Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 2:58 PM
Study NCT ID:
NCT07425405
Status:
RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Screen Exposure and Preoperative Anxiety in Children Aged 2-5 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 275}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative Anxiety Level Assessed by mYPAS Total Score', 'timeFrame': 'Immediately before anesthesia induction', 'description': 'Preoperative anxiety will be measured using the Modified Yale Preoperative Anxiety Scale (mYPAS), a validated observational tool for children aged 2-12 years. The total score ranges from 23.3 to 100, with higher scores indicating greater anxiety. The primary analysis will compare mYPAS total scores among three daily screen exposure groups (\\<1 hour/day, 1-2 hours/day, \\>2 hours/day).'}], 'secondaryOutcomes': [{'measure': 'Association Between Screen Content Type and Preoperative Anxiety (mYPAS)', 'timeFrame': 'Immediately before anesthesia induction (Day of surgery)', 'description': 'Association between the predominant content type watched during screen time (educational, non-violent cartoon/entertainment, adult content, action/violent content, YouTuber videos) and mYPAS total score.'}, {'measure': 'Association Between Parental Monitoring of Screen Content and Preoperative Anxiety (mYPAS)', 'timeFrame': 'Immediately before anesthesia induction (Day of surgery)', 'description': 'Association between parental supervision of viewed content (always selects content, sometimes checks, usually does not check) and mYPAS total score.'}, {'measure': 'Association Between Passive Screen Exposure and Preoperative Anxiety (mYPAS)', 'timeFrame': 'Immediately before anesthesia induction', 'description': 'Association between passive screen exposure (TV on in the background for most of the day vs turned off when not watched) and mYPAS total score.'}, {'measure': 'Association Between Reasons for Providing Screen and Preoperative Anxiety (mYPAS)', 'timeFrame': 'Immediately before anesthesia induction', 'description': 'Association between reported situations in which parents provide a screen (feeding difficulties, during housework, to calm tantrums, to facilitate sleep, as reward, for entertainment, never allowed) and mYPAS total score'}, {'measure': 'Association Between Parental Screen Use and Preoperative Anxiety (mYPAS)', 'timeFrame': 'Immediately before anesthesia induction', 'description': 'Association between maternal and paternal daily phone/tablet use (outside work) and mYPAS total score.'}, {'measure': 'Association Between Parental Phone Use During Parent-Child Interaction and Preoperative Anxiety (mYPAS)', 'timeFrame': 'Immediately before anesthesia induction', 'description': 'Association between parental phone engagement while playing/communicating with the child (never/rarely/often) and mYPAS total score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Screen Exposure', 'Pediatric Anesthesia'], 'conditions': ['Preoperative Anxiety']}, 'descriptionModule': {'briefSummary': "This prospective observational study aims to evaluate whether daily screen exposure duration is associated with preoperative anxiety levels in children aged 2-5 years undergoing elective surgery.\n\nScreen exposure in early childhood has been associated with emotional and behavioral outcomes, including increased anxiety. However, its potential impact on anxiety in acute stress situations such as surgery has not been previously investigated. Preoperative anxiety in children is associated with difficult anesthetic induction, increased postoperative agitation, prolonged recovery, and behavioral disturbances.\n\nIn this study, parents will complete a structured questionnaire assessing their child's daily screen exposure duration and related factors. Children will be categorized into three groups according to reported daily screen time: less than 1 hour per day, 1-2 hours per day, and more than 2 hours per day.\n\nPreoperative anxiety will be assessed immediately before anesthesia induction using the Modified Yale Preoperative Anxiety Scale (mYPAS), a validated observational tool for measuring anxiety in young children.\n\nNo additional medical interventions will be performed beyond routine clinical care. The study seeks to determine whether higher screen exposure is associated with increased preoperative anxiety levels and to identify potential risk factors contributing to anxiety in preschool children undergoing surgery.", 'detailedDescription': 'Preoperative anxiety is a common and clinically significant problem in preschool-aged children undergoing elective surgery. Elevated anxiety levels before anesthesia induction have been associated with difficult induction, increased postoperative emergence agitation, prolonged recovery time, and long-term behavioral disturbances.\n\nEarly childhood is a critical developmental period characterized by ongoing emotional regulation maturation and increased sensitivity to environmental factors. In recent years, daily exposure to digital screens (television, tablets, smartphones) has increased substantially among children aged 2-5 years. Previous literature has linked excessive screen time with emotional dysregulation, anxiety symptoms, and behavioral problems. However, no clinical studies have investigated the relationship between daily screen exposure and preoperative anxiety in young children.\n\nThis study aims to address this gap in the literature.\n\nStudy Objective\n\nThe primary objective of this study is to evaluate the effect of daily screen exposure duration on preoperative anxiety levels in children aged 2-5 years undergoing elective surgery.\n\nSecondary objectives include:\n\nEvaluating the relationship between screen-related variables (age at first exposure, content type, passive exposure, parental screen time, bedroom screen presence) and preoperative anxiety.\n\nAssessing the influence of sociodemographic and clinical variables on anxiety levels.\n\nDetermining the prevalence of clinically significant preoperative anxiety in children with high screen exposure.\n\nStudy Design\n\nThis is a single-center, prospective observational study conducted at Kanuni Sultan Süleyman Training and Research Hospital.\n\nAfter obtaining written informed consent from parents or legal guardians, a structured "Sociodemographic and Screen Use Questionnaire" will be completed in the preoperative waiting area. The questionnaire includes information on daily screen exposure duration, age at first exposure, content type, parental screen use, passive exposure, bedroom screen presence, and previous medical experiences.\n\nChildren will be categorized into three groups based on reported daily screen exposure:\n\n\\<1 hour per day\n\n1-2 hours per day\n\nmore than 2 hours per day\n\nAnxiety Assessment\n\nPreoperative anxiety will be assessed immediately before anesthesia induction, either upon entry into the operating room or in the induction area, prior to any pharmacologic intervention.\n\nAnxiety will be measured using the Modified Yale Preoperative Anxiety Scale (mYPAS), a validated observational instrument for children aged 2-12 years. The scale evaluates five behavioral domains (activity, vocalization, emotional expressivity, state of arousal, and interaction with parents). Scores range from 23.3 to 100, with higher scores indicating higher anxiety levels.\n\nAssessment will be performed by a trained anesthesiologist through direct observation without interfering with routine clinical workflow.\n\nRisk and Safety Considerations\n\nThis study is non-interventional. No additional medical procedures will be performed. Data collection consists of a parent questionnaire and a single observational anxiety assessment. Therefore, no additional clinical risk is anticipated beyond standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of children aged 2-5 years scheduled for elective surgical procedures under general anesthesia at Kanuni Sultan Süleyman Training and Research Hospital. Participants will be enrolled prospectively after written informed consent is obtained from a parent or legal guardian. Children will be categorized based on parent-reported daily screen exposure duration. Preoperative anxiety will be assessed immediately before anesthesia induction using the Modified Yale Preoperative Anxiety Scale (mYPAS).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 2 to 5 years\n* Scheduled for elective surgical procedures under general anesthesia\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Parent or legal guardian able to provide written informed consent\n* Parent able to complete the structured questionnaire in Turkish\n\nExclusion Criteria:\n\n* Premedication administered or planned prior to anxiety assessment\n* Emergency surgical procedures\n* Known developmental delay or neurodevelopmental disorder\n* Known psychiatric disorder\n* Visual or hearing impairment that may interfere with behavioral assessment\n* Chronic use of sedative, antipsychotic, or antiepileptic medications\n* Anticipated need for postoperative intensive care\n* Incomplete or unreliable questionnaire data\n* Inability to perform mYPAS assessment prior to anesthesia induction'}, 'identificationModule': {'nctId': 'NCT07425405', 'briefTitle': 'Daily Screen Exposure and Preoperative Anxiety in Children Aged 2-5 Years', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'The Effect of Daily Screen Exposure Duration on Preoperative Anxiety in Children Aged 2-5 Years: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Screentime'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low Screen Exposure', 'description': 'Children aged 2-5 years with daily screen exposure less than 1 hour per day, as reported by parents through a structured questionnaire.'}, {'label': 'Moderate Screen Exposure', 'description': 'Children aged 2-5 years with daily screen exposure between 1 and 2 hours per day.'}, {'label': 'High Screen Exposure', 'description': 'Children aged 2-5 years with daily screen exposure greater than 2 hours per day.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'state': 'küçükçekmece', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Engin ihsan Turan, Principal investigator', 'role': 'CONTACT', 'email': 'enginihsan@hotmail.com', 'phone': '05382431114'}], 'facility': 'Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Engin Ihsan Turan', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}