Trial · NCT06103188

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

NCT06103188, Phase 3, Completed, University of Jordan; results first posted 2025-01-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively. Trials, record NCT06103188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06103188

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively
NCT number: NCT06103188
Status: Completed
Phases: Phase 3
Enrollment: 87 participants, actual
Lead sponsor: University of Jordan
Conditions: Anxiety, Preoperative Anxiety
Interventions: Placebo, Diazepam, Melatonin
First posted: 2023-10-26
Last updated: 2025-01-24
Results first posted: 2025-01-24

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	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 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	Change in Sedation Between Treatment Arms	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: 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).
Secondary	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 1. \- Orientation in either time or place 2. \- Orientation in both
Other	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.
Other	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 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.
Other	Change in Sedation Between Genders	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: 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).
Other	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 1. \- Orientation in either time or place 2. \- Orientation in both

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	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.	score on a scale	MEDIAN
PRIMARY	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.	score on a scale	MEDIAN
SECONDARY	Change in Sedation Between Treatment Arms	Before administration of premedication, and after 1 hour from the administration of the premedication.	score on a scale	MEDIAN
SECONDARY	Change in Orientation Between Treatment Arms	Before administration of premedication, and after 1 hour from the administration of the premedication.	score on a scale	MEDIAN
OTHER_PRE_SPECIFIED	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.	score on a scale	MEDIAN
OTHER_PRE_SPECIFIED	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.	score on a scale	MEDIAN
OTHER_PRE_SPECIFIED	Change in Sedation Between Genders	Before administration of premedication, and after 1 hour from the administration of the premedication.	score on a scale	MEDIAN
OTHER_PRE_SPECIFIED	Change in Orientation Between Genders	Before administration of premedication, and after 1 hour from the administration of the premedication.	score on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Treatment Arms	Melatonin		0	Inter-Quartile Range -5 to 5	score on a scale
Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Treatment Arms	Diazepam		0	Inter-Quartile Range -5 to 5	score on a scale
Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Treatment Arms	Placebo		0	Inter-Quartile Range -7.5 to 7.5	score on a scale
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms	Melatonin	APAIS difference	-0.5	Inter-Quartile Range -2 to 1	score on a scale
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms	Diazepam	APAIS difference	-1	Inter-Quartile Range -3 to 1	score on a scale
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms	Placebo	APAIS difference	0	Inter-Quartile Range -1 to 1	score on a scale
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms	Melatonin	Need for information subscale difference	0	Inter-Quartile Range -0.5 to 0.5	score on a scale
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms	Diazepam	Need for information subscale difference	0	Inter-Quartile Range -1.5 to 1.5	score on a scale
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms	Placebo	Need for information subscale difference	0	Inter-Quartile Range -1 to 1	score on a scale
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms	Melatonin	Anxiety subscale difference	0	Inter-Quartile Range -1.5 to 1.5	score on a scale

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Melatonin	29
Overall Study	STARTED	Diazepam	29
Overall Study	STARTED	Placebo	29
Overall Study	COMPLETED	Melatonin	28
Overall Study	COMPLETED	Diazepam	23
Overall Study	COMPLETED	Placebo	25
Overall Study	NOT COMPLETED	Melatonin	1
Overall Study	NOT COMPLETED	Diazepam	6
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals9

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Melatonin	28
Total, all-cause mortality	Diazepam	23
Total, all-cause mortality	Placebo	25
Total, other adverse events	Melatonin	28
Total, other adverse events	Diazepam	23
Total, other adverse events	Placebo	25
Total, serious adverse events	Melatonin	28
Total, serious adverse events	Diazepam	23
Total, serious adverse events	Placebo	25

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41346130	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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