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NCT Number: NCT06666686

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

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.

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Key information

Conditions

Cholecystectomy, Laparoscopic Anesthesia Induction Noise

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Namık Kemal University, Tekirdağ, Suleymanpasa, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Patient Identification Form

    Time frame: Pre-intervention

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

  2. Patient Follow-up Form-Part 1

    Time frame: perioperative

    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.

  3. Patient Follow-up Form-Part-2

    Time frame: before surgery (anesthesia induction phase)

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

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

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

    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".

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

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

    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".

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

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

    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.

  7. Patient Follow-up Form-Part-6

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

    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.

  8. Noise Meter

    Time frame: before surgery (anesthesia induction phase)

    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.

Sponsors and collaborators

Lead sponsor

Namik Kemal University

Other

Registry information

Official study 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

Acronym: Anesth-noise

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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