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RecruitingNCT07699809Updated Jul 13, 2026

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

An interventional study of lemon popsicle and Water blister pack in Thirst, Bowel Preparation for Colonoscopy and Colonoscopy, sponsored by Hospital Sirio-Libanes. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Hospital Sirio-Libanes · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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
02

Conditions studied

  • Thirst
  • Bowel Preparation for Colonoscopy
  • Colonoscopy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • both sexes
  • aged 18 years or older, with clear awareness and good cooperation
  • who underwent colonoscopy with hospital bowel preparation

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
158 participants (estimated)

Study arms

  • Experimental
    Intervention

    Group lemon popsicle: Group that will receive the lemon popsicle

    Other: lemon popsicle

  • Placebo comparator
    Placebo

    Group placebo: Group that will recive de placebo (water blister)

    Other: Water blister pack

Interventions

  • Otherlemon 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).

    Also known as: Thirst kit relife

  • OtherWater 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 minutes before the sedation for the exam starts (when the patient arrives in the examination room)

06

Study locations

1 of 1 sites recruiting
  • Hospital Sírio Libanês
    São Paulo, São Paulo, Brazil
    Recruiting
07

References and documents

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

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07699809
Lead sponsor
Hospital Sirio-Libanes
Responsible party
Sponsor
First posted
Jul 13, 2026
Start date
Dec 8, 2025
Primary completion
Aug 12, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Jul 13, 2026

Study contacts

Carlos Frederico Sparapan Marques
Contact
carlos.frederico@hc.fm.usp.br
+5511996250751
Júlia Bernardes Ferreira Gomes
Contact
julia.gomes@hsl.org.br
+5531984637761

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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