Effect of Postoperative Oral Rinsing on Dehydration-Related Discomfort, Comfort, and Bowel Movement

November 17, 2025 updated by: Pınar YILMAZ EKER, Cumhuriyet University

Effect of Postoperative Oral Rinsing on Thirst-Related Discomfort, Comfort Level, and Bowel Movement in Individuals Undergoing Abdominal Surgery: A Randomized Controlled Trial

The aim of this study is to evaluate the effects of oral rinsing with water in the postoperative period on thirst, comfort level, and bowel motility in patients undergoing abdominal surgery under general anesthesia.

This study was conducted as a randomized controlled trial with pretest-posttest design, including intervention and control groups. It was carried out between June 2024 and December 2024 with patients undergoing elective abdominal surgery. Sample size was calculated using G*Power 3.1.9.7 software, with an effect size of 0.50, α=0.05, and power=0.85. A total of 82 participants (41 per group) were initially planned, and considering a 10% data loss, the study was completed with 98 participants (49 in each group). Patients were stratified according to their diagnoses and randomized in a 1:1 ratio using block randomization with a random number table.

Three data collection forms were used. SPSS 22.00 package program was used to analyze the data. Skewnes-Kurtosis analyses were performed to determine the conformity of the data to a normal distribution. Frequency (n) and percentage (%) distributions were calculated to determine the sociodemographic and clinical characteristics of the participants. A t-test for independent samples was used to determine the mean differences between two independent groups, a t-test for dependent samples was used to compare pre- and post-intervention measurements, and a single-factor analysis of variance (ANOVA) was used for repeated measures. Cohen's d effect size was calculated to assess the significance of the difference between the groups in terms of the intervention. Statistical significance was accepted as p<0.05.

Study Overview

Study Type

Interventional

Enrollment (Actual)

98

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

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

Yes

Description

Included Criteria

  • To communicate,
  • Aged 18 or older,
  • Agreed to participate
  • Scheduled for elective surgery.

Exclusion Criteria

  • Over 80 years old,
  • Had a mental disorder that prevented them from rinsing their mouth,
  • Unconscious after surgery, were at
  • Risk of swallowing water during rinsing,
  • Underwent emergency surgery.

Refusion Criteria

  • Refused to complete the post-test
  • Intensive care after surgery

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abdominal surgery patients receiving oral rinsing
Abdominal surgery patients
The experimental group received a postoperative mouth rinse with pure water.
Other: rutine service operation
Abdominal surgery patients
No additional intervention will be made to the control group; only data collection forms will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores of Mental State Assessment pre-test post-test on experimental group
Time Frame: 1 day
Mini Mental State Assessment (MMSA): A cognitive screening tool with 11 items in five domains (orientation, registration, attention/calculation, recall, language). Scores range 0-30; ≤23 indicates impairment. Administration takes 5-10 minutes. Turkish validity and reliability are established.
1 day
Personal Information experimental group
Time Frame: 1 day
Personal Information Form: Developed by researchers based on literature and clinical observation. The first section includes demographic and clinical data (age, gender, education, diagnosis, preoperative fasting time, postoperative oral intake time). The second section records bowel sounds.
1 day
Scores of Surgical Period Thirst Discomfort pre-test post-test on experimental group
Time Frame: 1 day
Surgical Period Thirst Discomfort Scale (SPTDS): Adapted to 6 items with a 3-point Likert scale (0-2). Total score is 0-12; higher scores indicate greater thirst-related discomfort.Surgical Period Thirst Discomfort Scale (SPTDS)
1 day
Comfort levels pre-test post-test on experimental group
Time Frame: 1 day
VAS-10: A 10-cm line used to evaluate comfort; 0 = lowest, 10 = highest comfort. Higher scores reflect greater comfort.
1 day
Scores of Mental State Assessment pre-test post-test on control group
Time Frame: 1 day
Mini Mental State Assessment (MMSA): A cognitive screening tool with 11 items in five domains (orientation, registration, attention/calculation, recall, language). Scores range 0-30; ≤23 indicates impairment. Administration takes 5-10 minutes. Turkish validity and reliability are established.
1 day
Personal Information control group
Time Frame: 1 day
Personal Information Form: Developed by researchers based on literature and clinical observation. The first section includes demographic and clinical data (age, gender, education, diagnosis, preoperative fasting time, postoperative oral intake time). The second section records bowel sounds.
1 day
Scores of Surgical Period Thirst Discomfort pre-test post-test on control group
Time Frame: 1 day
Surgical Period Thirst Discomfort Scale (SPTDS): Adapted to 6 items with a 3-point Likert scale (0-2). Total score is 0-12; higher scores indicate greater thirst-related discomfort.Surgical Period Thirst Discomfort Scale (SPTDS)
1 day
Comfort levels pre-test post-test on control group
Time Frame: 1 day
VAS-10: A 10-cm line used to evaluate comfort; 0 = lowest, 10 = highest comfort. Higher scores reflect greater comfort.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pınar YILMAZ EKER, Asst. Prof. Dr., Cumhuriyet University
  • Study Director: Ayşegül KAYA İMREK, Res. Asst., Cumhuriyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

June 5, 2024

Primary Completion (Actual)

December 5, 2024

Study Completion (Actual)

December 5, 2024

Study Registration Dates

First Submitted

July 22, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to publish the study in an international journal.

IPD Sharing Time Frame

data were collected for 6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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