The Effect of Preoperative Chewing Gum on Anxiety and Sore Throat in Patients With Laryngeal Mask Airway

NCT06168981 | Unknown

• 1 other identifier: 2023/197
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Laryngeal Mask; Throat Pain; Anxiety

Keywords

Laryngeal mask; Pain; Chewing gum; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 α 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 α coefficients of the APAIS anxiety and information need subscales were 0.897 and 0.786, respectively

  After chewing gum for 2 minutes

Secondary Outcomes (1)

• Change from postoperative throat pain level at 2., 4., 6. hours

  Time frame: Postoperative time at 2., 4., 6., hours

Study Arms (2)

Chewing Gum

EXPERIMENTAL

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.

Other: Chewing Gum

Control Group

NO INTERVENTION

Anxiety level will be evaluated before and after routine nursing care.

Interventions

Chewing Gum OTHER

The patient will be asked to chew gum before the surgery during the 2 minutes. Anxiety level will evaluated before and after chewing gum.

Chewing Gum

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients will undergo breast surgery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Medipol University: lead

Study Sites (2)

Ankara Medipol University

Ankara, Keçiören, Turkey (Türkiye)

Location

Neslihan Ilkaz

Ankara, Keçiören, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 30662125 BACKGROUND

• 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.

  PMID: 16434761 BACKGROUND

• 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.

  PMID: 32776966 BACKGROUND

• 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.

  PMID: 33886521 BACKGROUND

• 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.

  PMID: 25744362 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31280554 BACKGROUND

• 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.

  PMID: 29624026 BACKGROUND

• 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.

  PMID: 35264684 BACKGROUND

MeSH Terms

Conditions

Pharyngitis; Anxiety Disorders; Pain

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Neslihan Ilkaz, PhD

  Ankara Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: December 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: March 31, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

TU (2)