The Effect of Cold Vapor Application on Postoperative Sore Throat
Primary Purpose
Sore Throat
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cold vapor
Sponsored by
About this trial
This is an interventional prevention trial for Sore Throat focused on measuring Extubation, Sore throat, Cold vapor, Nursing
Eligibility Criteria
Inclusion Criteria:
- 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
- Literate
- No hearing problem
- Patients without understanding difficulties
Exclusion Criteria:
- 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
- ASA classification III and above
- Mallampati classification III and IV patients
- Patients with an operation time of less than 30 minutes
Sites / Locations
- Hatice Özsoy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Cold vapor was applied 3 times in total at 0th,2nd and 6th hours.
No cold vapor was applied at 0th,2nd and 6th hours.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05317520
First Posted
July 27, 2021
Last Updated
April 7, 2022
Sponsor
Burdur Mehmet Akif Ersoy University
1. Study Identification
Unique Protocol Identification Number
NCT05317520
Brief Title
The Effect of Cold Vapor Application on Postoperative Sore Throat
Official Title
The Effect of Cold Vapor Application on Sore Throat in The Patients Extubated After Surgery: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2016 (Actual)
Primary Completion Date
August 17, 2017 (Actual)
Study Completion Date
May 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Burdur Mehmet Akif Ersoy University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
Keywords
Extubation, Sore throat, Cold vapor, Nursing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were divided into intervention and control groups using a simple randomized control method.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Cold vapor was applied 3 times in total at 0th,2nd and 6th hours.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No cold vapor was applied at 0th,2nd and 6th hours.
Intervention Type
Procedure
Intervention Name(s)
Cold vapor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sore throat
Description
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.
Time Frame
Within an hour after surgery
Title
Sore throat
Description
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.
Time Frame
2nd hour after surgery
Title
Sore throat
Description
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.
Time Frame
6th hour after surgery
Title
Sore throat
Description
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.
Time Frame
24th hour after surgery
Secondary Outcome Measure Information:
Title
Hoarseness
Description
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.
Time Frame
Within an hour after surgery
Title
Hoarseness
Description
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.
Time Frame
2nd hour after surgery
Title
Hoarseness
Description
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.
Time Frame
6th hour after surgery
Title
Hoarseness
Description
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.
Time Frame
24th hour after surgery
Title
Dry throat and swallowing difficulty
Description
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.
Time Frame
Within an hour after surgery
Title
Dry throat and swallowing difficulty
Description
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.
Time Frame
2nd hour after surgery
Title
Dry throat and swallowing difficulty
Description
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.
Time Frame
6th hour after surgery
Title
Dry throat and swallowing difficulty
Description
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.
Time Frame
24th hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Literate
No hearing problem
Patients without understanding difficulties
Exclusion Criteria:
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
ASA classification III and above
Mallampati classification III and IV patients
Patients with an operation time of less than 30 minutes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Özsoy
Organizational Affiliation
Burdur Mehmet Akif Ersoy University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hatice Özsoy
City
Merkez
State/Province
Burdur
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
Learn more about this trial
The Effect of Cold Vapor Application on Postoperative Sore Throat
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