- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06014216
Treating Post-Operative Thirst With Flavoured Ice Lollies or Water - a Comparative Study to Improve Post-operative Discomfort (THIRST)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The 2019 peri-operative quality improvement project (PQIP) run by the Royal College of Anaesthetists showed 79% of patients experience moderate to severe thirst post-operatively. As a significant source of post-operative discomfort, resolving patient thirst may significantly improve their experience.
Whilst provision of oral fluids may be able to alleviate some thirst, many patients are unable to drink sufficient quantities to quench their thirst following an anaesthetic. Furthermore, studies have shown that frozen water is able to quench thirst to a greater degree than liquids.
The purpose of this study is to determine whether ice lollies quench post-operative thirst to a greater degree than water. Patients are already routinely offered water post-operatively, the offering of flavoured ice lollies is a novel intervention for our hospital. The investigators intend to investigate two primary outcomes. First, can ice lollies quench post-operative thirst to a greater degree than water and therefore improve patient discomfort. Second, if ice lollies are found to be superior to water in quenching thirst and improving post-operative discomfort, do these patients take less time to recover from their operation?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gloucestershire
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Gloucester, Gloucestershire, United Kingdom, GL1 3NN
- Gloucestershire Royal Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients over 18 years of age
- Patients attending for elective surgery
Exclusion Criteria:
- Allergy to products within the ice lolly
- Designated nil-by-mouth by anaesthetic or surgical teams
- Patient less than 18 years old
- Patient unable to give consent
- Refusal of patient to be involved with study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients allocated ice lollies to treat post-operative thirst
Ice lollies consisted of a flavoured ice popsicle (blackcurrant) provided through hospital catering.
Participants were allocated a single ice popsicle with thirst scores recored pre and post intervention.
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Blackcurrant flavoured ice popsicles, 105ml volume.
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Other: Patients allocated water as control comparison
Water is a routine treatment for post-operative thirst and therefore used a control to compare our intervention against.
|
Water from tap, one cup given by recovery nurses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The primary outcome measure is the level of post-operative thirst following intervention with either water or ice lolly.
Time Frame: Intervention is to be given when the patient is adequately recovered from anaesthesia. An initial thirst score is recorded, then intervention given. Thirst scores are recorded again 15 minutes later to provide data for the primary outcome measure.
|
Data on pre and post-intervention thirst will be recorded using questionnaires and a numerical rating score from 0 to 10, with 0 being no thirst at all and 10 being very thirsty.
These scores will also be sub-divided into no thirst (0), mild thirst (1-3), moderate thirst (4-7) and severe thirst (8-10).
This data will undergo statistical analysis to challenge the null hypothesis for the primary outcome measure.
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Intervention is to be given when the patient is adequately recovered from anaesthesia. An initial thirst score is recorded, then intervention given. Thirst scores are recorded again 15 minutes later to provide data for the primary outcome measure.
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Collaborators and Investigators
Investigators
- Principal Investigator: David Sleep, BSc MSc MBBS D.Phil, Gloucestershire Hospitals NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21/093/GHT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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