The Effect of Cold Vapor Application on Postoperative Sore Throat

NCT05317520 | Completed DMC

• 1 other identifier: Mehmet Akif Ersoy University
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of cold vapor given in the post-extubation period on sore throat.

Conditions

Sore Throat

Keywords

Extubation; Sore throat; Cold vapor; Nursing

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  24th hour after surgery

Secondary Outcomes (8)

• Hoarseness

  Within an hour after surgery

• Hoarseness

  2nd hour after surgery

• Hoarseness

  6th hour after surgery

• Hoarseness

  24th hour after surgery

• Dry throat and swallowing difficulty

  Within an hour after surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Procedure: Cold vapor

Control group

NO INTERVENTION

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

Interventions

Cold vapor 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who accept the research
• Elective laparoscopic cholecystectomy surgery planned
• Patients in ASA I and II class
• years and over
• Mallampati classification I and II
• Operation time more than 30 minutes
• Literate
• No hearing problem
• Patients without understanding difficulties

You may not qualify if:

• 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

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Hatice Özsoy

Merkez, Burdur, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Hatice Özsoy

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Patients were divided into intervention and control groups using a simple randomized control method.

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: April 7, 2022
• Study Start: December 16, 2016
• Primary Completion: August 17, 2017
• Study Completion: May 17, 2018
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication
• Access Criteria: Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)