Anxiety Levels in Adolescents Undergoing Endoscopy

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04923490

Collaborator

(none)

180

Enrollment

Location

Actual Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: state and trait anxiety scale levels

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

180 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Jul 1, 2020

Outcome Measures

Primary Outcome Measures

anxiety level [before anesthesia induction]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bursa YIERH	Bursa		Turkey	16000

Sponsors and Collaborators

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

Principal Investigator: Ümran Ü Karaca, MD, Bursa Yüksek İhtisas Education and Research Hospital
Study Chair: Derya D Karasu, Assoc Prof, Bursa Yüksek İhtisas Education and Research Hospital
Study Chair: Şermin Ş Eminoğlu, MD, Bursa Yüksek İhtisas Education and Research Hospital
Study Chair: Şeyda Efsun ŞE Özgünay, Assoc Prof, Bursa Yüksek İhtisas Education and Research Hospital
Study Chair: Tuğba T Onur, MD, Bursa Yüksek İhtisas Education and Research Hospital