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Completed

NCT Number: NCT06103188

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Preoperative Anxiety

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jordan University Hospital

Amman, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

Diazepam

Drug

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

Melatonin

Drug

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

Primary outcomes

  1. Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Treatment Arms

    Time frame: 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.

  2. Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms

    Time frame: 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 scores of each item are summed to provide the total score.

    The minimum score possible is 6 and the maximum score is 30, the higher the score the higher the anxiety level and need for information.

    The scale consists of two subscales:

    Need for Information subscale: consists of two items (minimum score of 2 and maximum score of 10, the higher the score the more need for information).

    Anxiety subscale: consists of four items (minimum score of 4 and maximum score of 20, the higher the score the higher the anxiety level).

    The total scale is the sum of the two subscales.

Secondary outcomes

  1. Change in Sedation Between Treatment Arms

    Time frame: Before administration of premedication, and after 1 hour from the administration of the premedication.

    Ramsay sedation scale (RSS) is scored based on the level of sedation.

    It consists of six levels scored from 1 to 6:

    • - 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.

    As the patient becomes more sedated he receives a higher score on the scale (minimum of 1 and maximum of 6).

  2. Change in Orientation Between Treatment Arms

    Time frame: 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 outcomes

  1. Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Genders

    Time frame: 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.

  2. Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Genders

    Time frame: 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 scores of each item are summed to provide the total score.

    The minimum score possible is 6 and the maximum score is 30, the higher the score the higher the anxiety level and need for information.

    The scale consists of two subscales:

    Need for Information subscale: consists of two items (minimum score of 2 and maximum score of 10, the higher the score the more need for information).

    Anxiety subscale: consists of four items (minimum score of 4 and maximum score of 20, the higher the score the higher the anxiety level).

    The total scale is the sum of the two subscales.

  3. Change in Sedation Between Genders

    Time frame: Before administration of premedication, and after 1 hour from the administration of the premedication.

    Ramsay sedation scale (RSS) is scored based on the level of sedation.

    It consists of six levels scored from 1 to 6:

    • 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.

    As the patient becomes more sedated he receives a higher score on the scale (minimum of 1 and maximum of 6).

  4. Change in Orientation Between Genders

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2023
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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