The Effect of Preoperative Chewing Gum on Anxiety and Sore Throat in Patients With Laryngeal Mask Airway
NCT ID: NCT06168981
Last Updated: 2023-12-26
Study Results
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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ENROLLING_BY_INVITATION
NA
92 participants
INTERVENTIONAL
2023-12-01
2024-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Chewing Gum
Before the surgery, the patient will chew gum for 2 minutes and routine nursing care will be applied. Anxiety level will be evaluated before and after chewing gum.
Chewing Gum
The patient will be asked to chew gum before the surgery during the 2 minutes. Anxiety level will evaluated before and after chewing gum.
Control Group
Anxiety level will be evaluated before and after routine nursing care.
No interventions assigned to this group
Interventions
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Chewing Gum
The patient will be asked to chew gum before the surgery during the 2 minutes. Anxiety level will evaluated before and after chewing gum.
Eligibility Criteria
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Inclusion Criteria
* Being intubated with a laryngeal mask
* Being ASA (American Society of Anesthesiologists) I-II
Exclusion Criteria
* Having asthma
* Having chronic laryngitis
* Having gastroesophageal reflux
* Steroid use in the preoperative or intraoperative period
* Mallampati score greater than two
18 Years
FEMALE
Yes
Sponsors
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Ankara Medipol University
OTHER
Responsible Party
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Neslihan Ilkaz
Assistant Professor
Principal Investigators
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Neslihan Ilkaz, PhD
Role: PRINCIPAL_INVESTIGATOR
Ankara Medipol University
Locations
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Ankara Medipol University
Ankara, Keçiören, Turkey (Türkiye)
Neslihan Ilkaz
Ankara, Keçiören, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2023/197
Identifier Type: -
Identifier Source: org_study_id