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

NCT ID: NCT06666686

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cholecystectomy, Laparoscopic Noise Anesthesia Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Active noise control headphone

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Passive noise control headphone

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Namik Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Cagla AVCU

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Namık Kemal University

Tekirdağ, Suleymanpasa, Turkey (Türkiye)

Site Status

Namık Kemal University

Tekirdağ, Süleymanpaşa, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 37598384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37837796 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38180393 (View on PubMed)

Other Identifiers

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Anesthesia noise

Identifier Type: -

Identifier Source: org_study_id

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