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

NCT06939842 | Completed

• 1 other identifier: IUC-SN-KT-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thirst; Sore Throat

Keywords

Lumbar Disc Disease; Thirst; Menthol; Ice

Outcome Measures

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.

  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

  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

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

Study Arms (3)

Menthol ice group

EXPERIMENTAL

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

Other: Menthol ice

Frozen saline group

EXPERIMENTAL

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

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.

Other: No Interventions

Interventions

Menthol ice OTHER

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.

Menthol ice group

Frozen saline OTHER

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.

Frozen saline group

No Interventions OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa Institute of Graduate Studies

Istanbul, Turkey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pharyngitis; Intervertebral disc disease

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Kübra TUNCEL, PhD-candidate

  Istanbul University-Cerrahpasa Institute of Graduate Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.)

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: April 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: November 30, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)