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

NCT07236749 | Completed DMC

• 1 other identifier: 2024-01/33
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Thirst; Comfort; Bowel Movements; Abdominal Surgeries

Keywords

Postoperative Thirst; Comfort; Bowel Movements; Abdominal surgeries; Nursing care; perioperative care

Outcome Measures

Primary Outcomes (8)

• Scores of Mental State Assessment pre-test post-test on experimental group

  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

  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

  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

  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

  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

  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

  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

  VAS-10: A 10-cm line used to evaluate comfort; 0 = lowest, 10 = highest comfort. Higher scores reflect greater comfort.

  1 day

Study Arms (2)

Abdominal surgery patients receiving oral rinsing

EXPERIMENTAL

Abdominal surgery patients

Other: oral rinsing

rutine service operation

OTHER

Abdominal surgery patients

Other: rutine service operation

Interventions

oral rinsing OTHER

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

Abdominal surgery patients receiving oral rinsing

rutine service operation OTHER

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

rutine service operation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

Location

Related Publications (3)

• Babacan-Yildiz G, Ur-Ozcelik E, Kolukisa M, Isik AT, Gursoy E, Kocaman G, Celebi A. [Validity and Reliability Studies of Modified Mini Mental State Examination (MMSE-E) For Turkish Illiterate Patients With Diagnosis of Alzheimer Disease]. Turk Psikiyatri Derg. 2016 Spring;27(1):41-6. Turkish.

  PMID: 27369684 RESULT

• Yaray O, Akesen B, Ocaklioglu G, Aydinli U. Validation of the Turkish version of the visual analog scale spine score in patients with spinal fractures. Acta Orthop Traumatol Turc. 2011;45(5):353-8. doi: 10.3944/AOTT.2011.2528.

  PMID: 22033000 RESULT

• Özsoy, H. , Güreş, Z., Dolgun, E. & Yavuz van Giersbergen, M. (2023). Cerrahi Dönem Susuzluğa Bağlı Rahatsızlık Ölçeği (CDSBRÖ) Türkçe Geçerlik ve Güvenirliği. Fırat Üniversitesi Sağlık Bilimleri Dergisi, 37 (3), 237- 242.

  RESULT

Study Officials

• Pınar YILMAZ EKER, Asst. Prof. Dr.

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

• Ayşegül KAYA İMREK, Res. Asst.

  Cumhuriyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study used a stratified random sampling method. Patients were stratified by clinical diagnosis and gender and randomized into blocks. Using a random number table, the first patient to arrive was assigned to the experimental group, and subsequent patients were sampled using a 1:1 allocation method until strata and blocks were equal in both groups.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: Randomised conrtolled trial

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: November 19, 2025
• Study Start: June 5, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data were collected for 6 months

Locations

TU (1)