Pregnancy, Cesarean Section, Spinal AnesthesiaNCT07386054
The Effectiveness of Binaural Beats on Midazolam Requirement During Cesarean Section With Spinal Anesthesia
A study testing binaural beats and Midazolam in people with Pregnancy, Cesarean Section, Spinal Anesthesia, run by Yonsei University.
Trial summary
Spinal anesthesia is preferred for cesarean section in many institutions due to concerns regarding the potential effects of general anesthetic agents on the fetus. However, during cesarean section under spinal anesthesia, parturients remain fully conscious and may experience significant anxiety, tension, or fear… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Pregnancy, Cesarean Section, Spinal Anesthesia
- What is being tested?
- binaural beats and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Jan 2027
- Phase
- Interventional
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged ≥20 years undergoing cesarean section under spinal anesthesia who request intraoperative sedation.
Who cannot join
- Parturients with hearing impairment or those using hearing aids B. Parturients who have received opioid analgesics or sedative medications within 1 week prior to enrollment C. Parturients with known hypersensitivity to benzodiazepines D. Parturients in whom a difficult airway is anticipated E. Parturients with arrhythmias, cardiovascular disease, impaired cardiac function, or reduced circulating blood volume F. Parturients with severe respiratory disease for whom the use of sedative medications is considered inappropriate G. Parturients with hepatic failure H. Parturients with renal failure or those receiving dialysis I. Parturients with other significant maternal medical histories or fetal conditions (e.g., fetal anomalies, intrauterine growth restriction) that are considered likely to increase maternal anxiety J. Patients who are unable to read the informed consent form (e.g., foreign nationals) K. Participants deemed inappropriate for participation in this clinical trial at the discretion of the investigator or study personnel
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Spinal anesthesia is preferred for cesarean section in many institutions due to concerns regarding the potential effects of general anesthetic agents on the fetus. However, during cesarean section under spinal anesthesia, parturients remain fully conscious and may experience significant anxiety, tension, or fear intraoperatively. For this reason, sedative agents such as midazolam are commonly administered after delivery, once the risk of neonatal exposure is considered minimal, to facilitate maternal sedation. Nevertheless, administration of midazolam at higher doses may be associated with adverse maternal effects, including respiratory depression, apnea, and hemodynamic instability.
Binaural beats are a brainwave entrainment technique in which two auditory stimuli of slightly different frequencies are presented separately to each ear, resulting in the perception of an interference frequency that may induce synchronization of brain activity. Previous studies have reported that exposure to binaural beats designed to generate low-frequency brainwaves associated with relaxation or sleep may reduce pain, anxiety, and promote sedation in both adult and pediatric populations.
The investigators hypothesize that the use of binaural beats during cesarean section under spinal anesthesia may reduce the required dose of midazolam for sedation, thereby decreasing the risk of drug-related adverse effects. The primary objective of this study is to evaluate whether exposure to binaural beats reduces the total dose of midazolam required for sedation in parturients undergoing cesarean section under spinal anesthesia. Secondary objectives include comparison of perioperative anxiety levels, maternal satisfaction, and other perioperative outcomes between the binaural beats group and the control group.
- Being tested
- binaural beats, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
binaural beatsBiological
Immediately after admission to the operating room, patients will be fitted with earphones connected to an audio device (Sony Digital Media Player, NW-A306), and the assigned auditory intervention will be initiated. Patients allocated to the binaural beats group will receive auditory stimuli through the earphones, with a frequency difference of 0.5-4 Hz between the two ears to generate an interference frequency via binaural beats. No background music will be provided, and the volume will be set at a level comparable to normal conversational speech.
MidazolamBiological
Patients in the control group will wear the earphones without exposure to any auditory stimuli.
| Study group | Role | What they receive |
|---|---|---|
| ear phone with binaural beats | Experimental | Patient group who receives remimazolam for sedation after delivery Receives: Biological: binaural beats |
| ear phone with no sound | Active comparator | Patient group who receives midazolam for sedation after delivery Receives: Biological: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total dose of midazolam administered to achieve a score of ≤3 on the Observer's Assessment of Alertness/Sedation (OAA/S) scale during sedation induction.
The cumulative dose of midazolam administered from the initiation of sedation until achievement of an OAA/S score of ≤3 will be recorded.
Measured: 1, 2, 3, 4, 5, 10, 20, 30 minutes after sedative administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, Cesarean Section, Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seung Hyun Kim, Professor, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386054
- Sponsor's protocol ID
- 4-2025-0594
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Binaural Beats on Midazolam Requirement During Cesarean Section With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07386054
- Acronym / sponsor ID
- 4-2025-0594
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
Spinal anesthesia is preferred for cesarean section in many institutions due to concerns regarding the potential effects of general anesthetic agents on the fetus. However, during cesarean section under spinal anesthesia, parturients remain fully conscious and may experience significant anxiety, tension, or fear intraoperatively. For this reason, sedative agents such as midazolam are commonly administered after delivery, once the risk of neonatal exposure is considered minimal, to facilitate maternal sedation. Nevertheless, administration of midazolam at higher doses may be associated with adverse maternal effects, including respiratory depression, apnea, and hemodynamic instability.
Binaural beats are a brainwave entrainment technique in which two auditory stimuli of slightly different frequencies are presented separately to each ear, resulting in the perception of an interference frequency that may induce synchronization of brain activity. Previous studies have reported that exposure to binaural beats designed to generate low-frequency brainwaves associated with relaxation or sleep may reduce pain, anxiety, and promote sedation in both adult and pediatric populations.
The investigators hypothesize that the use of binaural beats during cesarean section under spinal anesthesia may reduce the required dose of midazolam for sedation, thereby decreasing the risk of drug-related adverse effects. The primary objective of this study is to evaluate whether exposure to binaural beats reduces the total dose of midazolam required for sedation in parturients undergoing cesarean section under spinal anesthesia. Secondary objectives include comparison of perioperative anxiety levels, maternal satisfaction, and other perioperative outcomes between the binaural beats group and the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ear phone with binaural beats | Experimental | Biological: binaural beatsPatient group who receives remimazolam for sedation after delivery |
| ear phone with no sound | Active comparator | Biological: MidazolamPatient group who receives midazolam for sedation after delivery |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients aged ≥20 years undergoing cesarean section under spinal anesthesia who request intraoperative sedation.
Key exclusion criteria (1 listed)
- Parturients with hearing impairment or those using hearing aids B. Parturients who have received opioid analgesics or sedative medications within 1 week prior to enrollment C. Parturients with known hypersensitivity to benzodiazepines D. Parturients in whom a difficult airway is anticipated E. Parturients with arrhythmias, cardiovascular disease, impaired cardiac function, or reduced circulating blood volume F. Parturients with severe respiratory disease for whom the use of sedative medications is considered inappropriate G. Parturients with hepatic failure H. Parturients with renal failure or those receiving dialysis I. Parturients with other significant maternal medical histories or fetal conditions (e.g., fetal anomalies, intrauterine growth restriction) that are considered likely to increase maternal anxiety J. Patients who are unable to read the informed consent form (e.g., foreign nationals) K. Participants deemed inappropriate for participation in this clinical trial at the discretion of the investigator or study personnel
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 beatsImmediately after admission to the operating room, patients will be fitted with earphones connected to an audio device (Sony Digital Media Player, NW-A306), and the assigned auditory intervention will be initiated. Patients allocated to the binaural beats group will receive auditory stimuli through the earphones, with a frequency difference of 0.5-4 Hz between the two ears to generate an interference frequency via binaural beats. No background music will be provided, and the volume will be set at a level comparable to normal conversational speech. | Biological | ear phone with binaural beats |
| MidazolamPatients in the control group will wear the earphones without exposure to any auditory stimuli. | Biological | ear phone with no sound |
Primary outcome
the total dose of midazolam administered to achieve a score of ≤3 on the Observer's Assessment of Alertness/Sedation (OAA/S) scale during sedation induction.
Time frame: 1, 2, 3, 4, 5, 10, 20, 30 minutes after sedative administration
The cumulative dose of midazolam administered from the initiation of sedation until achievement of an OAA/S score of ≤3 will be recorded.
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 4 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Pregnancy, Cesarean Section, Spinal Anesthesia
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Recruiting
Comparison of Different Anesthetic Techniques on Hearing Outcomes in Neonates After Cesarean Delivery
Pregnancy, Neonatal Hearing Function
Not yet recruitingPhase 4
Dexamethasone Versus Ondansetron for Preventing Post-Spinal Hypotension in Preeclampsia
Preeclampsia, Spinal Anesthesia-Induced Hypotension
Not yet recruiting
Effect of Oxytocin Bolus Versus Slow Infusion on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia
Cesarean Section, Hypotension
Active, not recruitingObservational study
Evaluation of Postoperative Hearing Loss After Spinal Anesthesia for Elective Cesarean Section in Pregnant Women
Hearing Loss; Post-Dural Puncture Headache; Cesarean Delivery
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.
Seung Hyun Kim, Professor principal investigator
Severance Hospital
Questions about this trial
What is this clinical trial studying?
A study testing binaural beats and Midazolam in people with Pregnancy, Cesarean Section, Spinal Anesthesia, run by Yonsei University.
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 1 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Seung Hyun Kim, Professor (82-10-3292-2351, anesshkim@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total dose of midazolam administered to achieve a score of ≤3 on the Observer's Assessment of Alertness/Sedation (OAA/S) scale during sedation induction. (time frame: 1, 2, 3, 4, 5, 10, 20, 30 minutes after sedative administration). 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 4 Feb 2026.