The Effect of Noise Control During Anesthesia Induction in Laparoscopic Cholecystectomy Surgery (Anesth-noise)

April 8, 2026 updated by: Cagla AVCU, Namik Kemal University

The Effect of Noise Control During Anesthesia Induction in Laparoscopic Cholecystectomy Surgery on Postoperative Hemodynamic Parameters, Pain, Nausea and Vomiting, and Recovery Time From Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When the studies in the literature are examined, there is no study evaluating the effects of noise level and active and passive noise control method and headphone usage during anesthesia induction on patients undergoing laparoscopic cholecystectomy surgery, which is the most frequently applied among laparoscopic surgeries.

This study aims to eliminate these deficiencies in the literature, to reveal the benefits of active and passive noise control headphone usage for noise control as it is an easy and cheap method and has no side effects, and to popularize this application.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Suleymanpasa
      • Tekirdağ, Suleymanpasa, Turkey (Türkiye), 59000
        • Namık Kemal University
    • Süleymanpaşa
      • Tekirdağ, Süleymanpaşa, Turkey (Türkiye), 59000
        • Namık Kemal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Active noise control
This is the group where active noise control headphones are applied. Headphones will be applied to patients from the beginning to the end of anesthesia induction.
Device: Active noise control headphone
This is the group where active noise control headphones are applied. Headphones will be applied to patients from the beginning to the end of anesthesia induction.
Experimental: Passive noise control
This is the group where passive noise control headphones are applied. Headphones will be applied to patients from the beginning to the end of anesthesia induction.
Device: Passive noise control headphone
This is the group where passive noise control headphones are applied. Headphones will be applied to patients from the beginning to the end of anesthesia induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Identification Form
Time Frame: Pre-intervention
This form, prepared by researchers in line with the literature, consists of questions about the individual and surgical characteristics of the patients.
Pre-intervention
Patient Follow-up Form-Part 1
Time Frame: perioperative
This part includes the evaluation and recording of the patients' hemodynamic parameters (temperature (°C), pulse rate(dk), respiratory rate (dk), oxygen saturation (%) and blood pressure (mmHg)) after admission to the operating room, during the anesthesia induction phase, during the surgical process from the end of anesthesia induction to the termination of anesthesia and every 15 minutes in the post-anesthesia care unit.
perioperative
Patient Follow-up Form-Part-2
Time Frame: before surgery (anesthesia induction phase)
In this part, the noise level measurement during the anesthesia induction phase will be recorded.
before surgery (anesthesia induction phase)
Patient Follow-up Form-Part-3 (Numerical Analog Scale)
Time Frame: in the post-anesthesia care unit (up to 2 hours post surgery)
This part is used to measure the pain intensity of patients in the post-anesthesia care unit. The form consists of a 10 cm long ruler with pain intensity scores ranging from 0 to 10, with "0 = No Pain" and "10 = Most Severe Pain".
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)
Time Frame: in the post-anesthesia care unit (up to 2 hours post surgery)
This scale is used to measure the severity of nausea in patients in the post-anesthesia care unit. The severity of nausea is scored by the patient between 0 and 10 using a 100 mm long ruler, with "0 = No Nausea at All" and "100 = Most Severe Nausea Possible".
in the post-anesthesia care unit (up to 2 hours post surgery)
Patient Follow-up Form-Part-5 (Modified Aldrete Score)
Time Frame: in the post-anesthesia care unit (up to 2 hours post surgery)
It is a scoring system used to assess whether patients are ready to be transferred from the post-anesthesia care unit to the clinic. It consists of 5 parameters: "Activity", "Respiration", "Circulation", "Consciousness" and "Oxygen Saturation" and each parameter is scored as "0", "1" and "2". A total score of 9 and above indicates that transfer to the clinic is appropriate.
in the post-anesthesia care unit (up to 2 hours post surgery)
Patient Follow-up Form-Part-6
Time Frame: in the post-anesthesia care unit (up to 2 hours post surgery)
The part includes the vomiting (if any, how many times), status of premedication, anesthetic drugs, anesthesia induction duration, the duration between anesthesia induction and the termination of anesthesia, and the duration of stay in the post-anesthesia care unit.
in the post-anesthesia care unit (up to 2 hours post surgery)
Noise Meter
Time Frame: before surgery (anesthesia induction phase)
During the anesthesia induction phase, the noise level of the operating room will be measured with a handheld noise measuring device. The device will be placed approximately 120 cm away from the patient's head. The noise level will be measured and recorded from the beginning of anesthesia induction to termination.
before surgery (anesthesia induction phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namik Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

October 19, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Anesthesia noise

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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