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CompletedNCT05048628Updated Feb 20, 2025

The Effect of Ice, Green Tea and Arnica Montana Application on Post-Operative Intubation Related Sore Throat and Hoarseness

An interventional study of Comparıson in Sore Throat and Hoarseness, sponsored by Eastern Mediterranean University. Completed at 1 site in Cyprus. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.

Primary conditionHoarsenessRegistry: PharyngitisReclassifiedWhy we changed it
Registry
Pharyngitis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hoarseness
Why
  1. The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Hoarseness.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study was planned to determine the effect of arnica montana, green tea mouthwash and ice particles impregnation on postoperative sore throat and hoarseness.

Read the detailed description

Research Hypotheses Hl: Gargling with green tea after surgery reduces sore throat. H2: Impregnation of postoperative ice particles reduces sore throat. H3: Post-operative gargling with arnico montana reduces sore throat. H4: Gargling with green tea after surgery reduces hoarseness. H5: Impregnation of postoperative ice particles reduces hoarseness. H6: Postoperative mouthwash with arnico montana reduces hoarseness.

Research Question

  1. Do ice particles impregnation, gargling with green tea and gargling with arnico montana reduce intubation-related sore throat in patients undergoing general anesthesia?
  2. Do ice particles impregnation, gargling with green tea and gargling with arnico montana reduce hoarseness due to intubation in patients undergoing general anesthesia?
02

Conditions studied

  • Sore Throat
  • Hoarseness

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Keywords

  • green tea
  • arnico montana
  • ice Application
  • Endotracheal Intubation
  • Sore Throat
  • Nursing
  • Hoarseness
03

In context

Hoarseness Reclassified

52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.

This study's enrollment of 176 is above the median of 108 across 44 interventional studies indexed under Hoarseness.

Browse Hoarseness studies →

Lead sponsor

Eastern Mediterranean University is the lead sponsor of 141 studies on the registry; 17 are open to participants now.

Compared within Hoarseness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. The counts are of registry records indexed under each term, 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

  • To agree to participate in the research,
  • To be 18 years or older,
  • To know how to read and write,
  • No hearing problem,
  • Not having difficulty in understanding,
  • To live before the operation,
  • Having experience before surgery,
  • The duration of the operation is 30 minutes or more,7
  • No nasogastric catheter

Exclusion criteria

Exclusion Criteria:

  • Having a sore throat before surgery,
  • Having hoarseness before surgery,
  • To have oral and neck surgery,
  • Having a history of allergy,
  • Having a nasogastric catheter,
  • The duration of the operation is less than 30 minutes,
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
176 participants (actual)

Study arms

  • Active comparator
    İce Pieces İmpregnated Group

    Impregnation of pieces of ice was delivered to us; one ice cube is planned after wearing and movements automatically by the throat purchase to exit use and sound program, and move with one ice cube after movement. It can be used after extubation. It is in sound class with Visual Analogue Scale (VAS) for the use of customers before and after the application. Extubation is in the last 0. hours, no small application is made, only in sound class with VAS. Evaluated by Stout's Hoarseness Scale

  • Active comparator
    Green Tea Gargle Solution Group

    To the patients included in the gargle group with green tea; four after, six after eigth after hours after extubation, the patients of the intervention group were asked to gargle 30 cc of green tea and before the application and after the patient's oral intake was requested by the physician to prevent sore throat and hoarseness afterwards, patients' sore throat is measured with Visual Analogue Scale (VAS) and hoarseness is measured with Stout's Hoarseness Scale. At the 0. th hour after extubation, no treatment is applied to the patients, only sore throat is evaluated with VAS and hoarseness is evaluated with Stout's Hoarseness Scale.0

  • Active comparator
    Arnica Montana Tea Gargle Solution Group

    To the patients included in the gargle group with arnica montana tea; four after, six after eigth after hours after extubation, the patients of the intervention group were asked to gargle 30 cc of arnica montana tea and before the application and after the patient's oral intake was requested by the physician to prevent sore throat and hoarseness afterwards, patients' sore throat is measured with Visual Analogue Scale (VAS) and hoarseness is measured with Stout's Hoarseness Scale. At the 0th hour after extubation, no treatment is applied to the patients, only sore throat is evaluated with VAS and hoarseness is evaluated with Stout's Hoarseness Scale.

  • No intervention
    Control Group

    Patients in the control group; sore throat and hoarseness scores at 0 hour immediately after extubation,to collect at 4, 6 and 8 hours after extubation, sore throat (Visual Analogue Scale) VAS; Stout s Voice if hoarseness It is evaluated with the Slightness Scale.

Interventions

  • OtherComparıson

    Only evaluation will be made at 0, 4, 6, and 8 hours after surgery without intervention in the control group. For other groups; Evaluation will be made at the 0th hour after the operation without application. The application will be made at the 4th, 6th, and 8th hours after the surgery and the resulting pain and hoarseness will be evaluated.

06

What researchers measure

Primary outcomes

  1. Stout's hoarseness evaluation form

    Stout's hoarseness evaluation form maximum 0= sound normal minimum of 3 = complete silence, speech

    Time frame: one day

  2. visual analog scale

    the visual analog scale criterion was used to evaluate sore throat. minimum 0 = no pain maximum 10 = severe pain

    Time frame: one day

07

Study locations

1 site
  • Eastern Mediterranean University, Nursing Department, Faculty of Health Sciences
    Famagusta, North Cyprus via Mersin 10, Turkey, Famagusta 99628, Cyprus
08

References and documents

Publications

  • Jafari H, Ariaeifar MR, Yazdani Charati J, Soleimani A, Nasiri Formi E. The Effect of Green Tea Gargle Solution on Sore Throat After Coronary Artery Bypass Grafting: A Randomized Clinical Trial. Anesth Pain Med. 2016 May 9;6(3):e32108. doi: 10.5812/aapm.32108. eCollection 2016 Jun. PubMed 27642569 ↗
  • Tsintzas D, Vithoulkas G. Treatment of Postoperative Sore Throat With the Aid of the Homeopathic Remedy Arnica montana: A Report of Two Cases. J Evid Based Complementary Altern Med. 2017 Oct;22(4):926-928. doi: 10.1177/2156587217735986. Epub 2017 Nov 2. PubMed 29228804 ↗
  • Bulut H, Erden S, Demir SG, Cakar B, Erdogan Z, Demir N, Ay A, Aydin E. The Effect of Cold Vapor Applied for Sore Throat in the Early Postoperative Period. J Perianesth Nurs. 2016 Aug;31(4):291-7. doi: 10.1016/j.jopan.2014.10.005. Epub 2016 Feb 24. PubMed 27444760 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05048628
Responsible party
Gülcan Dürüst Sakallı (lecturer, Eastern Mediterranean University) — Principal investigator
First posted
Sep 17, 2021
Start date
Jun 14, 2021
Primary completion
Mar 24, 2022
Completion
Mar 29, 2022
Last update
Feb 20, 2025

Study contacts

gülcan dürüst sakallı, lecturer
principal investigator · doğu akdeniz üniversitesi

Oversight

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

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