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

Sore Throat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05048628
• Other study ID #: EasternMU-SBF-HB-GDS-01
• Status: Completed
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: March 29, 2022

Study information

• Verified date: October 2022
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: March 29, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Dysphonia
• Hoarseness
• Pharyngitis
• Sore Throat

Intervention

Other:
• Comparison
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.

Locations

Country	Name	City	State
Cyprus	Dogu Akdeniz Üniveristesi	Famagusta	Famagusta, North Cyprus Via Mersin 10 Turkey

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

References & Publications (3)

Bulut H, Erden S, Demir SG, Çakar 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. — View 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.3 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stout's hoarseness evaluation form	Stout's hoarseness evaluation form maximum 0= sound normal; minimum of 3 = complete silence, speech	one day
Primary	visual analog scale	the visual analog scale criterion was used to evaluate sore throat. minimum 0 = no pain; maximum 10 = severe pain	one day