Clinical trial NCT06666686: The Effect of Noise Control During Anesthesia Induction in Laparoscopic Cholecystectomy Surgery
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cholecystectomy, Laparoscopic
Noise
Anesthesia Induction
Keywords: Anesthesia induction
Noise control
Laparoscopic cholecystectomy
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Identification Form
timeFrame: Pre-intervention
measure: Patient Follow-up Form-Part 1
timeFrame: perioperative
measure: Patient Follow-up Form-Part-2
timeFrame: before surgery (anesthesia induction phase)
measure: Patient Follow-up Form-Part-3 (Numerical Analog Scale)
timeFrame: in the post-anesthesia care unit (up to 2 hours post surgery)
measure: Patient Follow-up Form-Part-4 (Visual Analog Scale for Assessment of Nausea)
timeFrame: in the post-anesthesia care unit (up to 2 hours post surgery)
measure: Patient Follow-up Form-Part-5 (Modified Aldrete Score)
timeFrame: in the post-anesthesia care unit (up to 2 hours post surgery)
measure: Patient Follow-up Form-Part-6
timeFrame: in the post-anesthesia care unit (up to 2 hours post surgery)
measure: Noise Meter
timeFrame: before surgery (anesthesia induction phase)
Secondary outcomes:
Other outcomes:
Locations:
city: Tekirdag
country: Turkey
facility: Namık Kemal University
state: Suleymanpasa
city: Tekirdağ
country: Turkey
facility: Namık Kemal University
state: Süleymanpaşa
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.