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.
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
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.
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 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:
- - 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).
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
- - Orientation in either time or place
- - 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Ismail, University of Jordan
- Investigators
- Omar Ismail, Principal investigator, University of Jordan
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