Administration of a 'Thirst Relieve Kit' Versus Placebo in Patients After Hospital-based Bowel Preparation for Colonoscopy and Assessment of Thirst Intensity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lemon popsicle, Water blister pack.
- Who it may be relevant to
- Registry conditions: Thirst, Bowel Preparation for Colonoscopy, Colonoscopy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this study is to evaluate whether a "thirst kit" (lemon popsicle) is effective in reducing thirst intensity in patients undergoing hospital bowel preparation for colonoscopy. The study also aims to assess the impact of the thirst kit on associated symptoms and patient satisfaction. The main questions it aims to answer are: * Does the thirst kit reduce the intensity of thirst after bowel preparation for colonoscopy? * Does the thirst kit reduce symptoms such as dry mouth and dry throat? * How satisfied are patients when using the thirst kit compared to a placebo? Researchers will compare the thirst kit to a placebo to determine its effectiveness in managing thirst during the pre-colonoscopy period. Participants will: * Be randomly assigned to receive either the thirst kit (lemon popsicle) or a placebo * Use the assigned intervention during the hospital preparation period for colonoscopy * Rate thirst intensity, associated symptoms, and satisfaction using numerical scales
Interventions
- Other lemon popsicle
The intervention group receives a "Thirst relife kit A" consisting of an encouraging message and a 60g lemon-flavored popsicle from the Jundiá® brand (Ingredients: water, sugar, glucose syrup, concentrated lemon juice, citric acid, thickeners, artificial flavoring). - Other Water blister pack
The control group receives a "Thirst Relife Kit B" consisting of the same encouraging message, a cotton ball, and a 10 ml blister pack of distilled water.
Primary outcome measures
- The primary outcome of the study is the intensity of thirst, assessed using a numerical scale (0-10) after administration of the thirst kit or placebo. [Time frame: 10 minutes before the sedation for the exam starts (when the patient arrives in the examination room)]
Eligibility criteria
Inclusion criteria
- both sexes
- aged 18 years or older, with clear awareness and good cooperation
- who underwent colonoscopy with hospital bowel preparation
Exclusion criteria
- any risk of oral fluid aspiration
- swallowing disorders
- post-operative advanced head and neck surgeries
- advanced head and neck neoplasia, active oral diseases (oral mucosal lesions, stomatitis, among others)
- history of gastric surgeries (gastrectomized, upper gastrointestinal tract surgeries for obesity)
- use of GLP-1 analog medications and derivatives in the last 10 days according to hospital protocol (e.g., semaglutide, liraglutide, dulaglutide, tirzepatide...)
- history of dementia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Brazil · 1 center
- Hospital Sírio Libanês — São Paulo
Publications
- 1. International Agency for Research on Cancer. GLOBOCAN 2020: estimated cancer incidence, mortality and prevalence worldwide in 2020. Lyon: IARC; 2021. 2. Islami F, Ward EM, Sung H, Cronin KA, Tangka FKL, Sherman RL, et al. Annual report to the nation on the status of cancer, part I: National cancer statistics. J Natl Cancer Inst. 2021. 3. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram
Identifiers
NCT: NCT07699809 · AVAP-NG ID = 3998