Effectiveness of Menthol Chewing Gum in the Management of Thirst

NCT ID: NCT03200197

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-03-31

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.

Detailed Description

There is evidence that chewing gum is effective in relieving thirst in the surgical patient in the preoperative period as it stimulates the salivary glands by means of mechano and chemoreceptors, increasing the salivary pH and flow, lubricating the oral cavity, acting in this way on peripheral thirst, which is triggered by dehydration of the oral mucosa. Furthermore, menthol gum stimulates the cold receptors, known as TRPM8, which are responsible for deactivating centers of thirst. Thus, the risk of bronchoaspiration due to gastric fullness is avoided and the discomfort of a dry mouth is reduced.Preliminary evidence indicates that the chewing gum strategy assists in the relief of a dry mouth and thirst in patients undergoing dialysis and head and neck radiotherapy. However, there is no scientific evidence of controlled studies with results that can be generalized regarding the use of chewing gum to reduce thirst and its discomforts in surgical patients in the preoperative period when they remain in a fasted state.

Conditions

Thirst

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

menthol chewing gum

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.

Group Type: EXPERIMENTAL

Menthol chewing gum

Intervention Type: 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.

Usual care (maintenance of fasting)

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.

Group Type: ACTIVE_COMPARATOR

Usual care (fasting)

Intervention Type: 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.

Interventions

Menthol chewing gum

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.

Intervention Type: OTHER

Usual care (fasting)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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);

Exclusion Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual de Londrina

OTHER

Sponsor Role: lead

Responsible Party

Aline Korki Arrabal Garcia

Master of Science Degree in Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ligia Fahl Fonseca

Role: STUDY_DIRECTOR

State University of Londrina

Other Identifiers

Aline Korki Arrabal Garcia

Identifier Type: -

Identifier Source: org_study_id