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Cholecystectomy, LaparoscopicAnesth-noiseNCT06666686

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

A study of Cholecystectomy, Laparoscopic and Noise, run by Namik Kemal University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Oct 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Namık Kemal University

    Tekirdağ, Suleymanpasa, 59000

  • Namık Kemal University

    Tekirdağ, Süleymanpaşa, 59000

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Active noise control headphone, Passive noise control headphone
Keywords
Anesthesia induction, Noise control, Laparoscopic cholecystectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active noise control headphoneDevice

    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.

  • Passive noise control headphoneDevice

    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.

Study groups in NCT06666686
Study groupRoleWhat they receive
Control groupNo interventionControl group
Active noise controlExperimentalThis 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.
Receives: Device: Active noise control headphone
Passive noise controlExperimentalThis 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.
Receives: Device: Passive noise control headphone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Identification Form

    This form, prepared by researchers in line with the literature, consists of questions about the individual and surgical characteristics of the patients.

    Measured: Pre-intervention

  2. Patient Follow-up Form-Part 1

    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.

    Measured: perioperative

  3. Patient Follow-up Form-Part-2

    In this part, the noise level measurement during the anesthesia induction phase will be recorded.

    Measured: before surgery (anesthesia induction phase)

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

    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".

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

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

    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".

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

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

    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.

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

  7. Patient Follow-up Form-Part-6

    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.

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

  8. Noise Meter

    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.

    Measured: before surgery (anesthesia induction phase)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2024
  2. Study start1 Oct 2024
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

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
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06666686
Sponsor's protocol ID
Anesthesia noise
Acronym
Anesth-noise
Status last verified
Oct 2024
First submitted
19 Oct 2024
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • You S, Xu F, Zhu X, Qin S, Zheng X, Tao C, Wu Y, Chen Y, Shu B, Huang H, Duan G. Effect of intraoperative noise on postoperative pain in surgery patients under general anesthesia: evidence from a prospective study and mouse model. Int J Surg. 2023 Dec 1;109(12):3872-3882. doi: 10.1097/JS9.0000000000000672.

    PubMed 37598384

  • You S, Xu F, Wu Y, Qin S, Shu B, Chen Y, Chen Y, Huang H, Duan G. Effect of noise isolation using noise-cancelling headphones during laparoscopic surgery for postoperative pain reduction: A randomized clinical trial. J Clin Anesth. 2024 Feb;92:111286. doi: 10.1016/j.jclinane.2023.111286. Epub 2023 Oct 12.

    PubMed 37837796

  • Belyad S, Talakoub R, Aarabi A. The Effect of Soundproof Headphones During Orthopedic Surgery Under Spinal Anesthesia on Patients' Physiological Indices and Duration of Recovery: A Randomized, Controlled, Clinical Trial. J Perianesth Nurs. 2024 Jun;39(3):379-385. doi: 10.1016/j.jopan.2023.08.016. Epub 2024 Jan 4.

    PubMed 38180393

Questions about this trial

What is this clinical trial studying?

A study of Cholecystectomy, Laparoscopic and Noise, run by Namik Kemal University at 2 sites 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 10 inclusion and 4 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Identification Form (time frame: Pre-intervention). The study lists 8 primary outcomes in all. 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 NCT06666686, which also lists 3 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 13 Apr 2026.

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