Anxiety Levels in Adolescents Undergoing Endoscopy

Anxiety Clinical Trial

Official title:

Evaluation of State and Trait Anxiety Levels in Adolescents Undergoing Endoscopy Under Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04923490
• Other study ID #: bursa hospital
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: June 2021
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of our study was to evaluate the pre-procedure state and trait anxiety levels of adolescents patients hospitalized for the purpose of gastrointestinal endoscopy performed under sedation.

Description:

Although anxiety is known to be a disorder that is much more relevant for adults, it is seen at a frequency of approximately 6.5% in the childhood and adolescence. Anxiety is usually examined in two different forms, state anxiety and trait anxiety. A total of 180 pediatric patients who underwent GIS endoscopy in our hospital were included in our study. Demographic data (age, gender, height, weight, educational status, school and grade), additional diseases and diagnoses were recorded. Our aim was to evaluate the anxiety and trait anxiety levels of adolescents scheduled for gastrointestinal system (GIS) endoscopy under sedation, after being admitted as a single-day inpatient and before the procedure. A form evaluating state and trait anxiety levels (Spielberger's state and trait anxiety scale) and another form consisting of demographic data were given to the patients. We requested that the forms be filled by the children themselves. After monitoring in the endoscopy unit, sedation was applied with IV anesthetic drugs routinely.Oxygenation was provided with nasal O2 in all patients. Heart rate (HR), mean arterial pressure (MAP) and oxygen saturation (SpO2) were monitored. Also complications (bradycardia, tachycardia, arrhythmia, hypotension, hypertension, bronchospasm, decrease in SpO2, apnea) were recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children aged 11-18 years

• ASA I-II

• cooperative

• literate

• undergoing elective endoscopic procedures

Exclusion Criteria:

• under 11 years of age

• uncooperative

• illiterate

• had known psychiatric disorders or were using psychiatric drugs

• emergency endoscopy

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• state and trait anxiety scale levels
While the STAI-I anxiety level is scored as "(1) never, (2) somewhat, (3) frequently, and (4) almost always", the scoring options in STAI-II are "(1) almost never, (2) sometimes, (3) most of the time, and (4) almost always".

Locations

Country	Name	City	State
Turkey	Bursa YIERH	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anxiety level	Score between 0-19: No anxiety Score between 20-39: Mild anxiety Score between 40-59: Moderate anxiety Score between 60-79: Severe anxiety 80 and above score: Panic level anxiety	before anesthesia induction