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The Effect Of Binaural Beats On Postoperative Nausea-Vomiting Management in Laparoscopic Cholecystectomy Patients: A Randomized Controlled Study
Sponsor study identifier
interventional
76
1 country
1
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2026
Actual (reported)October 16, 2026
Actual (reported)January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Postoperative Nausea and Vomiting (PONV) Incidence
The first 24 hours after starting the 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.
Kütahya City Hospital
Kütahya, Turkey (Türkiye)
Garcia-Argibay M, Santed MA, Reales JM. Efficacy of binaural auditory beats in cognition, anxiety, and pain perception: a meta-analysis. Psychol Res. 2019 Mar;83(2):357-372. doi: 10.1007/s00426-018-1066-8. Epub 2018 Aug 2.
Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.
First Submitted
October 10, 2026
First Posted
October 16, 2026
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 30, 2027
Two hours post-surgery, after the patient's consciousness is clear and clinical condition is stable, a placebo sound recording without binaural beats will be played for 30 minutes under the same position and environmental conditions using stereo headphones with the same characteristics as the intervention group. The audio recording to be used in the control group will be prepared to be similar in duration, sound intensity, and carrier frequency characteristics to the audio recording in the intervention group, but without creating a frequency difference between the two ears. Thus, similar auditory conditions will be provided in both groups without creating a binaural beats effect. Postoperative nausea and vomiting will be evaluated at the assessment times determined using the Postoperative Nausea and Vomiting Impact Scale. Additionally, the type, dose, and administration time of antiemetic drugs used for nausea and vomiting treatment within the first 24 hours postoperatively will be rec
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 21, 2026
Record last verified: 2026-10
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