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

Namik Kemal University105 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

105

Conditions

Cholecystectomy, Laparoscopic Noise Anesthesia Induction

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Namık Kemal University

Tekirdağ, Suleymanpasa, Turkey (Türkiye)

Namık Kemal University

Tekirdağ, Süleymanpaşa, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: perioperative

Patient Follow-up Form-Part-2

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

Time frame: 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".

Time frame: 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".

Time frame: 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.

Data from ClinicalTrials.gov

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