Anxiety Levels in Adolescents Undergoing Endoscopy

June 9, 2021 updated by: Umran Karaca, Bursa Yüksek İhtisas Education and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16000
        • Bursa YIERH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

180 pediatric patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anxiety level
Time Frame: 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
before anesthesia induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bursa hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Abstract of record

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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