Menthol Popsicle to Manage the Elderly Patient's Thirst in the Immediate Postoperative Period

The Use of the Menthol Popsicle to Manage the Elderly Patient's Thirst in the Immediate Postoperative Period: a Randomized Clinical Trial

Thirst is defined as the desire for water seeking and consumption, and is a prevalent symptom in the immediate postoperative period in all age groups. The elderly surgical patient, despite presenting reduced physiological responses to thirst and satiety, in clinical practice, it is observed that they have high thirst intensity. There is evidence that strategies using cold temperatures are effective in quenching thirst of the surgical patient, for this reason, the present study is justified, in order to find strategies that help to reduce thirst in this specific population that is the elderly surgical patient.

Study Overview

• Status: Completed
• Conditions: Thirst
• Intervention / Treatment: Other: Menthol popsicle

Detailed Description

The present study aims to: compare the intensity and discomfort of thirst in the use of the menthol popsicle and usual care in elderly patients in the immediate postoperative period. This is a randomized clinical trial, to be performed in a public tertiary hospital. The sample size calculation will be performed after the pilot test is conducted. Two groups will be formed through randomization. The tested intervention consists of the menthol popsicle (experimental group). Thirst intensity (primary outcome) will be measured by means of the Visual Numerical Scale and the discomfort of thirst (secondary outcome) through the Perioperative Thirst Discomfort Scale, in two moments: at the end of the first assesment of the patient and 20 minutes after the intervention. With the results of this study the intend is to offer to the scientific society subsidies on thirst presented by the elderly patients, generating evidence for the improvement of clinical practice. In addition to contributing to the preparation of health professionals in the assertive care of the elderly population, it is estimated to deepen the knowledge about appropriate and innovative interventions to manage the postoperative thirst of the elderly, considered to be this, a representative and growing part of the world population.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • PR-Paraná
    • Cambé, PR-Paraná, Brazil, 86192430
      • Marilia Ferrari Conchon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective Surgeries;
• Aged 60 years and over;
• Being fasting;
• Verbalize thirst;
• Have been approved in the assesment of Safety Protocol of Thirst Management (SPTM)

Exclusion Criteria:

• Patients with ingestion and swallowing restrictions;
• Patients with self-reported allergy to mint;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menthol popsicle; Allocation concealment was performed through the use of individual opaque envelopes numbered externally in sequence, containing the randomly defined group information.This was performed by a researcher who did not participate in the data collection. The intensity of the initial thirst was measured by Visual 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 20 minutes of the intervention (menthol popsicle), the final intensity and discomfort were measured using the same scales.	Other: Menthol popsicle; The menthol popsicle composed of 0.05% menthol, 0.05% saccharin, 20ml ultrafiltered water and 2% cereal alcohol. The menthol popsicle was supported by a stick, allowing patients to taste more comfortably, with autonomy and safety; Other Names: Menthol ice
No Intervention: Usual care (maintenance of fasting); When allocated in the control group, the intensity of the initial thirst was measured by Visual 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 absolute fasting of food and drinks for 20 minutes, the final intensity and discomfort were measured using the same scales.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thirst intensity	For assesment of thirst intensity , a Visual Numeral Scale (VNS) was used, with a range from 0 (no thirst) to 10 (very intense thirst), as reported by the patients when questioned.	Measured at the beginning of the survey. For the experimental group, this measurement was made again 20 minutes after tasting the menthol popsicle. For the control group, this measure was made 20 minutes after the randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thirst discomfort	The Perioperative Thirst Discomfort Scale (PTDS) was used to assess thirst discomfort. 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 (not uncomfortable), 1 (a little uncomfortable), and 2 (very uncomfortable). The final sum of the PTDS can range from 0 to 14 points, and 14 corresponds to the most intense thirst discomfort reported by the patient.	Measured at the beginning of the survey. For the experimental group, this measurement was made again 20 minutes after tasting the menthol popsicle. For the control group, this measure was made 20 minutes after the randomization

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Universidade Estadual de Londrina
• Investigators: Study Director: Cristina M Galvão, University of Sao Paulo; Study Director: Ligia F Fonseca, Universidade Estadual de Londrina

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): July 20, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Elderly; Randomized Controlled Trial; Postoperative Period; Thirst; Ice; Menthol; Surgical Patient
• Additional Relevant MeSH Terms: Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: 87689318.4.0000.5393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No