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

Samsun University

Status: Completed

Conditions: Sedation; Anxiety; Anesthesia

Treatments: Other: Intranasal dexmedetomidine

Study type: Observational

Funder types: Other

Identifiers

NCT07077200

Intranasal Dex Vs Short Videos

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

İntranasal Dexmedetomidine

Description:

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).

Treatment:

Other: Intranasal dexmedetomidine

Short videos

Description:

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.