- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506226
Cold Water Gargling After Major Abdominal Surgery
March 31, 2026 updated by: Seda Akutay, TC Erciyes University
The Effect of Cold Gargling on Oral Dryness, Thirst Severity, and Patient Satisfaction in Patients Who Have Undergone Major Abdominal Surgery: A Randomized Controlled Trial
This randomized controlled trial examined the effect of cold water gargling on postoperative oral dryness, thirst severity, and patient satisfaction in patients who underwent major abdominal surgery.
Patients were randomly assigned to either the intervention group (cold water gargling) or the control group (standard care).
Thirst severity and oral dryness were assessed using a Visual Analog Scale (VAS; 0-10) at postoperative 8, 12, and 24 hours.
Perioperative thirst-related discomfort was evaluated using the Perioperative Thirst Discomfort Scale (PTDS; score range 0-12), and patient satisfaction was assessed using a VAS (0-10) at postoperative 24 hours.
The study was conducted at Erciyes University Faculty of Medicine Gevher Nesibe Hospital, General Surgery Clinic.
A total of 88 patients were enrolled (44 per group).
The study aimed to provide evidence for a simple, low-cost nursing intervention to improve postoperative patient comfort.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kayseri
-
Kayseri, Kayseri, Turkey (Türkiye), 38030
- Erciyes University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 18 years or older
- Scheduled for elective major abdominal surgery
- Able to communicate verbally
- Willing to participate and provided written informed consent
- No restriction on gargling (intact swallowing reflex)
Exclusion Criteria:
- Presence of oral mucositis, oral ulceration, or any oral pathology
- History of dysphagia or swallowing difficulties
- Presence of nausea or vomiting preventing gargling
- Altered level of consciousness or inability to cooperate
- Receiving intravenous fluid therapy that resolves thirst symptoms
- Patients who required reoperation during the study period
- Patients transferred to the intensive care unit postoperatively
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Patients in the control group received standard postoperative care per hospital protocol.
No gargling intervention was applied.
Oral intake restrictions were maintained as per routine clinical practice.
|
|
|
Other: Intervention group
Patients in the intervention group gargled with cold water (approximately 10 mL, 4°C) for 30 seconds at postoperative 8, 12, and 24 hours.
Gargling was performed under nurse supervision.
Patients were instructed not to swallow the water.
|
Patients gargled with cold water at postoperative 8, 12, and 24 hours.
Each gargling session involved approximately 10 mL of cold water (approximately 4°C) for 30 seconds.
The procedure was performed under nurse supervision.
Patients were instructed not to swallow the water and to spit it out after gargling.
No oral fluid intake was permitted during the study period per standard postoperative protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thirst Severity
Time Frame: Postoperative 8, 12, and 24 hours
|
Assessed using a Visual Analog Scale (VAS; 0=no thirst, 10=very severe thirst)
|
Postoperative 8, 12, and 24 hours
|
|
Oral Dryness Severity
Time Frame: Postoperative 8, 12, and 24 hours
|
Assessed using a Visual Analog Scale (VAS; 0=no oral dryness, 10=very severe oral dryness)
|
Postoperative 8, 12, and 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perioperative Thirst-Related Discomfort
Time Frame: Postoperative 24 hours
|
Assessed using the Perioperative Thirst Discomfort Scale (PTDS; Turkish version).
6-item, 3-point Likert scale.
Total score range 0-12; higher scores indicate greater discomfort.
|
Postoperative 24 hours
|
|
Patient Satisfaction
Time Frame: Postoperative 24 hours
|
Assessed using a Visual Analog Scale (VAS; 0=not satisfied at all, 10=very satisfied)
|
Postoperative 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 19, 2025
Primary Completion (Actual)
March 1, 2026
Study Completion (Actual)
March 1, 2026
Study Registration Dates
First Submitted
March 26, 2026
First Submitted That Met QC Criteria
March 26, 2026
First Posted (Actual)
April 1, 2026
Study Record Updates
Last Update Posted (Actual)
April 6, 2026
Last Update Submitted That Met QC Criteria
March 31, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- ErciyesUniversity_
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
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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