RBR-8c3chr7 Use of Popsicle with Mint in decreasing thirst after Prostatectomy surgery: randomized clinical trial

Date of registration: 02/08/2023 ^(mm/dd/yyyy)
Last approval date : 02/08/2023 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1274-6442

• Public title:

  en

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

  pt-br

  Uso do Picolé com Menta na diminuição da sede após a cirurgia de Prostatectomia: ensaio clínico randomizado

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 59006122.9.0000.5293
    Issuing authority: Plataforma Brasil
  • 5.462.098
    Issuing authority: Cômite de Ética de Pesquisa (CEP) da Liga Norteriograndese Contra o Câncer

Sponsors

• Primary sponsor: Liga Norteriograndense Contra o Câncer
• Secondary sponsor:
  • Institution: Liga Norteriograndense Contra o Câncer
• Supporting source:
  • Institution: Liga Norteriograndense Contra o Câncer

Health conditions

• Health conditions:

  en

  Prostatic Neoplasms; Postoperative Care

  pt-br

  Neoplasias de Próstata; Cuidados Pós-Operatórios

• General descriptors for health conditions:

  en

  F01.658.293.787 Thirst

  pt-br

  F01.658.293.787 Sede

• Specific descriptors:

  en

  E02.760.731.700 Postoperative Care

  pt-br

  E02.760.731.700 Cuidados Pós-Operatórios

  en

  C04.588.945.440.770 Prostatic Neoplasms

  pt-br

  C04.588.945.440.770 Neoplasias da Próstata

Interventions

• Interventions:

  en

  This is a two-arm, double-blind, randomized controlled clinical trial. Control group: 22 men submitted to Prostatectomy will receive popsicle composed of filtered water and sugar after surgery. Control Intervention: 22 men submitted to Prostatectomy will receive popsicle composed of filtered water, sugar and mint after surgery. The popsicles were randomly distributed after the surgery and with the patient still fasting.

  pt-br

  Trata-se de um estudo clínico randomizado controlado de dois braços, duplo-cego. Grupo controle: 22 homens submetidos a Prostatectomia receberão picolé composto de água filtrada e açúcar após a cirurgia. Grupo Intervenção: 22 homens submetidos a Prostatectomia receberão picolé composto de água filtrada, açúcar e menta após a cirurgia. Os picolés foram distribuídos de forma aleatória, após a realização da cirurgia e com o paciente ainda em jejum.

• Descriptors:

  en

  D02.033.415.510.500.605 Menthol

  pt-br

  D02.033.415.510.500.605 Mentol

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 03/01/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  44	F	18 Y	60 Y

• Inclusion criteria:

  en

  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

  pt-br

  Ter entre 18 e 60 anos; Ser do sexo feminino; Estar em jejum mínimo de 6h; Aprovação na avaliação do Protocolo de Segurança no Manejo da Sede

• Exclusion criteria:

  en

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

  pt-br

  Restrição hídrica à ingesta ou deglutição; Ter algum tipo de alergia ou hipersensibilidade a mentol ou corante verde

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Single-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  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

  pt-br

  Desfecho esperado 1: Espera-se encontrar a diminuição da sede avaliado pela Escala de Desconforto da Sede Perioperatória (EDESP), a partir da constatação nas medições pré e pós-intervenção

  en

  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

  pt-br

  Desfecho encontrado 1: Foi possível verificar que as notas apresentadas antes e depois da cintervenção foram consideradas diferentes, do ponto de vista estatístico, verificadas através do teste ANOVA, trazendo evidências de que o uso do picolé mentolado pode ter apresentado algum efeito positivo na questão da sede na comparação pré e pós intervenção, entretanto, entre os grupos em si, isto é, mentol x placebo, não foi encontrada diferença

• Secondary outcomes:

  en

  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

  pt-br

  Desfecho esperado 1: Diminuição de desconfortos secundários relacionada a sede através dos subtópicos da Escala de Desconforto da Sede Perioperatória (EDESP), que são: Minha boca está seca; Meus lábios estão ressecados; Minha língua está grossa; Minha saliva está grossa; Minha garganta está seca; Sinto um gosto ruim na boca; Tenho vontade de beber água

  en

  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

  pt-br

  Desfecho encontrado 1: Foi possível verificar que as notas apresentadas antes e depois da intervenção foram consideradas diferentes, do ponto de vista estatístico, verificadas através do teste ANOVA, trazendo evidências de que o uso do picolé mentolado pode ter apresentado algum efeito positivo na questão da sede na comparação pré e pós intervenção, entretanto, entre os grupos em si, isto é, mentol x placebo, não foi encontrada diferença

Summary Results

• Baseline char:

  en

  The baseline characteristics of the study participants are similar in order to avoid bias in the research. The information follows: The patients in the sample had a mean age of approximately 66.7 years with a standard deviation of 7.0. These values remained very close in both groups. More than half of the patients are brown (75.0%) with married marital status (70.0%). Half of the sample had incomplete elementary school education (50.0%). About 34.1% of patients are retired and 56.8% have a family income of 01 to 02 minimum wages

• Participants flow:

  en

  50 patients were evaluated for study eligibility, of these, 6 were excluded: 1 for not meeting the inclusion criteria and 5 withdrew from the research. Thus, 44 went on to the randomization process: 22 in the control group and 22 in the intervention group, contemplating the expected statistical sample of 44 participants

• Adverse events:

  en

  here was no unfavorable change in the health of any participant

• Outcome measure:

  en

  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). The data referring to the primary outcomes was presented through the boxplot referring to the final score before and after the intervention in each of the randomization groups. With regard to the primary outcomes (NE and EDESP – Final score), the test detected changes in the scores of both scales with respect to time (EN: p-value < 0.0001; ղ_p^2 = 0.8479 – EDESP: p-value < 0.0001; ղ_p^2 = 0.7862) and for the group x time interaction (EN: p-value = 0.0021; ղ_p^2 = 0.0713 – EDESP: p-value = 0.0014; ղ_p^2 = 0.0706). For the groups, no difference was detected (NS: p-value < 0.2045; ղ_p^2 = 0.0269 – EDESP: p-value = 0.9630; ղ_p^2 < 0.0001). In other words, it is possible to verify that the notes presented before and after the surgery were considered different, from a statistical point of view, providing evidence that the use of mentholated popsicles may have had a positive effect on the question of thirst in the pre and post comparison. intervention, however, between the groups themselves, that is, menthol x placebo, no difference was found. Because the effect size is small, especially on the EDESP scale (ղ_p^2 < 0.0001), it is possible that, clinically, no difference was found either. Regarding the other outcomes, with the exception of the item 'dry lips', the test detected a difference only between times with p-value < 0.0001. The effect sizes can be seen in Table 2. The item 'My lips are dry' was able to detect difference in scores between groups (p-value = 0.0242; ղ_p^2 = 0.0701) between times (p-value = 0.4330; ղ_p^ 2 < 0.0001) and for the group x time interaction (p-value = 0.0953; ղ_p^2 = 0.0023). Thus, the test provides evidence that patients who received menthol and placebo had different scores, as well as between times (before and after the intervention)

• Results summary:

  en

  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

Data Sharing Plan

• Data Sharing Plan:

  en

  No

Contacts

• Public contact
  • Full name: Rodrigo Assis Neves Dantas
  • • Address: Campus Universitário - Lagoa Nova
    • City: Natal / Brazil
    • Zip code: 59078-970
  • Phone: +55084999763599
  • Email: rodrigoenf@yahoo.com.br
  • Affiliation: Universidade Federal do Rio Grande do Norte
   
• Scientific contact
  • Full name: Rodrigo Assis Neves Dantas
  • • Address: Campus Universitário - Lagoa Nova
    • City: Natal / Brazil
    • Zip code: 59078-970
  • Phone: +55084999763599
  • Email: rodrigoenf@yahoo.com.br
  • Affiliation: Universidade Federal do Rio Grande do Norte
   
• Site contact
  • Full name: Rodrigo Assis Neves Dantas
  • • Address: Campus Universitário - Lagoa Nova
    • City: Natal / Brazil
    • Zip code: 59078-970
  • Phone: +55084999763599
  • Email: rodrigoenf@yahoo.com.br
  • Affiliation: Universidade Federal do Rio Grande do Norte
   

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