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Investigating the effect of diazepam in anxiety level before endoscopy in children aged 2 to 12 years:a clinical trial

Investigating the effect of diazepam in anxiety level before endoscopy in children aged 2 to 12 years:a clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250408065254N1
Enrollment
60
Registered
2025-06-02
Start date
2025-05-05
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety. Separation anxiety disorder of childhood

Interventions

Intervention 1: Intervention group: Patients aged 2 to 12 years referring to the Gastroenterology Clinic of Shahrivar 17 Hospital are candidates for non-emergency diagnostic upper endoscopy by taking

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: The study population was patients aged 2 to 12 years who referred to the Gastroenterology Clinic of Shahrivar 17 Hospital and were candidates for non-emergency diagnostic upper endoscopy.

Exclusion criteria

Exclusion criteria: (1) Children with severe psychiatric disorders (according to family history; low IQ (ID), autism/schizophrenia, severe anxiety, etc. are considered for drug treatment). (2) Children with developmental disorders (3) Severe cognitive impairment (4) Hemodynamic instability (5) Taking anti-anxiety and anticonvulsant medications and other medications that have hypnotic properties. (6) Children whose parents are unwilling to participate in the study Patients with muscle weakness and sleep apnea (such as enlarged tonsils and adenoids)

Design outcomes

Primary

MeasureTime frame
Assessing patients' anxiety levels before the procedure. Timepoint: During the waiting period before performing the procedure. Method of measurement: Modified-Yale-Preoperative-Anxiety-Scale-m-YPAS.

Secondary

MeasureTime frame
The incidence of complications caused by anesthetic drugs for sedation during endoscopy,. Timepoint: The same day of the procedure. Method of measurement: It is recorded in a checklist prepared by the anesthesiologist present at the procedure site.;The average dose of anesthetic drugs used for sedation during endoscopy. Timepoint: The same day of the procedure. Method of measurement: It is recorded in a checklist prepared by the anesthesiologist present at the procedure site.;Mean time to wakefulness after endoscopy. Timepoint: The same day of the procedure. Method of measurement: It is recorded in a checklist prepared by the anesthesiologist present at the procedure site.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Soudeh Salehi

Rasht University of Medical Sciences

Dr.salehi_79@yahoo.com+98 13 3336 9026

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026