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NCT Number: NCT07236749

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral rinsing

Other

The experimental group received a postoperative mouth rinse with pure water.

rutine service operation

Other

No additional intervention will be made to the control group; only data collection forms will be applied.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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)

  8. 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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 19, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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