Trial Outcomes & Findings for Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively (NCT NCT06103188)
NCT ID: NCT06103188
Last Updated: 2025-01-24
Results Overview
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.
COMPLETED
PHASE3
87 participants
Before administration of premedication, and after 1 hour from the administration of the premedication.
2025-01-24
Participant Flow
Participant milestones
| Measure |
Melatonin
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
29
|
|
Overall Study
COMPLETED
|
28
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
4
|
Reasons for withdrawal
| Measure |
Melatonin
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
4
|
Baseline Characteristics
Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively
Baseline characteristics by cohort
| Measure |
Melatonin
n=28 Participants
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
n=23 Participants
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
n=25 Participants
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
36 years
n=5 Participants
|
43 years
n=7 Participants
|
37 years
n=5 Participants
|
38.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Amsterdam Preoperative Anxiety and Information Scale
Baseline APAIS
|
10 units on a scale
n=5 Participants
|
11 units on a scale
n=7 Participants
|
6 units on a scale
n=5 Participants
|
10 units on a scale
n=4 Participants
|
|
Baseline Amsterdam Preoperative Anxiety and Information Scale
Baseline APAIS Need for Information subscale
|
3.5 units on a scale
n=5 Participants
|
5 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
4 units on a scale
n=4 Participants
|
|
Baseline Amsterdam Preoperative Anxiety and Information Scale
Baseline APAIS Anxiety subscale
|
7.5 units on a scale
n=5 Participants
|
6 units on a scale
n=7 Participants
|
4 units on a scale
n=5 Participants
|
6 units on a scale
n=4 Participants
|
|
Baseline Visual Analogue Scale for Anxiety score (VAS-A)
|
10 units on a scale
n=5 Participants
|
30 units on a scale
n=7 Participants
|
20 units on a scale
n=5 Participants
|
30 units on a scale
n=4 Participants
|
|
Baseline Ramsay sedation score
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=4 Participants
|
|
Baseline orientation score
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Melatonin
n=28 Participants
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
n=23 Participants
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
n=25 Participants
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
|---|---|---|---|
|
Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Treatment Arms
|
0 score on a scale
Interval -5.0 to 5.0
|
0 score on a scale
Interval -5.0 to 5.0
|
0 score on a scale
Interval -7.5 to 7.5
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Melatonin
n=28 Participants
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
n=23 Participants
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
n=25 Participants
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
|---|---|---|---|
|
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms
APAIS difference
|
-0.5 score on a scale
Interval -2.0 to 1.0
|
-1 score on a scale
Interval -3.0 to 1.0
|
0 score on a scale
Interval -1.0 to 1.0
|
|
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms
Need for information subscale difference
|
0 score on a scale
Interval -0.5 to 0.5
|
0 score on a scale
Interval -1.5 to 1.5
|
0 score on a scale
Interval -1.0 to 1.0
|
|
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms
Anxiety subscale difference
|
0 score on a scale
Interval -1.5 to 1.5
|
0 score on a scale
Interval -1.0 to 1.0
|
0 score on a scale
Interval -0.5 to 0.5
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Melatonin
n=28 Participants
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
n=23 Participants
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
n=25 Participants
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
|---|---|---|---|
|
Change in Sedation Between Treatment Arms
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Melatonin
n=28 Participants
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
n=23 Participants
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
n=25 Participants
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
|---|---|---|---|
|
Change in Orientation Between Treatment Arms
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Melatonin
n=37 Participants
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
n=39 Participants
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
|---|---|---|---|
|
Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Genders
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -10.0 to 10.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Melatonin
n=37 Participants
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
n=39 Participants
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
|---|---|---|---|
|
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Genders
Difference on the APAIS scale
|
0 score on a scale
Interval -1.0 to 1.0
|
-1 score on a scale
Interval -3.0 to 1.0
|
—
|
|
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Genders
Difference on the APAIS Need for Information subscale
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -1.0 to 1.0
|
—
|
|
Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Genders
Difference on the APAIS Anxiety subscale
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -1.5 to 1.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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).
Outcome measures
| Measure |
Melatonin
n=37 Participants
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
n=39 Participants
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
|---|---|---|---|
|
Change in Sedation Between Genders
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Melatonin
n=37 Participants
A 5mg melatonin pill
Melatonin: Melatonin will be given to the patients 1 hour prior to their planned surgery.
|
Diazepam
n=39 Participants
A 5mg diazepam pill
Diazepam: Diazepam will be given to the patients 1 hour prior to their planned surgery.
|
Placebo
A 5mg vitamin B12 pill
Placebo: The placebo pill will be given to the patients 1 hour prior to their planned surgery.
|
|---|---|---|---|
|
Change in Orientation Between Genders
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
Adverse Events
Melatonin
Diazepam
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place