The Effect Of Preoperative Anxiety Level On Postoperative SoreThroat

NCT06191783 | Completed

• 1 other identifier: FY-2023-20
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Tympanoplasty is the general name given to operations in which the defect in the tympanic membrane is repaired with a connective tissue graft to correct the pathology in chronic otitis media and its sequelae. The pathology in the middle ear and mastoid system may vary from a central tympanic membrane perforation in which the mucosa and ossicles in the middle ear are completely dry to cholesteatoma in which the entire membrane and ossicles in the middle ear are destroyed and sometimes complications such as facial paralysis, labyrinth fistula, meningitis and brain abscess are observed. A simple myringoplasty in which only the perforated eardrum is repaired is the simplest type of tympanoplasty. A radical masteidectomy is a procedure in which the middle ear and the outer ear mastoid system are moulded into a single cavity. Anxiety is an emotional state defined as a restless feeling whose source is usually uncertain. It may cause abnormal haemodynamic changes as a result of sympathetic, parasympathetic and endocrine stimulation. Patients' anxiety and fear increase during the time they are waiting for the operation. Elimination of anxiety in the preoperative preparation period is important to improve the quality of postoperative recovery and reduce costs (4). Scales such as State-Trait Anxiety Inventory (STAI: State-Trait Anxiety Inventory), APAIS, Hospital Depression and Anxiety Scale (HADS), and Beck Anxiety Scale (Beck Anxiety Scale), which measure trait and state anxiety separately, can be used to determine anxiety levels. Postoperative sore throat (POST) is a common complication of general anesthesia. Although it is less harmful than other complications, it decreases postoperative comfort of patients and may prolong hospital stay. After intubation, patients may experience complications such as hoarseness, dysphagia, cough and dry throat with POST. The incidence related to tracheal intubation has been reported to be 62% and it is thought to be caused by injury with laryngoscopy or damage to the tracheal mucosa due to cuff pressure. Sore throat in the postoperative period negatively affects patient comfort and may lead to an unpleasant anesthetic experience. This study aimed to reveal the relationship between preoperative anxiety level and postoperative sore throat and other complications in patients undergoing tympanoplasty.

Conditions

Sore-throat; Anxiety

Keywords

anxiety; sore throat; STAI; tympanoplasty

Outcome Measures

Primary Outcomes (1)

• STAI-I&sore throat

  It will be investigated how effective the anxiety level is in patients with sore throat according to NRS (Numeric Rating Scale) at 0, 2, 4 and 24 hours.

  postopertive 24 hours

Secondary Outcomes (1)

• cough, nausea-vomiting and hoarseness

  postoperative 24 hours

Eligibility Criteria

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

Study Population

The study will enrol volunteer men and women between the ages of 18 and 65 who have undergone a tympanoplasty.

You may qualify if:

• Intubated under general anesthesia
• Surgical time ≥30 minutes and ≤ 4 hours
• years old
• ASA I-II patients will be included in the study

You may not qualify if:

• Those who are unable to read and understand the consent form and anxiety assessment scale
• Previous vocal cord surgery
• Previous head and neck surgery
• Pregnant women
• Patients using steroids
• Antidepressant drug users and patients diagnosed with psychiatric illness will be excluded from the study.

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Balikesir University Faculty of Medicine

Balıkesir, Turkey (Türkiye)

Location

Related Publications (2)

• Jiang J, Wang Z, Xu Q, Chen Q, Lu W. Development of a nomogram for prediction of postoperative sore throat in patients under general anaesthesia: a single-centre, prospective, observational study. BMJ Open. 2022 May 3;12(5):e059084. doi: 10.1136/bmjopen-2021-059084.

  PMID: 35504632 BACKGROUND

• Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.

  PMID: 29624026 RESULT

MeSH Terms

Conditions

Pharyngitis; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Nazan Kocaoğlu

  Balikesir University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 5, 2024
• Study Start: February 2, 2023
• Primary Completion: July 2, 2024
• Study Completion: August 2, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)