The Effect of Cold Vapor Application on Postoperative Sore Throat

NCT ID: NCT05317520

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-16
• Study Completion Date: 2018-05-17

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.

Conditions

Sore Throat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

Cold vapor was applied 3 times in total at 0th,2nd and 6th hours.

Group Type: EXPERIMENTAL

Cold vapor

Intervention Type: PROCEDURE

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.

Control group

No cold vapor was applied at 0th,2nd and 6th hours.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cold vapor

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Burdur Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Özsoy

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice Özsoy

Role: PRINCIPAL_INVESTIGATOR

Burdur Mehmet Akif Ersoy University

Locations

Hatice Özsoy

Merkez, Burdur, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Mehmet Akif Ersoy University

Identifier Type: -

Identifier Source: org_study_id