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

NCT ID: NCT07236749

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2024-12-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Thirst Comfort Bowel Movements Abdominal Surgeries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised conrtolled trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Abdominal surgery patients receiving oral rinsing

Abdominal surgery patients

Group Type EXPERIMENTAL

oral rinsing

Intervention Type OTHER

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

rutine service operation

Abdominal surgery patients

Group Type OTHER

rutine service operation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

oral rinsing

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

Intervention Type OTHER

rutine service operation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cumhuriyet University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pınar YILMAZ EKER

Asst. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pınar YILMAZ EKER, Asst. Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Cumhuriyet University

Ayşegül KAYA İMREK, Res. Asst.

Role: STUDY_DIRECTOR

Cumhuriyet University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sivas Cumhuriyet University

Sivas, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 27369684 (View on PubMed)

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.

Reference Type RESULT
PMID: 22033000 (View on PubMed)

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.

Reference Type RESULT

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-01/33

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Waiting Time in the Premedication Room on Anxiety
NCT06477731 ACTIVE_NOT_RECRUITING