Phase 3 N=87 Randomized Quadruple-blind Treatment

Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively

Anxiety · Preoperative Anxiety

Bottom Line

View on ClinicalTrials.gov: NCT06103188 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Treatment Arms — 0; 0; 0 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Diazepam (Drug); Melatonin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Jordan
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Treatment Arms	0; 0; 0	—
PRIMARY Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms	-0.5; -1; 0; 0; 0; 0	—
SECONDARY Change in Sedation Between Treatment Arms	0; 0; 0	—
SECONDARY Change in Orientation Between Treatment Arms	0; 0; 0	—

Summary

The goal of this clinical trial is to compare the effect of melatonin, diazepam, and placebo on the level of anxiety in patients undergoing surgery. The main question it aims to answer is: • Is melatonin effective in reducing the anxiety of patients undergoing surgery? Participants will be asked to answer a questionnaire then they will receive either melatonin, diazepam, or placebo, and then after an hour, they will answer the same questionnaire again. Researchers will compare melatonin, diazepam, and placebo to see if melatonin is as effective in reducing the level of anxiety as diazepam in patients undergoing surgery.

Eligibility Criteria

Inclusion Criteria

ASA 1 or 2
Posted for general anesthesia
Aging between 18 and 65 years

Exclusion Criteria

Allergy to any of the drugs under study
Pregnancy
Illiteracy
Any mental illness
Taking antipsychotics, antidepressants, anxiolytics, or sedatives

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06103188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.