An observational study in Anesthesia and Anxiety, sponsored by Bahçeşehir University. Not yet recruiting. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Bahçeşehir University · Observational
This observational study will investigate whether problematic digital media use is associated with anxiety in children undergoing a planned upper gastrointestinal endoscopy, a camera examination of the upper digestive tract. The study hypothesis is that problematic media use is associated with the child's anxiety immediately before sedation. Associations with sedation medicine requirements and recovery after the procedure will also be explored.
The study will include 60 children aged 6 to 11 years. Parents or legal guardians will complete a questionnaire about their child's media use and provide information on screen time and viewing habits. An independent observer will assess anxiety at three time points: on arrival in the preparation area, before transfer to the procedure room, and immediately before sedation.
Researchers will record the medicines and doses used for sedation or anaesthesia, procedure duration, agitation during recovery, recovery time, readiness for discharge, and sedation-related adverse events. Endoscopy and sedation will be managed according to routine clinical practice.
5,113 studies on the registry are indexed under Anxiety Disorders; 1,418 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 636 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Bahçeşehir University is the lead sponsor of 124 studies on the registry; 24 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Eligible children aged 6-11 years scheduled for elective diagnostic upper gastrointestinal endoscopy at the Pediatric Endoscopy Unit will be enrolled consecutively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Antiepileptic use alone is not an exclusion criterion; the anesthesiologist will assess eligibility individually.
Behavioral: Problematic Media Use
Problematic media use will be assessed using the parent-reported 9-item PMKÖ-KF. Parents will rate the child's typical behavior during the preceding month on a 5-point scale (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always). The score will be calculated as the mean of the nine item responses (range: 1-5); higher scores indicate greater problematic media use. Media use will not be assigned or modified by investigators.
Modified Yale Preoperative Anxiety Scale (mYPAS) scores
The Modified Yale Preoperative Anxiety Scale (mYPAS) will be assessed at three time points: T1, upon admission to the preparation area; T2, immediately before transfer to the procedure room; and T3, immediately before sedation initiation. The mYPAS score (0-100) at T3 is the primary outcome and will be analyzed as a continuous variable. The association between the T3 mYPAS score and the PMKÖ-KF mean score (mean of nine items, range 1-5; higher scores indicate greater problematic media use) will be evaluated.
Time frame: During the preprocedural assessment, before sedation and endoscopy.
Secondary Anxiety, Sedation, and Recovery Outcomes
Secondary outcomes include associations between media use and anxiety; sedative/anesthetic use and additional medication; procedure duration and completion; recovery agitation (Watcha Agitation Score); recovery status (Modified Aldrete Score); time to eye opening and discharge readiness; recovery-unit stay; and sedation-related adverse events.
Time frame: From preparation-area admission through recovery-unit discharge.
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Jan 2027, 2 months later.
Of 263 non-industry observational studies under Anxiety Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 49. This study's planned 2 months is below that.
Counting every sponsor, half of 285 studies reached it within 18 months; a quarter within 6 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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