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

Thirst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621800
• Other study ID #: 87689318.4.0000.5393
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Thirst

Intervention

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

Locations

Country	Name	City	State
Brazil	Marilia Ferrari Conchon	Cambé	PR-Paraná

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Universidade Estadual de Londrina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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