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NCT Number: NCT07077200

Comparison of Intranasal Dexmedetomidine and Short Video Viewing in the Preoperative Anxiety

This observational study aims to compare the effects of short video viewing and intranasal dexmedetomidine administration-both of which are part of routine clinical practices in the pediatric endoscopy unit-on preoperative anxiety levels and the need for intravenous sedation. Patients who are exposed to these interventions as part of routine clinical care will be included in the study.

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Key information

Conditions

Anesthesia Anxiety Anxiety Disorders Mental Disorders Sedation

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsun University Faculty of Medicine

Samsun, Turkey (Türkiye)

About this study

Pediatric patients scheduled for upper or lower gastrointestinal endoscopy in the hospital's endoscopy unit and who receive either short video viewing or intranasal dexmedetomidine as part of standard clinical practice will be included in this study. The primary objective is to compare these two modalities in terms of preoperative anxiety, requirement for sedative agents, difficulty of intravenous access, and levels of satisfaction reported by parents and endoscopists.

This study will be conducted with a prospective and observational design. Preoperative anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at three distinct time points:

T1: Upon arrival in the preoperative holding area, T2: Prior to transfer to the endoscopy suite, T3: immediately before anesthesia induction. The consumption of sedative agents (e.g., propofol) will be recorded in terms of total dosage (mg) and dosage per kilogram of body weight (mg/kg). The difficulty of intravenous access will be rated on a 5-point scale. Parental satisfaction will be assessed using the PedsQL Healthcare Satisfaction Scale, while endoscopist satisfaction will be evaluated using a 5-point Likert scale. Statistical analyses will be performed to compare the outcomes between the two study groups.

Short Video Viewing Group:

All patients will be brought to the preoperative preparation area. Anxiety assessments using the mYPAS will be conducted at the designated time points. Patients will be allowed to watch short videos (such as YouTube Shorts, TikTok, Instagram Shorts, or cartoons), selected based on their preferences and filtered for age-appropriateness. Patients who refuse to watch the videos or encounter technical difficulties will be excluded from the study.

Intranasal Dexmedetomidine Group:

Patients in this group will receive intranasal dexmedetomidine via a mucosal atomiser device at a dose of 3 mcg/kg upon arrival at the preoperative holding area. mYPAS assessments will be carried out at the same three time points.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 2-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II

Exclusion criteria

  • Patients under 2, over 12, or with ASA score >2
  • Epilepsy
  • Cardiovascular diseases
  • Refuse to participate

Treatment and study plan

Intranasal dexmedetomidine

Other

This intervention is distinguished by the use of intranasal dexmedetomidine at a standardized dose of 3 mcg/kg, administered non-invasively upon the child's arrival in the preoperative holding area. Unlike other pharmacological methods that often require intravenous access or oral administration, this approach minimizes procedural stress and discomfort, which is particularly advantageous in pediatric populations.

Dexmedetomidine is a selective alpha-2 adrenergic agonist known for its anxiolytic, sedative, and analgesic properties, without causing significant respiratory depression-a key concern with agents like benzodiazepines or opioids. Its intranasal delivery provides a rapid onset of action while maintaining hemodynamic stability, which is critical during the preoperative period.

This intervention is also notable for its comparison with a non-pharmacological strategy-short video viewing-making the study unique in evaluating the relative efficacy of a low-risk pharmacologic option

Primary outcomes

  1. Modified Yale Preoperative Anxiety Scale (mYPAS) scores

    Time frame: 1hour

    Preoperative anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at three distinct time points:

    T1: upon arrival in the preoperative holding area, T2: prior to transfer to the endoscopy suite, T3: immediately before anesthesia induction.

Secondary outcomes

  1. Recovery Time

    Time frame: 1 hour

    The duration of patient monitoring in the recovery unit continued until a Modified Aldrete Score of 9 or higher was achieved.

  2. Sedation Scores

    Time frame: 2 hour

    Sedation levels assessed using the Ramsay Sedation Scale (RSS) in the preoperative preparation unit, procedure room, and recovery unit constituted the secondary outcome of the study.

  3. The difficulty level of intravenous (IV) access

    Time frame: 1 hour

    "The difficulty level of intravenous (IV) access was assessed using a 5-point Likert scale.

  4. Endoscopist satisfaction

    Time frame: 2 hour

    Endoscopist satisfaction was evaluated with a 5-point Likert scale.

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Comparison of Intranasal Dexmedetomidine and Short Video Viewing in the Management of Preoperative Anxiety and Sedation in Pediatric Endoscopy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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