Scale for Evaluating Oral and Pharyngolaryngeal Symptoms After General Anesthesia

NCT06755853 | Recruiting DMC

• 1 other identifier: SEOPSAGA
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

More than 320 million surgical procedures are performed worldwide each year, and most of these procedures are performed under general anesthesia. In such anesthesia practices, patients' airways are usually managed by endotracheal intubation (ETT) or laryngeal mask (LM). These airway management techniques can lead to various pharyngolaryngeal symptoms in the postoperative period. The most common complications include sore throat, hoarseness, difficulty swallowing, and laryngeal injuries. Endotracheal intubation can cause laryngeal injuries, especially during tube placement and removal. These injuries can lead to serious complications such as edema, granuloma, thickening of the vocal cords, subluxation, and nerve palsy. The frequency of postoperative pharyngolaryngeal symptoms varies depending on the type of surgical intervention the patient has undergone, the duration of intubation, and the experience of the operators. Most pharyngolaryngeal injuries are associated with factors such as incorrect placement of the endotracheal tube, overinflation, prolonged indwelling, or incorrect use of the laryngeal mask. However, these symptoms are often considered transient and are often overlooked by patients or healthcare professionals. However, in some cases, long-term functional disorders related to voice, swallowing, and airway patency may develop. The assessment of pharyngolaryngeal symptoms is critical for more effective management of patients throughout the treatment process and for optimizing their care. Early recognition and management of these symptoms by nurses and other healthcare professionals can reduce complications and increase patient satisfaction. There is no standard scale in the literature that can assess and classify these symptoms after surgical anesthesia. Existing assessments usually address symptoms separately and are usually performed with subjective measurements. The aim of this study was to develop a scale that can more systematically assess oral and pharyngolaryngeal symptoms such as sore throat, hoarseness, and difficulty swallowing after surgical interventions. Conducting validity and reliability tests of this scale will be an important step in improving patient care during surgical procedures and managing postoperative symptoms more effectively. The aim of this study was to develop a scale to assess pharyngolaryngeal symptoms after general anesthesia and to determine its validity and reliability.

Conditions

General Anesthesia

Keywords

general anesthesia; Oropharyngeal Symptom; Pharyngolaryngeal Symptom; Scale Development

Outcome Measures

Primary Outcomes (4)

• Draft Scale for Assessing Oral and Pharyngolaryngeal Symptoms After General Anesthesia

  Since a similar scale to the Post-General Anesthesia Oral and Pharyngolaryngeal Symptom Assessment Scale could not be found, a 46-item oral and pharyngolaryngeal symptom assessment scale created by the researcher based on literature will be used to develop the scale. Reliability and validity studies of the draft scale will be conducted.

  Scale Development work takes an average of 2 years

• Draft Scale for Evaluating Oral and Pharyngolaryngeal Symptoms After General Anesthesia Expert Opinion Evaluation Form

  In order for the draft scale prepared by the researcher to be evaluated by experts, the suitability of the scale items/questions will be measured with the "Expert Opinion Evaluation Form for the Draft Scale for the Evaluation of Oral and Pharyngolaryngeal Symptoms After General Anesthesia".

  average 2 months

• Vizuel Analog Skalası (VAS)

  The VAS value is determined by measuring the distance between the leftmost end of the scale and the marked point. The scale can be used to evaluate subjective conditions such as pain, anxiety, hunger, thirst, dry mouth, fatigue, weakness, and nausea. The values range from 0 to 10, and higher values indicate an increase in the severity of the symptoms being evaluated. A Visual Analog Scale (VAS) consisting of a total of 10 symptoms (sore throat, dry throat, difficulty swallowing, hoarseness, numbness in the tongue, difficulty speaking, shortness of breath, numbness/abnormal sensation in the throat, change in taste, and dry mouth) consisting of the same content as the prepared draft scale was created. VAS will be used to determine the parallel form reliability of the draft scale.

  average 2 years

• Sociodemographic Characteristics Form

  The Sociodemographic Characteristics Form created by the researcher consists of a total of 20 questions. The sociodemographic characteristics form was created by the researcher in accordance with the literature. As a result of the literature review, risk factors leading to pharyngolaryngeal injury (gender, age, weight in kilograms, smoking, gastroesophageal reflux history, type and duration of surgical intervention, type of tube used, tube size, difficult intubation, multiple applications of laryngoscope, use of gastric tube, muscle relaxation, use of propofol, postoperative vomiting, pharyngeal aspiration status) will be reported.

  average 2 years

Study Arms (1)

patients receiving general anesthesia

During general anesthesia, endotracheal intubation or laryngeal mask is usually used to ensure airway patency and prevent aspiration. Both endotracheal tube the researcher will meet face to face with the sample group who volunteered to participate in the study and apply the Informed Consent Form and Sociodemographic Characteristics Form (questions 1-9) before surgery. After surgery, the patient will fill in questions 10-20 of the Sociodemographic Characteristics Form according to the information received from the patient file or healthcare personnel. The Post-General Anesthesia Oral and Pharygolaryngeal Symptoms Assessment Scale will be applied at the 2nd hour after surgery. As a result of the literature review, it was seen that pharyngolaryngeal symptoms were generally evaluated at the 1st, 2nd and 24th hours after surgery.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In order to develop a scale, the sample should be at least 5 times the number of items in the scale and at least 10 times to increase its reliability. For the pilot application, it is sufficient to select 30-50 participants who can represent the target audience. Accordingly, the pilot study will be conducted with 50 people. After the pilot study, construct validity analyses will be conducted using Explanatory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) with the remaining items. If there is a sufficiently large sample, it is often recommended to apply EFA to half of the data and CFA to the other half. Therefore, at least five times as many patients as the number of items will be included in the sample group for EFA and at least five times as many patients for CFA.

You may qualify if:

• Patients between the ages of 18-65
• Patients who have received general anesthesia
• Patients who are conscious
• Patients who can communicate verbally
• Patients who volunteer to participate in the study

You may not qualify if:

• Patients who received spinal-epidural or regional anesthesia
• Patients who have any discomfort in the oral-pharynx-larynx regions
• Patients who have undergone any surgical intervention in the oral-pharynx-larynx regions.

Sponsors & Collaborators

• Nuh Naci Yazgan University: lead

Study Sites (1)

Erciyes Universty

Kayseri, Türkiye, Turkey (Türkiye)

RECRUITING

Study Officials

• Fadime Ertural, Lecturer

  Nuh Naci Yazgan University

  PRINCIPAL INVESTIGATOR

• Salime Mucuk, Prof. Dr.

  TC Erciyes University

  STUDY DIRECTOR

Central Study Contacts

Fadime Ertural, Lecturer

CONTACT

+905535904409; fertural@nny.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 1, 2025
• Study Start: May 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)