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

Sponsor

University of Jordan (Other)

Overall Status

Completed

CT.gov ID

NCT06103188

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

155.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Preoperative Anxiety	Drug: Placebo Drug: Diazepam Drug: Melatonin	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 2, 2023

Actual Primary Completion Date :

Oct 19, 2023

Actual Study Completion Date :

Oct 19, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo A 5mg vitamin B12 pill	Drug: Placebo The placebo pill will be given to the patients 1 hour prior to their planned surgery.
Active Comparator: Diazepam A 5mg diazepam pill	Drug: Diazepam Diazepam will be given to the patients 1 hour prior to their planned surgery.
Experimental: Melatonin A 5mg melatonin pill	Drug: Melatonin Melatonin will be given to the patients 1 hour prior to their planned surgery.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

A 5mg vitamin B12 pill

Drug: Placebo

The placebo pill will be given to the patients 1 hour prior to their planned surgery.

Active Comparator: Diazepam

A 5mg diazepam pill

Drug: Diazepam

Diazepam will be given to the patients 1 hour prior to their planned surgery.

Experimental: Melatonin

A 5mg melatonin pill

Drug: Melatonin

Melatonin will be given to the patients 1 hour prior to their planned surgery.

Outcome Measures

Primary Outcome Measures

Change in the anxiety score using the visual analogue score for anxiety between treatment arms [Before administration of premedication, and after 1 hour from the administration of the premedication.]
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.
Change in anxiety score based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) between treatment arms [Before administration of premedication, and after 1 hour from the administration of the premedication.]
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.

Secondary Outcome Measures

Change in sedation between treatment arms [Before administration of premedication, and after 1 hour from the administration of the premedication.]
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.
Change in orientation between treatment arms [Before administration of premedication, and after 1 hour from the administration of the premedication.]
Orientation will be assessed with a three-point scale as follows: 0 - None - Orientation in either time or place - Orientation in both

Other Outcome Measures

Change in the anxiety score using the visual analogue score for anxiety between genders [Before administration of premedication, and after 1 hour from the administration of the premedication.]
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.
Change in anxiety score based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) between genders [Before administration of premedication, and after 1 hour from the administration of the premedication.]
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.
Change in sedation between genders [Before administration of premedication, and after 1 hour from the administration of the premedication.]
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.
Change in orientation between genders [Before administration of premedication, and after 1 hour from the administration of the premedication.]
Orientation will be assessed with a three-point scale as follows: 0 - None - Orientation in either time or place - Orientation in both