Spinal SurgeryNCT06857760
Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort
A study testing Ice cube, Mouth wash and Menthol lozenge in people with Spinal Surgery, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effects of postoperative methods on nausea, thirst and comfort levels of patients undergoing spinal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Surgery
- What is being tested?
- Ice cube, Mouth wash and Menthol lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2026to 8 May 2026
- 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
- Adult patients who underwent lumbar disc herniation (LDH) surgery
- LDH surgery patients who recieve general anesthesia
- The patients who were conscious
- The duration of surgery is between 0-3 hours
Who cannot join
- Patients who cannot understand and speak Turkish
- Allergic patients to menthol
- Patients who received spinal anesthesia
- Patients with lesions on the oral mucosa and lips
- Patients requiring intensive care after surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to determine the effects of postoperative methods on nausea, thirst and comfort levels of patients undergoing spinal surgery.
Read the detailed description
Within the scope of this randomized controlled study, it is aimed to evaluate the effectiveness of ice, mouthwash and menthol lozenge interventions to provide effects on postoperative nausea, thirst and comfort in patients undergoing spinal surgery
- Conditions
- Spinal Surgery
- Being tested
- Ice cube, Mouth wash, Menthol lozenge
- Keywords
- nausea, thirst, comfort
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice cubeOther
ıce cube
Mouth washOther
Mouth wash
Menthol lozengeOther
menthol lozenge
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Routine care |
| Ice cube | Experimental | Not described Receives: Other: Ice cube |
| Mouth wash | Experimental | Not described Receives: Other: Mouth wash |
| Menthol lozenge | Experimental | Not described Receives: Other: Menthol lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea
Nausea level: It consists of a numeric scale. Among the numbers, ''0'' corresponds to ''no thirst/nausea'' and ''10'' corresponds to ''very much thirst/nausea''. As the number increases, nausea and thirst will be accepted as increased. There is no cut-off point.
Measured: once before the application and 60, 120, 180 and 240 min. after arrival at the clinic
Thirst
Thirst level: A minimum score of 12 and a maximum score of 60 can be obtained from the scale. The higher the score obtained from the scale, the higher the level of thirst discomfort of the patients.
Measured: once before the application and 60, 120, 180 and 240 min. after arrival at the clinic
Comfort
Comfort level: The highest score that can be obtained from the scale is 192 and the lowest score is 48. A high SCS scoring indicates a high comfort level of the individual.
Measured: once before the application and 240 min. after arrival at the clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start28 Feb 2026
- Primary completion8 May 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal SurgeryStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trials
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge İşeri, Ondokuz Mayıs University
- Investigators
- Özge İşeri, PhD, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857760
- Sponsor's protocol ID
- A.30.2.ODM.0.20.08/569-677
- Status last verified
- Oct 2026
- First submitted
- 22 Feb 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Since this is a doctoral study, the results can be shared at the end of the thesis
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort
- ClinicalTrials.gov ID
- NCT06857760
- Acronym / sponsor ID
- A.30.2.ODM.0.20.08/569-677
- Conditions
- Spinal Surgery
- Keywords
- nausea, thirst, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 4 Mar 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 was to determine the effects of postoperative methods on nausea, thirst and comfort levels of patients undergoing spinal surgery.
Detailed description
Within the scope of this randomized controlled study, it is aimed to evaluate the effectiveness of ice, mouthwash and menthol lozenge interventions to provide effects on postoperative nausea, thirst and comfort in patients undergoing spinal surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized clinical trials
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Routine care |
| Ice cube | Experimental | Other: Ice cube |
| Mouth wash | Experimental | Other: Mouth wash |
| Menthol lozenge | Experimental | Other: Menthol lozenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients who underwent lumbar disc herniation (LDH) surgery
- LDH surgery patients who recieve general anesthesia
- The patients who were conscious
- The duration of surgery is between 0-3 hours
Key exclusion criteria (5 listed)
- Patients who cannot understand and speak Turkish
- Allergic patients to menthol
- Patients who received spinal anesthesia
- Patients with lesions on the oral mucosa and lips
- Patients requiring intensive care after surgical intervention
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 cubeıce cube | Other | Ice cube |
| Mouth washMouth wash | Other | Mouth wash |
| Menthol lozengementhol lozenge | Other | Menthol lozenge |
Primary outcome
Nausea
Time frame: once before the application and 60, 120, 180 and 240 min. after arrival at the clinic
Nausea level: It consists of a numeric scale. Among the numbers, ''0'' corresponds to ''no thirst/nausea'' and ''10'' corresponds to ''very much thirst/nausea''. As the number increases, nausea and thirst will be accepted as increased. There is no cut-off point.
Thirst
Time frame: once before the application and 60, 120, 180 and 240 min. after arrival at the clinic
Thirst level: A minimum score of 12 and a maximum score of 60 can be obtained from the scale. The higher the score obtained from the scale, the higher the level of thirst discomfort of the patients.
Comfort
Time frame: once before the application and 240 min. after arrival at the clinic
Comfort level: The highest score that can be obtained from the scale is 192 and the lowest score is 48. A high SCS scoring indicates a high comfort level of the individual.
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 2 Oct 2026.
- Individual participant dataSharing planned: Undecided. Since this is a doctoral study, the results can be shared at the end of the thesis
Related trials for Spinal Surgery
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
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.
Özge İşeri, PhD principal investigator
Ondokuz Mayıs 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 Ice cube, Mouth wash and Menthol lozenge in people with Spinal Surgery, run by Ondokuz Mayıs 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 4 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 2 Oct 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?
Nausea (time frame: once before the application and 60, 120, 180 and 240 min. after arrival at the clinic). The study lists 3 primary outcomes in all. 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 2 Oct 2026.