Cold Water Gargling After Major Abdominal Surgery
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kayseri
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Kayseri, Kayseri, Turkey (Türkiye), 38030
- Erciyes University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
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|
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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
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
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- ErciyesUniversity_
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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