Laparoscopic CholecystectomyNCT07879274
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
A study testing Binaural Beats Application in people with Laparoscopic Cholecystectomy, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Binaural Beats Application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2027to 30 Sep 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older
- Have elective laparoscopic cholecystectomy planned
- Be classified as ASA physical status I-II by the American Society of Anesthesiologists (ASA)
- Have a stable consciousness level in the postoperative period (Glasgow Coma Scale Score 15)
- Have adequate auditory perception 6. Be willing to participate in the study and provide written consent.
Who cannot join
- Those with hearing impairment or serious ear pathology,
- Patients using anxiolytics, antidepressants, antipsychotics, or regular antiemetic medications,
- Those with a history of accompanying medical conditions that can cause nausea and vomiting (e.g., vestibular dysfunction),
- Patients with a nasogastric tube.
- Patients who require postoperative intensive care,
- Those who experience serious complications during and after surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kütahya City Hospital
Kütahya
Hatice Akkaya PhD, +905416645105, cnr_hatice@hotmail.com
About this study
Official title: The Effect Of Binaural Beats On Postoperative Nausea-Vomiting Management in Laparoscopic Cholecystectomy Patients: A Randomized Controlled Study
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.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Binaural Beats Application, Placebo
- Keywords
- Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting, Binaural Beats, Antiemetics
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural Beats ApplicationOther
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.
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| Binaural Beat Group | Experimental | Not described Receives: Other: Binaural Beats Application |
| Control group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Nausea and Vomiting (PONV) Incidence
Measured: The first 24 hours after starting the binaural beats application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasret Topalı, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879274
- Sponsor's protocol ID
- 2026-Binaural Beats
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30073406Gan 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.
PubMed 32467512
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Binaural Beats On Postoperative Nausea-Vomiting Management in Laparoscopic Cholecystectomy Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07879274
- Acronym / sponsor ID
- 2026-Binaural Beats
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting, Binaural Beats, Antiemetics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Oct 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binaural Beat Group | Experimental | Other: Binaural Beats Application |
| Control group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18 years of age or older
- Have elective laparoscopic cholecystectomy planned
- Be classified as ASA physical status I-II by the American Society of Anesthesiologists (ASA)
- Have a stable consciousness level in the postoperative period (Glasgow Coma Scale Score 15)
- Have adequate auditory perception 6. Be willing to participate in the study and provide written consent.
Key exclusion criteria (6 listed)
- Those with hearing impairment or serious ear pathology,
- Patients using anxiolytics, antidepressants, antipsychotics, or regular antiemetic medications,
- Those with a history of accompanying medical conditions that can cause nausea and vomiting (e.g., vestibular dysfunction),
- Patients with a nasogastric tube.
- Patients who require postoperative intensive care,
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 Beats ApplicationIn 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. | Other | Binaural Beat Group |
| PlaceboTwo 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 | Other | Control group |
Primary outcome
Postoperative Nausea and Vomiting (PONV) Incidence
Time frame: The first 24 hours after starting the binaural beats application
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 21 Oct 2026.
- Results publication: PubMed 30073406Garcia-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.
- Results publication: PubMed 32467512Gan 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural Beats Application in people with Laparoscopic Cholecystectomy, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Hasret Topali PhD (+905347058822, hasrettopali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Nausea and Vomiting (PONV) Incidence (time frame: The first 24 hours after starting the binaural beats application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07879274, which also lists 2 linked publications.
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 21 Oct 2026.