NCT07506226

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 26, 2026

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Thirst Severity

    Assessed using a Visual Analog Scale (VAS; 0=no thirst, 10=very severe thirst)

    Postoperative 8, 12, and 24 hours

  • Oral Dryness Severity

    Assessed using a Visual Analog Scale (VAS; 0=no oral dryness, 10=very severe oral dryness)

    Postoperative 8, 12, and 24 hours

Secondary Outcomes (2)

  • Perioperative Thirst-Related Discomfort

    Postoperative 24 hours

  • Patient Satisfaction

    Postoperative 24 hours

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Cold water gargling

Control group

NO INTERVENTION

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38030, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 1, 2026

Study Start

March 19, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations