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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Sponsor: Bitlis Eren University
Summary
This research is a single-center, parallel-group, single-blind, randomized controlled experimental study planned to evaluate the effect of postoperative binaural beats (BB) application on the incidence of postoperative nausea and vomiting (PONV) and the need for antiemetics in patients undergoing elective laparoscopic cholecystectomy. The research will be conducted in two phases. In the first phase, 30-minute binaural beats audio recordings containing alpha (10 Hz) and theta (6 Hz) frequencies will be developed to ensure standardization. In the second phase, the effect of the developed sound recordings on postoperative nausea and vomiting will be evaluated. The research will be conducted in the General Surgery Department of Kütahya City Hospital between January and September 2027. A total of 76 patients who meet the inclusion criteria for the study are planned to be randomized into intervention (n=38) and control (n=38) groups in a 1:1 ratio. Patients in the intervention group will listen to a binaural beats audio recording at approximately 60 dB sound level for 30 minutes through stereo headphones, starting 2 hours after being admitted to the surgical ward. In the control group, patients will listen to a placebo sound recording with similar acoustic properties but without binaural beats for the same duration and under the same environmental conditions. Both groups will receive standard postoperative care. The primary outcome measure of the study is the incidence of postoperative nausea and vomiting. The secondary outcome measures are the total score of the Postoperative Nausea and Vomiting Impact Scale, the clinically significant postoperative nausea and vomiting incidence rate, and the need for rescue antiemetics. Nausea-vomiting assessments will be conducted at postoperative 2nd, 6th, and 24th hours; the use of antiemetic drugs will be obtained from patient records. The obtained data will be analyzed using appropriate statistical methods and compared between groups.
Official title: THE EFFECT OF BINAURAL BEATS ON POSTOPERATIVE NAUSEA-VOMITING MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS: A RANDOMIZED CONTROLLED STUDY
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2027-01-01
Completion Date
2027-09-30
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Binaural Beats Application
In the second hour post-surgery, after confirming that the patient's consciousness is clear and clinical condition is stable, the patient will be comfortably positioned in a semi-sitting position. The patient will be fitted with stereo headphones, and a pre-developed and standardized binaural beats audio recording containing alpha (10 Hz) and theta (6 Hz) frequencies will be played for 30 minutes. The sound level will be adjusted to approximately 60 dB and standardized for all participants. During the procedure, the patient will be ensured to rest without talking and with minimal disturbance. Postoperative nausea and vomiting will be evaluated at postoperative 2nd, 6th, and 24th hours using the Postoperative Nausea and Vomiting Impact Scale. Additionally, the type, dose (mg), administration time, and number of administrations of antiemetic drugs used for nausea and vomiting treatment within the first 24 hours postoperatively will be recorded from the nurse's monitoring records.
Locations (1)
Kütahya City Hospital
Kütahya, Turkey (Türkiye)