- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236749
Effect of Postoperative Oral Rinsing on Dehydration-Related Discomfort, Comfort, and Bowel Movement
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
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sivas, Turkey (Türkiye)
- Sivas Cumhuriyet University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Pınar YILMAZ EKER, Asst. Prof. Dr., Cumhuriyet University
- Study Director: Ayşegül KAYA İMREK, Res. Asst., Cumhuriyet University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024-01/33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
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
Studies a U.S. FDA-regulated device product
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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