CompletedNot Applicable

The Effect of Noise Control During Anesthesia Induction in Laparoscopic Cholecystectomy Surgery

Turkey (Türkiye)105 participantsStarted 2024-10-01

Plain-language summary

This study aims to determine the effects of active and passive noise control method and headphone usage and noise level during anesthesia induction in laparoscopic cholecystectomy surgery on hemodynamic parameters, pain, nausea and vomiting, and recovery time from anesthesia in patients after surgery.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged between 18-65, * Diagnosed with cholecystitis or cholelithiasis, * Planned for elective laparoscopic cholecystectomy, * Have an ASA I or ASA II anesthesia classification, * Oriented to person, place and time, * Undergoing general anesthesia, * Not having a psychiatric or cognitive/mental disease (dementia etc.), * Not having vision, hearing and communication problems, * Speaking, reading and writing Turkish, * Patients who agree to participate in the study verbally and in writing will be included. Exclusion Criteria: * Patients who underwent spinal anesthesia, * Transferred to units such as intensive care after surgery, * Underwent emergency laparoscopic cholecystectomy, * Patients who were planned for elective open cholecystectomy will not be included in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Identification Form

Timeframe: Pre-intervention

Patient Follow-up Form-Part 1

Timeframe: perioperative

Patient Follow-up Form-Part-2

Timeframe: before surgery (anesthesia induction phase)

Patient Follow-up Form-Part-3 (Numerical Analog Scale)

Timeframe: in the post-anesthesia care unit (up to 2 hours post surgery)

Patient Follow-up Form-Part-4 (Visual Analog Scale for Assessment of Nausea)

Timeframe: in the post-anesthesia care unit (up to 2 hours post surgery)

Patient Follow-up Form-Part-5 (Modified Aldrete Score)

Timeframe: in the post-anesthesia care unit (up to 2 hours post surgery)

Patient Follow-up Form-Part-6

Timeframe: in the post-anesthesia care unit (up to 2 hours post surgery)

Trial details

NCT IDNCT06666686

SponsorNamik Kemal University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Cholecystectomy, Laparoscopic trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.