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

NCT07077200 | Completed

• 1 other identifier: Intranasal Dex Vs Short Videos
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Sedation; Anxiety

Keywords

Intranasal dexmedetomidine; Non-operating room anesthesia; Preoperative anxiety; Pediatric endoscopy; Short video viewing

Outcome Measures

Primary Outcomes (1)

• Modified Yale Preoperative Anxiety Scale (mYPAS) scores

  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.

  1hour

Secondary Outcomes (4)

• Recovery Time

  1 hour

• Sedation Scores

  2 hour

• The difficulty level of intravenous (IV) access

  1 hour

• Endoscopist satisfaction

  2 hour

Study Arms (2)

İntranasal Dexmedetomidine

Patients will be admitted to the preoperative holding area prior to the procedure. Upon arrival, intranasal dexmedetomidine will be administered at a dose of 3 mcg/kg via a mucosal atomiser device. The Modified Yale Preoperative Anxiety Scale (mYPAS) will be used to assess anxiety levels at three time intervals: upon arrival in the procedure room, immediately before transfer to the procedure room, and at the initiation of sedoanalgesia (induction).

Other: Intranasal dexmedetomidine

Short videos

Patients will be admitted to the preoperative holding area prior to the procedure. The Modified Yale Preoperative Anxiety Scale (mYPAS) will be used to assess anxiety levels at the following time points: upon arrival in the holding area, immediately before transfer to the procedure room, and at the initiation of sedoanalgesia. In the waiting area, children will be allowed to watch short videos on a platform of their choice (e.g., YouTube Shorts, TikTok, Instagram Shorts, cartoons, etc.) using the phone or tablet they typically use at home with their families. All content will be filtered for child-appropriate material. Children who refuse to watch or encounter technical issues during the video session will be excluded from the study.

Interventions

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

İntranasal Dexmedetomidine

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study included patients aged 2-12 years, classified as ASA I-II, who were scheduled to undergo endoscopy and/or colonoscopy by a pediatric gastroenterologist based on a clinical indication

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University Faculty of Medicine

Samsun, Turkey (Türkiye)

Location

Related Publications (1)

• Turunc E, Ustun YB, Bilgin S, Kaya C, Koksal E, Dost B. Effect of nebulized dexmedetomidine on gag reflex suppression and sedation quality in pediatric patients undergoing gastrointestinal endoscopy: a randomized controlled trial. BMC Anesthesiol. 2025 May 3;25(1):227. doi: 10.1186/s12871-025-03106-x.

  PMID: 40319232 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Caner Genc, M.D.

  Samsun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor (Anesthesiology Specialist)

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 22, 2025
• Study Start: July 1, 2025
• Primary Completion: October 3, 2025
• Study Completion: October 10, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)