Postoperative ThirstNCT07236749
Effect of Postoperative Oral Rinsing on Dehydration-Related Discomfort, Comfort, and Bowel Sounds
A study testing oral rinsing and rutine service operation in people with Postoperative Thirst and Comfort, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Thirst, Comfort, Bowel Movements
- What is being tested?
- oral rinsing and rutine service operation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2024to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Postoperative Oral Rinsing on Thirst-Related Discomfort, Comfort Level, and Bowel Sounds 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.
- Conditions
- Postoperative Thirst, Comfort, Bowel Movements, Abdominal Surgeries
- Being tested
- oral rinsing, rutine service operation
- Keywords
- Postoperative Thirst, Comfort, Bowel Movements, Abdominal surgeries, Nursing care, perioperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral rinsingOther
The experimental group received a postoperative mouth rinse with pure water.
rutine service operationOther
No additional intervention will be made to the control group; only data collection forms will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal surgery patients receiving oral rinsing | Experimental | Abdominal surgery patients Receives: Other: oral rinsing |
| rutine service operation | Other | Abdominal surgery patients Receives: Other: rutine service operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start5 Jun 2024
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative ThirstStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised conrtolled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar YILMAZ EKER, Cumhuriyet University
- Investigators
- Pınar YILMAZ EKER, Asst. Prof. Dr., Principal investigator, Cumhuriyet UniversityAyşegül KAYA İMREK, Res. Asst., Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236749
- Sponsor's protocol ID
- 2024-01/33
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to publish the study in an international journal.
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.
PubMed 27369684Yaray 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.
PubMed 22033000Özsoy, 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 at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Oral Rinsing on Thirst-Related Discomfort, Comfort Level, and Bowel Sounds in Individuals Undergoing Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07236749
- Acronym / sponsor ID
- 2024-01/33
- Conditions
- Postoperative Thirst, Comfort, Bowel Movements, Abdominal Surgeries
- Keywords
- Postoperative Thirst, Comfort, Bowel Movements, Abdominal surgeries, Nursing care, perioperative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised conrtolled trial
| Arm | Type | Receives |
|---|---|---|
| Abdominal surgery patients receiving oral rinsing | Experimental | Other: oral rinsingAbdominal surgery patients |
| rutine service operation | Other | Other: rutine service operationAbdominal surgery patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral rinsingThe experimental group received a postoperative mouth rinse with pure water. | Other | Abdominal surgery patients receiving oral rinsing |
| rutine service operationNo additional intervention will be made to the control group; only data collection forms will be applied. | Other | rutine service operation |
Primary outcome
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.
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.
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)
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.
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.
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.
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Results publication: PubMed 27369684Babacan-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.
- Results publication: PubMed 22033000Yaray 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.
- Results publicationÖzsoy, 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.
- Individual participant dataSharing planned: Yes. We plan to publish the study in an international journal.
Related trials for Postoperative Thirst
Not yet recruiting
The Effects of Menthol and Cold Spray Applications on Thirst and Comfort in Bariatric Surgery
Thirst in Bariatric Surgery Patients
Recruiting
Early Oral Hydration in Relieving Postoperative Thirst
Thirst; Due to Deprivation of Water, Patient Satisfaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pınar YILMAZ EKER, Asst. Prof. Dr. principal investigator
Cumhuriyet University
Ayşegül KAYA İMREK, Res. Asst. study director
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral rinsing and rutine service operation in people with Postoperative Thirst and Comfort, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of Mental State Assessment pre-test post-test on experimental group (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07236749, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.