Clinical trial NCT06168981: The Effect of Preoperative Chewing Gum on Anxiety and Sore Throat in Patients With Laryngeal Mask Airway
Official title: The Effect of Preoperative Chewing Gum on Anxiety and Sore Throat in Patients With Laryngeal Mask Airway: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Laryngeal Mask
Throat Pain
Anxiety
Keywords: Laryngeal mask
Pain
Chewing gum
Anxiety
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was planned to investigate the effect of chewing gum in the preoperative period on patients' sore throat and anxiety levels.

Detailed description: Postoperative sore throat is a common complaint (1,2). It is reported in the literature that there are various pharmacological methods to reduce this condition, such as the use of nebula, corticosteroids, nonsteroidal anti-inflammatory drugs, or lidocaine. However, these methods have various advantages and disadvantages (3,4). Chewing gum, one of the non-pharmacological methods may be safer for the patient. Chewing gum increases salivary gland secretion and provides lubrication of the oral cavity (5). For this reason, it was thought that chewing gum before surgery could reduce throat pain after using a laryngeal mask due to the effect it provides. It has been determined that there are few experimental studies on the subject in the literature (6,7).

The presence of preoperative anxiety may lead to an increase in the need for intraoperative anesthesia and analgesic consumption in the postoperative period (8,9). However, it may cause a decrease in patient satisfaction and prolong the recovery process in the postoperative period (8,9). Pharmacological approaches can be applied to address this concern. However, non-pharmacological approaches may be safer for patients. Chewing gum during this process can also reduce patients' anxiety levels. A sufficient number of studies on the subject could not be found (10).

The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the patients before and after the surgery, the study will conduct with various data collection forms.

These forms are; patient Identification form, Amsterdam Preoperative Anxiety and Information Scale (APAIS), Visual Analogue Scale (VAS). Patients will randomize. The chewing gum group in group- I (n=46), and group II (n=46) will be the control group. We have two stage.In first stage; anxiety levels will be measured for both group. In second stage; throat pain will evaluated at 2.-4.-6. hours.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective surgery
* Being intubated with a laryngeal mask
* Being ASA (American Society of Anesthesiologists) I-II

Exclusion Criteria:

* Using cigarette

  * Having asthma
  * Having chronic laryngitis
  * Having gastroesophageal reflux
  * Steroid use in the preoperative or intraoperative period
  * Mallampati score greater than two

Primary outcomes:
measure: Change from preoperative anxiety level in a 2 minutes
timeFrame: After chewing gum for 2 minutes
Secondary outcomes:
measure: Change from postoperative throat pain level at 2., 4., 6. hours
timeFrame: Time frame: Postoperative time at 2., 4., 6., hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Medipol University
state: Keçiören
city: Ankara
country: Turkey
facility: Neslihan Ilkaz
state: Keçiören
Study officials:
affiliation: Ankara Medipol University
name: Neslihan Ilkaz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Segaran S, Bacthavasalame AT, Venkatesh RR, Zachariah M, George SK, Kandasamy R. Comparison of Nebulized Ketamine with Nebulized Magnesium Sulfate on the Incidence of Postoperative Sore Throat. Anesth Essays Res. 2018 Oct-Dec;12(4):885-890. doi: 10.4103/aer.AER_148_18.
citation: Miller DM, Camporota L. Advantages of ProSeal and SLIPA airways over tracheal tubes for gynecological laparoscopies. Can J Anaesth. 2006 Feb;53(2):188-93. doi: 10.1007/BF03021826.
citation: Yu J, Ren L, Min S, Yang Y, Lv F. Nebulized pharmacological agents for preventing postoperative sore throat: A systematic review and network meta-analysis. PLoS One. 2020 Aug 10;15(8):e0237174. doi: 10.1371/journal.pone.0237174. eCollection 2020.
citation: Wang G, Qi Y, Wu L, Jiang G. Comparative Efficacy of 6 Topical Pharmacological Agents for Preventive Interventions of Postoperative Sore Throat After Tracheal Intubation: A Systematic Review and Network Meta-analysis. Anesth Analg. 2021 Jul 1;133(1):58-67. doi: 10.1213/ANE.0000000000005521.
citation: Hashiba T, Takeuchi K, Shimazaki Y, Takeshita T, Yamashita Y. Chewing xylitol gum improves self-rated and objective indicators of oral health status under conditions interrupting regular oral hygiene. Tohoku J Exp Med. 2015 Jan;235(1):39-46. doi: 10.1620/tjem.235.39.
citation: 6. Abdelgalil, A. S., Abdelrahman, A. S., & Hassan, M. E. (2023). Preoperative gum chewing for different durations to prevent postoperative sore throat after endotracheal intubation: A randomized controlled trial. Trends in Anaesthesia and Critical Care, 101216.
citation: Zemla AJ, Nowicka-Sauer K, Jarmoszewicz K, Wera K, Batkiewicz S, Pietrzykowska M. Measures of preoperative anxiety. Anaesthesiol Intensive Ther. 2019;51(1):64-69. doi: 10.5603/AIT.2019.0013.
citation: Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.
citation: Bang YJ, Lee JH, Kim CS, Lee YY, Min JJ. Anxiolytic effects of chewing gum during preoperative fasting and patient-centered outcome in female patients undergoing elective gynecologic surgery: randomized controlled study. Sci Rep. 2022 Mar 9;12(1):4165. doi: 10.1038/s41598-022-07942-6.