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CompletedNCT06939842Updated Dec 15, 2025

The Effect of Menthol Ice and Frozen Saline Applications After Lumbar Disc Surgery

An interventional study of Menthol ice and Frozen saline in Thirst and Sore Throat, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.

Primary conditionPharyngitis(the registry's first term)UnverifiedIs this wrong?The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Thirst
  • Sore Throat

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Keywords

  • Lumbar Disc Disease
  • Thirst
  • Menthol
  • Ice
03

In context

Pharyngitis Unverified

226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's enrollment of 102 is below the median of 144 across 188 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.

Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • Without menthol allergy
  • According to the (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)

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Menthol ice group

    The menthol ice group will be given menthol ice by the researcher.

    Other: Menthol ice

  • Experimental
    Frozen saline group

    The frozen saline group will be given frozen saline by the researcher.

    Other: Frozen saline

  • Other
    Control group

    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.

    Other: No Interventions

Interventions

  • OtherMenthol ice

    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.

  • OtherFrozen saline

    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.

  • OtherNo Interventions

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    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).

Secondary outcomes

  1. 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.

    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).

  2. 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.

    Time frame: Baseline (pre-intervention) (total of one time point within post-op period)

07

Study locations

1 site
  • Istanbul University-Cerrahpasa Institute of Graduate Studies
    Istanbul, Turkey, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06939842
Responsible party
Kübra TUNCEL (Principal Investigator, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Apr 23, 2025
Start date
Apr 15, 2025
Primary completion
Oct 15, 2025
Completion
Nov 30, 2025
Last update
Dec 15, 2025

Study contacts

Kübra TUNCEL, PhD-candidate
principal investigator · Istanbul University-Cerrahpasa Institute of Graduate Studies

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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