Sore-throatNCT06191783
The Effect Of Preoperative Anxiety Level On Postoperative SoreThroat
An observational study of Sore-throat and Anxiety, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sore-throat, Anxiety
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2023to 2 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enrol volunteer men and women between the ages of 18 and 65 who have undergone a tympanoplasty.
Who may be able to join
- Intubated under general anesthesia
- Surgical time ≥30 minutes and ≤ 4 hours
- 18-65 years old
- ASA I-II patients will be included in the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balikesir University Faculty of Medicine
Balıkesir
About this study
Official title: The Effect Of Preoperative Anxiety Level On Postoperative SoreThroat In Tympanoplasty Patients
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.
Read more
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.
Read the detailed description
Demographic data (age, gender, height, weight, body mass index (BMI) and ASA classification will be recorded preoperatively. The trait and state anxiety scale (STAI-T and STAI-S) will be administered at the preoperative visit. Standard anesthesia monitoring (electrocardiogram-ECG, noninvasive blood pressure-NIBP, pulse oximetry-SPO2, temperature, EtCO2- End Tidal Carbon Dioxide), neuromuscular monitoring (TOF) will be performed before anesthesia induction. These data will be recorded at 5 minute (min) intervals from the beginning to the end of the operation. A vascular access of appropriate width will be opened and 10 ml/kg balanced crystalloid fluid infusion will be started. Lidocaine 1 mg/kg, fentanyl 1 mg/kg, propofol 2-3 mg/kg and rocuronium 0.6 mg/kg will be administered intravenously (IV). Then, when the Train of four rate (TOFR) response is zero, orotracheal intubation will be performed with Macintosh bleyd 3 or 4 by selecting straight tubes with an inner diameter of 8.0-8.5 mm for male patients and 7-7.5 mm for female patients. (In case of neuromuscular blocker requirement, rocuronium 0.1 mg/kg IV will be administered additionally. Endotracheal tube (ETT) cuff pressure will be adjusted to 20-30 cmH2O with a cuff manometer. ETT cuff pressure will be measured at 20 minute intervals and recorded in the file. Anesthesia maintenance will be performed with 0.5 L/min fresh gas flow, oxygen concentration with inspiratory oxygen level between 40-45, sevoflurane with a minimum alveolar concentration (MAK) of 1.0. Mechanical ventilation will be performed with Volume-Auto Flow mode with EtCO₂ between 35-40 mmHg. Analgesia maintenance will be provided with remifentanil infusion (0.6-15 mcg/kg/hour). In case of (±) 15% change in the haemodynamic parameters of the patient compared to the baseline values, remifentanil infusion dose will be intervened by increasing and decreasing at the specified intervals and the amount consumed intraoperatively at the end of the operation will be recorded. Hypotension will be defined as hypotension when systolic arterial pressure decreases by 30% compared to baseline. In the treatment, 250 ml of 0.9% NaCl rapid infusion will be administered first. If no response is obtained, 10 mg ephedrine IV will be given. When bradycardia occurs (heart rate ≤50 beats/min), atropine 0.5 mg IV will be administered.
Paracetamol 10 mg/kg and tramadol 1 mg/kg will be administered before the operation is terminated. Fresh gas flow will be increased to 8 L/min at the end of the operation. Sugammadex 4 mg/kg will be administered IV to terminate neuromuscular blockade. When TOFR is 0.9, the patient will be extubated and transferred to the postoperative recovery unit (PACU). Patients with Aldrete score ≥ 9 will be transferred from PACU to the ward.
The time from skin incision until the end of the surgical procedure will be recorded as "Operation Time". The time between the termination of sevoflurane (Sevorane 100% inhalation solution) flow and extubation will be recorded as "Extubation Time", and the time between anesthesia induction and extubation will be recorded as "Anesthesia Time". The time between the patient's admission to the PACU and discharge to the ward will be recorded as "Recovery Time".
Postoperative complaints of sore throat, hoarseness, cough, nausea and vomiting will be recorded at 0, 2, 4 and 24 hours using numerical rating scales (NRS). At the and of the study patients will be evaluated according to STAI-I and divided into 2 groups. Group 1: Patients below 45 points - no anxiety. Group 2: Patients with scores above 45 - there is anxiety.
The intraoperative data and postoperative complication status of the volunteers will be followed up by an anesthetist who is not aware of the results of the anxiety rating scale and recorded in the file.
Numerical Rating Scale (NRS): Zero indicates no pain and ten points indicates unbearable pain.
All patients will be asked whether they have sore throat at 0, 2, 4, 12 and 24 hours postoperatively. Patients will be asked to give a score between 0-10 for sore throat.
- Conditions
- Sore-throat, Anxiety
- Keywords
- anxiety, sore throat, STAI, tympanoplasty
- Medical subject headings
- Pharyngitis, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postopertive 24 hours
Secondary outcomes (1)
cough, nausea-vomiting and hoarseness
All patients will be asked whether they complain of hoarseness at 0, 2, 4, 12 and 24 hours postoperatively. Patients will be asked to give a score between 0-1-2-3 for hoarseness.
All patients will be asked about cough at 0, 2, 4, 12 and 24 hours postoperatively. Patients will be asked to give a score between 0-1-2-3 for cough complaint.
All patients will be asked about nausea and vomiting at 0, 2, 4, 12 and 24 hours postoperatively. Patients will be asked to give a score between 0-1-2-3 for nausea and vomiting.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start2 Feb 2023
- Primary completion2 Jul 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sore-throatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazan KOCAOGLU, MD, Balikesir University
- Investigators
- Nazan Kocaoğlu, Study director, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191783
- Sponsor's protocol ID
- FY-2023-20
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35504632Stamenkovic 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.
PubMed 29624026
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Preoperative Anxiety Level On Postoperative SoreThroat In Tympanoplasty Patients
- ClinicalTrials.gov ID
- NCT06191783
- Acronym / sponsor ID
- FY-2023-20
- Conditions
- Sore-throat, Anxiety
- Keywords
- anxiety, sore throat, STAI, tympanoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Demographic data (age, gender, height, weight, body mass index (BMI) and ASA classification will be recorded preoperatively. The trait and state anxiety scale (STAI-T and STAI-S) will be administered at the preoperative visit. Standard anesthesia monitoring (electrocardiogram-ECG, noninvasive blood pressure-NIBP, pulse oximetry-SPO2, temperature, EtCO2- End Tidal Carbon Dioxide), neuromuscular monitoring (TOF) will be performed before anesthesia induction. These data will be recorded at 5 minute (min) intervals from the beginning to the end of the operation. A vascular access of appropriate width will be opened and 10 ml/kg balanced crystalloid fluid infusion will be started. Lidocaine 1 mg/kg, fentanyl 1 mg/kg, propofol 2-3 mg/kg and rocuronium 0.6 mg/kg will be administered intravenously (IV). Then, when the Train of four rate (TOFR) response is zero, orotracheal intubation will be performed with Macintosh bleyd 3 or 4 by selecting straight tubes with an inner diameter of 8.0-8.5 mm for male patients and 7-7.5 mm for female patients. (In case of neuromuscular blocker requirement, rocuronium 0.1 mg/kg IV will be administered additionally. Endotracheal tube (ETT) cuff pressure will be adjusted to 20-30 cmH2O with a cuff manometer. ETT cuff pressure will be measured at 20 minute intervals and recorded in the file. Anesthesia maintenance will be performed with 0.5 L/min fresh gas flow, oxygen concentration with inspiratory oxygen level between 40-45, sevoflurane with a minimum alveolar concentration (MAK) of 1.0. Mechanical ventilation will be performed with Volume-Auto Flow mode with EtCO₂ between 35-40 mmHg. Analgesia maintenance will be provided with remifentanil infusion (0.6-15 mcg/kg/hour). In case of (±) 15% change in the haemodynamic parameters of the patient compared to the baseline values, remifentanil infusion dose will be intervened by increasing and decreasing at the specified intervals and the amount consumed intraoperatively at the end of the operation will be recorded. Hypotension will be defined as hypotension when systolic arterial pressure decreases by 30% compared to baseline. In the treatment, 250 ml of 0.9% NaCl rapid infusion will be administered first. If no response is obtained, 10 mg ephedrine IV will be given. When bradycardia occurs (heart rate ≤50 beats/min), atropine 0.5 mg IV will be administered.
Paracetamol 10 mg/kg and tramadol 1 mg/kg will be administered before the operation is terminated. Fresh gas flow will be increased to 8 L/min at the end of the operation. Sugammadex 4 mg/kg will be administered IV to terminate neuromuscular blockade. When TOFR is 0.9, the patient will be extubated and transferred to the postoperative recovery unit (PACU). Patients with Aldrete score ≥ 9 will be transferred from PACU to the ward.
The time from skin incision until the end of the surgical procedure will be recorded as "Operation Time". The time between the termination of sevoflurane (Sevorane 100% inhalation solution) flow and extubation will be recorded as "Extubation Time", and the time between anesthesia induction and extubation will be recorded as "Anesthesia Time". The time between the patient's admission to the PACU and discharge to the ward will be recorded as "Recovery Time".
Postoperative complaints of sore throat, hoarseness, cough, nausea and vomiting will be recorded at 0, 2, 4 and 24 hours using numerical rating scales (NRS). At the and of the study patients will be evaluated according to STAI-I and divided into 2 groups. Group 1: Patients below 45 points - no anxiety. Group 2: Patients with scores above 45 - there is anxiety.
The intraoperative data and postoperative complication status of the volunteers will be followed up by an anesthetist who is not aware of the results of the anxiety rating scale and recorded in the file.
Numerical Rating Scale (NRS): Zero indicates no pain and ten points indicates unbearable pain.
All patients will be asked whether they have sore throat at 0, 2, 4, 12 and 24 hours postoperatively. Patients will be asked to give a score between 0-10 for sore throat.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enrol volunteer men and women between the ages of 18 and 65 who have undergone a tympanoplasty.
Key inclusion criteria (4 listed)
- Intubated under general anesthesia
- Surgical time ≥30 minutes and ≤ 4 hours
- 18-65 years old
- ASA I-II patients will be included in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
STAI-I&sore throat
Time frame: postopertive 24 hours
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.
1 secondary outcome
cough, nausea-vomiting and hoarseness
Time frame: postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Background: PubMed 35504632Jiang 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.
- Results publication: PubMed 29624026Stamenkovic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazan Kocaoğlu study director
Balikesir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sore-throat and Anxiety, run by Balikesir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STAI-I&sore throat (time frame: postopertive 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06191783, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.