Sore ThroatNCT05048628
The Effect of Ice, Green Tea and Arnica Montana Application on Post-Operative Intubation Related Sore Throat and Hoarseness
A study testing Comparıson in people with Sore Throat and Hoarseness, run by Eastern Mediterranean University at 1 site in Cyprus.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sore Throat, Hoarseness
- What is being tested?
- Comparıson
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteCyprus
- Study dates
- 14 Jun 2021to 29 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- Having experience before surgery,
- The duration of the operation is 30 minutes or more,7
- No nasogastric catheter
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Eastern Mediterranean University, Nursing Department, Faculty of Health Sciences
Famagusta, North Cyprus Via Mersin 10, Turkey, Ammochostos, 99628
About this study
The study was planned to determine the effect of arnica montana, green tea mouthwash and ice particles impregnation on postoperative sore throat and hoarseness.
Read the 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?
- Conditions
- Sore Throat, Hoarseness
- Being tested
- Comparıson
- Keywords
- green tea, arnico montana, ice Application, Endotracheal Intubation, Sore Throat, Nursing, Hoarseness
- Medical subject headings
- Pharyngitis, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComparısonOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Comparıson |
| 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 Receives: Other: Comparıson |
| 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. Receives: Other: Comparıson |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stout's hoarseness evaluation form
Stout's hoarseness evaluation form maximum 0= sound normal
minimum of 3 = complete silence, speech
Measured: one day
visual analog scale
the visual analog scale criterion was used to evaluate sore throat. minimum 0 = no pain
maximum 10 = severe pain
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start14 Jun 2021
- Primary completion24 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Dürüst Sakallı, Eastern Mediterranean University
- Investigators
- gülcan dürüst sakallı, lecturer, Principal investigator, doğu akdeniz üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048628
- Sponsor's protocol ID
- EasternMU-SBF-HB-GDS-01
- Status last verified
- Oct 2022
- First submitted
- 13 Jul 2021
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27642569Tsintzas 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.
PubMed 29228804Bulut 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.
PubMed 27444760
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ice, Green Tea and Arnica Montana Application on Post-Operative Intubation Related Sore Throat and Hoarseness
- ClinicalTrials.gov ID
- NCT05048628
- Acronym / sponsor ID
- EasternMU-SBF-HB-GDS-01
- Conditions
- Sore Throat, Hoarseness
- Keywords
- green tea, arnico montana, ice Application, Endotracheal Intubation, Sore Throat, Nursing, Hoarseness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| İce Pieces İmpregnated Group | Active comparator | Other: ComparısonImpregnation 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 | Other: ComparısonTo 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 | Other: ComparısonTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComparısonOnly 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. | Other | Arnica Montana Tea Gargle Solution Group, Green Tea Gargle Solution Group, İce Pieces İmpregnated Group |
Primary outcome
Stout's hoarseness evaluation form
Time frame: one day
Stout's hoarseness evaluation form maximum 0= sound normal minimum of 3 = complete silence, speech
visual analog scale
Time frame: one day
the visual analog scale criterion was used to evaluate sore throat. minimum 0 = no pain maximum 10 = severe pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Results publication: PubMed 27642569Jafari 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 publication: PubMed 29228804Tsintzas 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 publication: PubMed 27444760Bulut 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gülcan dürüst sakallı, lecturer principal investigator
doğu akdeniz üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparıson in people with Sore Throat and Hoarseness, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stout's hoarseness evaluation form (time frame: one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05048628, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.