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

Last updated: December 20, 2024
Sponsor: University of Jordan
Overall Status: Completed

Phase

3

Condition

Anxiety Disorders

Mood Disorders

Panic Disorders

Treatment

Diazepam

Placebo

Melatonin

Clinical Study ID

NCT06103188
M001
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  • ASA 1 or 2

  • Posted for general anesthesia

  • Aging between 18 and 65 years

Exclusion

Exclusion Criteria:

  • Allergy to any of the drugs under study

  • Pregnancy

  • Illiteracy

  • Any mental illness

  • Taking antipsychotics, antidepressants, anxiolytics, or sedatives

Study Design

Total Participants: 87
Treatment Group(s): 3
Primary Treatment: Diazepam
Phase: 3
Study Start date:
October 02, 2023
Estimated Completion Date:
October 30, 2023

Study Description

Anxiety is a tense unpleasant sensation experienced by many individuals secondary to their concerns or due to the anticipation of an unpleasant experience like a surgery. Even with the advancement of medical treatment, preoperative anxiety remains a widespread complaint that affects the patients psychologically and physically, and at the same time adversely affecting the outcome of the operation and the experience of the patient.

In this triple-blind, randomized clinical study, we aim to compare melatonin to diazepam regarding its efficacy in reducing preoperative anxiety, as well as assessing multiple other effects such as sedation, orientation, and cognition, by applying validated tools to patients undergoing elective surgeries before and after administering the premedication.

Connect with a study center

  • Jordan University Hospital

    Amman,
    Jordan

    Site Not Available

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