NCT05048628

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2022

Completed
Last Updated

February 20, 2025

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

July 13, 2021

Last Update Submit

February 18, 2025

Conditions

Keywords

green teaarnico montanaice ApplicationEndotracheal IntubationSore ThroatNursingHoarseness

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 COMPARATOR

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

Green Tea Gargle Solution Group

ACTIVE COMPARATOR

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

Arnica Montana Tea Gargle Solution Group

ACTIVE COMPARATOR

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.

Control Group

NO INTERVENTION

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

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 27642569BACKGROUND
  • 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.

    PMID: 29228804BACKGROUND
  • 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.

    PMID: 27444760BACKGROUND

MeSH Terms

Conditions

PharyngitisHoarseness

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVoice DisordersLaryngeal DiseasesRespiration DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Respiratory

Study Officials

  • gülcan dürüst sakallı, lecturer

    doğu akdeniz üniversitesi

    PRINCIPAL INVESTIGATOR

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

Locations