NCT04923490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

June 3, 2021

Last Update Submit

June 9, 2021

Conditions

Anxiety

Keywords

Adolescentanxietyendoscopyanesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

state and trait anxiety scale levelsBEHAVIORAL

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".

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

180 pediatric patients

You may qualify if:

  • Children aged 11-18 years
  • ASA I-II
  • cooperative
  • literate
  • undergoing elective endoscopic procedures

You may not qualify if:

  • under 11 years of age
  • uncooperative
  • illiterate
  • had known psychiatric disorders or were using psychiatric drugs
  • emergency endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa YIERH

Bursa, 16000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Ümran Ü Karaca, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

  • Derya D Karasu, Assoc Prof

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR

  • Şermin Ş Eminoğlu, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR

  • Şeyda Efsun ŞE Özgünay, Assoc Prof

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR

  • Tuğba T Onur, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 11, 2021

Study Start

June 1, 2019

Primary Completion

March 1, 2020

Study Completion

July 1, 2020

Last Updated

June 11, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Abstract of record

Locations

TU(1)