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The Effectiveness of Binaural Beats on Midazolam Requirement During Cesarean Section With Spinal Anesthesia

NCT07386054 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-04

No results posted yet for this study

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 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.

Conditions

  • Pregnancy, Cesarean Section, Spinal Anesthesia

Interventions

BIOLOGICAL

binaural beats

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.

BIOLOGICAL

Midazolam

Patients in the control group will wear the earphones without exposure to any auditory stimuli.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Seung Hyun Kim, Professor · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-01-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07386054 on ClinicalTrials.gov