ThirstNCT06939842
The Effect of Menthol Ice and Frozen Saline Applications After Lumbar Disc Surgery
A study testing Menthol ice and Frozen saline in people with Thirst and Sore Throat, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to determine the effect of postoperative menthol ice and frozen saline applications on thirst and sore throat in patients undergoing lumbar disc surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thirst, Sore Throat
- What is being tested?
- Menthol ice and Frozen saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 30 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knowing how to read, write and speak Turkish
- Having no obstacle in understanding and communicating the information given
- Agreeing to participate in the research verbally and in writing after being informed about the research
- Ages 18 and over
- Those who underwent surgery under general anesthesia
- Those who have not yet started oral intake in the postoperative period
Show all 10Show fewer
- Without menthol allergy
- According to the American Society of Anesthesiologists (ASA) classification; Class I, II and III, Normal healthy patient (ASA I); Patient with mild systemic disease (ASA II); Patient with serious systemic disease that does not affect daily activities (ASA III)
- Having no sore throat before surgery
- As a result of the evaluation made with the Safety Protocol for Management Thirst in the Early Postoperative Period , patients who provide appropriate conditions for ice application (the individual must be conscious and oriented after the surgery, the airway must be open with coughing, swallowing and breathing, and there is no nausea or vomiting)
Who cannot join
- Those who have severe nausea and vomiting at the time of application
- Those with a change in consciousness status/acute confusion after surgical intervention
- Those with chronic disease/diseases related to Ear-Nose-Throat Diseases
- Patients with difficult intubate
- Patients with psychiatric problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa Institute of Graduate Studies
Istanbul, Turkey
About this study
Official title: The Effect of Menthol Ice and Frozen Saline Applications on Patients' Thirst and Sore Throat After Lumbar Disc Surgery
The aim of the study was to determine the effect of postoperative menthol ice and frozen saline applications on thirst and sore throat in patients undergoing lumbar disc surgery.
Read the detailed description
In the postoperative period, patients become susceptible to many complications that may develop due to general anaesthesia, endotracheal intubation, surgical intervention and clinical conditions. One of the conditions that patients experience quite intensely in the postoperative period and which is usually ignored in clinics is the feeling of thirst. Another problem that may occur in patients undergoing surgery under general anaesthesia is discomfort due to endotracheal intubation. Patients may experience problems such as sore throat, hoarseness, difficulty swallowing and dry throat in the postoperative period due to endotracheal intubation. Diagnosis and control of postoperative thirst and sore throat contribute to patient comfort and prevention of complications. This study is considered important because it draws attention to postoperative thirst and sore throat, a problem that surgical patients have.
- Conditions
- Thirst, Sore Throat
- Being tested
- Menthol ice, Frozen saline, No Interventions
- Keywords
- Lumbar Disc Disease, Thirst, Menthol, Ice
- Medical subject headings
- Pharyngitis, Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol iceOther
When patients are brought from the operating theatre to the surgical clinic, patients will be waited until they are able to communicate. In the first stage, after filling in the Patient Identification Form before the intervention, thirst status with Perioperative Thirst Discomfort Scale (PTDS) and sore throat status with the Numerical Pain Scale (NPS) will be evaluated. In the second stage, evaluation will be made according to the Safety Protocol for the Management of Immediate Postoperative Thirst and menthol ice will be applied if the patients meet the criteria in the protocol. Thirst will be re-evaluated with PTDS and sore throat will be re-evaluated with NPS at 30th and 60th minutes after the first application. Immediately after this evaluation, menthol ice will be applied for the second time. After the second application, thirst will be re-evaluated with PTDS at 30th and 60th minutes and sore throat will be re-evaluated with NPS.
Frozen salineOther
When patients are brought from the operating theatre to the surgical clinic, patients will be waited until they are able to communicate. In the first stage, after filling in the Patient Identification Form before the intervention, thirst status with Perioperative Thirst Discomfort Scale (PTDS) and sore throat status with the Numerical Pain Scale (NPS) will be evaluated. In the second stage, evaluation will be made according to the Safety Protocol for the Management of Immediate Postoperative Thirst and frozen saline will be applied if the patients meet the criteria in the protocol. Thirst will be re-evaluated with PTDS and sore throat will be re-evaluated with NPS at 30th and 60th minutes after the first application. Immediately after this evaluation, frozen saline will be applied for the second time. After the second application, thirst will be re-evaluated with PTDS at 30th and 60th minutes and sore throat will be re-evaluated with NPS.
No InterventionsOther
When patients are brought from the operating theatre to the surgical clinic, patients will be waited until they are able to communicate. In the first stage, after filling in the Patient Introduction Form before the intervention, thirst status with Perioperative Thirst Discomfort Scale (PTDS) and sore throat status with Numerical Pain Scale(NPS) will be evaluated. Patients in the control group will be waited for approximately 10 minutes, taking into account the application times in the intervention groups. No intervention will be applied during the waiting period. After 10 minutes of waiting time, thirst will be re-evaluated with PTDS and sore throat will be re-evaluated with NPS at 30th and 60th minutes. Considering the 2nd application time in the intervention groups, it will be waited again for approximately 10 minutes without any intervention. After the waiting period, thirst will be re-evaluated with PTDS at 30th and 60th minutes and sore throat will be re-evaluated with NPS.
| Study group | Role | What they receive |
|---|---|---|
| Menthol ice group | Experimental | The menthol ice group will be given menthol ice by the researcher. Receives: Other: Menthol ice |
| Frozen saline group | Experimental | The frozen saline group will be given frozen saline by the researcher. Receives: Other: Frozen saline |
| Control group | Other | There will be no intervention to the control group. Routine practices of the clinic (moisturizing the lips with wetgauze, cotton or tissue) will be performed by the nurses of the Surgery Clinics. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on the Perioperative Thirst Discomfort Scale
The Perioperative Thirst Discomfort Scale is a 6-item self-report instrument. It uses a 3-point Likert response format with each item rated as: 0 = Did not disturb, 1 = Somewhat disturbed, and 2 = Very disturbed. The total score ranges from 0 to 12, with higher scores indicating greater perioperative thirst discomfort. The scale has no sub-dimensions. It is used to quantitatively assess patients' perceived thirst discomfort during the perioperative period.
Measured: Baseline (pre-intervention), and at 30 and 60 minutes after each of two interventions (total of 5 time points within 2 hours post-op).
Secondary outcomes (2)
Throat Pain Intensity as Measured by the Numerical Pain Scale
Throat pain intensity was assessed using a Numerical Pain Scale ranging from 0 to 10, where 0 indicates no throat pain and 10 indicates the worst throat pain imaginable. Participants rated their throat pain by selecting a number that best described its intensity at the time of assessment. The Numerical Pain Scale is a validated and widely used tool for measuring subjective pain.
Measured: Baseline (pre-intervention), and at 30 and 60 minutes after each of two interventions (total of 5 time points within 2 hours post-op).
Eligibility for Oral Hydration Administration According to the Safety Protocol for Management Thirst in the Immediate Postoperative Period
The Safety Protocol for Thirst Management in the Immediate Postoperative Period is a checklist-based protocol designed to evaluate whether patients in the early post-anesthesia period are eligible for oral water or ice administration. The protocol assesses key clinical criteria such as level of consciousness, airway patency, and presence of nausea or vomiting. Only patients who meet all the checklist criteria are considered suitable for oral water or ice administration.
Measured: Baseline (pre-intervention) (total of one time point within post-op period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start15 Apr 2025
- Primary completion15 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThirstStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups with control group (The study was planned as an open-label, randomized, controlled, parallel group interventional study. Participants will be randomly assigned to groups.)
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra TUNCEL, Istanbul University - Cerrahpasa
- Investigators
- Kübra TUNCEL, PhD-candidate, Principal investigator, Istanbul University-Cerrahpasa Institute of Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939842
- Sponsor's protocol ID
- IUC-SN-KT-01
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menthol Ice and Frozen Saline Applications on Patients' Thirst and Sore Throat After Lumbar Disc Surgery
- ClinicalTrials.gov ID
- NCT06939842
- Acronym / sponsor ID
- IUC-SN-KT-01
- Conditions
- Thirst, Sore Throat
- Keywords
- Lumbar Disc Disease, Thirst, Menthol, Ice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 23 Apr 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 the study was to determine the effect of postoperative menthol ice and frozen saline applications on thirst and sore throat in patients undergoing lumbar disc surgery.
Detailed description
In the postoperative period, patients become susceptible to many complications that may develop due to general anaesthesia, endotracheal intubation, surgical intervention and clinical conditions. One of the conditions that patients experience quite intensely in the postoperative period and which is usually ignored in clinics is the feeling of thirst. Another problem that may occur in patients undergoing surgery under general anaesthesia is discomfort due to endotracheal intubation. Patients may experience problems such as sore throat, hoarseness, difficulty swallowing and dry throat in the postoperative period due to endotracheal intubation. Diagnosis and control of postoperative thirst and sore throat contribute to patient comfort and prevention of complications. This study is considered important because it draws attention to postoperative thirst and sore throat, a problem that surgical patients have.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups with control group (The study was planned as an open-label, randomized, controlled, parallel group interventional study. Participants will be randomly assigned to groups.)
| Arm | Type | Receives |
|---|---|---|
| Menthol ice group | Experimental | Other: Menthol iceThe menthol ice group will be given menthol ice by the researcher. |
| Frozen saline group | Experimental | Other: Frozen salineThe frozen saline group will be given frozen saline by the researcher. |
| Control group | Other | Other: No InterventionsThere will be no intervention to the control group. Routine practices of the clinic (moisturizing the lips with wetgauze, cotton or tissue) will be performed by the nurses of the Surgery Clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Knowing how to read, write and speak Turkish
- Having no obstacle in understanding and communicating the information given
- Agreeing to participate in the research verbally and in writing after being informed about the research
- Ages 18 and over
- Those who underwent surgery under general anesthesia
Key exclusion criteria (5 listed)
- Those who have severe nausea and vomiting at the time of application
- Those with a change in consciousness status/acute confusion after surgical intervention
- Those with chronic disease/diseases related to Ear-Nose-Throat Diseases
- Patients with difficult intubate
- Patients with psychiatric problems
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 |
|---|---|---|
| Menthol iceWhen patients are brought from the operating theatre to the surgical clinic, patients will be waited until they are able to communicate. In the first stage, after filling in the Patient Identification Form before the intervention, thirst status with Perioperative Thirst Discomfort Scale (PTDS) and sore throat status with the Numerical Pain Scale (NPS) will be evaluated. In the second stage, evaluation will be made according to the Safety Protocol for the Management of Immediate Postoperative Thirst and menthol ice will be applied if the patients meet the criteria in the protocol. Thirst will be re-evaluated with PTDS and sore throat will be re-evaluated with NPS at 30th and 60th minutes after the first application. Immediately after this evaluation, menthol ice will be applied for the second time. After the second application, thirst will be re-evaluated with PTDS at 30th and 60th minutes and sore throat will be re-evaluated with NPS. | Other | Menthol ice group |
| Frozen salineWhen patients are brought from the operating theatre to the surgical clinic, patients will be waited until they are able to communicate. In the first stage, after filling in the Patient Identification Form before the intervention, thirst status with Perioperative Thirst Discomfort Scale (PTDS) and sore throat status with the Numerical Pain Scale (NPS) will be evaluated. In the second stage, evaluation will be made according to the Safety Protocol for the Management of Immediate Postoperative Thirst and frozen saline will be applied if the patients meet the criteria in the protocol. Thirst will be re-evaluated with PTDS and sore throat will be re-evaluated with NPS at 30th and 60th minutes after the first application. Immediately after this evaluation, frozen saline will be applied for the second time. After the second application, thirst will be re-evaluated with PTDS at 30th and 60th minutes and sore throat will be re-evaluated with NPS. | Other | Frozen saline group |
| No InterventionsWhen patients are brought from the operating theatre to the surgical clinic, patients will be waited until they are able to communicate. In the first stage, after filling in the Patient Introduction Form before the intervention, thirst status with Perioperative Thirst Discomfort Scale (PTDS) and sore throat status with Numerical Pain Scale(NPS) will be evaluated. Patients in the control group will be waited for approximately 10 minutes, taking into account the application times in the intervention groups. No intervention will be applied during the waiting period. After 10 minutes of waiting time, thirst will be re-evaluated with PTDS and sore throat will be re-evaluated with NPS at 30th and 60th minutes. Considering the 2nd application time in the intervention groups, it will be waited again for approximately 10 minutes without any intervention. After the waiting period, thirst will be re-evaluated with PTDS at 30th and 60th minutes and sore throat will be re-evaluated with NPS. | Other | Control group |
Primary outcome
Total Score on the Perioperative Thirst Discomfort Scale
Time frame: Baseline (pre-intervention), and at 30 and 60 minutes after each of two interventions (total of 5 time points within 2 hours post-op).
The Perioperative Thirst Discomfort Scale is a 6-item self-report instrument. It uses a 3-point Likert response format with each item rated as: 0 = Did not disturb, 1 = Somewhat disturbed, and 2 = Very disturbed. The total score ranges from 0 to 12, with higher scores indicating greater perioperative thirst discomfort. The scale has no sub-dimensions. It is used to quantitatively assess patients' perceived thirst discomfort during the perioperative period.
2 secondary outcomes
Throat Pain Intensity as Measured by the Numerical Pain Scale
Time frame: Baseline (pre-intervention), and at 30 and 60 minutes after each of two interventions (total of 5 time points within 2 hours post-op).
Eligibility for Oral Hydration Administration According to the Safety Protocol for Management Thirst in the Immediate Postoperative Period
Time frame: Baseline (pre-intervention) (total of one time point within post-op period)
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 15 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Kübra TUNCEL, PhD-candidate principal investigator
Istanbul University-Cerrahpasa Institute of Graduate Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menthol ice and Frozen saline in people with Thirst and Sore Throat, run by Istanbul University - Cerrahpasa 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 10 inclusion and 5 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 15 Dec 2025. 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?
Total Score on the Perioperative Thirst Discomfort Scale (time frame: Baseline (pre-intervention), and at 30 and 60 minutes after each of two interventions (total of 5 time points within 2 hours post-op).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.