Effectiveness of Menthol Chewing Gum in the Management of Thirst

NCT03200197 | Completed

• 1 other identifier: Aline Korki Arrabal Garcia
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study was to compare the effectiveness of menthol chewing gum compared to maintained fasting (usual care) in reducing the intensity of the surgical patient's thirst during the preoperative period. The hypothesis of the study was that the use of menthol chewing gum in surgical patients in the preoperative period would be more effective than the maintenance of fasting with regard to the decrease in thirst and its discomforts.

Conditions

Thirst

Keywords

Chewing gum; Artificial saliva; Saliva; Mastication; Salivary glands; Xerostomia

Outcome Measures

Primary Outcomes (1)

• intensity of thirst

  Alteration in the evaluation of the final intensity of thirst in relation to the evaluation of the initial intensity of thirst \[10 minutes\]. For evaluation of the intensity of thirst, a Verbal Numeral Scale (VNS) was used, with a range from 0 (no thirst) to 10 (very intense thirst), as reported by the patients when questioned.

  10 minutes

Secondary Outcomes (1)

• discomfort of thirst

  10 minutes

Study Arms (2)

menthol chewing gum

EXPERIMENTAL

Allocation concealment was performed through the use of individual opaque envelopes numbered externally in sequence, containing the randomly defined group information.This step was performed by a researcher who did not participate in the data collection. The intensity of the initial thirst was measured by means of the Verbal Numerical Scale (VNS), which ranged from 0 (no thirst) to 10 (very intense thirst) and the discomfort of the initial thirst was measured through the Perioperative Thirst Discomfort Scale (PTDS), which is composed of 7 attributes and ranges from 0 to 14. After using the intervention (menthol chewing gum) for 10 minutes, chewing at a natural rhythm and swallowing the saliva produced, the intensity and final discomfort were measured using the same scales.

Other: Menthol chewing gum

Usual care (maintenance of fasting)

ACTIVE COMPARATOR

Allocation concealment was performed through the use of individual opaque envelopes numbered externally in sequence, containing the randomly defined group information.This step was performed by a researcher who did not participate in the data collection.The intensity of the initial thirst was measured by means of the Verbal Numerical Scale (VNS), which ranged from 0 (no thirst) to 10 (very intense thirst) and the discomfort of the initial thirst was measured through the Perioperative Thirst Discomfort Scale (PTDS), which is composed of 7 attributes and ranges from 0 to 14. After maintaining the usual care, that is, reaffirming the need for fasting for 10 minutes, the intensity and final discomfort were measured using the same scales.

Other: Usual care (fasting)

Interventions

Menthol chewing gum OTHER

The experimental group received one unit of mentholated chewing gum, chewing and swallowing the saliva in a natural rhythm for 10 minutes. The menthol chewing gum used is called TRÍDENT®and is composed as follows: base gum, hydrogenated vegetable oil, vegetable oil, sweeteners: sorbitol, xylitol, mannitol, maltitol, aspartame, acesulfame potassium, and sucralose, humectants: glycerin and triacetin, flavorings (contains wheat derivatives), anti-humectant talc, emulsifiers: esters of mono- and diglycerides of fatty acids with acetic acid, soy lectin and mono and diglycerides of fatty acids and colorings: tartrazine and brilliant blue FCF, presenting a weight of 1.8g per unit.

menthol chewing gum

Usual care (fasting) OTHER

The control group received the usual care given at the hospitalization units, that is, when the patient reported thirst, the need to maintain fasting for 10 minutes was reaffirmed.

Usual care (maintenance of fasting)

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective Surgeries;
• Aged between 12 and 65 years;
• Did not receive preanesthetic medication;
• Oriented in time and space;
• Present dentition (natural or artificial);
• Fasting for a minimum of three hours;
• Available for collection at least 3 hours prior to the scheduled surgical procedure;
• Verbalize thirst spontaneously or when questioned with an intensity greater than or equal to three on the Verbal Numerical Scale (VNS);

You may not qualify if:

• Allergy to menthol;
• Chewing restriction;
• Swallowing restriction;
• Patients who presented nausea, vomiting, or pain;
• Patients with chronic xerostomia;
• Chronic renal patients;

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ligia Fahl Fonseca

  State University of Londrina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science Degree in Nursing

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 27, 2017
• Study Start: November 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-06