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Laryngeal MaskNCT06168981

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

A study testing Chewing Gum in people with Laryngeal Mask and Throat Pain, run by Ankara Medipol University at 2 sites in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Laryngeal Mask, Throat Pain, Anxiety
What is being tested?
Chewing Gum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Dec 2023to 31 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Ankara Medipol University

    Ankara, Keçiören

  • Neslihan Ilkaz

    Ankara, Keçiören

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Chewing Gum
Keywords
Laryngeal mask, Pain, Chewing gum, Anxiety
Medical subject headings
Pharyngitis, Anxiety Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chewing GumOther

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

Study groups in NCT06168981
Study groupRoleWhat they receive
Chewing GumExperimentalBefore 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.
Receives: Other: Chewing Gum
Control GroupNo interventionAnxiety level will be evaluated before and after routine nursing care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: After chewing gum for 2 minutes

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2023
  2. Study start1 Dec 2023
  3. Primary completion31 Jan 2024 (estimated)
  4. Study completion31 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06168981
Sponsor's protocol ID
2023/197
Status last verified
Dec 2023
First submitted
5 Dec 2023
Last updated
26 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30662125

  • 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.

    PubMed 16434761

  • 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.

    PubMed 32776966

  • 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.

    PubMed 33886521

  • 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.

    PubMed 25744362

  • 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.

    PubMed 31280554

  • 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.

    PubMed 29624026

  • 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.

    PubMed 35264684

  • Erten E, Parlak EA, Ilkaz N. The Effect of Preoperative Chewing Gum on Anxiety and Postoperative Sore Throat in Patients Using a Laryngeal Mask Airway: A Randomized Controlled Trial. Int J Nurs Pract. 2026 Aug;32(4):e70171. doi: 10.1111/ijn.70171.

    PubMed 42460602

Questions about this trial

What is this clinical trial studying?

A study testing Chewing Gum in people with Laryngeal Mask and Throat Pain, run by Ankara Medipol University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from preoperative anxiety level in a 2 minutes (time frame: After chewing gum for 2 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06168981, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.

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