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

Not Applicable
Conditions
Anxiety
Laryngeal Mask
Throat Pain
Interventions
Other: Chewing Gum
Registration Number
NCT06168981
Lead Sponsor
Ankara Medipol University
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.

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
Female
Target Recruitment
92
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Chewing GumChewing GumBefore 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.
Primary Outcome Measures
NameTimeMethod
Change from preoperative anxiety level in a 2 minutesAfter 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

Secondary Outcome Measures
NameTimeMethod
Change from postoperative throat pain level at 2., 4., 6. hoursTime 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.

Trial Locations

Locations (2)

Ankara Medipol University

🇹🇷

Ankara, Keçiören, Turkey

Neslihan Ilkaz

🇹🇷

Ankara, Keçiören, Turkey

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