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Effectiveness of Menthol Chewing Gum in the Management of Thirst

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ClinicalTrials.gov Identifier: NCT03200197
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Aline Korki Arrabal Garcia, Universidade Estadual de Londrina

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.

Condition or disease Intervention/treatment Phase
Thirst Other: Menthol chewing gum Other: Usual care (fasting) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Menthol Chewing Gum in the Management of Preoperative Thirst: Randomized Clinical Trial
Actual Study Start Date : November 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. intensity of thirst [ Time Frame: 10 minutes ]
    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.


Secondary Outcome Measures :
  1. discomfort of thirst [ Time Frame: 10 minutes ]
    Alteration in the evaluation of the final discomfort of thirst in relation to the evaluation of the initial discomfort of thirst [10 minutes]. The Perioperative Thirst Discomfort Scale (PTDS) was used to evaluate the discomfort of the thirst.This scale is composed of 7 attributes that evaluate the signs of discomfort of perioperative thirst, as follows: dry mouth, dry lips, thick tongue, thick saliva, bad taste in the mouth, and desire to drink water. Each attribute varies between 0 (no inconvenience), 1 (a little inconvenient), and 2 (very inconvenient). The final sum of the PTDS can range from 0 to 14 points.



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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200197


Sponsors and Collaborators
Universidade Estadual de Londrina
Investigators
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Study Director: Ligia Fahl Fonseca State University of Londrina

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Responsible Party: Aline Korki Arrabal Garcia, Master of Science Degree in Nursing, Universidade Estadual de Londrina
ClinicalTrials.gov Identifier: NCT03200197     History of Changes
Other Study ID Numbers: Aline Korki Arrabal Garcia
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aline Korki Arrabal Garcia, Universidade Estadual de Londrina:
Chewing gum
Artificial saliva
Saliva
Mastication
Salivary glands
Xerostomia
Additional relevant MeSH terms:
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Menthol
Antipruritics
Dermatologic Agents