Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy (PMU-ASR-ENDO)
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.
調査の概要
研究の種類
入学 (推定)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Eligible children aged 6-11 years scheduled for elective diagnostic upper gastrointestinal endoscopy at the Pediatric Endoscopy Unit will be enrolled consecutively.
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Children Undergoing Elective Upper Gastrointestinal Endoscopy
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Modified Yale Preoperative Anxiety Scale (mYPAS) scores
時間枠：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. |
During the preprocedural assessment, before sedation and endoscopy.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Secondary Anxiety, Sedation, and Recovery Outcomes
時間枠：From preparation-area admission through recovery-unit discharge.
|
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. |
From preparation-area admission through recovery-unit discharge.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。