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

Sponsor

Eastern Mediterranean University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05048628

Collaborator

(none)

176

Enrollment

Location

Arms

14.6

Anticipated Duration (Months)

12.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sore Throat Hoarseness	Other: Comparıson	N/A

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?

Study Design

Study Type:

Interventional

Anticipated Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.Four Groups. Group were comprised of control group, green tea Gargle Solution group, ice pieces impregnated group, arnica montana tea Gargle Solution group.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Multiple blinding (data collectors, participants, statistician, and reporters) was performed in the Randomized Controlled Experiment.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 14, 2021

Actual Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Other: Comparıson 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.
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	Other: Comparıson 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.
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.	Other: Comparıson 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.
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.

Outcome Measures

Primary Outcome Measures

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