The Effect of Ice, Green Tea and Arnica Montana Application on Post-Operative Intubation Related Sore Throat and Hoarseness
1 other identifier
interventional
176
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2021
CompletedFirst Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
September 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2022
CompletedFebruary 20, 2025
October 1, 2022
9 months
July 13, 2021
February 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stout's hoarseness evaluation form
Stout's hoarseness evaluation form maximum 0= sound normal minimum of 3 = complete silence, speech
one day
visual analog scale
the visual analog scale criterion was used to evaluate sore throat. minimum 0 = no pain maximum 10 = severe pain
one day
Study Arms (4)
İce Pieces İmpregnated Group
ACTIVE COMPARATORImpregnation 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
Green Tea Gargle Solution Group
ACTIVE COMPARATORTo 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
Arnica Montana Tea Gargle Solution Group
ACTIVE COMPARATORTo 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.
Control Group
NO INTERVENTIONPatients 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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastern Mediterranean University, Nursing Department, Faculty of Health Sciences
Famagusta, North Cyprus Via Mersin 10, Turkey, Ammochostos, 99628, Cyprus
Related Publications (3)
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.
PMID: 27642569BACKGROUNDTsintzas 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.
PMID: 29228804BACKGROUNDBulut 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.
PMID: 27444760BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
gülcan dürüst sakallı, lecturer
doğu akdeniz üniversitesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Multiple blinding (data collectors, participants, statistician, and reporters) was performed in the Randomized Controlled Experiment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
July 13, 2021
First Posted
September 17, 2021
Study Start
June 14, 2021
Primary Completion
March 24, 2022
Study Completion
March 29, 2022
Last Updated
February 20, 2025
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share