search
Back to results

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

Primary Purpose

Sore Throat, Hoarseness

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Comparıson
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sore Throat focused on measuring green tea, arnico montana, ice Application, Endotracheal Intubation, Sore Throat, Nursing, Hoarseness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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,

Sites / Locations

  • Doğu Akdeniz Üniveristesi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

İce Pieces İmpregnated Group

Green Tea Gargle Solution Group

Arnica Montana Tea Gargle Solution Group

Control Group

Arm Description

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

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

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.

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.

Outcomes

Primary Outcome Measures

Stout's hoarseness evaluation form
Stout's hoarseness evaluation form maximum 0= sound normal minimum of 3 = complete silence, speech
visual analog scale
the visual analog scale criterion was used to evaluate sore throat. minimum 0 = no pain maximum 10 = severe pain

Secondary Outcome Measures

Full Information

First Posted
July 13, 2021
Last Updated
October 24, 2022
Sponsor
Eastern Mediterranean University
search

1. Study Identification

Unique Protocol Identification Number
NCT05048628
Brief Title
The Effect of Ice, Green Tea and Arnica Montana Application on Post-Operative Intubation Related Sore Throat and Hoarseness
Official Title
The Effect of Ice, Green Tea and Arnica Montana Application on Post-Operative Intubation Related Sore Throat and Hoarseness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
March 24, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat, Hoarseness
Keywords
green tea, arnico montana, ice Application, Endotracheal Intubation, Sore Throat, Nursing, Hoarseness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Four Groups. Group were comprised of control group, green tea Gargle Solution group, ice pieces impregnated group, arnica montana tea Gargle Solution group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Multiple blinding (data collectors, participants, statistician, and reporters) was performed in the Randomized Controlled Experiment.
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
İce Pieces İmpregnated Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Green Tea Gargle Solution Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arnica Montana Tea Gargle Solution Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Comparıson
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stout's hoarseness evaluation form
Description
Stout's hoarseness evaluation form maximum 0= sound normal minimum of 3 = complete silence, speech
Time Frame
one day
Title
visual analog scale
Description
the visual analog scale criterion was used to evaluate sore throat. minimum 0 = no pain maximum 10 = severe pain
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
gülcan dürüst sakallı, lecturer
Organizational Affiliation
doğu akdeniz üniversitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doğu Akdeniz Üniveristesi
City
Famagusta
State/Province
Famagusta, North Cyprus Via Mersin 10 Turkey
ZIP/Postal Code
99628
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27642569
Citation
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.
Results Reference
result
PubMed Identifier
29228804
Citation
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.
Results Reference
result
PubMed Identifier
27444760
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs