Sore ThroatNCT05317520
The Effect of Cold Vapor Application on Postoperative Sore Throat
A study testing Cold vapor in people with Sore Throat, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
To determine the effect of cold vapor given in the post-extubation period on sore throat. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sore Throat
- What is being tested?
- Cold vapor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2016to 17 May 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who accept the research
- Elective laparoscopic cholecystectomy surgery planned
- Patients in ASA I and II class
- 18 years and over
- Mallampati classification I and II
- Operation time more than 30 minutes
Show all 9Show fewer
- Literate
- No hearing problem
- Patients without understanding difficulties
Who cannot join
- Overweight patients (Body Mass Index ≥ 40)
- Patients with sore throat and lower respiratory tract infection
- Patients with Chronic Obstructive Pulmonary Disease (COPD)
- Patients with a history of allergies
- Patients with hearing problems
- illiterate patients
Show all 9Show fewer
- ASA classification III and above
- Mallampati classification III and IV patients
- Patients with an operation time of less than 30 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cold Vapor Application on Sore Throat in The Patients Extubated After Surgery: A Randomized Control Trial
To determine the effect of cold vapor given in the post-extubation period on sore throat.
Read the detailed description
General anesthesia increases the comfort of the patient by ensuring that the patient does not feel the surgical interventions and pain during the operation. The necessity of intubation is known in patients who have undergone surgery under general anesthesia. Intubation provides benefits such as keeping the airway open, controlling the airway and breathing, reducing respiratory effort and dead space volume, preventing aspiration, and facilitating resuscitation in case of any problem.
Although surgical interventions are an important treatment option for health problems, postoperative complications such as sore throat, dry throat, hoarseness and dysphagia due to laryngeal and pharyngeal traumas caused by intubation are frequently observed especially in patients receiving general anesthesia.
Although it is seen in the literature that pharmacological, non-pharmacological and herbal methods are applied to reduce postoperative sore throat, there are not enough studies examining the effect of cold steam application on sore throat. With this research, it is expected that the cold steam given in the postoperative period will contribute to the relief of sore throat.
- Conditions
- Sore Throat
- Being tested
- Cold vapor
- Keywords
- Extubation, Sore throat, Cold vapor, Nursing
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold vaporProcedure or surgery
The Ramsey Sedation Scale was used to assess wakefulness after patients were extubated and arrived at the recovery unit at the 0th hour postoperatively. Sore throat, localization of pain, hoarseness, dry throat, and swallowing difficulty were evaluated in patients with a score of 2 according to this scale. Sore throat of the patients was evaluated with Numerical Rating Scale. Then, cold vapor was applied for 15 minutes with a vapor machine used as a standard in the hospital by the researcher. After the cold vapor application was finished, the patients' sore throat, localization of pain, hoarseness, swallowing difficulty and dry throat were re-evaluated with the same forms.
Sore throat were evaluated before the application of cold vapor at the 2nd and 6th hours. Then cold vapor was applied for 15 minutes. After the cold vapor application was finished, sore throat were re-evaluated.
At the 24th hour, cold vapor was not applied to the patients. Only sore throat were evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Cold vapor was applied 3 times in total at 0th,2nd and 6th hours. Receives: Procedure: Cold vapor |
| Control group | No intervention | No cold vapor was applied at 0th,2nd and 6th hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sore throat
In our study, a horizontally prepared Numerical Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of their sore throat on a scale of 0 to 10. The scale begins with the absence of pain (0) and ends with excruciating pain (10).
When the patient came to the recovery unit, the severity of sore throat was evaluated before and after the application of cold vapor at 0th hour.
Measured: Within an hour after surgery
Sore throat
In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10).
The severity of sore throat was evaluated before and after the application of cold vapor at 2nd hour postoperatively.
Measured: 2nd hour after surgery
Sore throat
In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10).
The severity of sore throat was evaluated before and after the application of cold vapor at 6th hour postoperatively.
Measured: 6th hour after surgery
Sore throat
In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10).
Cold vapor was not applied to the patients at the 24th hour.. Only sore throat were evaluated.
Measured: 24th hour after surgery
Secondary outcomes (8)
Hoarseness
To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating.Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech).
When the patient came to the recovery unit, the severity of hoarseness was evaluated before and after the application of cold vapor at the 0th hour.
Measured: Within an hour after surgery
Hoarseness
To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating. Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech).
The severity of hoarseness was evaluated before and after the application of cold vapor at the 2nd hour postoperatively.
Measured: 2nd hour after surgery
Hoarseness
To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating. Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech).
The severity of hoarseness was evaluated before and after the application of cold vapor at the 6th hour postoperatively.
Measured: 6th hour after surgery
Hoarseness
To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating. Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech).
Cold vapor was not applied to the patients at the 24th hour. Only hoarseness was evaluated.
Measured: 24th hour after surgery
Dry throat and swallowing difficulty
The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable).
When the patient came to the recovery unit, the severity of throat dryness and swallowing difficulty was evaluated before and after the application of cold vapor at the 0th hour.
Measured: Within an hour after surgery
Dry throat and swallowing difficulty
The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable).
At the 2nd hour postoperatively, the severity of throat dryness and swallowing difficulty were evaluated before and after the application of cold vapor.
Measured: 2nd hour after surgery
Dry throat and swallowing difficulty
The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable).
At the 6th hour postoperatively, the severity of throat dryness and swallowing difficulty were evaluated before and after the application of cold vapor.
Measured: 6th hour after surgery
Dry throat and swallowing difficulty
The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable).
Cold vapor was not applied to the patients at the 24th hour. Only dry throat and swallowing difficulty were evaluated.
Measured: 24th hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start16 Dec 2016
- Primary completion17 Aug 2017
- Study completion17 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were divided into intervention and control groups using a simple randomized control method.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Özsoy, Burdur Mehmet Akif Ersoy University
- Investigators
- Hatice Özsoy, Principal investigator, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317520
- Sponsor's protocol ID
- Mehmet Akif Ersoy University
- Status last verified
- Apr 2022
- First submitted
- 27 Jul 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Vapor Application on Sore Throat in The Patients Extubated After Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05317520
- Acronym / sponsor ID
- Mehmet Akif Ersoy University
- Conditions
- Sore Throat
- Keywords
- Extubation, Sore throat, Cold vapor, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 17 Aug 2017 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 7 Apr 2022 (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.
To determine the effect of cold vapor given in the post-extubation period on sore throat.
Detailed description
General anesthesia increases the comfort of the patient by ensuring that the patient does not feel the surgical interventions and pain during the operation. The necessity of intubation is known in patients who have undergone surgery under general anesthesia. Intubation provides benefits such as keeping the airway open, controlling the airway and breathing, reducing respiratory effort and dead space volume, preventing aspiration, and facilitating resuscitation in case of any problem.
Although surgical interventions are an important treatment option for health problems, postoperative complications such as sore throat, dry throat, hoarseness and dysphagia due to laryngeal and pharyngeal traumas caused by intubation are frequently observed especially in patients receiving general anesthesia.
Although it is seen in the literature that pharmacological, non-pharmacological and herbal methods are applied to reduce postoperative sore throat, there are not enough studies examining the effect of cold steam application on sore throat. With this research, it is expected that the cold steam given in the postoperative period will contribute to the relief of sore throat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were divided into intervention and control groups using a simple randomized control method.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Cold vaporCold vapor was applied 3 times in total at 0th,2nd and 6th hours. |
| Control group | No intervention | –No cold vapor was applied at 0th,2nd and 6th hours. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Those who accept the research
- Elective laparoscopic cholecystectomy surgery planned
- Patients in ASA I and II class
- 18 years and over
- Mallampati classification I and II
Key exclusion criteria (9 listed)
- Overweight patients (Body Mass Index ≥ 40)
- Patients with sore throat and lower respiratory tract infection
- Patients with Chronic Obstructive Pulmonary Disease (COPD)
- Patients with a history of allergies
- Patients with hearing problems
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 |
|---|---|---|
| Cold vaporThe Ramsey Sedation Scale was used to assess wakefulness after patients were extubated and arrived at the recovery unit at the 0th hour postoperatively. Sore throat, localization of pain, hoarseness, dry throat, and swallowing difficulty were evaluated in patients with a score of 2 according to this scale. Sore throat of the patients was evaluated with Numerical Rating Scale. Then, cold vapor was applied for 15 minutes with a vapor machine used as a standard in the hospital by the researcher. After the cold vapor application was finished, the patients' sore throat, localization of pain, hoarseness, swallowing difficulty and dry throat were re-evaluated with the same forms. Sore throat were evaluated before the application of cold vapor at the 2nd and 6th hours. Then cold vapor was applied for 15 minutes. After the cold vapor application was finished, sore throat were re-evaluated. At the 24th hour, cold vapor was not applied to the patients. Only sore throat were evaluated. | Procedure or surgery | Intervention group |
Primary outcome
Sore throat
Time frame: Within an hour after surgery
In our study, a horizontally prepared Numerical Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of their sore throat on a scale of 0 to 10. The scale begins with the absence of pain (0) and ends with excruciating pain (10). When the patient came to the recovery unit, the severity of sore throat was evaluated before and after the application of cold vapor at 0th hour.
Sore throat
Time frame: 2nd hour after surgery
In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10). The severity of sore throat was evaluated before and after the application of cold vapor at 2nd hour postoperatively.
Sore throat
Time frame: 6th hour after surgery
In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10). The severity of sore throat was evaluated before and after the application of cold vapor at 6th hour postoperatively.
Sore throat
Time frame: 24th hour after surgery
In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10). Cold vapor was not applied to the patients at the 24th hour.. Only sore throat were evaluated.
8 secondary outcomes
Hoarseness
Time frame: Within an hour after surgery
Hoarseness
Time frame: 2nd hour after surgery
Hoarseness
Time frame: 6th hour after surgery
Hoarseness
Time frame: 24th hour after surgery
Dry throat and swallowing difficulty
Time frame: Within an hour after surgery
Dry throat and swallowing difficulty
Time frame: 2nd hour after surgery
Dry throat and swallowing difficulty
Time frame: 6th hour after surgery
Dry throat and swallowing difficulty
Time frame: 24th hour after surgery
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 14 Apr 2022.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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.
Hatice Özsoy principal investigator
Burdur Mehmet Akif Ersoy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold vapor in people with Sore Throat, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
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 9 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 14 Apr 2022. 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 Turkey (Türkiye). 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?
Sore throat (time frame: Within an hour after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2022.