AnesthesiaPMU-ASR-ENDONCT07916168
Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
An observational study of Anesthesia and Anxiety, run by Bahçeşehir University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Anxiety
- What is being tested?
- Problematic Media Use
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 15 Feb 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Eligible children aged 6-11 years scheduled for elective diagnostic upper gastrointestinal endoscopy at the Pediatric Endoscopy Unit will be enrolled consecutively.
Who may be able to join
- Age 6-11 years; ASA I-II; scheduled for elective diagnostic upper GI endoscopy under sedation or general anesthesia.
- Turkish-speaking parent/legal representative able to report media use and complete forms; written consent and child assent.
Who cannot join
- Emergency or therapeutic endoscopy; concurrent colonoscopy/other procedure; ASA III-IV.
- Condition or communication difficulty preventing reliable mYPAS assessment.
- Regular sedative/antipsychotic use; unreliable media-use report; prior enrollment; incomplete PMU scale or essential data.
- Antiepileptic use alone is not an exclusion criterion; the anesthesiologist will assess eligibility individually.
About this study
Official title: Association Between Problematic Media Use and Preprocedural Anxiety, Sedation, and Recovery Outcomes in Children Undergoing Elective Upper Gastrointestinal Endoscopy: A Prospective Observational Cohort Study
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.
- Conditions
- Anesthesia, Anxiety
- Being tested
- Problematic Media Use
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problematic Media UseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Children Undergoing Elective Upper Gastrointestinal Endoscopy | Not described Receives: Behavioral: Problematic Media Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the preprocedural assessment, before sedation and endoscopy.
Secondary outcomes (1)
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.
Measured: From preparation-area admission through recovery-unit discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Kaygisiz, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916168
- Sponsor's protocol ID
- bau_endoscopy_pediatric
- Acronym
- PMU-ASR-ENDO
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Problematic Media Use and Preprocedural Anxiety, Sedation, and Recovery Outcomes in Children Undergoing Elective Upper Gastrointestinal Endoscopy: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07916168
- Acronym / sponsor ID
- PMU-ASR-ENDO / bau_endoscopy_pediatric
- Conditions
- Anesthesia, Anxiety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children Undergoing Elective Upper Gastrointestinal Endoscopy | – | Behavioral: Problematic Media Use |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Eligible children aged 6-11 years scheduled for elective diagnostic upper gastrointestinal endoscopy at the Pediatric Endoscopy Unit will be enrolled consecutively.
Key inclusion criteria (2 listed)
- Age 6-11 years; ASA I-II; scheduled for elective diagnostic upper GI endoscopy under sedation or general anesthesia.
- Turkish-speaking parent/legal representative able to report media use and complete forms; written consent and child assent.
Key exclusion criteria (4 listed)
- Emergency or therapeutic endoscopy; concurrent colonoscopy/other procedure; ASA III-IV.
- Condition or communication difficulty preventing reliable mYPAS assessment.
- Regular sedative/antipsychotic use; unreliable media-use report; prior enrollment; incomplete PMU scale or essential data.
- Antiepileptic use alone is not an exclusion criterion; the anesthesiologist will assess eligibility individually.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problematic Media UseProblematic 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. | Behavioural | Children Undergoing Elective Upper Gastrointestinal Endoscopy |
Primary outcome
Modified Yale Preoperative Anxiety Scale (mYPAS) scores
Time frame: During the preprocedural assessment, before sedation and endoscopy.
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.
1 secondary outcome
Secondary Anxiety, Sedation, and Recovery Outcomes
Time frame: From preparation-area admission through recovery-unit discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Anxiety, run by Bahçeşehir University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Yale Preoperative Anxiety Scale (mYPAS) scores (time frame: During the preprocedural assessment, before sedation and endoscopy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.