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

NCT ID: NCT03621800

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-07
• Study Completion Date: 2018-08-01

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.

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.

Conditions

Thirst

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Menthol popsicle

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Menthol ice

Eligibility Criteria

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;

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual de Londrina

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Marilia Ferrari Conchon

Doctorade Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina M Galvão

Role: STUDY_DIRECTOR

University of Sao Paulo

Ligia F Fonseca

Role: STUDY_DIRECTOR

Universidade Estadual de Londrina

Locations

Marilia Ferrari Conchon

Cambé, PR-Paraná, Brazil

Countries

Brazil

Other Identifiers

87689318.4.0000.5393

Identifier Type: -

Identifier Source: org_study_id