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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | A 5mg vitamin B12 pill |
|
| Diazepam | Active Comparator | A 5mg diazepam pill |
|
| Melatonin | Experimental | A 5mg melatonin pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | The placebo pill will be given to the patients 1 hour prior to their planned surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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 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. | Before administration of premedication, and after 1 hour from the administration of the premedication. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sedation Between Treatment Arms | Ramsay sedation scale (RSS) is scored based on the level of sedation. It consists of six levels scored from 1 to 6:
As the patient becomes more sedated he receives a higher score on the scale (minimum of 1 and maximum of 6). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar Ismail | University of Jordan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University Hospital | Amman | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41346130 | Derived | Ismail O, Albdour K, Jaber K, Jaber Y, Alsaras A, Younis A, Froukh U, Momani Y, Abu-Halaweh S. The efficacy of melatonin as a preoperative anxiolytic in real-world setting: a randomized controlled trial. Hosp Pract (1995). 2025 Feb;53(1):2600245. doi: 10.1080/21548331.2025.2600245. Epub 2025 Dec 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Melatonin | A 5mg melatonin pill Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery. |
| FG001 | Diazepam | A 5mg diazepam pill Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery. |
| FG002 | Placebo | A 5mg vitamin B12 pill Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Melatonin | A 5mg melatonin pill Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery. |
| BG001 | Diazepam | A 5mg diazepam pill Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | Before administration of premedication, and after 1 hour from the administration of the premedication. |
|
Within one day of admission of the drug (until the participants were discharged home).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Melatonin | A 5mg melatonin pill Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Omar Ismail | Jordan University Hospital | +962791301329 | omar.moh.isml@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2024 | Oct 30, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2024 | Dec 20, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003975 | Diazepam |
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| 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. |
|
| Before administration of premedication, and after 1 hour from the administration of the premedication. |
| Change in Orientation Between Treatment Arms | Orientation will be assessed with a three-point scale as follows: 0 - None
| Before administration of premedication, and after 1 hour from the administration of the premedication. |
| Before administration of premedication, and after 1 hour from the administration of the premedication. |
| 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 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. | Before administration of premedication, and after 1 hour from the administration of the premedication. |
| Change in Sedation Between Genders | Ramsay sedation scale (RSS) is scored based on the level of sedation. It consists of six levels scored from 1 to 6:
As the patient becomes more sedated he receives a higher score on the scale (minimum of 1 and maximum of 6). | Before administration of premedication, and after 1 hour from the administration of the premedication. |
| Change in Orientation Between Genders | Orientation will be assessed with a three-point scale as follows: 0 - None
| Before administration of premedication, and after 1 hour from the administration of the premedication. |
| BG002 | Placebo | A 5mg vitamin B12 pill Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Amsterdam Preoperative Anxiety and Information Scale | The Amsterdam Preoperative Anxiety and Information Scale consists of 6 items with the responses to each item ranging from a score of 1 to 5. The minimum score possible is 6 and the maximum score is 30, the higher the score the higher the anxiety level. The scale is the sum of two subscales:
| Median | Inter-Quartile Range | units on a scale |
|
| Baseline Visual Analogue Scale for Anxiety score (VAS-A) | 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. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline Ramsay sedation score | Ramsay sedation scale (RSS) is scored based on the level of sedation. It consists of six levels scored from 1 to 6:
| Median | Inter-Quartile Range | units on a scale |
|
| Baseline orientation score | Orientation is assessed with a three-point scale as follows: 0 - None
| Median | Inter-Quartile Range | units on a scale |
|
A 5mg diazepam pill Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery. |
| OG002 | Placebo | A 5mg vitamin B12 pill Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery. |
|
|
| 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 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. | Posted | Median | Inter-Quartile Range | score on a scale | Before administration of premedication, and after 1 hour from the administration of the premedication. |
|
|
|
| Secondary | Change in Sedation Between Treatment Arms | Ramsay sedation scale (RSS) is scored based on the level of sedation. It consists of six levels scored from 1 to 6:
As the patient becomes more sedated he receives a higher score on the scale (minimum of 1 and maximum of 6). | Posted | Median | Inter-Quartile Range | score on a scale | 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
| Posted | Median | Inter-Quartile Range | score on a scale | Before administration of premedication, and after 1 hour from the administration of the premedication. |
|
|
|
| Other Pre-specified | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Before administration of premedication, and after 1 hour from the administration of the premedication. |
|
|
|
| Other Pre-specified | 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 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. | Posted | Median | Inter-Quartile Range | score on a scale | Before administration of premedication, and after 1 hour from the administration of the premedication. |
|
|
|
| Other Pre-specified | Change in Sedation Between Genders | Ramsay sedation scale (RSS) is scored based on the level of sedation. It consists of six levels scored from 1 to 6:
As the patient becomes more sedated he receives a higher score on the scale (minimum of 1 and maximum of 6). | Posted | Median | Inter-Quartile Range | score on a scale | Before administration of premedication, and after 1 hour from the administration of the premedication. |
|
|
|
| Other Pre-specified | Change in Orientation Between Genders | Orientation will be assessed with a three-point scale as follows: 0 - None
| Posted | Median | Inter-Quartile Range | score on a scale | Before administration of premedication, and after 1 hour from the administration of the premedication. |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Diazepam | A 5mg diazepam pill Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Placebo | A 5mg vitamin B12 pill Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
|
| Anxiety subscale difference |
|
| Difference on the APAIS Anxiety subscale |
|