se of Popsicle with Mint in decreasing thirst after Prostatectomy surgery: randomized clinical trial

Not Applicable

• Conditions: Prostatic Neoplasms; Postoperative Care; F01.658.293.787

• Registration Number: RBR-8c3chr7
• Lead Sponsor: iga Norteriograndense Contra o Câncer

Brief Summary

Considering to improve the thirst problem, the technique of supplying a little volume of cold liquid in the oral cavity is used to lubricate the mucosa. Therefore, interventions such as iced or menthol popsicles, menthol chewing gum, wet gauze with cold saline solution, cold water for gargling and frozen gauze with saline solution are the main methods used to stimulate thirst quenching in patients during the period before the surgery. This study aims to evaluate the effectiveness of using mentholated popsicle in relieving postoperative thirst in patients undergoing radical prostatectomy. This is a randomized, controlled, single-blind clinical trial, with a quantitative approach that will comply with the standards recommended by the Consolidated Standards of Reporting Trials. The population consisted of male patients undergoing elective radical prostatectomy surgery who are in the immediate postoperative period. The sample will be probabilistic, simple random, with patients who attend elective radical prostatectomy surgery. The study will consist of two groups: a control and an experimental one. The CG will consist of patients who will receive popsicles without the addition of menthol substrate and the EG will consist of patients who will receive popsicles with the addition of 0.05% menthol substrate. The instrument for data collection is subdivided into three parts: 1) Patient identification, clinical and sociodemographic data; 2) Data regarding the surgical procedure and anesthetic process; 3) Data referring to the intensity of thirst through the Numerical Scale (EN) and thirst discomfort through the Perioperative Thirst Discomfort Scale (EDESP). In order to analyze the results regarding the intensity of thirst, the numeric scale (EN) was used and the assessment of thirst discomfort was measured using the Perioperative Thirst Discomfort Scale (EDESP). Data referring to the primary outcomes were presented through the boxplot referring to the final score before and after the intervention in each of the randomization groups. It was possible to verify that the notes presented before and after the surgery were considered different, from the statistical point of view, providing evidence that the use of mentholated popsicles may have had a positive effect on the issue of thirst in the comparison pre and post intervention, however, between the groups themselves, that is, menthol x placebo, no difference was found. Through the analyzes carried out, it was not possible to detect significant differences between the groups, menthol versus placebo. The difference identified is related to the intensity of thirst in relation to pre and post surgery. The graphics suggested, in general, lower scores in the post-intervention period. Another notable point, through the ANOVA, especially for the primary outcomes, were the significances in the interactions, suggesting that the group in which the patient participated in the research, menthol or placebo, may have presented different performances according to the time under analysis, before or after intervention

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-27
• Study Start: 2023-02-08
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Be between 18 and 60 years old; Being female;Fasting for at least 6 hours; Approval in the evaluation of the Security Protocol in the Management of Headquarters

Exclusion Criteria

Water restriction during ingestion or swallowing; Having an allergy or hypersensitivity to menthol or green dye

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1: It is expected to find a decrease in thirst assessed by the Perioperative Thirst Discomfort Scale (EDESP), based on the pre- and post-intervention measurements ;Outcome found 1: It was possible to verify that the notes presented before and after the intervention were considered different, from the statistical point of view, verified through the ANOVA test, providing evidence that the use of mentholated popsicles may have had a positive effect on the issue of thirst in the pre-comparison. and post intervention, however, between the groups themselves, that is, menthol x placebo, no difference was found

Secondary Outcome Measures

Name	Time	Method
Expected outcome 1: Decrease in secondary discomfort related to thirst through the subtopics of the Perioperative Thirst Discomfort Scale (EDESP), which are: My mouth is dry; My lips are dry; My tongue is thick; My saliva is thick; My throat is dry; I have a bad taste in my mouth; I want to drink water;Desfecho encontrado 1: It was possible to verify that the notes presented before and after the intervention were considered different, from the statistical point of view, verified through the ANOVA test, providing evidence that the use of mentholated popsicles may have had a positive effect on the issue of thirst in the pre-comparison. and post intervention, however, between the groups themselves, that is, menthol x placebo, no difference was found