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

December 20, 2023 updated by: Neslihan Ilkaz, Ankara Medipol University

The Effect of Preoperative Chewing Gum on Anxiety and Sore Throat in Patients With Laryngeal Mask Airway: A Randomised Controlled Trial

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Keçiören
      • Ankara, Keçiören, Turkey
        • Ankara Medipol University
      • Ankara, Keçiören, Turkey
        • Neslihan Ilkaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: Control Group
Anxiety level will be evaluated before and after routine nursing care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from preoperative anxiety level in a 2 minutes
Time Frame: After chewing gum for 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from postoperative throat pain level at 2., 4., 6. hours
Time Frame: Time frame: Postoperative time 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Medipol University

Investigators

  • Principal Investigator: Neslihan Ilkaz, PhD, Ankara Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/197

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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