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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Namık Kemal University | Tekirdağ | Suleymanpasa | 59000 | Turkey (Türkiye) | ||
| Namık Kemal University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37598384 | Background | 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. | |
| 37837796 | Background |
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| 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. |
|
| 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) |
| Tekirdağ |
| Süleymanpaşa |
| 59000 |
| Turkey (Türkiye) |
| 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. |
| 38180393 | 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. |