Patient SatisfactionNCT06507696
Comparison of the Efficiency of Two Different Methods in Managing Early Postoperative Thirst
A study testing Ice Application and Wetted Gauze Application in people with Patient Satisfaction and Nursing Caries, run by Acibadem University at 2 sites in Turkey (Türkiye).
Trial summary
Postoperative thirst is one of the most common problems in patients. Thirst is a subjective symptom. Thirst can cause unwanted problems in patients such as anxiety, discomfort and nausea. It may even cause anxiety, hypertension, dysrhythmia, non-compliance with treatment and increased need for anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Nursing Caries, Post-Op Complication
- What is being tested?
- Ice Application and Wetted Gauze Application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 31 Mar 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years
- undergoing elective surgery
- Patients undergoing surgery other than gastrointestinal system surgery
- Patients in class I, II, III according to the American anesthesiologists' association classification (ASA)
- Patients who have completed a minimum of 6 hours of strict fasting and 3 hours of thirst
- Patients who can verbally express a thirst level of 4 points or more according to visual benchmark scale in the early postoperative period
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- Patients who comply with the safety protocol in the early postoperative period
- Patients who can express their thirst in the early postoperative period/recovery unit
- Patients with a duration of surgical anesthesia ≥1 hour and taken to the recovery unit at the end of surgery will be included in the study.
Who cannot join
- Emergency planned surgeries
- Patients who had a second surgical intervention during the hospitalization period
- Patients who need intensive care after surgery
- Patients with problems in the extubation process after surgery
- Patients with altered state of consciousness after surgery
- Patients with fluid electrolyte imbalance (hypovolemia and sodium imbalance)
Show all 11Show fewer
- Patients with swallowing difficulties and fluid intake restriction
- Foreign patients with language barriers
- Patients with menthol allergy
- Patients with problems in the head, neck, throat and mouth will be excluded from the sample.
- Women who have just given birth and are breastfeeding.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Yasemin Uslu
Istanbul, Ataşehir, 34752
Acıbadem University
Istanbul, Eyalet/Yerleşke, 34752
About this study
Official title: Comparison of the Efficacy of Ice and Soaked Gauze in Managing Early Postoperative Thirst
Postoperative thirst is one of the most common problems in patients. Thirst is a subjective symptom. Thirst can cause unwanted problems in patients such as anxiety, discomfort and nausea. It may even cause anxiety, hypertension, dysrhythmia, non-compliance with treatment and increased need for anesthesia. Although different methods have been applied in the management of thirst in the existing literature and positive results have been obtained, studies with high evidence value are very limited. The aim of this study was to compare the effectiveness of two different methods in thirst management.
Read the detailed description
In this study, the investigators compared the effectiveness of two of the methods proposed in the literature for the relief of postoperative thirst.
These methods are ice application and wet gauze. A numerical comparison scale was used to assess and monitor thirst (0=no thirst, 10=worst perceived thirst).
In patients with a thirst score of 4 and above in the early postoperative period, the duration of thirst severity and the method of quenching thirst with oral ice or wet gauze impregnation were compared. In addition, a control group without any intervention was included. The thirst conditions of these three groups were compared.
A total of 240 patients, 80 in each group, were included in the study. Oral ice was applied in one group, wet gauze in the second group and no intervention was applied in the third group.
- Conditions
- Patient Satisfaction, Nursing Caries, Post-Op Complication
- Being tested
- Ice Application, Wetted Gauze Application
- Keywords
- thirst management, postoperative care, surgical patient, surgical thirsty
- Medical subject headings
- Patient Satisfaction, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice ApplicationOther
Drinking water was placed in a syringe and filled in the refrigerator
Wetted Gauze ApplicationOther
Sterile gauze soaked with drinking water
| Study group | Role | What they receive |
|---|---|---|
| Ice Application | Experimental | * In ice application, 5 ml of drinking water was filled in a 10 ml syringe and frozen by inserting a plastic piston into it and then these frozen ice cubes were given into the mouths of the patients.
* The ice cubes were prepared before the application and stored in the freezer section of the refrigerator.
* The ice was taken out of the frozen syringe and the nurse moved it around the patient's mouth to melt it.
* By holding the ice cubes from the piston part to the researcher, the patient was allowed to suck and melt them in the mouth. Receives: Other: Ice Application |
| Wetted Gauze Application | Experimental | * During wetted gauze application, sterile gauze swabs were wetted with drinking water.
* Sterile gauze swabs (10 cm*10cm) were wetted with 5 ml and applied for 5 minutes.
* The wetted end part of the gauze swabs was allowed to be sucked in the patient's mouth by the researcher. Receives: Other: Wetted Gauze Application |
| No intervention | No intervention | Patients in the control group did not receive any application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thirst score
Visual Comparion Scale (VCS) was used to assess thirst. In this scale, thirst was graded from 0 to 10. 0=no thirst, 10=the most severe thirst.
The scale was evaluated as 0-3 points mild thirst, 4-6 points moderate thirst, 7-10 points severe thirst.
- First follow-up (T1): Patient's thirst level measured by VCS and intervention (ice application or wet gauze application)
- Second follow-up (T2); evaluation was performed with VCS 5 minutes after the application.
- Third follow-up (T3); evaluation was performed with VCS 30 minutes after the application.
- Fourth follow-up (T4); assessment was performed with VCS 60 minutes after the application.
Fifth follow-up (T5); evaluation was performed with VCS 90 minutes after the application.
The thirst level of the patient was measured 5 times in total. At 90 minutes, data collection was terminated.
Scores between 5 measurement values were compared.
Measured: Using Thirst Visual Comparion Scale score after immediately after surgery (T1) 5th min.(T2), 30th min.(T3), 60th min.(T4), 90th min.(T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Jan 2023
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Parallel Assignment Randomized controlled
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Uslu, Acibadem University
- Investigators
- Fevzi Toraman, Prof. Dr., Study director, Acıbadem Mehmet Ali Aydınlar Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507696
- Sponsor's protocol ID
- 2022-21/01
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Serato VM, Fonseca LF, Birolim MM, Rossetto EG, Mai LD, Garcia AKA. Package of menthol measures for thirst relief: a randomized clinical study. Rev Bras Enferm. 2019 Jun 27;72(3):600-608. doi: 10.1590/0034-7167-2018-0057. English, Portuguese.
PubMed 31269122Peyrot des Gachons C, Avrillier J, Gleason M, Algarra L, Zhang S, Mura E, Nagai H, Breslin PA. Oral Cooling and Carbonation Increase the Perception of Drinking and Thirst Quenching in Thirsty Adults. PLoS One. 2016 Sep 29;11(9):e0162261. doi: 10.1371/journal.pone.0162261. eCollection 2016.
PubMed 27685093Nascimento LAD, Garcia AKA, Conchon MF, Aroni P, Pierotti I, Martins PR, Nakaya TG, Fonseca LF. Advances in the Management of Perioperative Patients' Thirst. AORN J. 2020 Feb;111(2):165-179. doi: 10.1002/aorn.12931.
PubMed 31997333Nascimento LA, Fonseca LF, Rosseto EG, Santos CB. [Development of a safety protocol for management thirst in the immediate postoperative period]. Rev Esc Enferm USP. 2014 Oct;48(5):834-43. doi: 10.1590/s0080-6234201400005000009. Portuguese.
PubMed 25493487Conchon MF, Fonseca LF. Efficacy of an Ice Popsicle on Thirst Management in the Immediate Postoperative Period: A Randomized Clinical Trial. J Perianesth Nurs. 2018 Apr;33(2):153-161. doi: 10.1016/j.jopan.2016.03.009. Epub 2017 Mar 21.
PubMed 29580594Cho EA, Kim KH, Park JY. [Effects of frozen gauze with normal saline and ice on thirst and oral condition of laparoscopic cholecystectomy patients: pilot study]. J Korean Acad Nurs. 2010 Oct;40(5):714-23. doi: 10.4040/jkan.2010.40.5.714. Korean.
PubMed 21157173
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Ice and Soaked Gauze in Managing Early Postoperative Thirst
- ClinicalTrials.gov ID
- NCT06507696
- Acronym / sponsor ID
- 2022-21/01
- Conditions
- Patient Satisfaction, Nursing Caries, Post-Op Complication
- Keywords
- thirst management, postoperative care, surgical patient, surgical thirsty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 18 Jul 2024 (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.
Postoperative thirst is one of the most common problems in patients. Thirst is a subjective symptom. Thirst can cause unwanted problems in patients such as anxiety, discomfort and nausea. It may even cause anxiety, hypertension, dysrhythmia, non-compliance with treatment and increased need for anesthesia. Although different methods have been applied in the management of thirst in the existing literature and positive results have been obtained, studies with high evidence value are very limited. The aim of this study was to compare the effectiveness of two different methods in thirst management.
Detailed description
In this study, the investigators compared the effectiveness of two of the methods proposed in the literature for the relief of postoperative thirst.
These methods are ice application and wet gauze. A numerical comparison scale was used to assess and monitor thirst (0=no thirst, 10=worst perceived thirst).
In patients with a thirst score of 4 and above in the early postoperative period, the duration of thirst severity and the method of quenching thirst with oral ice or wet gauze impregnation were compared. In addition, a control group without any intervention was included. The thirst conditions of these three groups were compared.
A total of 240 patients, 80 in each group, were included in the study. Oral ice was applied in one group, wet gauze in the second group and no intervention was applied in the third group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Ice Application | Experimental | Other: Ice Application* In ice application, 5 ml of drinking water was filled in a 10 ml syringe and frozen by inserting a plastic piston into it and then these frozen ice cubes were given into the mouths of the patients. * The ice cubes were prepared before the application and stored in the freezer section of the refrigerator. * The ice was taken out of the frozen syringe and the nurse moved it around the patient's mouth to melt it. * By holding the ice cubes from the piston part to the researcher, the patient was allowed to suck and melt them in the mouth. |
| Wetted Gauze Application | Experimental | Other: Wetted Gauze Application* During wetted gauze application, sterile gauze swabs were wetted with drinking water. * Sterile gauze swabs (10 cm*10cm) were wetted with 5 ml and applied for 5 minutes. * The wetted end part of the gauze swabs was allowed to be sucked in the patient's mouth by the researcher. |
| No intervention | No intervention | –Patients in the control group did not receive any application |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18-65 years
- undergoing elective surgery
- Patients undergoing surgery other than gastrointestinal system surgery
- Patients in class I, II, III according to the American anesthesiologists' association classification (ASA)
- Patients who have completed a minimum of 6 hours of strict fasting and 3 hours of thirst
Key exclusion criteria (11 listed)
- Emergency planned surgeries
- Patients who had a second surgical intervention during the hospitalization period
- Patients who need intensive care after surgery
- Patients with problems in the extubation process after surgery
- Patients with altered state of consciousness after 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 |
|---|---|---|
| Ice ApplicationDrinking water was placed in a syringe and filled in the refrigerator | Other | Ice Application |
| Wetted Gauze ApplicationSterile gauze soaked with drinking water | Other | Wetted Gauze Application |
Primary outcome
Thirst score
Time frame: Using Thirst Visual Comparion Scale score after immediately after surgery (T1) 5th min.(T2), 30th min.(T3), 60th min.(T4), 90th min.(T5)
Visual Comparion Scale (VCS) was used to assess thirst. In this scale, thirst was graded from 0 to 10. 0=no thirst, 10=the most severe thirst. The scale was evaluated as 0-3 points mild thirst, 4-6 points moderate thirst, 7-10 points severe thirst. * First follow-up (T1): Patient's thirst level measured by VCS and intervention (ice application or wet gauze application) * Second follow-up (T2); evaluation was performed with VCS 5 minutes after the application. * Third follow-up (T3); evaluation was performed with VCS 30 minutes after the application. * Fourth follow-up (T4); assessment was performed with VCS 60 minutes after the application. Fifth follow-up (T5); evaluation was performed with VCS 90 minutes after the application. The thirst level of the patient was measured 5 times in total. At 90 minutes, data collection was terminated. Scores between 5 measurement values were compared.
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 18 Jul 2024.
- Results publication: PubMed 31269122Serato VM, Fonseca LF, Birolim MM, Rossetto EG, Mai LD, Garcia AKA. Package of menthol measures for thirst relief: a randomized clinical study. Rev Bras Enferm. 2019 Jun 27;72(3):600-608. doi: 10.1590/0034-7167-2018-0057. English, Portuguese.
- Results publication: PubMed 27685093Peyrot des Gachons C, Avrillier J, Gleason M, Algarra L, Zhang S, Mura E, Nagai H, Breslin PA. Oral Cooling and Carbonation Increase the Perception of Drinking and Thirst Quenching in Thirsty Adults. PLoS One. 2016 Sep 29;11(9):e0162261. doi: 10.1371/journal.pone.0162261. eCollection 2016.
- Results publication: PubMed 31997333Nascimento LAD, Garcia AKA, Conchon MF, Aroni P, Pierotti I, Martins PR, Nakaya TG, Fonseca LF. Advances in the Management of Perioperative Patients' Thirst. AORN J. 2020 Feb;111(2):165-179. doi: 10.1002/aorn.12931.
- Results publication: PubMed 25493487Nascimento LA, Fonseca LF, Rosseto EG, Santos CB. [Development of a safety protocol for management thirst in the immediate postoperative period]. Rev Esc Enferm USP. 2014 Oct;48(5):834-43. doi: 10.1590/s0080-6234201400005000009. Portuguese.
- Results publication: PubMed 29580594Conchon MF, Fonseca LF. Efficacy of an Ice Popsicle on Thirst Management in the Immediate Postoperative Period: A Randomized Clinical Trial. J Perianesth Nurs. 2018 Apr;33(2):153-161. doi: 10.1016/j.jopan.2016.03.009. Epub 2017 Mar 21.
- Results publication: PubMed 21157173Cho EA, Kim KH, Park JY. [Effects of frozen gauze with normal saline and ice on thirst and oral condition of laparoscopic cholecystectomy patients: pilot study]. J Korean Acad Nurs. 2010 Oct;40(5):714-23. doi: 10.4040/jkan.2010.40.5.714. Korean.
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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.
Fevzi Toraman, Prof. Dr. study director
Acıbadem Mehmet Ali Aydınlar Üniversitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice Application and Wetted Gauze Application in people with Patient Satisfaction and Nursing Caries, run by Acibadem University at 2 sites 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 9 inclusion and 11 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 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Thirst score (time frame: Using Thirst Visual Comparion Scale score after immediately after surgery (T1) 5th min.(T2), 30th min.(T3), 60th min.(T4), 90th min.(T5)). 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 NCT06507696, which also lists 6 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 18 Jul 2024.