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

NCT03621800 | Completed

• 1 other identifier: 87689318.4.0000.5393
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thirst

Keywords

Thirst; Elderly; Postoperative Period; Surgical Patient; Menthol; Ice; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Thirst discomfort

  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

Study Arms (2)

Menthol popsicle

EXPERIMENTAL

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

Usual care (maintenance of fasting)

NO INTERVENTION

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.

Interventions

Menthol popsicle OTHER

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

Also known as: Menthol ice

Menthol popsicle

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Universidade Estadual de Londrina: collaborator

Study Sites (1)

Marilia Ferrari Conchon

Cambé, PR-Paraná, 86192430, Brazil

Location

Study Officials

• Cristina M Galvão

  University of Sao Paulo

  STUDY DIRECTOR

• Ligia F Fonseca

  Universidade Estadual de Londrina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorade Student

Model Details: This is a study with an experimental research design. Randomized clinical trial, parallel, prospective and monocentric.

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: June 7, 2018
• Primary Completion: July 20, 2018
• Study Completion: August 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)