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

NCT06666686 | Completed

• 1 other identifier: Anesthesia noise
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cholecystectomy, Laparoscopic; Noise; Anesthesia Induction

Keywords

Anesthesia induction; Noise control; Laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (8)

• 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.

  Pre-intervention

• 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.

  perioperative

• Patient Follow-up Form-Part-2

  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)

  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)

  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)

  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

  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

  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)

Study Arms (3)

Control group

NO INTERVENTION

Control group

Active noise control

EXPERIMENTAL

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

Passive noise control

EXPERIMENTAL

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

Interventions

Active noise control headphone DEVICE

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.

Active noise control

Passive noise control headphone DEVICE

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.

Passive noise control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (2)

Namık Kemal University

Tekirdağ, Suleymanpasa, 59000, Turkey (Türkiye)

Location

Namık Kemal University

Tekirdağ, Süleymanpaşa, 59000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 37598384 BACKGROUND

• 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.

  PMID: 37837796 BACKGROUND

• 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.

  PMID: 38180393 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 30, 2024
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 13, 2026

Record last verified: 2024-10

Locations

TU (2)