procedures.
- Good collaboration in activities provided by the study
- No abnormalities at audiometric testing for the frequencies between 256 and 260 Hz.
Who cannot join
- Insufficient level of cooperation or hearing loss
- Contraindications to the use of binaural beats (a history of epilepsy)
- Treatment with anti-anxiety drugs or major tranquillizers
- Clinical Instability defined as the inclusion criteria
- Denial of informed consent to participate in the study
- Presence of cognitive impairment (MMSE less than or equal to 24)
- Presence of neurological diseases or neurological damage that interfere with the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Binaural Beat Premedication Reduces Post-operative Morphine Consumption in Elderly Patient Submitted to Knee Surgery
The Investigators verify the effectiveness of "Binaural Beats" as premedication instrument in elderly patients submitted to orthopedic surgery to reduce anxiety , post operative pain and morphine consumption
Read the detailed description
Need for surgery is increasing among elderly population, for increase in average life expectancy and for improved in surgical and anesthetic techniques.
A big problem in this kind of patients is the high incidence of delirium and cognitive impairment in post-operative period , which increase with age, depending on the type of intervention (especially Orthopaedics and Cardiac Surgery) and the administration of some agents, particularly sedatives and opioids .
Premedication is usually carried using anxiolytic and / or narcotic drugs in order to reduce anxiety and discomfort related to the intervention and anesthesia. The preoperative anxiety in fact increases the demand for intra and post operative anesthetics and analgesics and contribute to increase the post operative pain. For this reason the use of a pharmacological premedication is controversial in elderly patient, for the risk of side effects of drugs on one side, and for the other to the discomfort resulting from the increased level of anxiety in absence of premedication. .
Some recent surgical guidelines warn against premedication drug in patients over sixty-five, considering that occurrence of delirium and cognitive impairment may worsen the prognosis, limiting the use of such drugs to what is strictly necessary and only in the immediacy of the surgical act.
To reduce perioperative pain and anxiety , some authors used "Binaural Beats". This simple technique , described for the first time since by Gerald Oster , include the presentation of two acoustic stimuli with similar frequencies through the two channels of stereo headphones. The interference of their waves which occurs at the level of the central nervous system, produces a composite signal with a frequency resulting from the difference of the two original frequencies. For example if you give an acoustic stimulus of 100 Hz to an ear and simultaneously administering another acoustic stimulation of 104 Hz to the opposite ,ear the person who listens to these stimuli will perceive a "Binaural Beat" of 4 Hz caused by the difference between the two frequencies. These Binaural Beats are of interest because they have been thought to cause hemispheric synchronization and influence the EEG frequency like light stimulation .
Binaural Beats have already been used in humans undergoing outpatient surgery in uro-gynecological and have been shown to help increase patient comfort by reducing the state of anxiety and pain without interfering negatively with postoperative functional recovery .
In this study, we applied BBs as premedication in elderly patients who underwent major orthopaedic surgery aimed to reduce anxiety , postoperative pain and morphine consumption.
Feeling/level of anxiety is evaluated using STAI Y1 . This scale is a psychological inventory that consists of 20 questions on a self-report of anxiety about an event.
Feeling/level of pain is evaluated with the use of Numerical Rating Scale (NRS) .It consist to asking the patients to report her/his feeling of pain using an eleven-point scale : 0 = no pain, 10 most severe imaginable pain.
Cumulative morphine consumpion is evaluated through PCA registration. Patient Controlled Analgesia (PCA) is an electronic device that allows a patients to activate intravenous administration of morphine to themselves during the post-operative period. Each request and drug administration is automatically recorded by the device.
- Conditions
- Anxiety, Postoperative Pain, Morphine Consumption
- Being tested
- Sound with Binaural Beats, Sound without Binaural Beats
- Keywords
- Binaural Beat, Elderly, preoperative medication, postoperative merphine consumption, postoperative pain
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound with Binaural BeatsDevice
Acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz generated by the special program Gnaural in stereo option
Sound without Binaural BeatsDevice
Acoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the program Gnaural in mono option
| Study group | Role | What they receive |
|---|---|---|
| Group A : Sound with Binaural Beats | Experimental | Acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz through generated by the software "Gnaural" in stereo option Receives: Device: Sound with Binaural Beats |
| Group B : Sound without Binaural Beats | Active comparator | Acoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the software "Gnaural" in mono option Receives: Device: Sound without Binaural Beats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction on postoperative morphine consumption
Difference of cumulative morphine consumption between Binaural Beat group vs Control group through patient-controlled analgesia device (PCA)
Measured: in the first post-operative day
Secondary outcomes (1)
Reduction in the level of preoperative anxiety assessed by State Anxiety inventory (STAI-1)
Measurement of anxiety assessed by STAI-1 after a 20 minutes of binaural beat listening session and comparison between the two groups . The State- Trait Anxiety Inventory is a validated 40-item self-report measure that contains 20 items measuring state anxiety (STAI-1) and 20 items measuring trait anxiety (STAI-2).Scores for state and trait components each range from 20 to 80 with a higher score corresponding to higher anxiety levels.
The anxiety level is considered low when the STAI is between 20 and 40, moderate between 41 and 60, high between 61 and 80
Measured: at 20 minutes after a binaural beat listening session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start1 Sep 2016
- Primary completion15 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Nord Ovest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Tani, Azienda USL Toscana Nord Ovest
- Investigators
- Alessandro Tani, MD, Principal investigator, Usl Area Vasta Nord Ovest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712749
- Sponsor's protocol ID
- IDE
- Status last verified
- Mar 2018
- First submitted
- 4 Mar 2016
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.
PubMed 20007989Kain ZN, Sevarino F, Alexander GM, Pincus S, Mayes LC. Preoperative anxiety and postoperative pain in women undergoing hysterectomy. A repeated-measures design. J Psychosom Res. 2000 Dec;49(6):417-22. doi: 10.1016/s0022-3999(00)00189-6.
PubMed 11182434Ozalp G, Sarioglu R, Tuncel G, Aslan K, Kadiogullari N. Preoperative emotional states in patients with breast cancer and postoperative pain. Acta Anaesthesiol Scand. 2003 Jan;47(1):26-9. doi: 10.1034/j.1399-6576.2003.470105.x.
PubMed 12492793Padmanabhan R, Hildreth AJ, Laws D. A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery. Anaesthesia. 2005 Sep;60(9):874-7. doi: 10.1111/j.1365-2044.2005.04287.x.
PubMed 16115248Kliempt P, Ruta D, Ogston S, Landeck A, Martay K. Hemispheric-synchronisation during anaesthesia: a double-blind randomised trial using audiotapes for intra-operative nociception control. Anaesthesia. 1999 Aug;54(8):769-73. doi: 10.1046/j.1365-2044.1999.00958.x.
PubMed 10460529Dabu-Bondoc S, Vadivelu N, Benson J, Perret D, Kain ZN. Hemispheric synchronized sounds and perioperative analgesic requirements. Anesth Analg. 2010 Jan 1;110(1):208-10. doi: 10.1213/ANE.0b013e3181bea424. Epub 2009 Oct 27.
PubMed 19861358Goodin P, Ciorciari J, Baker K, Carey AM, Harper M, Kaufman J. A high-density EEG investigation into steady state binaural beat stimulation. PLoS One. 2012;7(4):e34789. doi: 10.1371/journal.pone.0034789. Epub 2012 Apr 9.
PubMed 22496862Le Scouarnec RP, Poirier RM, Owens JE, Gauthier J, Taylor AG, Foresman PA. Use of binaural beat tapes for treatment of anxiety: a pilot study of tape preference and outcomes. Altern Ther Health Med. 2001 Jan;7(1):58-63.
PubMed 11191043Schmidt WD, O'Connor PJ, Cochrane JB, Cantwell M. Resting metabolic rate is influenced by anxiety in college men. J Appl Physiol (1985). 1996 Feb;80(2):638-42. doi: 10.1152/jappl.1996.80.2.638.
PubMed 8929609Millar K, Jelicic M, Bonke B, Asbury AJ. Assessment of preoperative anxiety: comparison of measures in patients awaiting surgery for breast cancer. Br J Anaesth. 1995 Feb;74(2):180-3. doi: 10.1093/bja/74.2.180.
PubMed 7696068Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.
PubMed 12402719Hollenberg SM. Preoperative cardiac risk assessment. Chest. 1999 May;115(5 Suppl):51S-57S. doi: 10.1378/chest.115.suppl_2.51s.
PubMed 10331334Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Binaural Beat Premedication Reduces Post-operative Morphine Consumption in Elderly Patient Submitted to Knee Surgery
- ClinicalTrials.gov ID
- NCT02712749
- Acronym / sponsor ID
- IDE
- Conditions
- Anxiety, Postoperative Pain, Morphine Consumption
- Keywords
- Binaural Beat, Elderly, preoperative medication, postoperative merphine consumption, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda USL Toscana Nord OvestUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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 Investigators verify the effectiveness of "Binaural Beats" as premedication instrument in elderly patients submitted to orthopedic surgery to reduce anxiety , post operative pain and morphine consumption
Detailed description
Need for surgery is increasing among elderly population, for increase in average life expectancy and for improved in surgical and anesthetic techniques.
A big problem in this kind of patients is the high incidence of delirium and cognitive impairment in post-operative period , which increase with age, depending on the type of intervention (especially Orthopaedics and Cardiac Surgery) and the administration of some agents, particularly sedatives and opioids .
Premedication is usually carried using anxiolytic and / or narcotic drugs in order to reduce anxiety and discomfort related to the intervention and anesthesia. The preoperative anxiety in fact increases the demand for intra and post operative anesthetics and analgesics and contribute to increase the post operative pain. For this reason the use of a pharmacological premedication is controversial in elderly patient, for the risk of side effects of drugs on one side, and for the other to the discomfort resulting from the increased level of anxiety in absence of premedication. .
Some recent surgical guidelines warn against premedication drug in patients over sixty-five, considering that occurrence of delirium and cognitive impairment may worsen the prognosis, limiting the use of such drugs to what is strictly necessary and only in the immediacy of the surgical act.
To reduce perioperative pain and anxiety , some authors used "Binaural Beats". This simple technique , described for the first time since by Gerald Oster , include the presentation of two acoustic stimuli with similar frequencies through the two channels of stereo headphones. The interference of their waves which occurs at the level of the central nervous system, produces a composite signal with a frequency resulting from the difference of the two original frequencies. For example if you give an acoustic stimulus of 100 Hz to an ear and simultaneously administering another acoustic stimulation of 104 Hz to the opposite ,ear the person who listens to these stimuli will perceive a "Binaural Beat" of 4 Hz caused by the difference between the two frequencies. These Binaural Beats are of interest because they have been thought to cause hemispheric synchronization and influence the EEG frequency like light stimulation .
Binaural Beats have already been used in humans undergoing outpatient surgery in uro-gynecological and have been shown to help increase patient comfort by reducing the state of anxiety and pain without interfering negatively with postoperative functional recovery .
In this study, we applied BBs as premedication in elderly patients who underwent major orthopaedic surgery aimed to reduce anxiety , postoperative pain and morphine consumption.
Feeling/level of anxiety is evaluated using STAI Y1 . This scale is a psychological inventory that consists of 20 questions on a self-report of anxiety about an event.
Feeling/level of pain is evaluated with the use of Numerical Rating Scale (NRS) .It consist to asking the patients to report her/his feeling of pain using an eleven-point scale : 0 = no pain, 10 most severe imaginable pain.
Cumulative morphine consumpion is evaluated through PCA registration. Patient Controlled Analgesia (PCA) is an electronic device that allows a patients to activate intravenous administration of morphine to themselves during the post-operative period. Each request and drug administration is automatically recorded by the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : Sound with Binaural Beats | Experimental | Device: Sound with Binaural BeatsAcoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz through generated by the software "Gnaural" in stereo option |
| Group B : Sound without Binaural Beats | Active comparator | Device: Sound without Binaural BeatsAcoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the software "Gnaural" in mono option |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Subjects over 65 years aged candidated to elective major orthopedic surgery
- Stable hemodynamic and clinical conditions (ASA 1/2, Goldman Desky Class 1)
- Absence of cognitive impairment (MMSE greater than 24)
- Valid consent expression to the study participation
- No history of epilepsy and other chronic neurological diseases that may interfere with the study procedures.
Key exclusion criteria (7 listed)
- Insufficient level of cooperation or hearing loss
- Contraindications to the use of binaural beats (a history of epilepsy)
- Treatment with anti-anxiety drugs or major tranquillizers
- Clinical Instability defined as the inclusion criteria
- Denial of informed consent to participate in the study
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 |
|---|---|---|
| Sound with Binaural BeatsAcoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz generated by the special program Gnaural in stereo option | Device | Group A : Sound with Binaural Beats |
| Sound without Binaural BeatsAcoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the program Gnaural in mono option | Device | Group B : Sound without Binaural Beats |
Primary outcome
Reduction on postoperative morphine consumption
Time frame: in the first post-operative day
Difference of cumulative morphine consumption between Binaural Beat group vs Control group through patient-controlled analgesia device (PCA)
1 secondary outcome
Reduction in the level of preoperative anxiety assessed by State Anxiety inventory (STAI-1)
Time frame: at 20 minutes after a binaural beat listening session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Background: PubMed 20007989Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.
- Background: PubMed 11182434Kain ZN, Sevarino F, Alexander GM, Pincus S, Mayes LC. Preoperative anxiety and postoperative pain in women undergoing hysterectomy. A repeated-measures design. J Psychosom Res. 2000 Dec;49(6):417-22. doi: 10.1016/s0022-3999(00)00189-6.
- Background: PubMed 12492793Ozalp G, Sarioglu R, Tuncel G, Aslan K, Kadiogullari N. Preoperative emotional states in patients with breast cancer and postoperative pain. Acta Anaesthesiol Scand. 2003 Jan;47(1):26-9. doi: 10.1034/j.1399-6576.2003.470105.x.
- Background: PubMed 16115248Padmanabhan R, Hildreth AJ, Laws D. A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery. Anaesthesia. 2005 Sep;60(9):874-7. doi: 10.1111/j.1365-2044.2005.04287.x.
- Background: PubMed 10460529Kliempt P, Ruta D, Ogston S, Landeck A, Martay K. Hemispheric-synchronisation during anaesthesia: a double-blind randomised trial using audiotapes for intra-operative nociception control. Anaesthesia. 1999 Aug;54(8):769-73. doi: 10.1046/j.1365-2044.1999.00958.x.
- Background: PubMed 19861358Dabu-Bondoc S, Vadivelu N, Benson J, Perret D, Kain ZN. Hemispheric synchronized sounds and perioperative analgesic requirements. Anesth Analg. 2010 Jan 1;110(1):208-10. doi: 10.1213/ANE.0b013e3181bea424. Epub 2009 Oct 27.
- Background: PubMed 22496862Goodin P, Ciorciari J, Baker K, Carey AM, Harper M, Kaufman J. A high-density EEG investigation into steady state binaural beat stimulation. PLoS One. 2012;7(4):e34789. doi: 10.1371/journal.pone.0034789. Epub 2012 Apr 9.
- Background: PubMed 11191043Le Scouarnec RP, Poirier RM, Owens JE, Gauthier J, Taylor AG, Foresman PA. Use of binaural beat tapes for treatment of anxiety: a pilot study of tape preference and outcomes. Altern Ther Health Med. 2001 Jan;7(1):58-63.
- Background: PubMed 8929609Schmidt WD, O'Connor PJ, Cochrane JB, Cantwell M. Resting metabolic rate is influenced by anxiety in college men. J Appl Physiol (1985). 1996 Feb;80(2):638-42. doi: 10.1152/jappl.1996.80.2.638.
- Background: PubMed 7696068Millar K, Jelicic M, Bonke B, Asbury AJ. Assessment of preoperative anxiety: comparison of measures in patients awaiting surgery for breast cancer. Br J Anaesth. 1995 Feb;74(2):180-3. doi: 10.1093/bja/74.2.180.
- Background: PubMed 12402719Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.
- Background: PubMed 10331334Hollenberg SM. Preoperative cardiac risk assessment. Chest. 1999 May;115(5 Suppl):51S-57S. doi: 10.1378/chest.115.suppl_2.51s.
- gnaural software generating binaural beatLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Alessandro Tani, MD principal investigator
Usl Area Vasta Nord Ovest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound with Binaural Beats and Sound without Binaural Beats in people with Anxiety and Postoperative Pain, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 1 Apr 2019. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction on postoperative morphine consumption (time frame: in the first post-operative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712749, which also lists 13 linked publications.
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 1 Apr 2019.