Administration of a 'Thirst Relieve Kit' Versus Placebo in Patients After Hospital-based Bowel Preparation for Colonoscopy and Assessment of Thirst Intensity

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

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy; Thirst; Bowel Preparation for Colonoscopy
• Intervention / Treatment: Other: lemon popsicle; Other: Water blister pack

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlos Frederico Sparapan Marques; Phone Number: +5511996250751; Email: carlos.frederico@hc.fm.usp.br
• Study Contact Backup: Name: Júlia Bernardes Ferreira Gomes; Phone Number: +5531984637761; Email: julia.gomes@hsl.org.br

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil
      • Recruiting
      • Hospital Sirio Libanes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Group lemon popsicle: Group that will receive the lemon popsicle	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 Names: Thirst kit relife
Placebo Comparator: Placebo; Group placebo: Group that will recive de placebo (water blister)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The intensity of thirst, measured using a numerical scale from 0 to 10, was assessed after administration of the thirst kit or placebo in patients undergoing hospital preparation for colonoscopy.	10 minutes before the sedation for the exam starts (when the patient arrives in the examination room)

Collaborators and Investigators

• Sponsor: Hospital Sirio-Libanes

Publications and helpful links

General 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 I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-49. 4. Winawer SJ, Zauber AG, O'Brien MJ, Ho MN, Gottlieb L, Sternberg SS, et al. Randomized comparison of surveillance intervals after colonoscopic removal of newly diagnosed adenomatous polyps: the National Polyp Study Workgroup. N Engl J Med. 1993;328(13):901-6. 5. Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, et al. Prevention of colorectal cancer by colonoscopic polypectomy: the National Polyp Study Workgroup. N Engl J Med. 1993;329(27):1977-81. 6. Knudsen AB, Rutter CM, Peterse EFP, Lietz AP, Seguin CL, Meester RGS, et al. Colorectal cancer screening: an updated modeling study for the US Preventive Services Task Force. JAMA. 2021;325(19):1998-2011. doi:10.1001/jama.2021.5746. 7. Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005;61(3):378-84. 8. Parente F, Marino B, Crosta C. Bowel preparation before colonoscopy in the era of mass screening for colorectal cancer: a practical approach. Dig Liver Dis. 2009;41(2):87-95. doi:10.1016/j.dld.2008.06.005. 9. Green SM, Leroy PL, Roback MG, Irwin MG, Andolfatto G, Babl FE, et al. An international multidisciplinary consensus statement on fasting before procedural sedation in adults and children. Anaesthesia. 2020;75(3):374-85. doi:10

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: AVAP-NG ID = 3998

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No