- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06857760
Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort
May 8, 2026 updated by: Özge İşeri, Ondokuz Mayıs University
The aim of this study was to determine the effects of postoperative methods on nausea, thirst and comfort levels of patients undergoing spinal surgery.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Özge İşeri Özge İşeri, Assistant Professor, PhD
- Phone Number: 03623121919
- Email: ozgepekiniseri@gmail.com
Study Contact Backup
- Name: Ayşe Kale Postgraduate doctorate student, RN, MSc
- Email: ayse.kale@amasya.edu.tr
Study Locations
-
-
-
Amasya, Turkey (Türkiye)
- Recruiting
- Amasya Şerefeddin Sabuncuoğlu Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Routine care
|
|
|
Experimental: Ice cube
|
ıce cube
|
|
Experimental: Mouth wash
|
Mouth wash
|
|
Experimental: Menthol lozenge
|
menthol lozenge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
once before the application and 60, 120, 180 and 240 min. after arrival at the clinic
|
|
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.
|
once before the application and 60, 120, 180 and 240 min. after arrival at the clinic
|
|
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.
|
once before the application and 240 min. after arrival at the clinic
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Özge İşeri, PhD, Ondokuz Mayıs University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2025
Primary Completion (Actual)
December 30, 2025
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
February 22, 2025
First Submitted That Met QC Criteria
February 27, 2025
First Posted (Actual)
March 4, 2025
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 8, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A.30.2.ODM.0.20.08/569-677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Since this is a doctoral study, the results can be shared at the end of the thesis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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