Anxiety Clinical Trial
Official title:
The Effect of Preoperative Chewing Gum on Anxiety and Sore Throat in Patients With Laryngeal Mask Airway: A Randomised Controlled Trial
Verified date | December 2023 |
Source | Ankara Medipol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was planned to investigate the effect of chewing gum in the preoperative period on patients' sore throat and anxiety levels.
Status | Enrolling by invitation |
Enrollment | 92 |
Est. completion date | March 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Medipol University | Ankara | Keçiören |
Turkey | Neslihan Ilkaz | Ankara | Keçiören |
Lead Sponsor | Collaborator |
---|---|
Ankara Medipol University |
Turkey,
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.
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from preoperative anxiety level in a 2 minutes | In this section, the anxiety level will decrease or disappear. This status will evaluate with Amsterdam Preoperative Anxiety and Information Scale (APAIS). APAIS consists of two scales, including a four-item anxiety scale and two-items information requirement. Items are rated on a Likert scale from 1 ("not at all worried") to 5 ("very worried"). The score ranges for the anxiety subscale and the information need subscale are 4-20 and 2-10, respectively. High scores are associated with higher levels of anxiety and need for information. Cronbach's a coefficients for the anxiety subscale and the information need subscale were 0.86 and 0.68, respectively (Moerman et al.1996).
Çetinkaya et al. The validity and reliability of the Turkish translation of APAIS was verified in 2019. Cronbach's a coefficients of the APAIS anxiety and information need subscales were 0.897 and 0.786, respectively |
After chewing gum for 2 minutes | |
Secondary | Change from postoperative throat pain level at 2., 4., 6. hours | In this section, the degree of postoperative throat pain level will decrease or disappear. This status will evaluate with Visual Analogue Scale (VAS). VAS is a horizontal line with a length of 10 cm. According to VAS, 0 is the lowest level and 10 is the highest level. | Time frame: Postoperative time at 2., 4., 6., hours |
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