AnxietyPhase 3NCT06103188

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

A Phase 3 study testing Diazepam and Melatonin in people with Anxiety and Preoperative Anxiety, run by University of Jordan at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Anxiety, Preoperative Anxiety
What is being tested?: Diazepam and Melatonin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 87 participants
Where: 1 siteJordan
Study dates: 2 Oct 2023to 30 Oct 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ASA 1 or 2
Posted for general anesthesia
Aging between 18 and 65 years

Who cannot join

Allergy to any of the drugs under study
Pregnancy
Illiteracy
Any mental illness
Taking antipsychotics, antidepressants, anxiolytics, or sedatives

Trial locations and contacts

1 site in 1 country.

Jordan1 site

Jordan University Hospital
Amman

Other trials in Jordan

About this study

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

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.

Read the 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.

Conditions: Anxiety, Preoperative Anxiety
Being tested: Placebo, Diazepam, Melatonin
Keywords: Preoperative anxiety, Anxiolytic, Melatonin, Diazepam, Sedation, Premedication
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
The placebo pill will be given to the patients 1 hour prior to their planned surgery.
DiazepamDrug
Diazepam will be given to the patients 1 hour prior to their planned surgery.
MelatoninDrug
Melatonin will be given to the patients 1 hour prior to their planned surgery.

Study groups in NCT06103188
Study group	Role	What they receive
Placebo	Placebo comparator	A 5mg vitamin B12 pill Receives: Drug: Placebo
Diazepam	Active comparator	A 5mg diazepam pill Receives: Drug: Diazepam
Melatonin	Experimental	A 5mg melatonin pill Receives: Drug: Melatonin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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:
1. - Patient is anxious and agitated or restless, or both
2. - Patient is cooperative, oriented, and tranquil
3. - Patient responds to commands only
4. - Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
5. - Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
6. - 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).
Measured: 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
1. - Orientation in either time or place
2. - Orientation in both
Measured: Before administration of premedication, and after 1 hour from the administration of the premedication.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 202330 Oct 2023

First posted26 Oct 2023
Study start2 Oct 2023
Primary completion30 Oct 2023
Study completion30 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06103188
Sponsor's protocol ID: M001
Status last verified: Dec 2024
First submitted: 21 Oct 2023
Last updated: 24 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 41346130

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing Melatonin to Diazepam as a Premedication: a Triple-blind, Randomized, Placebo Controlled Clinical Trial
ClinicalTrials.gov ID: NCT06103188
Acronym / sponsor ID: M001
Conditions: Anxiety, Preoperative Anxiety
Keywords: Preoperative anxiety, Anxiolytic, Melatonin, Diazepam, Sedation, Premedication
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: University of JordanUniversity, hospital or other
Study start: 2 Oct 2023 (actual)
Primary completion: 30 Oct 2023 (actual)
Study completion: 30 Oct 2023 (actual)
First posted: 26 Oct 2023 (actual)
Results: Posted 24 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboA 5mg vitamin B12 pill
Diazepam	Active comparator	Drug: DiazepamA 5mg diazepam pill
Melatonin	Experimental	Drug: MelatoninA 5mg melatonin pill

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

ASA 1 or 2
Posted for general anesthesia
Aging between 18 and 65 years

Key exclusion criteria (5 listed)

Allergy to any of the drugs under study
Pregnancy
Illiteracy
Any mental illness
Taking antipsychotics, antidepressants, anxiolytics, or sedatives

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboThe placebo pill will be given to the patients 1 hour prior to their planned surgery.	Drug	Placebo
DiazepamDiazepam will be given to the patients 1 hour prior to their planned surgery.	Drug	Diazepam
MelatoninMelatonin will be given to the patients 1 hour prior to their planned surgery.	Drug	Melatonin

Primary outcome

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.
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.

2 secondary outcomes

Change in Sedation Between Treatment Arms
Time frame: Before administration of premedication, and after 1 hour from the administration of the premedication.
Change in Orientation Between Treatment Arms
Time frame: Before administration of premedication, and after 1 hour from the administration of the premedication.

Results and safety

Results posted to the registry on 24 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Melatonin	29	28
Diazepam	29	23
Placebo	29	25

Primary outcome: 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.. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Melatonin n = 28	Diazepam n = 23	Placebo n = 25
Value	0 (-5 to 5)	0 (-5 to 5)	0 (-7.5 to 7.5)

Primary outcome: 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.. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Melatonin n = 28	Diazepam n = 23	Placebo n = 25
APAIS difference	-0.5 (-2 to 1)	-1 (-3 to 1)	0 (-1 to 1)
Need for information subscale difference	0 (-0.5 to 0.5)	0 (-1.5 to 1.5)	0 (-1 to 1)
Anxiety subscale difference	0 (-1.5 to 1.5)	0 (-1 to 1)	0 (-0.5 to 0.5)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within one day of admission of the drug (until the participants were discharged home).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Melatonin	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Diazepam	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Placebo	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41346130Ismail 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Omar Ismail principal investigator

University of Jordan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diazepam and Melatonin in people with Anxiety and Preoperative Anxiety, run by University of Jordan at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06103188, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.