An interventional study of Binaural Beats Application and Placebo in Laparoscopic Cholecystectomy, sponsored by Bitlis Eren University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Bitlis Eren University · Not applicable, Interventional, and Other
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.
629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.
This study's planned enrollment of 76 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Bitlis Eren University is the lead sponsor of 49 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Other: Binaural Beats Application
Other: Placebo
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.
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
Postoperative Nausea and Vomiting (PONV) Incidence
Time frame: The first 24 hours after starting the binaural beats application
Plan to share: No
Start is estimated for Jan 2027; primary completion for Apr 2027, 3 months later.
Of 168 non-industry interventional studies with no phase under Postoperative Nausea and Vomiting, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 3 months is below that.
Counting every sponsor, half of 168 studies reached it within 12 months; a quarter within 5 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Bitlis Eren University