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

Anxiety Clinical Trial

Official title:

Comparing Melatonin to Diazepam as a Premedication: a Triple-blind, Randomized, Placebo Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06103188
• Other study ID #: M001
• Status: Completed
• Phase: Phase 3
• Start date: October 2, 2023
• Est. completion date: October 19, 2023

Study information

• Verified date: October 2023
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 19, 2023
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Preoperative Anxiety

Intervention

Drug:
• Placebo
The placebo pill will be given to the patients 1 hour prior to their planned surgery.
• Diazepam
Diazepam will be given to the patients 1 hour prior to their planned surgery.
• Melatonin
Melatonin will be given to the patients 1 hour prior to their planned surgery.

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the anxiety score using the visual analogue score for anxiety between genders	VAS (Visual Analogue Score) Anxiety Scale is a 100 mm long scale. The scale is marked in millimeters from 0 to 100, where 0 correlates with no anxiety at all, and 100 correlates to anxiety as bad as possible. The maximum score is 100 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The more the reduction in anxiety from baseline, the better the outcome.	Before administration of premedication, and after 1 hour from the administration of the premedication.
Other	Change in anxiety score based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) between genders	The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a self-reported questionnaire. The scale consists of six items, four of which assess the patient's anxiety, while the last two assess the patients' need-for-information and the patient must choose how much he agrees with each item on a scale of 1 (not at all) to 5 (very much). The more the reduction in the anxiety score from baseline the better the outcome.	Before administration of premedication, and after 1 hour from the administration of the premedication.
Other	Change in sedation between genders	Sedation will be assessed with Ramsay sedation scale (RSS) as follows: - Patient is anxious and agitated or restless, or both; - Patient is cooperative, oriented, and tranquil; - Patient responds to commands only; - Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; - Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; - Patient exhibits no response.	Before administration of premedication, and after 1 hour from the administration of the premedication.
Other	Change in orientation between genders	Orientation will be assessed with a three-point scale as follows: 0 - None; - Orientation in either time or place; - Orientation in both	Before administration of premedication, and after 1 hour from the administration of the premedication.
Primary	Change in the anxiety score using the visual analogue score for anxiety between treatment arms	VAS (Visual Analogue Score) Anxiety Scale is a 100 mm long scale. The scale is marked in millimeters from 0 to 100, where 0 correlates with no anxiety at all, and 100 correlates to anxiety as bad as possible. The maximum score is 100 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The more the reduction in anxiety from baseline, the better the outcome.	Before administration of premedication, and after 1 hour from the administration of the premedication.
Primary	Change in anxiety score based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) between treatment arms	The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a self-reported questionnaire. The scale consists of six items, four of which assess the patient's anxiety, while the last two assess the patients' need-for-information and the patient must choose how much he agrees with each item on a scale of 1 (not at all) to 5 (very much). The more the reduction in the anxiety score from baseline the better the outcome.	Before administration of premedication, and after 1 hour from the administration of the premedication.
Secondary	Change in sedation between treatment arms	Sedation will be assessed with Ramsay sedation scale (RSS) as follows: - Patient is anxious and agitated or restless, or both; - Patient is cooperative, oriented, and tranquil; - Patient responds to commands only; - Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; - Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; - Patient exhibits no response.	Before administration of premedication, and after 1 hour from the administration of the premedication.
Secondary	Change in orientation between treatment arms	Orientation will be assessed with a three-point scale as follows: 0 - None; - Orientation in either time or place; - Orientation in both	Before administration of premedication, and after 1 hour from the administration of the premedication.