Clinical trial NCT04923490: Anxiety Levels in Adolescents Undergoing Endoscopy
Official title: Evaluation of State and Trait Anxiety Levels in Adolescents Undergoing Endoscopy Under Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: Adolescent
anxiety
endoscopy
anesthesia
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-06-11
Enrollment: 180
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 180 pediatric patients

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: anxiety level
timeFrame: before anesthesia induction
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa YIERH
Study officials:
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Ümran Ü Karaca, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Derya D Karasu, Assoc Prof
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Şermin Ş Eminoğlu, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Şeyda Efsun ŞE Özgünay, Assoc Prof
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Tuğba T Onur, MD
role: STUDY_CHAIR
References: